Clinical Endocrinology News

VANCOUVER, BRITISH COLUMBIA — Conditions like diabetes and dementia are common in patients who are admitted to long-term care facilities, but aggressive management of these conditions in long-term care residents is not recommended, according to a presentation given at the Family Medicine Forum (FMF) 2024.

Hospitalizations for hypoglycemia are risky for patients with diabetes who are residents of long-term care facilities, particularly those aged 75 years or older, said Adam Gurau, MD, a family physician in Toronto. Gurau completed a fellowship in care of the elderly at the University of Toronto, in Ontario, Canada.

“A lot of studies have shown diabetes-related hospitalizations,” said Gurau. He cited a 2014 study that found that hypoglycemia hospitalization rates were twice as high in older patients (age, 75 years or older) as in younger patients (age, 65-74 years).

“It is important to keep in mind that our residents in long-term care are at increasing risk for hypoglycemia, and we really should try to reduce [this risk] and not use dangerous medications or potentially dangerous [means of] diabetes management,” said Gurau.

A Canadian study that examined the composite risk for emergency department visits, hospitalizations, or death within 30 days of reaching intensive glycemic control with high-risk agents (such as insulin or sulfonylureas) suggested little benefit and possible harm in using these agents in adults aged 75 years or older.

In addition, current guidelines on diabetes management encourage a different approach. “Looking at some of the more recent North American guidelines, many of them actually now recommend relaxing glycemic targets to reduce overtreatment and prevent hypoglycemia,” said Gurau.

 

Deprescribing Medications

Medication reviews present opportunities for taking a global view of a patient’s treatments and determining whether any drug can be removed from the list. “What we want to do is optimize medications,” said Gurau. “We’re not talking about adding medications. We’re talking about removing medications, which is, I think, what we should be doing.”

Some research suggests that patients are open to deprescribing. One survey examined older adults (mean age, 79.1 years) with three or more chronic conditions who had been prescribed at least five medications. The researchers found that most participants (77%) were willing to deprescribe one or more medicines if a doctor advised that it was possible. “General practitioners may be able to increase deprescribing by building trust with their patients and communicating evidence about the risks of medication use,” the researchers wrote.

About 62% of seniors living in a residential care home have a diagnosis of Alzheimer’s disease or another dementia, according to the Alzheimer Society of Canada. Evidence suggests that nonpharmacologic approaches, such as massage and touch therapy and music, can manage neuropsychiatric symptoms, such as aggression and agitation, that are associated with dementia in older adults, noted Gurau.

“We want to focus on nonpharmacologic approaches for many of these [long-term care] residents,” said Gurau. “We have to do as much as we can to exhaust all the nonpharmacologic approaches.”

 

Preventing Hospitalizations

Another challenge to tackle in long-term care is the unnecessary transfer of residents to hospital emergency departments, according to Gurau. “In many situations, it’s worth trying as hard as we can to treat them in the nursing home, as opposed to having them go to hospital.”

Researchers estimated that 25% of the transfers from long-term care facilities in Canada to hospital emergency departments in 2014 were potentially preventable.

Urinary tract infections accounted for 30% of hospital emergency department visits for potentially preventable conditions by older patients who are residents in long-term care, according to 2013-2014 data from the Canadian Institute for Health Information.

“There are lots of downsides to going to the hospital [from long-term care],” Gurau told this news organization. “There are risks for infections, risks for increasing delirium and agitation [in patients with dementia], and risks for other behavior that can really impact somebody’s life.”

Gurau reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

VANCOUVER, BRITISH COLUMBIA — Conditions like diabetes and dementia are common in patients who are admitted to long-term care facilities, but aggressive management of these conditions in long-term care residents is not recommended, according to a presentation given at the Family Medicine Forum (FMF) 2024.

Hospitalizations for hypoglycemia are risky for patients with diabetes who are residents of long-term care facilities, particularly those aged 75 years or older, said Adam Gurau, MD, a family physician in Toronto. Gurau completed a fellowship in care of the elderly at the University of Toronto, in Ontario, Canada.

“A lot of studies have shown diabetes-related hospitalizations,” said Gurau. He cited a 2014 study that found that hypoglycemia hospitalization rates were twice as high in older patients (age, 75 years or older) as in younger patients (age, 65-74 years).

“It is important to keep in mind that our residents in long-term care are at increasing risk for hypoglycemia, and we really should try to reduce [this risk] and not use dangerous medications or potentially dangerous [means of] diabetes management,” said Gurau.

A Canadian study that examined the composite risk for emergency department visits, hospitalizations, or death within 30 days of reaching intensive glycemic control with high-risk agents (such as insulin or sulfonylureas) suggested little benefit and possible harm in using these agents in adults aged 75 years or older.

In addition, current guidelines on diabetes management encourage a different approach. “Looking at some of the more recent North American guidelines, many of them actually now recommend relaxing glycemic targets to reduce overtreatment and prevent hypoglycemia,” said Gurau.

 

Deprescribing Medications

Medication reviews present opportunities for taking a global view of a patient’s treatments and determining whether any drug can be removed from the list. “What we want to do is optimize medications,” said Gurau. “We’re not talking about adding medications. We’re talking about removing medications, which is, I think, what we should be doing.”

Some research suggests that patients are open to deprescribing. One survey examined older adults (mean age, 79.1 years) with three or more chronic conditions who had been prescribed at least five medications. The researchers found that most participants (77%) were willing to deprescribe one or more medicines if a doctor advised that it was possible. “General practitioners may be able to increase deprescribing by building trust with their patients and communicating evidence about the risks of medication use,” the researchers wrote.

About 62% of seniors living in a residential care home have a diagnosis of Alzheimer’s disease or another dementia, according to the Alzheimer Society of Canada. Evidence suggests that nonpharmacologic approaches, such as massage and touch therapy and music, can manage neuropsychiatric symptoms, such as aggression and agitation, that are associated with dementia in older adults, noted Gurau.

“We want to focus on nonpharmacologic approaches for many of these [long-term care] residents,” said Gurau. “We have to do as much as we can to exhaust all the nonpharmacologic approaches.”

 

Preventing Hospitalizations

Another challenge to tackle in long-term care is the unnecessary transfer of residents to hospital emergency departments, according to Gurau. “In many situations, it’s worth trying as hard as we can to treat them in the nursing home, as opposed to having them go to hospital.”

Researchers estimated that 25% of the transfers from long-term care facilities in Canada to hospital emergency departments in 2014 were potentially preventable.

Urinary tract infections accounted for 30% of hospital emergency department visits for potentially preventable conditions by older patients who are residents in long-term care, according to 2013-2014 data from the Canadian Institute for Health Information.

“There are lots of downsides to going to the hospital [from long-term care],” Gurau told this news organization. “There are risks for infections, risks for increasing delirium and agitation [in patients with dementia], and risks for other behavior that can really impact somebody’s life.”

Gurau reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

VANCOUVER, BRITISH COLUMBIA — Conditions like diabetes and dementia are common in patients who are admitted to long-term care facilities, but aggressive management of these conditions in long-term care residents is not recommended, according to a presentation given at the Family Medicine Forum (FMF) 2024.

Hospitalizations for hypoglycemia are risky for patients with diabetes who are residents of long-term care facilities, particularly those aged 75 years or older, said Adam Gurau, MD, a family physician in Toronto. Gurau completed a fellowship in care of the elderly at the University of Toronto, in Ontario, Canada.

“A lot of studies have shown diabetes-related hospitalizations,” said Gurau. He cited a 2014 study that found that hypoglycemia hospitalization rates were twice as high in older patients (age, 75 years or older) as in younger patients (age, 65-74 years).

“It is important to keep in mind that our residents in long-term care are at increasing risk for hypoglycemia, and we really should try to reduce [this risk] and not use dangerous medications or potentially dangerous [means of] diabetes management,” said Gurau.

A Canadian study that examined the composite risk for emergency department visits, hospitalizations, or death within 30 days of reaching intensive glycemic control with high-risk agents (such as insulin or sulfonylureas) suggested little benefit and possible harm in using these agents in adults aged 75 years or older.

In addition, current guidelines on diabetes management encourage a different approach. “Looking at some of the more recent North American guidelines, many of them actually now recommend relaxing glycemic targets to reduce overtreatment and prevent hypoglycemia,” said Gurau.

 

Deprescribing Medications

Medication reviews present opportunities for taking a global view of a patient’s treatments and determining whether any drug can be removed from the list. “What we want to do is optimize medications,” said Gurau. “We’re not talking about adding medications. We’re talking about removing medications, which is, I think, what we should be doing.”

Some research suggests that patients are open to deprescribing. One survey examined older adults (mean age, 79.1 years) with three or more chronic conditions who had been prescribed at least five medications. The researchers found that most participants (77%) were willing to deprescribe one or more medicines if a doctor advised that it was possible. “General practitioners may be able to increase deprescribing by building trust with their patients and communicating evidence about the risks of medication use,” the researchers wrote.

About 62% of seniors living in a residential care home have a diagnosis of Alzheimer’s disease or another dementia, according to the Alzheimer Society of Canada. Evidence suggests that nonpharmacologic approaches, such as massage and touch therapy and music, can manage neuropsychiatric symptoms, such as aggression and agitation, that are associated with dementia in older adults, noted Gurau.

“We want to focus on nonpharmacologic approaches for many of these [long-term care] residents,” said Gurau. “We have to do as much as we can to exhaust all the nonpharmacologic approaches.”

 

Preventing Hospitalizations

Another challenge to tackle in long-term care is the unnecessary transfer of residents to hospital emergency departments, according to Gurau. “In many situations, it’s worth trying as hard as we can to treat them in the nursing home, as opposed to having them go to hospital.”

Researchers estimated that 25% of the transfers from long-term care facilities in Canada to hospital emergency departments in 2014 were potentially preventable.

Urinary tract infections accounted for 30% of hospital emergency department visits for potentially preventable conditions by older patients who are residents in long-term care, according to 2013-2014 data from the Canadian Institute for Health Information.

“There are lots of downsides to going to the hospital [from long-term care],” Gurau told this news organization. “There are risks for infections, risks for increasing delirium and agitation [in patients with dementia], and risks for other behavior that can really impact somebody’s life.”

Gurau reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

Women with polycystic ovary syndrome (PCOS) have 26% higher nulliparity rates and give birth at more advanced ages despite similar family aspirations and higher rates of fertility treatment. Later PCOS diagnosis is associated with double the rate of advanced maternal age at childbirth.

METHODOLOGY:

• A prospective cohort study followed 14,247 Australian women from 1996 (age, 18-23 years) to 2021 (age, 43-48 years), comparing 981 women with self-reported PCOS against 13,266 without PCOS.
• Participants completed surveys approximately every 3 years, with data collection including childbirth events, fertility issues, and treatment history from 20 weeks of gestational age, including stillbirths.
• Analysis focused on comparing parity, maternal age at deliveries, and factors associated with advanced maternal age between groups, with adjustments made for education level, area of residence, marital status, body mass index group, hypertension, and type 2 diabetes.

TAKEAWAY:

• Compared with women without PCOS, those with PCOS had fewer births (1.9 ± 1.2 vs 1.7 ± 1.3; P < .001) and higher nulliparity rates (18% vs 23%; P = .003).
• PCOS was associated with increased odds of advanced maternal age at first childbirth (adjusted odds ratio [aOR], 1.34; 95% CI, 1.04-1.75) and higher rates of gestational diabetes (aOR, 3.90; 95% CI, 2.99-5.10).
• Late PCOS diagnosis was linked to increased odds of advanced maternal age at first childbirth (aOR, 1.98; 95% CI, 1.22-3.22), emphasizing the importance of early diagnosis.
• Compared with women without PCOS, those with PCOS were older at first childbirth (28.8 ± 5.5 vs 29.5 ± 5.5 years) and second childbirth (31.1 ± 5.0 vs 32.1 ± 5.2 years) (P < .001 for both).

IN PRACTICE:

“Women with PCOS have increased infertility and have higher rates of seeking and using ovulation induction and IVF than those without PCOS. Moreover, women with PCOS are older at both first and second childbirth, have longer interconception periods, are of advanced maternal age, and have higher nulliparity and lower fecundity compared with women without PCOS,” the authors of the study wrote.

SOURCE:

This study was led by Maria Forslund, MD, PhD, Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg in Sweden. It was published online in American Journal of Obstetrics & Gynecology.

LIMITATIONS:

This study relied on self-reported PCOS diagnosis, though these data were previously validated in the cohort. While dropouts from the study were common, a previous modeling study showed no serious bias in estimates of associations between risk factors and health outcomes in the longitudinal models.

DISCLOSURES:

Forslund received support from the Swedish Medical Society (SLS-984944; SLS986952). The study was funded by the Australian Government’s Department of Health and Aged Care. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

TOPLINE:

Women with polycystic ovary syndrome (PCOS) have 26% higher nulliparity rates and give birth at more advanced ages despite similar family aspirations and higher rates of fertility treatment. Later PCOS diagnosis is associated with double the rate of advanced maternal age at childbirth.

METHODOLOGY:

• A prospective cohort study followed 14,247 Australian women from 1996 (age, 18-23 years) to 2021 (age, 43-48 years), comparing 981 women with self-reported PCOS against 13,266 without PCOS.
• Participants completed surveys approximately every 3 years, with data collection including childbirth events, fertility issues, and treatment history from 20 weeks of gestational age, including stillbirths.
• Analysis focused on comparing parity, maternal age at deliveries, and factors associated with advanced maternal age between groups, with adjustments made for education level, area of residence, marital status, body mass index group, hypertension, and type 2 diabetes.

TAKEAWAY:

• Compared with women without PCOS, those with PCOS had fewer births (1.9 ± 1.2 vs 1.7 ± 1.3; P < .001) and higher nulliparity rates (18% vs 23%; P = .003).
• PCOS was associated with increased odds of advanced maternal age at first childbirth (adjusted odds ratio [aOR], 1.34; 95% CI, 1.04-1.75) and higher rates of gestational diabetes (aOR, 3.90; 95% CI, 2.99-5.10).
• Late PCOS diagnosis was linked to increased odds of advanced maternal age at first childbirth (aOR, 1.98; 95% CI, 1.22-3.22), emphasizing the importance of early diagnosis.
• Compared with women without PCOS, those with PCOS were older at first childbirth (28.8 ± 5.5 vs 29.5 ± 5.5 years) and second childbirth (31.1 ± 5.0 vs 32.1 ± 5.2 years) (P < .001 for both).

IN PRACTICE:

“Women with PCOS have increased infertility and have higher rates of seeking and using ovulation induction and IVF than those without PCOS. Moreover, women with PCOS are older at both first and second childbirth, have longer interconception periods, are of advanced maternal age, and have higher nulliparity and lower fecundity compared with women without PCOS,” the authors of the study wrote.

SOURCE:

This study was led by Maria Forslund, MD, PhD, Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg in Sweden. It was published online in American Journal of Obstetrics & Gynecology.

LIMITATIONS:

This study relied on self-reported PCOS diagnosis, though these data were previously validated in the cohort. While dropouts from the study were common, a previous modeling study showed no serious bias in estimates of associations between risk factors and health outcomes in the longitudinal models.

