TOPLINE:

In middle-aged and older men with hypogonadism, excluding those at high prostate cancer risk, testosterone replacement therapy (TRT) showed low rates of adverse prostate events, including cancer.

METHODOLOGY:

• Uncertainty and concern exist about a link between prostate cancer risk and testosterone levels. Most professional society guidelines recommend against TRT in men with a history of or an increased risk for prostate cancer.
• The Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men  included 5204 men (ages 45-80, 17% Black, 80% White), randomly assigned to receive testosterone gel or placebo.
• Men with a history of cardiovascular disease or increased cardiovascular risk were evaluated to exclude those at increased prostate cancer risk (fasting testosterone < 300 ng/dL, ≥ 1 hypogonadal symptoms).
• The primary prostate safety endpoint was high-grade prostate cancer incidence (Gleason score, ≥ 4 + 3).
• Secondary endpoints were incidences of any prostate cancer, acute urinary retention, invasive procedure for benign prostatic hyperplasia, prostate biopsy, and new pharmacologic treatment for lower urinary tract symptoms.

TAKEAWAY:

• During 14,304 person-years of follow-up, high-grade prostate cancer incidence did not differ significantly between the TRT and placebo (0.19% vs 0.12%; P = .51) groups.
• The incidences of prostate cancer, acute urinary retention, invasive procedures for benign prostatic hyperplasia, prostate biopsy, and new pharmacologic treatment for lower urinary tract symptoms were also similar between the groups.
• TRT did not lead to an increase in lower urinary tract symptoms.
• The increase in prostate-specific antigen (PSA) levels was higher in the TRT group than in the placebo group (P < .001). However, the between-group difference did not widen after 12 months.

IN PRACTICE:

For “clinicians and patients who are considering testosterone replacement therapy for hypogonadism,” wrote the authors, “the study’s findings will facilitate a more informed appraisal of the potential prostate risks of testosterone replacement therapy.”

SOURCE:

Shalender Bhasin, MB, BS, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, led the study. It was published online in JAMA Network Open.

LIMITATIONS:

• The study findings do not apply to men with known prostate cancer or higher PSA values or those without confirmed hypogonadism.
• Although the TRAVERSE study was longer than many contemporary trials, carcinogens may require many years to induce malignant neoplasms.
• The trial’s structured evaluation of men after PSA testing did not include prostate imaging or other biomarker tests, which could affect the decision to perform a biopsy.

DISCLOSURES:

This study was funded by a consortium of testosterone manufacturers led by AbbVie Inc with additional financial support from Endo Pharmaceuticals, Acerus Pharmaceuticals Corp, and Upsher-Smith Laboratories. Mr. Bhasin and two coauthors declared receiving grants, consulting and personal fees, and other ties with pharmaceutical and device companies and other sources.

A version of this article appeared on Medscape.com.

TOPLINE:

In middle-aged and older men with hypogonadism, excluding those at high prostate cancer risk, testosterone replacement therapy (TRT) showed low rates of adverse prostate events, including cancer.

METHODOLOGY:

• Uncertainty and concern exist about a link between prostate cancer risk and testosterone levels. Most professional society guidelines recommend against TRT in men with a history of or an increased risk for prostate cancer.
• The Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men  included 5204 men (ages 45-80, 17% Black, 80% White), randomly assigned to receive testosterone gel or placebo.
• Men with a history of cardiovascular disease or increased cardiovascular risk were evaluated to exclude those at increased prostate cancer risk (fasting testosterone < 300 ng/dL, ≥ 1 hypogonadal symptoms).
• The primary prostate safety endpoint was high-grade prostate cancer incidence (Gleason score, ≥ 4 + 3).
• Secondary endpoints were incidences of any prostate cancer, acute urinary retention, invasive procedure for benign prostatic hyperplasia, prostate biopsy, and new pharmacologic treatment for lower urinary tract symptoms.

TAKEAWAY:

• During 14,304 person-years of follow-up, high-grade prostate cancer incidence did not differ significantly between the TRT and placebo (0.19% vs 0.12%; P = .51) groups.
• The incidences of prostate cancer, acute urinary retention, invasive procedures for benign prostatic hyperplasia, prostate biopsy, and new pharmacologic treatment for lower urinary tract symptoms were also similar between the groups.
• TRT did not lead to an increase in lower urinary tract symptoms.
• The increase in prostate-specific antigen (PSA) levels was higher in the TRT group than in the placebo group (P < .001). However, the between-group difference did not widen after 12 months.