DISCLOSURES:

Forslund received support from the Swedish Medical Society (SLS-984944; SLS986952). The study was funded by the Australian Government’s Department of Health and Aged Care. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

TOPLINE:

Women with polycystic ovary syndrome (PCOS) have 26% higher nulliparity rates and give birth at more advanced ages despite similar family aspirations and higher rates of fertility treatment. Later PCOS diagnosis is associated with double the rate of advanced maternal age at childbirth.

METHODOLOGY:

• A prospective cohort study followed 14,247 Australian women from 1996 (age, 18-23 years) to 2021 (age, 43-48 years), comparing 981 women with self-reported PCOS against 13,266 without PCOS.
• Participants completed surveys approximately every 3 years, with data collection including childbirth events, fertility issues, and treatment history from 20 weeks of gestational age, including stillbirths.
• Analysis focused on comparing parity, maternal age at deliveries, and factors associated with advanced maternal age between groups, with adjustments made for education level, area of residence, marital status, body mass index group, hypertension, and type 2 diabetes.

TAKEAWAY:

• Compared with women without PCOS, those with PCOS had fewer births (1.9 ± 1.2 vs 1.7 ± 1.3; P < .001) and higher nulliparity rates (18% vs 23%; P = .003).
• PCOS was associated with increased odds of advanced maternal age at first childbirth (adjusted odds ratio [aOR], 1.34; 95% CI, 1.04-1.75) and higher rates of gestational diabetes (aOR, 3.90; 95% CI, 2.99-5.10).
• Late PCOS diagnosis was linked to increased odds of advanced maternal age at first childbirth (aOR, 1.98; 95% CI, 1.22-3.22), emphasizing the importance of early diagnosis.
• Compared with women without PCOS, those with PCOS were older at first childbirth (28.8 ± 5.5 vs 29.5 ± 5.5 years) and second childbirth (31.1 ± 5.0 vs 32.1 ± 5.2 years) (P < .001 for both).

IN PRACTICE:

“Women with PCOS have increased infertility and have higher rates of seeking and using ovulation induction and IVF than those without PCOS. Moreover, women with PCOS are older at both first and second childbirth, have longer interconception periods, are of advanced maternal age, and have higher nulliparity and lower fecundity compared with women without PCOS,” the authors of the study wrote.

SOURCE:

This study was led by Maria Forslund, MD, PhD, Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg in Sweden. It was published online in American Journal of Obstetrics & Gynecology.

LIMITATIONS:

This study relied on self-reported PCOS diagnosis, though these data were previously validated in the cohort. While dropouts from the study were common, a previous modeling study showed no serious bias in estimates of associations between risk factors and health outcomes in the longitudinal models.

DISCLOSURES:

Forslund received support from the Swedish Medical Society (SLS-984944; SLS986952). The study was funded by the Australian Government’s Department of Health and Aged Care. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

TOPLINE:

Supplementation with vitamin D and calcium can reduce systolic and diastolic blood pressure in older individuals with overweight, particularly in those with a body mass index (BMI) > 30 and those diagnosed with hypertension.

METHODOLOGY:

• Large cohort data have provided epidemiologic evidence linking vitamin D deficiency to a higher risk for cardiovascular disorders, including hypertension; however, evidence on the beneficial effects of vitamin D supplementation on blood pressure outcomes remains inconclusive.
• A post hoc analysis of a randomized controlled trial was conducted to investigate the effect of two doses of cholecalciferol (vitamin D3) on blood pressure in individuals aged 65 years or older with a BMI > 25 and serum vitamin D levels of 10-30 ng/mL.
• A total of 221 participants were recruited through outpatient departments, clinics, and advertisements in the greater Beirut area and received calcium supplementation in combination with either a low dose (600 IU/d, as recommended by the Institute of Medicine [IOM]) or a high dose (3750 IU/d) of vitamin D3.
• Blood pressure measurements were taken at baseline, 6 months, and 12 months using a SureSigns VS3 monitor.
• Participants were also stratified by BMI and hypertension status to assess the effects of vitamin D and calcium on blood pressure.

TAKEAWAY:

• Systolic and diastolic blood pressures were significantly reduced with vitamin D supplementation in the overall cohort (mean difference, 3.5 and 2.8 mm Hg, respectively; P = .005 and P = .002, respectively), with the effect more prominent in those in the high-dose vitamin D group.
• Participants with a BMI > 30 experienced reductions in both systolic and diastolic blood pressures in the overall cohort (P < .0001 and P = .01, respectively); although the systolic blood pressure was significantly reduced with both high- and low-dose vitamin D, the diastolic blood pressure decreased in the high-dose group only.
• Patients with hypertension benefited from all doses of vitamin D, regardless of the BMI.
• Systolic blood pressure at 6 and 12 months was significantly predicted by BMI and baseline systolic blood pressure measurements, although not by the dose of vitamin D received.

IN PRACTICE:

“Our study found vitamin D supplementation may decrease blood pressure in specific subgroups such as older people, people with obesity, and possibly those with low vitamin D levels,” said study author Ghada El-Hajj Fuleihan, MD, MPH, of the American University of Beirut Medical Center in Beirut, Lebanon, said in a news release. “High vitamin D doses compared to the IOM’s recommended daily dose did not provide additional health benefits.”

SOURCE:

This study was led by Maya Rahme, Department of Internal Medicine, Division of Endocrinology, Calcium Metabolism and Osteoporosis Program, World Health Organization Collaborating Center for Metabolic Bone Disorders, American University of Beirut Medical Center in Beirut, Lebanon. It was published online in Journal of the Endocrine Society.

LIMITATIONS:

This study’s limitations included the exploratory nature of the analyses and the low power of the subgroup analyses. Additionally, the study focused on older individuals who were sedentary and had overweight, many of whom had prediabetes — conditions known to influence blood pressure. The possible effect of calcium alone on blood pressure reduction was also unclear.

DISCLOSURES:

This study was supported by grants from the American University of Beirut, St Joseph University, and the Lebanese Council for National Scientific Research. No relevant conflicts of interest were disclosed by the authors.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

 

A version of this article appeared on Medscape.com.

TOPLINE:

Supplementation with vitamin D and calcium can reduce systolic and diastolic blood pressure in older individuals with overweight, particularly in those with a body mass index (BMI) > 30 and those diagnosed with hypertension.

METHODOLOGY:

• Large cohort data have provided epidemiologic evidence linking vitamin D deficiency to a higher risk for cardiovascular disorders, including hypertension; however, evidence on the beneficial effects of vitamin D supplementation on blood pressure outcomes remains inconclusive.
• A post hoc analysis of a randomized controlled trial was conducted to investigate the effect of two doses of cholecalciferol (vitamin D3) on blood pressure in individuals aged 65 years or older with a BMI > 25 and serum vitamin D levels of 10-30 ng/mL.
• A total of 221 participants were recruited through outpatient departments, clinics, and advertisements in the greater Beirut area and received calcium supplementation in combination with either a low dose (600 IU/d, as recommended by the Institute of Medicine [IOM]) or a high dose (3750 IU/d) of vitamin D3.
• Blood pressure measurements were taken at baseline, 6 months, and 12 months using a SureSigns VS3 monitor.
• Participants were also stratified by BMI and hypertension status to assess the effects of vitamin D and calcium on blood pressure.

TAKEAWAY:

• Systolic and diastolic blood pressures were significantly reduced with vitamin D supplementation in the overall cohort (mean difference, 3.5 and 2.8 mm Hg, respectively; P = .005 and P = .002, respectively), with the effect more prominent in those in the high-dose vitamin D group.
• Participants with a BMI > 30 experienced reductions in both systolic and diastolic blood pressures in the overall cohort (P < .0001 and P = .01, respectively); although the systolic blood pressure was significantly reduced with both high- and low-dose vitamin D, the diastolic blood pressure decreased in the high-dose group only.
• Patients with hypertension benefited from all doses of vitamin D, regardless of the BMI.
• Systolic blood pressure at 6 and 12 months was significantly predicted by BMI and baseline systolic blood pressure measurements, although not by the dose of vitamin D received.

IN PRACTICE:

“Our study found vitamin D supplementation may decrease blood pressure in specific subgroups such as older people, people with obesity, and possibly those with low vitamin D levels,” said study author Ghada El-Hajj Fuleihan, MD, MPH, of the American University of Beirut Medical Center in Beirut, Lebanon, said in a news release. “High vitamin D doses compared to the IOM’s recommended daily dose did not provide additional health benefits.”

SOURCE:

This study was led by Maya Rahme, Department of Internal Medicine, Division of Endocrinology, Calcium Metabolism and Osteoporosis Program, World Health Organization Collaborating Center for Metabolic Bone Disorders, American University of Beirut Medical Center in Beirut, Lebanon. It was published online in Journal of the Endocrine Society.

LIMITATIONS:

This study’s limitations included the exploratory nature of the analyses and the low power of the subgroup analyses. Additionally, the study focused on older individuals who were sedentary and had overweight, many of whom had prediabetes — conditions known to influence blood pressure. The possible effect of calcium alone on blood pressure reduction was also unclear.

DISCLOSURES:

This study was supported by grants from the American University of Beirut, St Joseph University, and the Lebanese Council for National Scientific Research. No relevant conflicts of interest were disclosed by the authors.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

 

A version of this article appeared on Medscape.com.

TOPLINE:

Supplementation with vitamin D and calcium can reduce systolic and diastolic blood pressure in older individuals with overweight, particularly in those with a body mass index (BMI) > 30 and those diagnosed with hypertension.

METHODOLOGY:

• Large cohort data have provided epidemiologic evidence linking vitamin D deficiency to a higher risk for cardiovascular disorders, including hypertension; however, evidence on the beneficial effects of vitamin D supplementation on blood pressure outcomes remains inconclusive.
• A post hoc analysis of a randomized controlled trial was conducted to investigate the effect of two doses of cholecalciferol (vitamin D3) on blood pressure in individuals aged 65 years or older with a BMI > 25 and serum vitamin D levels of 10-30 ng/mL.
• A total of 221 participants were recruited through outpatient departments, clinics, and advertisements in the greater Beirut area and received calcium supplementation in combination with either a low dose (600 IU/d, as recommended by the Institute of Medicine [IOM]) or a high dose (3750 IU/d) of vitamin D3.
• Blood pressure measurements were taken at baseline, 6 months, and 12 months using a SureSigns VS3 monitor.
• Participants were also stratified by BMI and hypertension status to assess the effects of vitamin D and calcium on blood pressure.

TAKEAWAY:

• Systolic and diastolic blood pressures were significantly reduced with vitamin D supplementation in the overall cohort (mean difference, 3.5 and 2.8 mm Hg, respectively; P = .005 and P = .002, respectively), with the effect more prominent in those in the high-dose vitamin D group.
• Participants with a BMI > 30 experienced reductions in both systolic and diastolic blood pressures in the overall cohort (P < .0001 and P = .01, respectively); although the systolic blood pressure was significantly reduced with both high- and low-dose vitamin D, the diastolic blood pressure decreased in the high-dose group only.
• Patients with hypertension benefited from all doses of vitamin D, regardless of the BMI.
• Systolic blood pressure at 6 and 12 months was significantly predicted by BMI and baseline systolic blood pressure measurements, although not by the dose of vitamin D received.

IN PRACTICE:

“Our study found vitamin D supplementation may decrease blood pressure in specific subgroups such as older people, people with obesity, and possibly those with low vitamin D levels,” said study author Ghada El-Hajj Fuleihan, MD, MPH, of the American University of Beirut Medical Center in Beirut, Lebanon, said in a news release. “High vitamin D doses compared to the IOM’s recommended daily dose did not provide additional health benefits.”

SOURCE:

This study was led by Maya Rahme, Department of Internal Medicine, Division of Endocrinology, Calcium Metabolism and Osteoporosis Program, World Health Organization Collaborating Center for Metabolic Bone Disorders, American University of Beirut Medical Center in Beirut, Lebanon. It was published online in Journal of the Endocrine Society.

LIMITATIONS:

This study’s limitations included the exploratory nature of the analyses and the low power of the subgroup analyses. Additionally, the study focused on older individuals who were sedentary and had overweight, many of whom had prediabetes — conditions known to influence blood pressure. The possible effect of calcium alone on blood pressure reduction was also unclear.

DISCLOSURES:

This study was supported by grants from the American University of Beirut, St Joseph University, and the Lebanese Council for National Scientific Research. No relevant conflicts of interest were disclosed by the authors.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

 

A version of this article appeared on Medscape.com.

SAN ANTONIO — Weight loss treatments aren’t reaching many of the people who need them most because of coverage barriers, new data suggested.

Findings from three studies presented at The Obesity Society’s Obesity Week 2024 meeting illustrate different aspects of the problem.

One, presented by Alissa S. Chen, MD, MPH, a postdoctoral fellow at Yale University, New Haven, Connecticut, found that people with obesity, particularly those with cardiovascular disease (CVD) and those who are Black and Hispanic, have high rates of cost-related prescription drug rationing. Those findings were simultaneously published as a research letter in JAMA Network Open.

“The implications are that structural barriers impede access to medications for Black and Hispanic adults with obesity, which might worsen if there’s not expanding coverage for GLP-1 RAs [glucagon-like peptide 1 receptor agonists], and it’s possible that broader insurance coverage could ameliorate some of these issues,” Chen said.

She noted that patients don’t always volunteer that information. “In my clinical practice, I always start by saying something like, ‘I have a lot of patients who can’t afford their medications. In the last week, was there a time [you didn’t take your medications due to cost]?’ ”

State Medicaid programs vary widely in the degree to which they cover weight loss treatments. But not a single one covers all modalities — nutrition counseling (NC), intensive behavioral therapy (IBT), obesity medications (OMs), and metabolic and bariatric surgery (MBS) — without restrictions or limitations, and only seven states cover them all with restrictions, according to a dual presentation by Christine Gallagher, MPAff, associate director for research and policy with the STOP Obesity Alliance at George Washington University, Washington, DC, and Tracy Zvenyach, PhD, MS, RN, director of policy strategy and alliances at the Obesity Action Coalition, also in Washington, DC.

Detailed Medicaid coverage data for each state are posted on the STOP Obesity Alliance website. (As of now, Medicare doesn’t cover medications specifically for obesity at all.)

A third presentation, by Treah Haggerty, MD, of the Department of Family Medicine and director of the Pediatric Medical Weight Management program at West Virginia University, Morgantown, was of a qualitative descriptive study exploring the impact on 22 individuals enrolled in a medical weight loss management program whose state employee insurance carrier made a policy decision to stop covering all anti-OMs in March 2024. All had been prescribed GLP-1 agonists for weight loss, and the decision forced most to stop using them.

Those findings were published in the September 2024 issue of Obesity Pillars.

“Patients perceive the discontinuation of anti-obesity medication coverage as stigmatizing and unjust, leading to feelings of hopelessness and fear. With more insurance companies denying coverage for these costly medications, more information is needed to identify best ways to address the loss of coverage with patients. Clinical management of these patients should incorporate evidence-based obesity treatments while navigating insurance constraints,” Haggerty said.

 

Create a Safe Space to Discuss the Barriers

Asked to comment, Session Moderator John D. Clark, MD, PhD, chief population health officer at Sharp Rees-Stealy Medical Group, San Diego, California, told Medscape Medical News, “Health systems and payers are determining what can and can’t be covered, and at the end of the day, it frequently comes down to finances…I think the big challenge is really identifying patients who may have the greatest need. ... If we have limited resources, how and where should we be directing those resources? I would say the current system hasn’t really answered that question or identified patients for whom we would say that the cost truly is less than either the financial or long-term health benefits.”

But Clark said, “When some of these newer anti-obesity medications are able to go generic and be less expensive, which will happen eventually, I think things will change ... and in the future, there will be more options on the market as well.”

In the meantime, he advised that clinicians “try to have conversations with patients about these barriers, acknowledge that these barriers exist, and create a safe space to discuss those barriers. ... Let’s see where we are right now, and let’s come up with a plan.”

 

People With Obesity More Susceptible to Drug Rationing

Chen reported on a sample of 51,720 adults who participated in the 2020-2022 National Health Interview Survey who did not have diabetes and who used at least one prescription medication of any type. Of those, 80% were White, 9.7% were Hispanic, and 9.7% were Black, and 33.9% overall had obesity.

Cost-related prescription rationing, defined as any self-reported skipping, taking less, or delaying filling a prescription to save money, was reported by 8.3% of those with obesity vs 5.9% without. After adjustment, rationing among those with obesity was significantly associated with younger age (aged 18-44 years), female sex, lower incomes, lack of health insurance coverage, and CVD.

The adjusted estimated probability of cost-related prescription drug rationing was 7.4% for those with CVD vs 4.4% for those without. By race/ethnicity, the proportions reporting rationing were 7.7%, 9.8%, and 10.7% for White, Black, and Hispanics, respectively.

“Given that few insurance providers cover GLP-1 RAs for obesity, cost-related prescription drug rationing could be exacerbated if patients were prescribed GLP-1 RAs at their current price of more than $1000 a month,” Chen noted, adding that the high prices could worsen health disparities among Black and Hispanic individuals with obesity.

 

Medicaid Coverage Lacking for All Obesity Treatments

For their project, Gallagher and Zvenyach delved into a database that aggregates Medicaid manuals, fee schedules, statutes, regulations, and preferred drug lists for each US state, both for Medicaid fee for service and top Medicaid managed care plans, in order to determine 2024 levels of coverage for NC, IBT, OMs, and MBS for adults with obesity.

No state provides coverage for all those treatments without either limitations — such as body mass index (BMI) cutoffs, age, or “comorbidity regardless of body mass index (BMI)” for OM and MBS — or outright restrictions, such as “proof of failed attempts.” And only seven states provide coverage for the four modalities “with limitations”: California, Arizona, New Mexico, South Carolina, Delaware, Rhode Island, and Massachusetts.

Twenty-two states don’t cover NC, although just one state doesn’t cover IBT. Overall, 37 states don’t cover OMs, and other states ranged considerably in various restrictions and limitations for OMs and MBS. Only four states fully covered the surgery without limitations or restrictions.

“The vast majority of states have significant barriers and conditions of coverage for obesity care,” Gallagher said.

Zvenyach added, “Most of the applied exclusions, limitations, or restrictions do not align with evidence-based practice standards or guidelines.”

 

When Coverage Stops, Hopelessness and Anger Emerge

Haggerty and colleagues’ research involved semi-structured interviews of the 22 participants — all of them women — who had lost their obesity medication coverage due to their insurers’ decision. Four themes emerged:

• 1. Feelings of hope replaced by hopelessness upon loss of medication coverage: One person said, “I’m afraid for my mental health. It’s tough to be in a situation where you’re never right. And it doesn’t matter what you do; it’s not going to work, and then to have just a glimmer of hope, a little spark of hey, look, this might help. And for someone else to take that away from you for no reason. I don’t know what am I supposed to do.”
• 2. Anger regarding the perceived injustice of anti-obesity medication coverage termination: For example, “They can pay for heart attacks, they could pay for me to have a stroke, they could pay for me to have diabetes, but they won’t let me have this one medicine that could take all of that away. Makes no sense.”
• 3. Perceptions of past and present stigma within the healthcare system and insurance company: “I’m not trying for vanity. I’m way too old to be a Victoria’s Secret model. I’m not trying to do it to be cute and skinny and hot. I just want to make it through a day of work and not be exhausted.”
• 4. Generational influences on obesity treatment: “I’m married, and my husband, since I’ve started this medicine, he’s been eating better. He’s been eating what I eat, and he’s been losing weight as well.”
• Some participants said they planned to cope in different ways, including trying to obtain compounded versions of the drugs from “spas” or online pharmacies, as well as skipping doses, reducing doses, or sharing medications — in other words, rationing.

Asked by this news organization what clinicians should keep in mind, Haggerty said, “that there are big barriers and that we need to take care of the patients within this system that has their arm tied behind their back.

Chen was funded by a grant from the National Institute on Aging outside the submitted work, and she was funded as a Yale National Clinician Scholar. A coauthor received grants from the Food and Drug Administration, Johnson & Johnson, the National Institutes of Health, the Agency for Healthcare Research and Quality, and Arnold Ventures. Another coauthor reported receiving personal fees from UpToDate and the Centers for Medicare & Medicaid Services. Gallagher has received research funding from Altimmune, Amgen, Boehringer Ingelheim, Currax, Eli Lilly and Company, Found, Novo Nordisk, Pfizer, Structure Therapeutics, and WeightWatchers. Haggerty reported article publishing charge was provided by West Virginia Alliance for Creative Health Solutions. Zvenyach and Clark had no disclosures.

A version of this article first appeared on Medscape.com.

SAN ANTONIO — Weight loss treatments aren’t reaching many of the people who need them most because of coverage barriers, new data suggested.

Findings from three studies presented at The Obesity Society’s Obesity Week 2024 meeting illustrate different aspects of the problem.

One, presented by Alissa S. Chen, MD, MPH, a postdoctoral fellow at Yale University, New Haven, Connecticut, found that people with obesity, particularly those with cardiovascular disease (CVD) and those who are Black and Hispanic, have high rates of cost-related prescription drug rationing. Those findings were simultaneously published as a research letter in JAMA Network Open.

“The implications are that structural barriers impede access to medications for Black and Hispanic adults with obesity, which might worsen if there’s not expanding coverage for GLP-1 RAs [glucagon-like peptide 1 receptor agonists], and it’s possible that broader insurance coverage could ameliorate some of these issues,” Chen said.

She noted that patients don’t always volunteer that information. “In my clinical practice, I always start by saying something like, ‘I have a lot of patients who can’t afford their medications. In the last week, was there a time [you didn’t take your medications due to cost]?’ ”

State Medicaid programs vary widely in the degree to which they cover weight loss treatments. But not a single one covers all modalities — nutrition counseling (NC), intensive behavioral therapy (IBT), obesity medications (OMs), and metabolic and bariatric surgery (MBS) — without restrictions or limitations, and only seven states cover them all with restrictions, according to a dual presentation by Christine Gallagher, MPAff, associate director for research and policy with the STOP Obesity Alliance at George Washington University, Washington, DC, and Tracy Zvenyach, PhD, MS, RN, director of policy strategy and alliances at the Obesity Action Coalition, also in Washington, DC.

Detailed Medicaid coverage data for each state are posted on the STOP Obesity Alliance website. (As of now, Medicare doesn’t cover medications specifically for obesity at all.)

A third presentation, by Treah Haggerty, MD, of the Department of Family Medicine and director of the Pediatric Medical Weight Management program at West Virginia University, Morgantown, was of a qualitative descriptive study exploring the impact on 22 individuals enrolled in a medical weight loss management program whose state employee insurance carrier made a policy decision to stop covering all anti-OMs in March 2024. All had been prescribed GLP-1 agonists for weight loss, and the decision forced most to stop using them.

Those findings were published in the September 2024 issue of Obesity Pillars.

“Patients perceive the discontinuation of anti-obesity medication coverage as stigmatizing and unjust, leading to feelings of hopelessness and fear. With more insurance companies denying coverage for these costly medications, more information is needed to identify best ways to address the loss of coverage with patients. Clinical management of these patients should incorporate evidence-based obesity treatments while navigating insurance constraints,” Haggerty said.

 

Create a Safe Space to Discuss the Barriers

Asked to comment, Session Moderator John D. Clark, MD, PhD, chief population health officer at Sharp Rees-Stealy Medical Group, San Diego, California, told Medscape Medical News, “Health systems and payers are determining what can and can’t be covered, and at the end of the day, it frequently comes down to finances…I think the big challenge is really identifying patients who may have the greatest need. ... If we have limited resources, how and where should we be directing those resources? I would say the current system hasn’t really answered that question or identified patients for whom we would say that the cost truly is less than either the financial or long-term health benefits.”

But Clark said, “When some of these newer anti-obesity medications are able to go generic and be less expensive, which will happen eventually, I think things will change ... and in the future, there will be more options on the market as well.”

In the meantime, he advised that clinicians “try to have conversations with patients about these barriers, acknowledge that these barriers exist, and create a safe space to discuss those barriers. ... Let’s see where we are right now, and let’s come up with a plan.”

 

People With Obesity More Susceptible to Drug Rationing

Chen reported on a sample of 51,720 adults who participated in the 2020-2022 National Health Interview Survey who did not have diabetes and who used at least one prescription medication of any type. Of those, 80% were White, 9.7% were Hispanic, and 9.7% were Black, and 33.9% overall had obesity.

Cost-related prescription rationing, defined as any self-reported skipping, taking less, or delaying filling a prescription to save money, was reported by 8.3% of those with obesity vs 5.9% without. After adjustment, rationing among those with obesity was significantly associated with younger age (aged 18-44 years), female sex, lower incomes, lack of health insurance coverage, and CVD.

The adjusted estimated probability of cost-related prescription drug rationing was 7.4% for those with CVD vs 4.4% for those without. By race/ethnicity, the proportions reporting rationing were 7.7%, 9.8%, and 10.7% for White, Black, and Hispanics, respectively.

“Given that few insurance providers cover GLP-1 RAs for obesity, cost-related prescription drug rationing could be exacerbated if patients were prescribed GLP-1 RAs at their current price of more than $1000 a month,” Chen noted, adding that the high prices could worsen health disparities among Black and Hispanic individuals with obesity.

 

Medicaid Coverage Lacking for All Obesity Treatments

For their project, Gallagher and Zvenyach delved into a database that aggregates Medicaid manuals, fee schedules, statutes, regulations, and preferred drug lists for each US state, both for Medicaid fee for service and top Medicaid managed care plans, in order to determine 2024 levels of coverage for NC, IBT, OMs, and MBS for adults with obesity.

No state provides coverage for all those treatments without either limitations — such as body mass index (BMI) cutoffs, age, or “comorbidity regardless of body mass index (BMI)” for OM and MBS — or outright restrictions, such as “proof of failed attempts.” And only seven states provide coverage for the four modalities “with limitations”: California, Arizona, New Mexico, South Carolina, Delaware, Rhode Island, and Massachusetts.

Twenty-two states don’t cover NC, although just one state doesn’t cover IBT. Overall, 37 states don’t cover OMs, and other states ranged considerably in various restrictions and limitations for OMs and MBS. Only four states fully covered the surgery without limitations or restrictions.

“The vast majority of states have significant barriers and conditions of coverage for obesity care,” Gallagher said.

Zvenyach added, “Most of the applied exclusions, limitations, or restrictions do not align with evidence-based practice standards or guidelines.”

 

When Coverage Stops, Hopelessness and Anger Emerge

Haggerty and colleagues’ research involved semi-structured interviews of the 22 participants — all of them women — who had lost their obesity medication coverage due to their insurers’ decision. Four themes emerged:

• 1. Feelings of hope replaced by hopelessness upon loss of medication coverage: One person said, “I’m afraid for my mental health. It’s tough to be in a situation where you’re never right. And it doesn’t matter what you do; it’s not going to work, and then to have just a glimmer of hope, a little spark of hey, look, this might help. And for someone else to take that away from you for no reason. I don’t know what am I supposed to do.”
• 2. Anger regarding the perceived injustice of anti-obesity medication coverage termination: For example, “They can pay for heart attacks, they could pay for me to have a stroke, they could pay for me to have diabetes, but they won’t let me have this one medicine that could take all of that away. Makes no sense.”
• 3. Perceptions of past and present stigma within the healthcare system and insurance company: “I’m not trying for vanity. I’m way too old to be a Victoria’s Secret model. I’m not trying to do it to be cute and skinny and hot. I just want to make it through a day of work and not be exhausted.”
• 4. Generational influences on obesity treatment: “I’m married, and my husband, since I’ve started this medicine, he’s been eating better. He’s been eating what I eat, and he’s been losing weight as well.”
• Some participants said they planned to cope in different ways, including trying to obtain compounded versions of the drugs from “spas” or online pharmacies, as well as skipping doses, reducing doses, or sharing medications — in other words, rationing.

Asked by this news organization what clinicians should keep in mind, Haggerty said, “that there are big barriers and that we need to take care of the patients within this system that has their arm tied behind their back.

Chen was funded by a grant from the National Institute on Aging outside the submitted work, and she was funded as a Yale National Clinician Scholar. A coauthor received grants from the Food and Drug Administration, Johnson & Johnson, the National Institutes of Health, the Agency for Healthcare Research and Quality, and Arnold Ventures. Another coauthor reported receiving personal fees from UpToDate and the Centers for Medicare & Medicaid Services. Gallagher has received research funding from Altimmune, Amgen, Boehringer Ingelheim, Currax, Eli Lilly and Company, Found, Novo Nordisk, Pfizer, Structure Therapeutics, and WeightWatchers. Haggerty reported article publishing charge was provided by West Virginia Alliance for Creative Health Solutions. Zvenyach and Clark had no disclosures.

A version of this article first appeared on Medscape.com.

SAN ANTONIO — Weight loss treatments aren’t reaching many of the people who need them most because of coverage barriers, new data suggested.

Findings from three studies presented at The Obesity Society’s Obesity Week 2024 meeting illustrate different aspects of the problem.

One, presented by Alissa S. Chen, MD, MPH, a postdoctoral fellow at Yale University, New Haven, Connecticut, found that people with obesity, particularly those with cardiovascular disease (CVD) and those who are Black and Hispanic, have high rates of cost-related prescription drug rationing. Those findings were simultaneously published as a research letter in JAMA Network Open.

“The implications are that structural barriers impede access to medications for Black and Hispanic adults with obesity, which might worsen if there’s not expanding coverage for GLP-1 RAs [glucagon-like peptide 1 receptor agonists], and it’s possible that broader insurance coverage could ameliorate some of these issues,” Chen said.