IN PRACTICE:

For “clinicians and patients who are considering testosterone replacement therapy for hypogonadism,” wrote the authors, “the study’s findings will facilitate a more informed appraisal of the potential prostate risks of testosterone replacement therapy.”

SOURCE:

Shalender Bhasin, MB, BS, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, led the study. It was published online in JAMA Network Open.

LIMITATIONS:

• The study findings do not apply to men with known prostate cancer or higher PSA values or those without confirmed hypogonadism.
• Although the TRAVERSE study was longer than many contemporary trials, carcinogens may require many years to induce malignant neoplasms.
• The trial’s structured evaluation of men after PSA testing did not include prostate imaging or other biomarker tests, which could affect the decision to perform a biopsy.

DISCLOSURES:

This study was funded by a consortium of testosterone manufacturers led by AbbVie Inc with additional financial support from Endo Pharmaceuticals, Acerus Pharmaceuticals Corp, and Upsher-Smith Laboratories. Mr. Bhasin and two coauthors declared receiving grants, consulting and personal fees, and other ties with pharmaceutical and device companies and other sources.

A version of this article appeared on Medscape.com.

TOPLINE:

In middle-aged and older men with hypogonadism, excluding those at high prostate cancer risk, testosterone replacement therapy (TRT) showed low rates of adverse prostate events, including cancer.

METHODOLOGY:

• Uncertainty and concern exist about a link between prostate cancer risk and testosterone levels. Most professional society guidelines recommend against TRT in men with a history of or an increased risk for prostate cancer.
• The Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men  included 5204 men (ages 45-80, 17% Black, 80% White), randomly assigned to receive testosterone gel or placebo.
• Men with a history of cardiovascular disease or increased cardiovascular risk were evaluated to exclude those at increased prostate cancer risk (fasting testosterone < 300 ng/dL, ≥ 1 hypogonadal symptoms).
• The primary prostate safety endpoint was high-grade prostate cancer incidence (Gleason score, ≥ 4 + 3).
• Secondary endpoints were incidences of any prostate cancer, acute urinary retention, invasive procedure for benign prostatic hyperplasia, prostate biopsy, and new pharmacologic treatment for lower urinary tract symptoms.

TAKEAWAY:

• During 14,304 person-years of follow-up, high-grade prostate cancer incidence did not differ significantly between the TRT and placebo (0.19% vs 0.12%; P = .51) groups.
• The incidences of prostate cancer, acute urinary retention, invasive procedures for benign prostatic hyperplasia, prostate biopsy, and new pharmacologic treatment for lower urinary tract symptoms were also similar between the groups.
• TRT did not lead to an increase in lower urinary tract symptoms.
• The increase in prostate-specific antigen (PSA) levels was higher in the TRT group than in the placebo group (P < .001). However, the between-group difference did not widen after 12 months.

IN PRACTICE:

For “clinicians and patients who are considering testosterone replacement therapy for hypogonadism,” wrote the authors, “the study’s findings will facilitate a more informed appraisal of the potential prostate risks of testosterone replacement therapy.”

SOURCE:

Shalender Bhasin, MB, BS, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, led the study. It was published online in JAMA Network Open.

LIMITATIONS:

• The study findings do not apply to men with known prostate cancer or higher PSA values or those without confirmed hypogonadism.
• Although the TRAVERSE study was longer than many contemporary trials, carcinogens may require many years to induce malignant neoplasms.
• The trial’s structured evaluation of men after PSA testing did not include prostate imaging or other biomarker tests, which could affect the decision to perform a biopsy.

DISCLOSURES:

This study was funded by a consortium of testosterone manufacturers led by AbbVie Inc with additional financial support from Endo Pharmaceuticals, Acerus Pharmaceuticals Corp, and Upsher-Smith Laboratories. Mr. Bhasin and two coauthors declared receiving grants, consulting and personal fees, and other ties with pharmaceutical and device companies and other sources.

A version of this article appeared on Medscape.com.

Radiation oncologists from the largest professional societies have come together to lobby for Medicare payment reform.

The American Society for Radiation Oncology (ASTRO) recently announced its partnership with three other groups — the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology — to change how the specialty is paid for services. 

Over the past decade, radiation oncologists have seen a 23% drop in Medicare reimbursement for radiation therapy services, with more cuts to come, according to a press release from ASTRO.