She noted that patients don’t always volunteer that information. “In my clinical practice, I always start by saying something like, ‘I have a lot of patients who can’t afford their medications. In the last week, was there a time [you didn’t take your medications due to cost]?’ ”

State Medicaid programs vary widely in the degree to which they cover weight loss treatments. But not a single one covers all modalities — nutrition counseling (NC), intensive behavioral therapy (IBT), obesity medications (OMs), and metabolic and bariatric surgery (MBS) — without restrictions or limitations, and only seven states cover them all with restrictions, according to a dual presentation by Christine Gallagher, MPAff, associate director for research and policy with the STOP Obesity Alliance at George Washington University, Washington, DC, and Tracy Zvenyach, PhD, MS, RN, director of policy strategy and alliances at the Obesity Action Coalition, also in Washington, DC.

Detailed Medicaid coverage data for each state are posted on the STOP Obesity Alliance website. (As of now, Medicare doesn’t cover medications specifically for obesity at all.)

A third presentation, by Treah Haggerty, MD, of the Department of Family Medicine and director of the Pediatric Medical Weight Management program at West Virginia University, Morgantown, was of a qualitative descriptive study exploring the impact on 22 individuals enrolled in a medical weight loss management program whose state employee insurance carrier made a policy decision to stop covering all anti-OMs in March 2024. All had been prescribed GLP-1 agonists for weight loss, and the decision forced most to stop using them.

Those findings were published in the September 2024 issue of Obesity Pillars.

“Patients perceive the discontinuation of anti-obesity medication coverage as stigmatizing and unjust, leading to feelings of hopelessness and fear. With more insurance companies denying coverage for these costly medications, more information is needed to identify best ways to address the loss of coverage with patients. Clinical management of these patients should incorporate evidence-based obesity treatments while navigating insurance constraints,” Haggerty said.

 

Create a Safe Space to Discuss the Barriers

Asked to comment, Session Moderator John D. Clark, MD, PhD, chief population health officer at Sharp Rees-Stealy Medical Group, San Diego, California, told Medscape Medical News, “Health systems and payers are determining what can and can’t be covered, and at the end of the day, it frequently comes down to finances…I think the big challenge is really identifying patients who may have the greatest need. ... If we have limited resources, how and where should we be directing those resources? I would say the current system hasn’t really answered that question or identified patients for whom we would say that the cost truly is less than either the financial or long-term health benefits.”

But Clark said, “When some of these newer anti-obesity medications are able to go generic and be less expensive, which will happen eventually, I think things will change ... and in the future, there will be more options on the market as well.”

In the meantime, he advised that clinicians “try to have conversations with patients about these barriers, acknowledge that these barriers exist, and create a safe space to discuss those barriers. ... Let’s see where we are right now, and let’s come up with a plan.”

 

People With Obesity More Susceptible to Drug Rationing

Chen reported on a sample of 51,720 adults who participated in the 2020-2022 National Health Interview Survey who did not have diabetes and who used at least one prescription medication of any type. Of those, 80% were White, 9.7% were Hispanic, and 9.7% were Black, and 33.9% overall had obesity.

Cost-related prescription rationing, defined as any self-reported skipping, taking less, or delaying filling a prescription to save money, was reported by 8.3% of those with obesity vs 5.9% without. After adjustment, rationing among those with obesity was significantly associated with younger age (aged 18-44 years), female sex, lower incomes, lack of health insurance coverage, and CVD.

The adjusted estimated probability of cost-related prescription drug rationing was 7.4% for those with CVD vs 4.4% for those without. By race/ethnicity, the proportions reporting rationing were 7.7%, 9.8%, and 10.7% for White, Black, and Hispanics, respectively.

“Given that few insurance providers cover GLP-1 RAs for obesity, cost-related prescription drug rationing could be exacerbated if patients were prescribed GLP-1 RAs at their current price of more than $1000 a month,” Chen noted, adding that the high prices could worsen health disparities among Black and Hispanic individuals with obesity.

 

Medicaid Coverage Lacking for All Obesity Treatments

For their project, Gallagher and Zvenyach delved into a database that aggregates Medicaid manuals, fee schedules, statutes, regulations, and preferred drug lists for each US state, both for Medicaid fee for service and top Medicaid managed care plans, in order to determine 2024 levels of coverage for NC, IBT, OMs, and MBS for adults with obesity.

No state provides coverage for all those treatments without either limitations — such as body mass index (BMI) cutoffs, age, or “comorbidity regardless of body mass index (BMI)” for OM and MBS — or outright restrictions, such as “proof of failed attempts.” And only seven states provide coverage for the four modalities “with limitations”: California, Arizona, New Mexico, South Carolina, Delaware, Rhode Island, and Massachusetts.

Twenty-two states don’t cover NC, although just one state doesn’t cover IBT. Overall, 37 states don’t cover OMs, and other states ranged considerably in various restrictions and limitations for OMs and MBS. Only four states fully covered the surgery without limitations or restrictions.

“The vast majority of states have significant barriers and conditions of coverage for obesity care,” Gallagher said.

Zvenyach added, “Most of the applied exclusions, limitations, or restrictions do not align with evidence-based practice standards or guidelines.”

 

When Coverage Stops, Hopelessness and Anger Emerge

Haggerty and colleagues’ research involved semi-structured interviews of the 22 participants — all of them women — who had lost their obesity medication coverage due to their insurers’ decision. Four themes emerged:

• 1. Feelings of hope replaced by hopelessness upon loss of medication coverage: One person said, “I’m afraid for my mental health. It’s tough to be in a situation where you’re never right. And it doesn’t matter what you do; it’s not going to work, and then to have just a glimmer of hope, a little spark of hey, look, this might help. And for someone else to take that away from you for no reason. I don’t know what am I supposed to do.”
• 2. Anger regarding the perceived injustice of anti-obesity medication coverage termination: For example, “They can pay for heart attacks, they could pay for me to have a stroke, they could pay for me to have diabetes, but they won’t let me have this one medicine that could take all of that away. Makes no sense.”
• 3. Perceptions of past and present stigma within the healthcare system and insurance company: “I’m not trying for vanity. I’m way too old to be a Victoria’s Secret model. I’m not trying to do it to be cute and skinny and hot. I just want to make it through a day of work and not be exhausted.”
• 4. Generational influences on obesity treatment: “I’m married, and my husband, since I’ve started this medicine, he’s been eating better. He’s been eating what I eat, and he’s been losing weight as well.”
• Some participants said they planned to cope in different ways, including trying to obtain compounded versions of the drugs from “spas” or online pharmacies, as well as skipping doses, reducing doses, or sharing medications — in other words, rationing.

Asked by this news organization what clinicians should keep in mind, Haggerty said, “that there are big barriers and that we need to take care of the patients within this system that has their arm tied behind their back.

Chen was funded by a grant from the National Institute on Aging outside the submitted work, and she was funded as a Yale National Clinician Scholar. A coauthor received grants from the Food and Drug Administration, Johnson & Johnson, the National Institutes of Health, the Agency for Healthcare Research and Quality, and Arnold Ventures. Another coauthor reported receiving personal fees from UpToDate and the Centers for Medicare & Medicaid Services. Gallagher has received research funding from Altimmune, Amgen, Boehringer Ingelheim, Currax, Eli Lilly and Company, Found, Novo Nordisk, Pfizer, Structure Therapeutics, and WeightWatchers. Haggerty reported article publishing charge was provided by West Virginia Alliance for Creative Health Solutions. Zvenyach and Clark had no disclosures.

A version of this article first appeared on Medscape.com.

TOPLINE:

Long-term treatment with TransCon parathyroid hormone (PTH), a replacement therapy for hypoparathyroidism, demonstrates sustained efficacy and safety in patients with hypoparathyroidism over 52 weeks, with 95% of participants able to discontinue conventional therapy.

METHODOLOGY:

• Conventional therapy for hypoparathyroidism (active vitamin D and elemental calcium) alleviates symptoms of hypocalcemia, but it does not improve insufficient PTH levels and is linked to long-term complications, such as nephrocalcinosis, nephrolithiasis, and renal dysfunction.
• This phase 3 (PaTHway) trial aimed to investigate the long-term efficacy, safety, and tolerability of TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism.
• Overall, 82 patients with chronic hypoparathyroidism (mean age, 48.6 years; 78% women; 93% White) were randomly assigned to receive TransCon PTH or placebo, both coadministered with conventional therapy for 26 weeks.
• At the 26-week visit, patients who completed the blinded treatment (n = 79) were assigned to receive only TransCon PTH with conventional therapy in an ongoing 156-week open-label extension.
• For this analysis at week 52, the main efficacy endpoint was the proportion of patients (n = 78) with normal serum calcium levels (8.3-10.6 mg/dL) and independence from conventional therapy (active vitamin D and therapeutic doses of calcium); safety assessments included serum chemistries, 24-hour urine calcium excretion, and treatment-emergent adverse events.

TAKEAWAY:

• At week 52, the majority of the patients receiving TransCon PTH achieved normal serum calcium levels within the normal range (86%) and independence from conventional therapy (95%). None required active vitamin D.
• In secondary endpoints, patients receiving TransCon PTH showed sustained improvement in Hypoparathyroidism Patient Experience Scale scores, reflecting better symptom management, enhanced functioning, and overall well-being through week 52.
• At week 52, the mean 24-hour urine calcium excretion in patients first randomized to TransCon PTH was 185.1 mg/d, remaining well below the upper limit of normal (≤ 250 mg/d), while the placebo group mean fell to 223.1 mg/d during the open-label extension of TransCon PTH.
• TransCon PTH was well-tolerated, with most treatment-emergent adverse events being mild or moderate and none leading to treatment discontinuation.

IN PRACTICE:

“These results suggest that TransCon PTH may improve outcomes and advance the standard of care for adults living with hypoparathyroidism,” the authors wrote.

SOURCE:

The study was led by Bart L. Clarke, MD, Mayo Clinic, Rochester, Minnesota. It was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study’s limitations included the open-label design during the extension period, which may have introduced bias in patient-reported outcomes. Additionally, the study population was predominantly women and White, which may have limited the generalizability of the findings. Further research is needed to assess the long-term effects of TransCon PTH on renal complications. One patient died of fatal cardiac arrest deemed unrelated to the study drug.

DISCLOSURES:

The study was funded by Ascendis Pharma A/S. Seven authors declared being current or former employees of Ascendis Pharma. The other authors declared receiving grants, research funding, honoraria, serving as consultants, advisory board members, study investigators, and other ties with Ascendis Pharma and multiple other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Long-term treatment with TransCon parathyroid hormone (PTH), a replacement therapy for hypoparathyroidism, demonstrates sustained efficacy and safety in patients with hypoparathyroidism over 52 weeks, with 95% of participants able to discontinue conventional therapy.

METHODOLOGY:

• Conventional therapy for hypoparathyroidism (active vitamin D and elemental calcium) alleviates symptoms of hypocalcemia, but it does not improve insufficient PTH levels and is linked to long-term complications, such as nephrocalcinosis, nephrolithiasis, and renal dysfunction.
• This phase 3 (PaTHway) trial aimed to investigate the long-term efficacy, safety, and tolerability of TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism.
• Overall, 82 patients with chronic hypoparathyroidism (mean age, 48.6 years; 78% women; 93% White) were randomly assigned to receive TransCon PTH or placebo, both coadministered with conventional therapy for 26 weeks.
• At the 26-week visit, patients who completed the blinded treatment (n = 79) were assigned to receive only TransCon PTH with conventional therapy in an ongoing 156-week open-label extension.
• For this analysis at week 52, the main efficacy endpoint was the proportion of patients (n = 78) with normal serum calcium levels (8.3-10.6 mg/dL) and independence from conventional therapy (active vitamin D and therapeutic doses of calcium); safety assessments included serum chemistries, 24-hour urine calcium excretion, and treatment-emergent adverse events.

TAKEAWAY:

• At week 52, the majority of the patients receiving TransCon PTH achieved normal serum calcium levels within the normal range (86%) and independence from conventional therapy (95%). None required active vitamin D.
• In secondary endpoints, patients receiving TransCon PTH showed sustained improvement in Hypoparathyroidism Patient Experience Scale scores, reflecting better symptom management, enhanced functioning, and overall well-being through week 52.
• At week 52, the mean 24-hour urine calcium excretion in patients first randomized to TransCon PTH was 185.1 mg/d, remaining well below the upper limit of normal (≤ 250 mg/d), while the placebo group mean fell to 223.1 mg/d during the open-label extension of TransCon PTH.
• TransCon PTH was well-tolerated, with most treatment-emergent adverse events being mild or moderate and none leading to treatment discontinuation.

IN PRACTICE:

“These results suggest that TransCon PTH may improve outcomes and advance the standard of care for adults living with hypoparathyroidism,” the authors wrote.

SOURCE:

The study was led by Bart L. Clarke, MD, Mayo Clinic, Rochester, Minnesota. It was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study’s limitations included the open-label design during the extension period, which may have introduced bias in patient-reported outcomes. Additionally, the study population was predominantly women and White, which may have limited the generalizability of the findings. Further research is needed to assess the long-term effects of TransCon PTH on renal complications. One patient died of fatal cardiac arrest deemed unrelated to the study drug.

DISCLOSURES:

The study was funded by Ascendis Pharma A/S. Seven authors declared being current or former employees of Ascendis Pharma. The other authors declared receiving grants, research funding, honoraria, serving as consultants, advisory board members, study investigators, and other ties with Ascendis Pharma and multiple other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Long-term treatment with TransCon parathyroid hormone (PTH), a replacement therapy for hypoparathyroidism, demonstrates sustained efficacy and safety in patients with hypoparathyroidism over 52 weeks, with 95% of participants able to discontinue conventional therapy.

METHODOLOGY:

• Conventional therapy for hypoparathyroidism (active vitamin D and elemental calcium) alleviates symptoms of hypocalcemia, but it does not improve insufficient PTH levels and is linked to long-term complications, such as nephrocalcinosis, nephrolithiasis, and renal dysfunction.
• This phase 3 (PaTHway) trial aimed to investigate the long-term efficacy, safety, and tolerability of TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism.
• Overall, 82 patients with chronic hypoparathyroidism (mean age, 48.6 years; 78% women; 93% White) were randomly assigned to receive TransCon PTH or placebo, both coadministered with conventional therapy for 26 weeks.
• At the 26-week visit, patients who completed the blinded treatment (n = 79) were assigned to receive only TransCon PTH with conventional therapy in an ongoing 156-week open-label extension.
• For this analysis at week 52, the main efficacy endpoint was the proportion of patients (n = 78) with normal serum calcium levels (8.3-10.6 mg/dL) and independence from conventional therapy (active vitamin D and therapeutic doses of calcium); safety assessments included serum chemistries, 24-hour urine calcium excretion, and treatment-emergent adverse events.

TAKEAWAY:

• At week 52, the majority of the patients receiving TransCon PTH achieved normal serum calcium levels within the normal range (86%) and independence from conventional therapy (95%). None required active vitamin D.
• In secondary endpoints, patients receiving TransCon PTH showed sustained improvement in Hypoparathyroidism Patient Experience Scale scores, reflecting better symptom management, enhanced functioning, and overall well-being through week 52.
• At week 52, the mean 24-hour urine calcium excretion in patients first randomized to TransCon PTH was 185.1 mg/d, remaining well below the upper limit of normal (≤ 250 mg/d), while the placebo group mean fell to 223.1 mg/d during the open-label extension of TransCon PTH.
• TransCon PTH was well-tolerated, with most treatment-emergent adverse events being mild or moderate and none leading to treatment discontinuation.