Traditionally, Medicare has reimbursed on the basis of the fraction of radiation delivered. But with moves toward hypofractionated regimens, deescalated therapy, and other changes in the field, reimbursement has continued to dwindle. 

The cuts have led to practice consolidation and closures that threaten patient access especially in rural and underserved areas, a spokesperson for the group told this news organization.

To reverse this trend, ASTRO recently proposed the Radiation Oncology Case Rate program, a legislative initiative to base reimbursements on patient volumes instead of fractions delivered. 

ASTRO is currently drafting a congressional bill to change the current payment structure, which “has become untenable,” the spokesperson said. 

A version of this article appeared on Medscape.com.

Radiation oncologists from the largest professional societies have come together to lobby for Medicare payment reform.

The American Society for Radiation Oncology (ASTRO) recently announced its partnership with three other groups — the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology — to change how the specialty is paid for services. 

Over the past decade, radiation oncologists have seen a 23% drop in Medicare reimbursement for radiation therapy services, with more cuts to come, according to a press release from ASTRO.

Traditionally, Medicare has reimbursed on the basis of the fraction of radiation delivered. But with moves toward hypofractionated regimens, deescalated therapy, and other changes in the field, reimbursement has continued to dwindle. 

The cuts have led to practice consolidation and closures that threaten patient access especially in rural and underserved areas, a spokesperson for the group told this news organization.

To reverse this trend, ASTRO recently proposed the Radiation Oncology Case Rate program, a legislative initiative to base reimbursements on patient volumes instead of fractions delivered. 

ASTRO is currently drafting a congressional bill to change the current payment structure, which “has become untenable,” the spokesperson said. 

A version of this article appeared on Medscape.com.

Radiation oncologists from the largest professional societies have come together to lobby for Medicare payment reform.

The American Society for Radiation Oncology (ASTRO) recently announced its partnership with three other groups — the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology — to change how the specialty is paid for services. 

Over the past decade, radiation oncologists have seen a 23% drop in Medicare reimbursement for radiation therapy services, with more cuts to come, according to a press release from ASTRO.

Traditionally, Medicare has reimbursed on the basis of the fraction of radiation delivered. But with moves toward hypofractionated regimens, deescalated therapy, and other changes in the field, reimbursement has continued to dwindle. 

The cuts have led to practice consolidation and closures that threaten patient access especially in rural and underserved areas, a spokesperson for the group told this news organization.

To reverse this trend, ASTRO recently proposed the Radiation Oncology Case Rate program, a legislative initiative to base reimbursements on patient volumes instead of fractions delivered. 

ASTRO is currently drafting a congressional bill to change the current payment structure, which “has become untenable,” the spokesperson said. 

A version of this article appeared on Medscape.com.

The US Preventive Services Task Force (USPSTF) has published draft recommendations that 6-year-olds with obesity be lectured to about diet and exercise.

Never mind that there are no reproducible or scalable studies demonstrating durable and clinically meaningful benefits of this for adults let alone children. Never mind that children are not household decision-makers on matters of grocery shopping, cooking, or exercise. Never mind the corollary that many children so lectured who fail to see an impact on their weight will perceive that as their own personal failures. And of course, never mind that we’re privileged to be in an era with safe, effective, pharmacotherapeutic options for obesity. No. We must teach children it’s their fault if they’re fat. Because ultimately that’s what many of them will learn.

That’s not to say there’s no room for counseling. But with children as young as 6, that counseling should be delivered exclusively to their parents and caregivers. That counseling should focus as much if not more so on the impact of weight bias and the biological basis of obesity rather than diet and exercise, while explicitly teaching parents the means to discuss nutrition without risking their children feeling worse about themselves, increasing the risk for conflict over changes, or heightening their children’s chance of developing eating disorders or maladaptive relationships with food.

But back to the USPSTF’s actual recommendation for those 6 years old and up. They’re recommending “at least” 26 hours of lectures over a year-long interprofessional intervention. Putting aside the reality that this isn’t scalable time-wise or cost-wise to reach even a fraction of the roughly 15 million US children with obesity, there is also the issue of service provision. Because when it comes to obesity, if the intervention is purely educational, even if you want to believe there is a syllabus out there that would have a dramatic impact, its impact will vary wildly depending on the skill and approach of the service providers. This inconvenient truth is also the one that makes it impossible to meaningfully compare program outcomes even when they share the same content.