IN PRACTICE:

“These results suggest that TransCon PTH may improve outcomes and advance the standard of care for adults living with hypoparathyroidism,” the authors wrote.

SOURCE:

The study was led by Bart L. Clarke, MD, Mayo Clinic, Rochester, Minnesota. It was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study’s limitations included the open-label design during the extension period, which may have introduced bias in patient-reported outcomes. Additionally, the study population was predominantly women and White, which may have limited the generalizability of the findings. Further research is needed to assess the long-term effects of TransCon PTH on renal complications. One patient died of fatal cardiac arrest deemed unrelated to the study drug.

DISCLOSURES:

The study was funded by Ascendis Pharma A/S. Seven authors declared being current or former employees of Ascendis Pharma. The other authors declared receiving grants, research funding, honoraria, serving as consultants, advisory board members, study investigators, and other ties with Ascendis Pharma and multiple other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

The 340B Drug Pricing Program began as a noble endeavor, a lifeline designed to help safety-net providers deliver affordable care to America’s most vulnerable populations. However, over the years, this well-intentioned program has strayed from its original purpose, becoming a lucrative space where profits often outweigh patients. Loopholes, lax oversight, and unchecked expansion have allowed some powerful players, such as certain disproportionate share hospitals and their “child sites” as well as for-profit pharmacies, to exploit the system. What was once a program to uplift underserved communities now risks becoming a case study in how good intentions can go astray without accountability.

What exactly is this “340B program” that has captured headlines and the interest of legislatures around the country? What ensures that pharmaceutical manufacturers continue to participate in this program? How lucrative is it? How have underserved populations benefited and how is that measured? 
 

The 340B Drug Pricing Program was established in 1992 under the Public Health Service Act. Its primary goal is to enable covered entities (such as hospitals and clinics serving low-income and uninsured patients) to purchase outpatient drugs from pharmaceutical manufacturers at significantly reduced prices in order to support their care of the low-income and underserved populations. Drug makers are required to participate in this program as a condition of their participation in Medicaid and Medicare Part B and offer these steep discounts to covered entities if they want their medications to be available to 38% of patients nationwide. 

The hospitals that make up 78% of the program’s spending are known as disproportionate share hospitals (DSHs). These hospitals must be nonprofit and have at least an 11.75% “disproportionate” share of low-income Medicare or Medicaid inpatients. The other types of non-hospital entities qualifying for 340B pricing are known as initial “federal grantees.” Some examples include federally qualified health centers (FQHC), Ryan White HIV/AIDS program grantees, and other types of specialized clinics, such as hemophilia treatment centers. It needs to be noted up front that it is not these initial non-hospital federal grantees that need more oversight or reform, since according to the Health Resources and Services Administration (HRSA) 2023 report they make up only 22% of all program spending. It is the large, predominantly DSH health systems that are profiting immensely through exponential growth of their clinics and contract pharmacies. However, these health systems have not been able to show exactly who are their eligible patients and how they have been benefiting them.

When the 340B program was established to offer financial relief to hospitals and clinics taking care of the uninsured, it allowed them to save 20%-50% on drug purchases, which could be reinvested in patient care services. It was hoped that savings from the program could be used to provide free or low-cost medications, free vaccines, and other essential health services, essentially allowing safety-net providers to serve their communities despite financial constraints. The initial grantees are fulfilling that mission, but there are concerns regarding DSHs. (See the Coalition of State Rheumatology Organization’s 340B explanatory statement and policy position for more.)

 

Why Should Independent Practice Physicians Care About This?

Independent doctors should care about the lack of oversight in the 340B program because it affects healthcare costs, patient assistance, market competition, and access to affordable care for underserved and uninsured patients.

It also plays a strong hand in the healthcare consolidation that continues to threaten private physician practices. These acquisitions threaten the viability of independent practices in a variety of specialties across the United States, including rheumatology. HRSA allows 340B-covered entities to register their off-campus outpatient facilities, or child sites, under their 340B designation. Covered entities can acquire drugs at the 340B price, while imposing markups on the reimbursement they submit to private insurance. The additional revenue these covered entities can pocket provides them with a cash flow advantage that physician practices and outpatient clinics will never be able to actualize. This uneven playing field may make rheumatology practices more susceptible to hospital acquisitions. In fact, between 2016 and 2022, large 340B hospitals were responsible for approximately 80% of hospital acquisitions.

Perhaps the most important reason that we should all be concerned about the trajectory of this well-meaning program is that we have seen patients with hospital debt being sued by DSHs who receive 340B discounts so that they can take care of the low-income patients they are suing. We have seen Medicaid patients be turned away from a DSH clinic after being discharged from that hospital, because the hospital had reached its disproportionate share (11.75%) of inpatient Medicare and Medicaid patients. While not illegal, that type of behavior by covered entities is WRONG! Oversight and reform are needed if the 340B program is going to live up to its purpose and not be just another well-intentioned program not fulfilling its mission.

 

Areas of Concern

There has been controversy regarding the limited oversight of the 340B program by HRSA, leading to abuse of the program. There are deep concerns regarding a lack of transparency in how savings from the program are being used, and there are concerns about the challenges associated with accurate tracking and reporting of 340B discounts, possibly leading to the duplication of discounts for both Medicaid and 340B. For example, a “duplicate discount” occurs if a manufacturer sells medications to a DSH at the 340B price and later pays a Medicaid rebate on the same drug. The extent of duplicate discounts in the 340B program is unknown. However, an audit of 1,536 cases conducted by HRSA between 2012 and 2019 found 429 instances of noncompliance related to duplicate discounts, which is nearly 30% of cases.

DSHs and their contracted pharmacies have been accused of exploiting the program by increasing the number of contract pharmacies and expanding the number of offsite outpatient clinics to maximize profits. As of mid-2024, the number of 340B contract pharmacies, counted by Drug Channels Institute (DCI), numbered 32,883 unique locations. According to DCI, the top five pharmacies in the program happen also to be among the top pharmacy revenue generators and are “for-profit.” They are CVS, Walgreens, Walmart, Express Scripts, and Optum RX. Additionally, a study in JAMA Health Forum showed that, from 2011 to 2019, contract pharmacies in areas with the lowest income decreased by 5.6% while those in the most affluent neighborhoods grew by 5%. 

There also has been tremendous growth in the number of covered entities in the 340B program, which grew from just over 8,100 in 2000 to 50,000 in 2020. Before 2004, DSHs made up less than 10% of these entities, but by 2020, they accounted for over 60%. Another study shows that DSHs are expanding their offsite outpatient clinics (“child clinics”) into the affluent neighborhoods serving commercially insured patients who are not low income, to capture the high commercial reimbursements for medications they acquired at steeply discounted prices. This clearly is diverting care away from the intended beneficiaries of the 340B program. 

Furthermore, DSHs have been acquiring specialty practices that prescribe some of the most expensive drugs, in order to take advantage of commercial reimbursement for medications that were acquired at the 340B discount price. Independent oncology practices have complained specifically about this happening in their area, where in some cases the DSHs have “stolen” their patients to profit off of the 340B pricing margins. This has the unintended consequence of increasing government spending, according to a study in the New England Journal of Medicine that showed price markups at 340B eligible hospitals were 6.59 times as high as those in independent physician practices after accounting for drug, patient, and geographic factors.

 

Legal Challenges and Legislation

On May 21, 2024, the US Court of Appeals for the DC Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing program are permissible. The court’s decision follows a lower court (3rd Circuit) ruling which concluded that the 340B statute does not require manufacturers to deliver 340B drugs to an “unlimited number of contract pharmacies.” We’re still awaiting a decision from the 7th Circuit Court on a similar issue. If the 7th Circuit agrees with the government, creating a split decision, there is an increase in the likelihood that the Supreme Court would take up the case.

Johnson & Johnson has also sued the federal government for blocking their proposed use of a rebate model for DSHs that purchase through 340B two of its medications, Stelara and Xarelto, whose maximum fair price was negotiated through the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. J&J states this would ensure that the claims are actually acquired and dispensed by a covered 340B entity, as well as ensuring there are no duplicate discounts as statutorily required by the IRA. When initially proposed, HRSA threatened to remove J&J’s access to Medicare and Medicaid if it pursued this change. J&J’s suit challenges that decision.

However, seven states (Arkansas, Kansas, Louisiana, Minnesota, Missouri, Mississippi, and West Virginia) have been active on this issue, passing laws to prevent manufacturers from limiting contract pharmacies’ ability to acquire 340B-discounted drugs. The model legislation also bans restrictions on the “number, location, ownership, or type of 340B contract pharmacy.”

It should also be noted that there are states that are looking for ways to encourage certain independent private practice specialties (such as gastroenterology and rheumatology) to see Medicaid patients, as well as increase testing for sexually transmitted diseases, by offering the possibility of obtaining 340B pricing in their clinics. 

Shifting our focus to Congress, six bipartisan Senators, known as the Group of 6, are working to modernize the 340B program, which hasn’t been updated since the original law in 1992. In 2024, legislation was introduced (see here and here) to reform a number of the features of the 340B drug discount program, including transparency, contract pharmacy requirements, and federal agency oversight.

 

Who’s Guarding the Hen House?

The Government Accountability Office and the Office of Inspector General over the last 5-10 years have asked HRSA to better define an “eligible” patient, to have more specifics concerning hospital eligibility criteria, and to have better oversight of the program to avoid duplicate discounts. HRSA has said that it doesn’t have the ability or the funding to achieve some of these goals. Consequently, little has been done on any of these fronts, creating frustration among pharmaceutical manufacturers and those calling for more oversight of the program to ensure that eligible patients are receiving the benefit of 340B pricing. Again, these frustrations are not pointed at the initial federally qualified centers or “grantees.”

HRSA now audits 200 covered entities a year, which is less than 2% of entities participating in the 340B program. HRSA expects the 340B entities themselves to have an oversight committee in place to ensure compliance with program requirements. 

So essentially, the fox is guarding the hen house?

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of advocacy and government affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

The 340B Drug Pricing Program began as a noble endeavor, a lifeline designed to help safety-net providers deliver affordable care to America’s most vulnerable populations. However, over the years, this well-intentioned program has strayed from its original purpose, becoming a lucrative space where profits often outweigh patients. Loopholes, lax oversight, and unchecked expansion have allowed some powerful players, such as certain disproportionate share hospitals and their “child sites” as well as for-profit pharmacies, to exploit the system. What was once a program to uplift underserved communities now risks becoming a case study in how good intentions can go astray without accountability.

What exactly is this “340B program” that has captured headlines and the interest of legislatures around the country? What ensures that pharmaceutical manufacturers continue to participate in this program? How lucrative is it? How have underserved populations benefited and how is that measured? 
 

The 340B Drug Pricing Program was established in 1992 under the Public Health Service Act. Its primary goal is to enable covered entities (such as hospitals and clinics serving low-income and uninsured patients) to purchase outpatient drugs from pharmaceutical manufacturers at significantly reduced prices in order to support their care of the low-income and underserved populations. Drug makers are required to participate in this program as a condition of their participation in Medicaid and Medicare Part B and offer these steep discounts to covered entities if they want their medications to be available to 38% of patients nationwide. 

The hospitals that make up 78% of the program’s spending are known as disproportionate share hospitals (DSHs). These hospitals must be nonprofit and have at least an 11.75% “disproportionate” share of low-income Medicare or Medicaid inpatients. The other types of non-hospital entities qualifying for 340B pricing are known as initial “federal grantees.” Some examples include federally qualified health centers (FQHC), Ryan White HIV/AIDS program grantees, and other types of specialized clinics, such as hemophilia treatment centers. It needs to be noted up front that it is not these initial non-hospital federal grantees that need more oversight or reform, since according to the Health Resources and Services Administration (HRSA) 2023 report they make up only 22% of all program spending. It is the large, predominantly DSH health systems that are profiting immensely through exponential growth of their clinics and contract pharmacies. However, these health systems have not been able to show exactly who are their eligible patients and how they have been benefiting them.

When the 340B program was established to offer financial relief to hospitals and clinics taking care of the uninsured, it allowed them to save 20%-50% on drug purchases, which could be reinvested in patient care services. It was hoped that savings from the program could be used to provide free or low-cost medications, free vaccines, and other essential health services, essentially allowing safety-net providers to serve their communities despite financial constraints. The initial grantees are fulfilling that mission, but there are concerns regarding DSHs. (See the Coalition of State Rheumatology Organization’s 340B explanatory statement and policy position for more.)

 

Why Should Independent Practice Physicians Care About This?

Independent doctors should care about the lack of oversight in the 340B program because it affects healthcare costs, patient assistance, market competition, and access to affordable care for underserved and uninsured patients.

It also plays a strong hand in the healthcare consolidation that continues to threaten private physician practices. These acquisitions threaten the viability of independent practices in a variety of specialties across the United States, including rheumatology. HRSA allows 340B-covered entities to register their off-campus outpatient facilities, or child sites, under their 340B designation. Covered entities can acquire drugs at the 340B price, while imposing markups on the reimbursement they submit to private insurance. The additional revenue these covered entities can pocket provides them with a cash flow advantage that physician practices and outpatient clinics will never be able to actualize. This uneven playing field may make rheumatology practices more susceptible to hospital acquisitions. In fact, between 2016 and 2022, large 340B hospitals were responsible for approximately 80% of hospital acquisitions.

Perhaps the most important reason that we should all be concerned about the trajectory of this well-meaning program is that we have seen patients with hospital debt being sued by DSHs who receive 340B discounts so that they can take care of the low-income patients they are suing. We have seen Medicaid patients be turned away from a DSH clinic after being discharged from that hospital, because the hospital had reached its disproportionate share (11.75%) of inpatient Medicare and Medicaid patients. While not illegal, that type of behavior by covered entities is WRONG! Oversight and reform are needed if the 340B program is going to live up to its purpose and not be just another well-intentioned program not fulfilling its mission.

 

Areas of Concern

There has been controversy regarding the limited oversight of the 340B program by HRSA, leading to abuse of the program. There are deep concerns regarding a lack of transparency in how savings from the program are being used, and there are concerns about the challenges associated with accurate tracking and reporting of 340B discounts, possibly leading to the duplication of discounts for both Medicaid and 340B. For example, a “duplicate discount” occurs if a manufacturer sells medications to a DSH at the 340B price and later pays a Medicaid rebate on the same drug. The extent of duplicate discounts in the 340B program is unknown. However, an audit of 1,536 cases conducted by HRSA between 2012 and 2019 found 429 instances of noncompliance related to duplicate discounts, which is nearly 30% of cases.

DSHs and their contracted pharmacies have been accused of exploiting the program by increasing the number of contract pharmacies and expanding the number of offsite outpatient clinics to maximize profits. As of mid-2024, the number of 340B contract pharmacies, counted by Drug Channels Institute (DCI), numbered 32,883 unique locations. According to DCI, the top five pharmacies in the program happen also to be among the top pharmacy revenue generators and are “for-profit.” They are CVS, Walgreens, Walmart, Express Scripts, and Optum RX. Additionally, a study in JAMA Health Forum showed that, from 2011 to 2019, contract pharmacies in areas with the lowest income decreased by 5.6% while those in the most affluent neighborhoods grew by 5%. 

There also has been tremendous growth in the number of covered entities in the 340B program, which grew from just over 8,100 in 2000 to 50,000 in 2020. Before 2004, DSHs made up less than 10% of these entities, but by 2020, they accounted for over 60%. Another study shows that DSHs are expanding their offsite outpatient clinics (“child clinics”) into the affluent neighborhoods serving commercially insured patients who are not low income, to capture the high commercial reimbursements for medications they acquired at steeply discounted prices. This clearly is diverting care away from the intended beneficiaries of the 340B program. 

Furthermore, DSHs have been acquiring specialty practices that prescribe some of the most expensive drugs, in order to take advantage of commercial reimbursement for medications that were acquired at the 340B discount price. Independent oncology practices have complained specifically about this happening in their area, where in some cases the DSHs have “stolen” their patients to profit off of the 340B pricing margins. This has the unintended consequence of increasing government spending, according to a study in the New England Journal of Medicine that showed price markups at 340B eligible hospitals were 6.59 times as high as those in independent physician practices after accounting for drug, patient, and geographic factors.

 

Legal Challenges and Legislation

On May 21, 2024, the US Court of Appeals for the DC Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing program are permissible. The court’s decision follows a lower court (3rd Circuit) ruling which concluded that the 340B statute does not require manufacturers to deliver 340B drugs to an “unlimited number of contract pharmacies.” We’re still awaiting a decision from the 7th Circuit Court on a similar issue. If the 7th Circuit agrees with the government, creating a split decision, there is an increase in the likelihood that the Supreme Court would take up the case.

Johnson & Johnson has also sued the federal government for blocking their proposed use of a rebate model for DSHs that purchase through 340B two of its medications, Stelara and Xarelto, whose maximum fair price was negotiated through the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. J&J states this would ensure that the claims are actually acquired and dispensed by a covered 340B entity, as well as ensuring there are no duplicate discounts as statutorily required by the IRA. When initially proposed, HRSA threatened to remove J&J’s access to Medicare and Medicaid if it pursued this change. J&J’s suit challenges that decision.

However, seven states (Arkansas, Kansas, Louisiana, Minnesota, Missouri, Mississippi, and West Virginia) have been active on this issue, passing laws to prevent manufacturers from limiting contract pharmacies’ ability to acquire 340B-discounted drugs. The model legislation also bans restrictions on the “number, location, ownership, or type of 340B contract pharmacy.”

It should also be noted that there are states that are looking for ways to encourage certain independent private practice specialties (such as gastroenterology and rheumatology) to see Medicaid patients, as well as increase testing for sexually transmitted diseases, by offering the possibility of obtaining 340B pricing in their clinics. 

Shifting our focus to Congress, six bipartisan Senators, known as the Group of 6, are working to modernize the 340B program, which hasn’t been updated since the original law in 1992. In 2024, legislation was introduced (see here and here) to reform a number of the features of the 340B drug discount program, including transparency, contract pharmacy requirements, and federal agency oversight.

 

Who’s Guarding the Hen House?

The Government Accountability Office and the Office of Inspector General over the last 5-10 years have asked HRSA to better define an “eligible” patient, to have more specifics concerning hospital eligibility criteria, and to have better oversight of the program to avoid duplicate discounts. HRSA has said that it doesn’t have the ability or the funding to achieve some of these goals. Consequently, little has been done on any of these fronts, creating frustration among pharmaceutical manufacturers and those calling for more oversight of the program to ensure that eligible patients are receiving the benefit of 340B pricing. Again, these frustrations are not pointed at the initial federally qualified centers or “grantees.”

HRSA now audits 200 covered entities a year, which is less than 2% of entities participating in the 340B program. HRSA expects the 340B entities themselves to have an oversight committee in place to ensure compliance with program requirements. 

So essentially, the fox is guarding the hen house?

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of advocacy and government affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

The 340B Drug Pricing Program began as a noble endeavor, a lifeline designed to help safety-net providers deliver affordable care to America’s most vulnerable populations. However, over the years, this well-intentioned program has strayed from its original purpose, becoming a lucrative space where profits often outweigh patients. Loopholes, lax oversight, and unchecked expansion have allowed some powerful players, such as certain disproportionate share hospitals and their “child sites” as well as for-profit pharmacies, to exploit the system. What was once a program to uplift underserved communities now risks becoming a case study in how good intentions can go astray without accountability.

What exactly is this “340B program” that has captured headlines and the interest of legislatures around the country? What ensures that pharmaceutical manufacturers continue to participate in this program? How lucrative is it? How have underserved populations benefited and how is that measured? 
 

The 340B Drug Pricing Program was established in 1992 under the Public Health Service Act. Its primary goal is to enable covered entities (such as hospitals and clinics serving low-income and uninsured patients) to purchase outpatient drugs from pharmaceutical manufacturers at significantly reduced prices in order to support their care of the low-income and underserved populations. Drug makers are required to participate in this program as a condition of their participation in Medicaid and Medicare Part B and offer these steep discounts to covered entities if they want their medications to be available to 38% of patients nationwide. 

The hospitals that make up 78% of the program’s spending are known as disproportionate share hospitals (DSHs). These hospitals must be nonprofit and have at least an 11.75% “disproportionate” share of low-income Medicare or Medicaid inpatients. The other types of non-hospital entities qualifying for 340B pricing are known as initial “federal grantees.” Some examples include federally qualified health centers (FQHC), Ryan White HIV/AIDS program grantees, and other types of specialized clinics, such as hemophilia treatment centers. It needs to be noted up front that it is not these initial non-hospital federal grantees that need more oversight or reform, since according to the Health Resources and Services Administration (HRSA) 2023 report they make up only 22% of all program spending. It is the large, predominantly DSH health systems that are profiting immensely through exponential growth of their clinics and contract pharmacies. However, these health systems have not been able to show exactly who are their eligible patients and how they have been benefiting them.

When the 340B program was established to offer financial relief to hospitals and clinics taking care of the uninsured, it allowed them to save 20%-50% on drug purchases, which could be reinvested in patient care services. It was hoped that savings from the program could be used to provide free or low-cost medications, free vaccines, and other essential health services, essentially allowing safety-net providers to serve their communities despite financial constraints. The initial grantees are fulfilling that mission, but there are concerns regarding DSHs. (See the Coalition of State Rheumatology Organization’s 340B explanatory statement and policy position for more.)

 

Why Should Independent Practice Physicians Care About This?

Independent doctors should care about the lack of oversight in the 340B program because it affects healthcare costs, patient assistance, market competition, and access to affordable care for underserved and uninsured patients.

It also plays a strong hand in the healthcare consolidation that continues to threaten private physician practices. These acquisitions threaten the viability of independent practices in a variety of specialties across the United States, including rheumatology. HRSA allows 340B-covered entities to register their off-campus outpatient facilities, or child sites, under their 340B designation. Covered entities can acquire drugs at the 340B price, while imposing markups on the reimbursement they submit to private insurance. The additional revenue these covered entities can pocket provides them with a cash flow advantage that physician practices and outpatient clinics will never be able to actualize. This uneven playing field may make rheumatology practices more susceptible to hospital acquisitions. In fact, between 2016 and 2022, large 340B hospitals were responsible for approximately 80% of hospital acquisitions.

Perhaps the most important reason that we should all be concerned about the trajectory of this well-meaning program is that we have seen patients with hospital debt being sued by DSHs who receive 340B discounts so that they can take care of the low-income patients they are suing. We have seen Medicaid patients be turned away from a DSH clinic after being discharged from that hospital, because the hospital had reached its disproportionate share (11.75%) of inpatient Medicare and Medicaid patients. While not illegal, that type of behavior by covered entities is WRONG! Oversight and reform are needed if the 340B program is going to live up to its purpose and not be just another well-intentioned program not fulfilling its mission.

 

Areas of Concern

There has been controversy regarding the limited oversight of the 340B program by HRSA, leading to abuse of the program. There are deep concerns regarding a lack of transparency in how savings from the program are being used, and there are concerns about the challenges associated with accurate tracking and reporting of 340B discounts, possibly leading to the duplication of discounts for both Medicaid and 340B. For example, a “duplicate discount” occurs if a manufacturer sells medications to a DSH at the 340B price and later pays a Medicaid rebate on the same drug. The extent of duplicate discounts in the 340B program is unknown. However, an audit of 1,536 cases conducted by HRSA between 2012 and 2019 found 429 instances of noncompliance related to duplicate discounts, which is nearly 30% of cases.

DSHs and their contracted pharmacies have been accused of exploiting the program by increasing the number of contract pharmacies and expanding the number of offsite outpatient clinics to maximize profits. As of mid-2024, the number of 340B contract pharmacies, counted by Drug Channels Institute (DCI), numbered 32,883 unique locations. According to DCI, the top five pharmacies in the program happen also to be among the top pharmacy revenue generators and are “for-profit.” They are CVS, Walgreens, Walmart, Express Scripts, and Optum RX. Additionally, a study in JAMA Health Forum showed that, from 2011 to 2019, contract pharmacies in areas with the lowest income decreased by 5.6% while those in the most affluent neighborhoods grew by 5%. 

There also has been tremendous growth in the number of covered entities in the 340B program, which grew from just over 8,100 in 2000 to 50,000 in 2020. Before 2004, DSHs made up less than 10% of these entities, but by 2020, they accounted for over 60%. Another study shows that DSHs are expanding their offsite outpatient clinics (“child clinics”) into the affluent neighborhoods serving commercially insured patients who are not low income, to capture the high commercial reimbursements for medications they acquired at steeply discounted prices. This clearly is diverting care away from the intended beneficiaries of the 340B program. 

Furthermore, DSHs have been acquiring specialty practices that prescribe some of the most expensive drugs, in order to take advantage of commercial reimbursement for medications that were acquired at the 340B discount price. Independent oncology practices have complained specifically about this happening in their area, where in some cases the DSHs have “stolen” their patients to profit off of the 340B pricing margins. This has the unintended consequence of increasing government spending, according to a study in the New England Journal of Medicine that showed price markups at 340B eligible hospitals were 6.59 times as high as those in independent physician practices after accounting for drug, patient, and geographic factors.

 

Legal Challenges and Legislation

On May 21, 2024, the US Court of Appeals for the DC Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing program are permissible. The court’s decision follows a lower court (3rd Circuit) ruling which concluded that the 340B statute does not require manufacturers to deliver 340B drugs to an “unlimited number of contract pharmacies.” We’re still awaiting a decision from the 7th Circuit Court on a similar issue. If the 7th Circuit agrees with the government, creating a split decision, there is an increase in the likelihood that the Supreme Court would take up the case.

Johnson & Johnson has also sued the federal government for blocking their proposed use of a rebate model for DSHs that purchase through 340B two of its medications, Stelara and Xarelto, whose maximum fair price was negotiated through the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. J&J states this would ensure that the claims are actually acquired and dispensed by a covered 340B entity, as well as ensuring there are no duplicate discounts as statutorily required by the IRA. When initially proposed, HRSA threatened to remove J&J’s access to Medicare and Medicaid if it pursued this change. J&J’s suit challenges that decision.

However, seven states (Arkansas, Kansas, Louisiana, Minnesota, Missouri, Mississippi, and West Virginia) have been active on this issue, passing laws to prevent manufacturers from limiting contract pharmacies’ ability to acquire 340B-discounted drugs. The model legislation also bans restrictions on the “number, location, ownership, or type of 340B contract pharmacy.”

It should also be noted that there are states that are looking for ways to encourage certain independent private practice specialties (such as gastroenterology and rheumatology) to see Medicaid patients, as well as increase testing for sexually transmitted diseases, by offering the possibility of obtaining 340B pricing in their clinics. 

Shifting our focus to Congress, six bipartisan Senators, known as the Group of 6, are working to modernize the 340B program, which hasn’t been updated since the original law in 1992. In 2024, legislation was introduced (see here and here) to reform a number of the features of the 340B drug discount program, including transparency, contract pharmacy requirements, and federal agency oversight.

 

Who’s Guarding the Hen House?

The Government Accountability Office and the Office of Inspector General over the last 5-10 years have asked HRSA to better define an “eligible” patient, to have more specifics concerning hospital eligibility criteria, and to have better oversight of the program to avoid duplicate discounts. HRSA has said that it doesn’t have the ability or the funding to achieve some of these goals. Consequently, little has been done on any of these fronts, creating frustration among pharmaceutical manufacturers and those calling for more oversight of the program to ensure that eligible patients are receiving the benefit of 340B pricing. Again, these frustrations are not pointed at the initial federally qualified centers or “grantees.”

HRSA now audits 200 covered entities a year, which is less than 2% of entities participating in the 340B program. HRSA expects the 340B entities themselves to have an oversight committee in place to ensure compliance with program requirements. 

So essentially, the fox is guarding the hen house?

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of advocacy and government affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

PHILADELPHIA — New research provides more evidence that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) do not increase the risk for pancreatic cancer.

Instead, the large electronic health record (EHR) analysis of patients with type 2 diabetes (T2D) found those taking GLP-1 RAs had a significantly lower risk for pancreatic cancer than peers on other antidiabetic medications. 

“Although there were previous reports suggesting possible association between pancreatic cancer and GLP-1 receptor agonist medications, this study provides reassurance that there is no observed increased incidence of pancreatic cancer in patients prescribed these medications,” said Khaled Alsabbagh Alchirazi, MD, a gastroenterology fellow with Aurora Healthcare in Brookfield, Wisconsin. 

He presented the study findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 

 

Important Topic

Patients with T2D are at increased risk for several malignancies, including pancreatic cancer. Given the unique mechanism of action of GLP-1 RAs in the pancreas, it was important to investigate the relationship between use of these drugs and incidence of pancreatic cancer, he explained.

Using the TriNetX database, the study team identified 4.95 million antidiabetic drug naive T2D patients who were prescribed antidiabetic medications for the first time between 2005 and 2020. None had a history of pancreatic cancer. 

A total of 245,532 were prescribed a GLP-1 RA. The researchers compared GLP-1 RAs users to users of other antidiabetic medications — namely, insulin, metformin, alpha-glucosidase inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), sulfonylureas, and thiazolidinediones. 

Patients were propensity score-matched based on demographics, health determinants, lifestyle factors, medical history, family history of cancers, and acute/chronic pancreatitis. 

The risk for pancreatic cancer was significantly lower among patients on GLP-1 RAs vs insulin (hazard ratio [HR], 0.47; 95% CI, 0.40-0.55), DPP-4i (HR, 0.80; 95% CI, 0.73-0.89), SGLT2i (HR, 0.78; 95% CI, 0.69-0.89), and sulfonylureas (HR, 0.84; 95% CI, 0.74-0.95), Alchirazi reported.

The results were consistent across different groups, including patients with obesity/ overweight on GLP-1 RAs vs insulin (HR, 0.53; 95% CI, 0.43-0.65) and SGLT2i (HR, 0.81; 95% CI, 0.69-0.96).

Strengths of the analysis included the large and diverse cohort of propensity score-matched patients. Limitations included the retrospective design and use of claims data that did not provide granular data on pathology reports.

The study by Alchirazi and colleagues aligns with a large population-based cohort study from Israel that found no evidence that GLP-1 RAs increase risk for pancreatic cancer over 7 years following initiation.

Separately, a study of more than 1.6 million patients with T2D found that treatment with a GLP-1 RA (vs insulin or metformin) was associated with lower risks for specific types of obesity-related cancers, including pancreatic cancer.

The study had no specific funding. Alchirazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — New research provides more evidence that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) do not increase the risk for pancreatic cancer.

Instead, the large electronic health record (EHR) analysis of patients with type 2 diabetes (T2D) found those taking GLP-1 RAs had a significantly lower risk for pancreatic cancer than peers on other antidiabetic medications. 

“Although there were previous reports suggesting possible association between pancreatic cancer and GLP-1 receptor agonist medications, this study provides reassurance that there is no observed increased incidence of pancreatic cancer in patients prescribed these medications,” said Khaled Alsabbagh Alchirazi, MD, a gastroenterology fellow with Aurora Healthcare in Brookfield, Wisconsin. 

He presented the study findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 

 

Important Topic

Patients with T2D are at increased risk for several malignancies, including pancreatic cancer. Given the unique mechanism of action of GLP-1 RAs in the pancreas, it was important to investigate the relationship between use of these drugs and incidence of pancreatic cancer, he explained.

Using the TriNetX database, the study team identified 4.95 million antidiabetic drug naive T2D patients who were prescribed antidiabetic medications for the first time between 2005 and 2020. None had a history of pancreatic cancer. 

A total of 245,532 were prescribed a GLP-1 RA. The researchers compared GLP-1 RAs users to users of other antidiabetic medications — namely, insulin, metformin, alpha-glucosidase inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), sulfonylureas, and thiazolidinediones. 

Patients were propensity score-matched based on demographics, health determinants, lifestyle factors, medical history, family history of cancers, and acute/chronic pancreatitis. 

The risk for pancreatic cancer was significantly lower among patients on GLP-1 RAs vs insulin (hazard ratio [HR], 0.47; 95% CI, 0.40-0.55), DPP-4i (HR, 0.80; 95% CI, 0.73-0.89), SGLT2i (HR, 0.78; 95% CI, 0.69-0.89), and sulfonylureas (HR, 0.84; 95% CI, 0.74-0.95), Alchirazi reported.

The results were consistent across different groups, including patients with obesity/ overweight on GLP-1 RAs vs insulin (HR, 0.53; 95% CI, 0.43-0.65) and SGLT2i (HR, 0.81; 95% CI, 0.69-0.96).

Strengths of the analysis included the large and diverse cohort of propensity score-matched patients. Limitations included the retrospective design and use of claims data that did not provide granular data on pathology reports.

The study by Alchirazi and colleagues aligns with a large population-based cohort study from Israel that found no evidence that GLP-1 RAs increase risk for pancreatic cancer over 7 years following initiation.

Separately, a study of more than 1.6 million patients with T2D found that treatment with a GLP-1 RA (vs insulin or metformin) was associated with lower risks for specific types of obesity-related cancers, including pancreatic cancer.

The study had no specific funding. Alchirazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — New research provides more evidence that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) do not increase the risk for pancreatic cancer.

Instead, the large electronic health record (EHR) analysis of patients with type 2 diabetes (T2D) found those taking GLP-1 RAs had a significantly lower risk for pancreatic cancer than peers on other antidiabetic medications. 

“Although there were previous reports suggesting possible association between pancreatic cancer and GLP-1 receptor agonist medications, this study provides reassurance that there is no observed increased incidence of pancreatic cancer in patients prescribed these medications,” said Khaled Alsabbagh Alchirazi, MD, a gastroenterology fellow with Aurora Healthcare in Brookfield, Wisconsin. 

He presented the study findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 

 

Important Topic

Patients with T2D are at increased risk for several malignancies, including pancreatic cancer. Given the unique mechanism of action of GLP-1 RAs in the pancreas, it was important to investigate the relationship between use of these drugs and incidence of pancreatic cancer, he explained.

Using the TriNetX database, the study team identified 4.95 million antidiabetic drug naive T2D patients who were prescribed antidiabetic medications for the first time between 2005 and 2020. None had a history of pancreatic cancer. 

A total of 245,532 were prescribed a GLP-1 RA. The researchers compared GLP-1 RAs users to users of other antidiabetic medications — namely, insulin, metformin, alpha-glucosidase inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), sulfonylureas, and thiazolidinediones. 

Patients were propensity score-matched based on demographics, health determinants, lifestyle factors, medical history, family history of cancers, and acute/chronic pancreatitis. 

The risk for pancreatic cancer was significantly lower among patients on GLP-1 RAs vs insulin (hazard ratio [HR], 0.47; 95% CI, 0.40-0.55), DPP-4i (HR, 0.80; 95% CI, 0.73-0.89), SGLT2i (HR, 0.78; 95% CI, 0.69-0.89), and sulfonylureas (HR, 0.84; 95% CI, 0.74-0.95), Alchirazi reported.

The results were consistent across different groups, including patients with obesity/ overweight on GLP-1 RAs vs insulin (HR, 0.53; 95% CI, 0.43-0.65) and SGLT2i (HR, 0.81; 95% CI, 0.69-0.96).

Strengths of the analysis included the large and diverse cohort of propensity score-matched patients. Limitations included the retrospective design and use of claims data that did not provide granular data on pathology reports.

The study by Alchirazi and colleagues aligns with a large population-based cohort study from Israel that found no evidence that GLP-1 RAs increase risk for pancreatic cancer over 7 years following initiation.

Separately, a study of more than 1.6 million patients with T2D found that treatment with a GLP-1 RA (vs insulin or metformin) was associated with lower risks for specific types of obesity-related cancers, including pancreatic cancer.

The study had no specific funding. Alchirazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

The decision to prescribe a compounded or brand-name glucagon-like peptide 1 (GLP-1) medication for obesity treatment was never simple, but recent developments have complicated it further.

Both Eli Lilly and Novo Nordisk have asked the Food and Drug Administration (FDA) to place their GLP-1 medications, tirzepatide and semaglutide, on its Demonstrable Difficulties for Compounding or DDC Lists, which would prohibit compounding the medications. Lawsuits are another issue. The Outsourcing Facility Association, a trade group, filed a lawsuit against the FDA, calling on it to restore tirzepatide to the shortage list after the FDA removed it on October 2, despite pharmacies still experiencing shortages, according to the association. The FDA is reevaluating the decision and won’t take action against compounders in the interim, with a joint status report scheduled for November 21.

In the midst of the lawsuits and pending decisions, healthcare providers are taking a variety of approaches when they need to decide between compounded vs brand-name GLP-1s for obesity treatment. The Alliance for Pharmacy Compounding, another trade group, offers a number of suggestions for doctors faced with compound or brand-name decisions and has a website tool to be sure a compounding pharmacy meets standards.

According to the FDA, a drug may be compounded for a patient who can’t be treated with an FDA-approved medication, such as a patient who has an allergy to a certain ingredient and needs medication to be made without it, or for a medication that appears on the FDA Drug Shortages List.

Here’s how five healthcare providers make the decision.

 

Physicians Weigh in

Hard pass: “I have no experience with compounded formulations by choice,” said W. Timothy Garvey, MD, MACE, an obesity specialist and the Charles E. Butterworth Jr professor and university professor at the University of Alabama at Birmingham. “I think our patients deserve better.”

However, he acknowledged: “This is a difficult situation when there is a lack of access to medications patients need.” Even so, “online prescriptions [for compounded medications] are often done without an evaluation for obesity complications and related diseases and ongoing active management, making a complications-centric approach to care impossible.”

That’s not the optimal approach to treating obesity or other chronic diseases, he said in an interview.

Rather than prescribe compounded GLP-1s for weight loss, he said, other options exist. Among them: Prescribe Ozempic off label for obesity.

“Plus, we have a good first-generation obesity medication — phentermine/topiramate — that gets close to 10% weight loss on average in clinical trials that is available and less expensive.”

Other options, he said, are to switch to lower doses of the brand name that may be available until the treatment dose needed is out of shortage status or, the less desirable option, wait for availability, which means the patient may be off the medication for a month or more.

He acknowledged none of these options solves “the problem of high costs [for brand-name drugs] and lack of insurance coverage.”

In agreement is Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

Brand names preferred: “Brand-name versions as far as I’m concerned are always preferred,” said Sarah Stombaugh, MD, an obesity medicine and family medicine physician in Charlottesville, Virginia. She terms it irresponsible for a prescriber to give a patient a compounded GLP-1 if the patient has prescription coverage and the brand name is available.

Her approach: She first checks the patients’ coverage. Do they have coverage for these medications for obesity? If so, she said, she will do a prior authorization to get the brand name approved. If a brand name is available but not covered, she explores other options. One is the cash pay option for Zepbound in vials. It’s more affordable than the typical $1000 cash price for the brand name GLP-1s but still pricey, at about $400-$549 for lower doses.

She looks at drug makers’ discount coupons, or whether a patient with a history of cardiovascular issues might qualify for coverage on Wegovy. Another option is to give the patient a prescription for Mounjaro or Ozempic to fill from a Canadian pharmacy for about $400 a month.

“I think a lot of people jump quickly to compounding,” she said.

She views it as a last resort and reminds other healthcare providers that the compounded medications aren’t cheap, either, typically costing $100-$500 a month depending on dosage. And, she said, “we have many who get the brand name for $25 a month [by using discount cards and insurance coverage].”

When prescribing a compounded medication is necessary, it’s important for healthcare providers to know that the quality of the compounding pharmacies varies greatly, Stombaugh said. A prescriber needs to pick the compounding pharmacy, not the patient, and needs to vet it, she said, asking about protocols it follows for sterility and for chemical analysis, for instance.

Stombaugh is hopeful that several new medications under study and now in phase 3 trials will soon provide enough competition to drive down the price of the current brand-name GLP-1s.

History of mistrust: Robert Dubin, MD, associate professor of research at the Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and program director for its obesity medicine fellowship, sees a role for compounding and has for several years, but acknowledged that many in his community are against it.

He estimates that about 75% of his colleagues in the Baton Rouge area are opposed to prescribing compounded GLP-1s. He chalks it up to a “track record of distrust,” based on reports of infractions called out by the FDA for some compounding pharmacies as well as physicians not being familiar with the process.

Dubin said he will prescribe a compounded medication if the brand name isn’t available. Cost is also a consideration. “If there’s not a problem with availability and there’s not a problem with cost, then why compound?”

For anyone considering prescribing compounded GLP-1s, he said, “The first step, I believe, is having a relationship with the compounding pharmacy. If you don’t have that, it could be very difficult. We don’t want to send people to a black hole, and we aren’t sure what is going to happen.” He urges colleagues to educate themselves about compounding pharmacies.

Official shortage list vs real world: “The official shortage list doesn’t always reflect the real world,” said Amanda Guarniere, NP, a nurse practitioner with a self-pay telehealth and in-person practice and director of growth for Collaborating Docs, a service based in Arlington, Virginia, that pairs nurse practitioners with supervising physicians.

“When Zepbound and Mounjaro came off the [FDA] shortage list a few weeks ago, patients were still calling around and couldn’t find it in their county.”

It’s important to vet compounding pharmacies before dealing with them, she said.

“I have accounts with two compounding pharmacies who I trust,” she said. She’s researched their quality control provided and is comfortable with their standards. When appropriate, the cost savings of compounded GLP-1s over brand name is “pretty significant,” with compounded medicine costs about 20% of brand-name costs.

When the brand name is back, how might a prescriber still write a prescription for a compounded version? “Compounded versions are typically compounded with something else,” Guarniere said.

For instance, compounded tirzepatide often includes vitamin B12 and other B vitamins, which may help with the side effect of nausea. So a prescriber might decide that the compounded prescription is more appropriate and justified because the patient would benefit from the additive, she said.

 

What Else to Know: Alliance Views

On November 7, the Alliance for Pharmacy Compounding, a trade group, responded to Lilly’s request to put tirzepatide on the “demonstrably difficult to compound (DDC)” list, asking the FDA to deny it. The group also took issue with criticism of compounded GLP-1s from the Novo Nordisk CEO.

The alliance offers perspective and a number of suggestions for doctors faced with compound or brand-name decisions, including using its website tool called “Is It Legit?” to be sure a compounding pharmacy meets standards.

“When these [GLP-1] drugs came out, I don’t think anybody anticipated them to be such blockbusters,” said Tenille Davis, PharmD, a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding. Shortages have plagued the GLP-1s since their approvals, with Wegovy approved on June 4, 2021, and Eli Lilly’s Zepbound on November 8, 2023.

The proposed “Demonstrably Difficult to Compound (DDC)” rule, published in March 2024, aims to finalize the six criteria for a medication to land on that list, she said. No drugs are currently on this list, Davis said.

For now, she said, prescribers faced with a compound vs brand-name decision should be aware of the pending lawsuit concerning tirzepatide and that the FDA has said it will cease most enforcement action until 2 weeks after it reviews the decision to remove the medication from the shortage list and issues a new determination.

Davis suggests prescribers have conversations now with their patients about their options and to tell them it may be necessary to transition from the compounded medicines to brand name. “This may require insurance prior authorizations, so if they are going to transition from compounded tirzepatide to Zepbound and Mounjaro, it’s good to start the process sooner rather than later so there isn’t an interruption in care.”

Earlier in 2024, the three leading obesity organizations issued a statement, advising patients that they do not recommend the use of compounded GLP-1s.

Garvey is a consultant on advisory boards for Eli Lilly, Novo Nordisk, and several other pharmaceutical companies. Apovian had no relevant disclosures. Stombaugh, Dubin, and Guarniere had no disclosures.

A version of this article appeared on Medscape.com.

The decision to prescribe a compounded or brand-name glucagon-like peptide 1 (GLP-1) medication for obesity treatment was never simple, but recent developments have complicated it further.

Both Eli Lilly and Novo Nordisk have asked the Food and Drug Administration (FDA) to place their GLP-1 medications, tirzepatide and semaglutide, on its Demonstrable Difficulties for Compounding or DDC Lists, which would prohibit compounding the medications. Lawsuits are another issue. The Outsourcing Facility Association, a trade group, filed a lawsuit against the FDA, calling on it to restore tirzepatide to the shortage list after the FDA removed it on October 2, despite pharmacies still experiencing shortages, according to the association. The FDA is reevaluating the decision and won’t take action against compounders in the interim, with a joint status report scheduled for November 21.

In the midst of the lawsuits and pending decisions, healthcare providers are taking a variety of approaches when they need to decide between compounded vs brand-name GLP-1s for obesity treatment. The Alliance for Pharmacy Compounding, another trade group, offers a number of suggestions for doctors faced with compound or brand-name decisions and has a website tool to be sure a compounding pharmacy meets standards.

According to the FDA, a drug may be compounded for a patient who can’t be treated with an FDA-approved medication, such as a patient who has an allergy to a certain ingredient and needs medication to be made without it, or for a medication that appears on the FDA Drug Shortages List.

Here’s how five healthcare providers make the decision.

 

Physicians Weigh in

Hard pass: “I have no experience with compounded formulations by choice,” said W. Timothy Garvey, MD, MACE, an obesity specialist and the Charles E. Butterworth Jr professor and university professor at the University of Alabama at Birmingham. “I think our patients deserve better.”

However, he acknowledged: “This is a difficult situation when there is a lack of access to medications patients need.” Even so, “online prescriptions [for compounded medications] are often done without an evaluation for obesity complications and related diseases and ongoing active management, making a complications-centric approach to care impossible.”

That’s not the optimal approach to treating obesity or other chronic diseases, he said in an interview.

Rather than prescribe compounded GLP-1s for weight loss, he said, other options exist. Among them: Prescribe Ozempic off label for obesity.

“Plus, we have a good first-generation obesity medication — phentermine/topiramate — that gets close to 10% weight loss on average in clinical trials that is available and less expensive.”

Other options, he said, are to switch to lower doses of the brand name that may be available until the treatment dose needed is out of shortage status or, the less desirable option, wait for availability, which means the patient may be off the medication for a month or more.

He acknowledged none of these options solves “the problem of high costs [for brand-name drugs] and lack of insurance coverage.”

In agreement is Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

Brand names preferred: “Brand-name versions as far as I’m concerned are always preferred,” said Sarah Stombaugh, MD, an obesity medicine and family medicine physician in Charlottesville, Virginia. She terms it irresponsible for a prescriber to give a patient a compounded GLP-1 if the patient has prescription coverage and the brand name is available.

Her approach: She first checks the patients’ coverage. Do they have coverage for these medications for obesity? If so, she said, she will do a prior authorization to get the brand name approved. If a brand name is available but not covered, she explores other options. One is the cash pay option for Zepbound in vials. It’s more affordable than the typical $1000 cash price for the brand name GLP-1s but still pricey, at about $400-$549 for lower doses.

She looks at drug makers’ discount coupons, or whether a patient with a history of cardiovascular issues might qualify for coverage on Wegovy. Another option is to give the patient a prescription for Mounjaro or Ozempic to fill from a Canadian pharmacy for about $400 a month.

“I think a lot of people jump quickly to compounding,” she said.

She views it as a last resort and reminds other healthcare providers that the compounded medications aren’t cheap, either, typically costing $100-$500 a month depending on dosage. And, she said, “we have many who get the brand name for $25 a month [by using discount cards and insurance coverage].”

When prescribing a compounded medication is necessary, it’s important for healthcare providers to know that the quality of the compounding pharmacies varies greatly, Stombaugh said. A prescriber needs to pick the compounding pharmacy, not the patient, and needs to vet it, she said, asking about protocols it follows for sterility and for chemical analysis, for instance.

Stombaugh is hopeful that several new medications under study and now in phase 3 trials will soon provide enough competition to drive down the price of the current brand-name GLP-1s.

History of mistrust: Robert Dubin, MD, associate professor of research at the Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and program director for its obesity medicine fellowship, sees a role for compounding and has for several years, but acknowledged that many in his community are against it.

He estimates that about 75% of his colleagues in the Baton Rouge area are opposed to prescribing compounded GLP-1s. He chalks it up to a “track record of distrust,” based on reports of infractions called out by the FDA for some compounding pharmacies as well as physicians not being familiar with the process.

Dubin said he will prescribe a compounded medication if the brand name isn’t available. Cost is also a consideration. “If there’s not a problem with availability and there’s not a problem with cost, then why compound?”

For anyone considering prescribing compounded GLP-1s, he said, “The first step, I believe, is having a relationship with the compounding pharmacy. If you don’t have that, it could be very difficult. We don’t want to send people to a black hole, and we aren’t sure what is going to happen.” He urges colleagues to educate themselves about compounding pharmacies.

Official shortage list vs real world: “The official shortage list doesn’t always reflect the real world,” said Amanda Guarniere, NP, a nurse practitioner with a self-pay telehealth and in-person practice and director of growth for Collaborating Docs, a service based in Arlington, Virginia, that pairs nurse practitioners with supervising physicians.

“When Zepbound and Mounjaro came off the [FDA] shortage list a few weeks ago, patients were still calling around and couldn’t find it in their county.”

It’s important to vet compounding pharmacies before dealing with them, she said.

“I have accounts with two compounding pharmacies who I trust,” she said. She’s researched their quality control provided and is comfortable with their standards. When appropriate, the cost savings of compounded GLP-1s over brand name is “pretty significant,” with compounded medicine costs about 20% of brand-name costs.

When the brand name is back, how might a prescriber still write a prescription for a compounded version? “Compounded versions are typically compounded with something else,” Guarniere said.

For instance, compounded tirzepatide often includes vitamin B12 and other B vitamins, which may help with the side effect of nausea. So a prescriber might decide that the compounded prescription is more appropriate and justified because the patient would benefit from the additive, she said.

 

What Else to Know: Alliance Views

On November 7, the Alliance for Pharmacy Compounding, a trade group, responded to Lilly’s request to put tirzepatide on the “demonstrably difficult to compound (DDC)” list, asking the FDA to deny it. The group also took issue with criticism of compounded GLP-1s from the Novo Nordisk CEO.

The alliance offers perspective and a number of suggestions for doctors faced with compound or brand-name decisions, including using its website tool called “Is It Legit?” to be sure a compounding pharmacy meets standards.

“When these [GLP-1] drugs came out, I don’t think anybody anticipated them to be such blockbusters,” said Tenille Davis, PharmD, a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding. Shortages have plagued the GLP-1s since their approvals, with Wegovy approved on June 4, 2021, and Eli Lilly’s Zepbound on November 8, 2023.

The proposed “Demonstrably Difficult to Compound (DDC)” rule, published in March 2024, aims to finalize the six criteria for a medication to land on that list, she said. No drugs are currently on this list, Davis said.

For now, she said, prescribers faced with a compound vs brand-name decision should be aware of the pending lawsuit concerning tirzepatide and that the FDA has said it will cease most enforcement action until 2 weeks after it reviews the decision to remove the medication from the shortage list and issues a new determination.

Davis suggests prescribers have conversations now with their patients about their options and to tell them it may be necessary to transition from the compounded medicines to brand name. “This may require insurance prior authorizations, so if they are going to transition from compounded tirzepatide to Zepbound and Mounjaro, it’s good to start the process sooner rather than later so there isn’t an interruption in care.”

Earlier in 2024, the three leading obesity organizations issued a statement, advising patients that they do not recommend the use of compounded GLP-1s.

Garvey is a consultant on advisory boards for Eli Lilly, Novo Nordisk, and several other pharmaceutical companies. Apovian had no relevant disclosures. Stombaugh, Dubin, and Guarniere had no disclosures.

A version of this article appeared on Medscape.com.

The decision to prescribe a compounded or brand-name glucagon-like peptide 1 (GLP-1) medication for obesity treatment was never simple, but recent developments have complicated it further.

Both Eli Lilly and Novo Nordisk have asked the Food and Drug Administration (FDA) to place their GLP-1 medications, tirzepatide and semaglutide, on its Demonstrable Difficulties for Compounding or DDC Lists, which would prohibit compounding the medications. Lawsuits are another issue. The Outsourcing Facility Association, a trade group, filed a lawsuit against the FDA, calling on it to restore tirzepatide to the shortage list after the FDA removed it on October 2, despite pharmacies still experiencing shortages, according to the association. The FDA is reevaluating the decision and won’t take action against compounders in the interim, with a joint status report scheduled for November 21.

In the midst of the lawsuits and pending decisions, healthcare providers are taking a variety of approaches when they need to decide between compounded vs brand-name GLP-1s for obesity treatment. The Alliance for Pharmacy Compounding, another trade group, offers a number of suggestions for doctors faced with compound or brand-name decisions and has a website tool to be sure a compounding pharmacy meets standards.

According to the FDA, a drug may be compounded for a patient who can’t be treated with an FDA-approved medication, such as a patient who has an allergy to a certain ingredient and needs medication to be made without it, or for a medication that appears on the FDA Drug Shortages List.

Here’s how five healthcare providers make the decision.

 

Physicians Weigh in

Hard pass: “I have no experience with compounded formulations by choice,” said W. Timothy Garvey, MD, MACE, an obesity specialist and the Charles E. Butterworth Jr professor and university professor at the University of Alabama at Birmingham. “I think our patients deserve better.”

However, he acknowledged: “This is a difficult situation when there is a lack of access to medications patients need.” Even so, “online prescriptions [for compounded medications] are often done without an evaluation for obesity complications and related diseases and ongoing active management, making a complications-centric approach to care impossible.”

That’s not the optimal approach to treating obesity or other chronic diseases, he said in an interview.

Rather than prescribe compounded GLP-1s for weight loss, he said, other options exist. Among them: Prescribe Ozempic off label for obesity.

“Plus, we have a good first-generation obesity medication — phentermine/topiramate — that gets close to 10% weight loss on average in clinical trials that is available and less expensive.”

Other options, he said, are to switch to lower doses of the brand name that may be available until the treatment dose needed is out of shortage status or, the less desirable option, wait for availability, which means the patient may be off the medication for a month or more.

He acknowledged none of these options solves “the problem of high costs [for brand-name drugs] and lack of insurance coverage.”

In agreement is Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

Brand names preferred: “Brand-name versions as far as I’m concerned are always preferred,” said Sarah Stombaugh, MD, an obesity medicine and family medicine physician in Charlottesville, Virginia. She terms it irresponsible for a prescriber to give a patient a compounded GLP-1 if the patient has prescription coverage and the brand name is available.

Her approach: She first checks the patients’ coverage. Do they have coverage for these medications for obesity? If so, she said, she will do a prior authorization to get the brand name approved. If a brand name is available but not covered, she explores other options. One is the cash pay option for Zepbound in vials. It’s more affordable than the typical $1000 cash price for the brand name GLP-1s but still pricey, at about $400-$549 for lower doses.

She looks at drug makers’ discount coupons, or whether a patient with a history of cardiovascular issues might qualify for coverage on Wegovy. Another option is to give the patient a prescription for Mounjaro or Ozempic to fill from a Canadian pharmacy for about $400 a month.

“I think a lot of people jump quickly to compounding,” she said.

She views it as a last resort and reminds other healthcare providers that the compounded medications aren’t cheap, either, typically costing $100-$500 a month depending on dosage. And, she said, “we have many who get the brand name for $25 a month [by using discount cards and insurance coverage].”

When prescribing a compounded medication is necessary, it’s important for healthcare providers to know that the quality of the compounding pharmacies varies greatly, Stombaugh said. A prescriber needs to pick the compounding pharmacy, not the patient, and needs to vet it, she said, asking about protocols it follows for sterility and for chemical analysis, for instance.

Stombaugh is hopeful that several new medications under study and now in phase 3 trials will soon provide enough competition to drive down the price of the current brand-name GLP-1s.

History of mistrust: Robert Dubin, MD, associate professor of research at the Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and program director for its obesity medicine fellowship, sees a role for compounding and has for several years, but acknowledged that many in his community are against it.

He estimates that about 75% of his colleagues in the Baton Rouge area are opposed to prescribing compounded GLP-1s. He chalks it up to a “track record of distrust,” based on reports of infractions called out by the FDA for some compounding pharmacies as well as physicians not being familiar with the process.

Dubin said he will prescribe a compounded medication if the brand name isn’t available. Cost is also a consideration. “If there’s not a problem with availability and there’s not a problem with cost, then why compound?”

For anyone considering prescribing compounded GLP-1s, he said, “The first step, I believe, is having a relationship with the compounding pharmacy. If you don’t have that, it could be very difficult. We don’t want to send people to a black hole, and we aren’t sure what is going to happen.” He urges colleagues to educate themselves about compounding pharmacies.

Official shortage list vs real world: “The official shortage list doesn’t always reflect the real world,” said Amanda Guarniere, NP, a nurse practitioner with a self-pay telehealth and in-person practice and director of growth for Collaborating Docs, a service based in Arlington, Virginia, that pairs nurse practitioners with supervising physicians.

“When Zepbound and Mounjaro came off the [FDA] shortage list a few weeks ago, patients were still calling around and couldn’t find it in their county.”

It’s important to vet compounding pharmacies before dealing with them, she said.

“I have accounts with two compounding pharmacies who I trust,” she said. She’s researched their quality control provided and is comfortable with their standards. When appropriate, the cost savings of compounded GLP-1s over brand name is “pretty significant,” with compounded medicine costs about 20% of brand-name costs.

When the brand name is back, how might a prescriber still write a prescription for a compounded version? “Compounded versions are typically compounded with something else,” Guarniere said.

For instance, compounded tirzepatide often includes vitamin B12 and other B vitamins, which may help with the side effect of nausea. So a prescriber might decide that the compounded prescription is more appropriate and justified because the patient would benefit from the additive, she said.

 

What Else to Know: Alliance Views

On November 7, the Alliance for Pharmacy Compounding, a trade group, responded to Lilly’s request to put tirzepatide on the “demonstrably difficult to compound (DDC)” list, asking the FDA to deny it. The group also took issue with criticism of compounded GLP-1s from the Novo Nordisk CEO.

The alliance offers perspective and a number of suggestions for doctors faced with compound or brand-name decisions, including using its website tool called “Is It Legit?” to be sure a compounding pharmacy meets standards.

“When these [GLP-1] drugs came out, I don’t think anybody anticipated them to be such blockbusters,” said Tenille Davis, PharmD, a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding. Shortages have plagued the GLP-1s since their approvals, with Wegovy approved on June 4, 2021, and Eli Lilly’s Zepbound on November 8, 2023.

The proposed “Demonstrably Difficult to Compound (DDC)” rule, published in March 2024, aims to finalize the six criteria for a medication to land on that list, she said. No drugs are currently on this list, Davis said.

For now, she said, prescribers faced with a compound vs brand-name decision should be aware of the pending lawsuit concerning tirzepatide and that the FDA has said it will cease most enforcement action until 2 weeks after it reviews the decision to remove the medication from the shortage list and issues a new determination.

Davis suggests prescribers have conversations now with their patients about their options and to tell them it may be necessary to transition from the compounded medicines to brand name. “This may require insurance prior authorizations, so if they are going to transition from compounded tirzepatide to Zepbound and Mounjaro, it’s good to start the process sooner rather than later so there isn’t an interruption in care.”

Earlier in 2024, the three leading obesity organizations issued a statement, advising patients that they do not recommend the use of compounded GLP-1s.

Garvey is a consultant on advisory boards for Eli Lilly, Novo Nordisk, and several other pharmaceutical companies. Apovian had no relevant disclosures. Stombaugh, Dubin, and Guarniere had no disclosures.

A version of this article appeared on Medscape.com.