The USPSTF’s draft recommendations also explicitly avoid what the American Academy of Pediatrics has rightly embraced: the use where appropriate of medications or surgery. While opponents of the use of pharmacotherapy for childhood obesity tend to point to a lack of long-term data as rationale for its denial, something that the USPSTF has done, again, we have long-term data demonstrating a lack of scalable, clinically meaningful efficacy for service only based programs.

Childhood obesity is a flood and its ongoing current is relentless. Given its tremendous impact, especially at its extremes, on both physical and mental health, this is yet another example of systemic weight bias in action — it’s as if the USPSTF is recommending a swimming lesson–only approach while actively fearmongering, despite an absence of plausible mechanistic risk, about the long-term use of life jackets.

Dr. Freedhoff is associate professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. Dr. Freedhoff has disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.

A version of this article appeared on Medscape.com.

The US Preventive Services Task Force (USPSTF) has published draft recommendations that 6-year-olds with obesity be lectured to about diet and exercise.

Never mind that there are no reproducible or scalable studies demonstrating durable and clinically meaningful benefits of this for adults let alone children. Never mind that children are not household decision-makers on matters of grocery shopping, cooking, or exercise. Never mind the corollary that many children so lectured who fail to see an impact on their weight will perceive that as their own personal failures. And of course, never mind that we’re privileged to be in an era with safe, effective, pharmacotherapeutic options for obesity. No. We must teach children it’s their fault if they’re fat. Because ultimately that’s what many of them will learn.

That’s not to say there’s no room for counseling. But with children as young as 6, that counseling should be delivered exclusively to their parents and caregivers. That counseling should focus as much if not more so on the impact of weight bias and the biological basis of obesity rather than diet and exercise, while explicitly teaching parents the means to discuss nutrition without risking their children feeling worse about themselves, increasing the risk for conflict over changes, or heightening their children’s chance of developing eating disorders or maladaptive relationships with food.

But back to the USPSTF’s actual recommendation for those 6 years old and up. They’re recommending “at least” 26 hours of lectures over a year-long interprofessional intervention. Putting aside the reality that this isn’t scalable time-wise or cost-wise to reach even a fraction of the roughly 15 million US children with obesity, there is also the issue of service provision. Because when it comes to obesity, if the intervention is purely educational, even if you want to believe there is a syllabus out there that would have a dramatic impact, its impact will vary wildly depending on the skill and approach of the service providers. This inconvenient truth is also the one that makes it impossible to meaningfully compare program outcomes even when they share the same content.

The USPSTF’s draft recommendations also explicitly avoid what the American Academy of Pediatrics has rightly embraced: the use where appropriate of medications or surgery. While opponents of the use of pharmacotherapy for childhood obesity tend to point to a lack of long-term data as rationale for its denial, something that the USPSTF has done, again, we have long-term data demonstrating a lack of scalable, clinically meaningful efficacy for service only based programs.

Childhood obesity is a flood and its ongoing current is relentless. Given its tremendous impact, especially at its extremes, on both physical and mental health, this is yet another example of systemic weight bias in action — it’s as if the USPSTF is recommending a swimming lesson–only approach while actively fearmongering, despite an absence of plausible mechanistic risk, about the long-term use of life jackets.

Dr. Freedhoff is associate professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. Dr. Freedhoff has disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.

A version of this article appeared on Medscape.com.

The US Preventive Services Task Force (USPSTF) has published draft recommendations that 6-year-olds with obesity be lectured to about diet and exercise.

Never mind that there are no reproducible or scalable studies demonstrating durable and clinically meaningful benefits of this for adults let alone children. Never mind that children are not household decision-makers on matters of grocery shopping, cooking, or exercise. Never mind the corollary that many children so lectured who fail to see an impact on their weight will perceive that as their own personal failures. And of course, never mind that we’re privileged to be in an era with safe, effective, pharmacotherapeutic options for obesity. No. We must teach children it’s their fault if they’re fat. Because ultimately that’s what many of them will learn.

That’s not to say there’s no room for counseling. But with children as young as 6, that counseling should be delivered exclusively to their parents and caregivers. That counseling should focus as much if not more so on the impact of weight bias and the biological basis of obesity rather than diet and exercise, while explicitly teaching parents the means to discuss nutrition without risking their children feeling worse about themselves, increasing the risk for conflict over changes, or heightening their children’s chance of developing eating disorders or maladaptive relationships with food.

But back to the USPSTF’s actual recommendation for those 6 years old and up. They’re recommending “at least” 26 hours of lectures over a year-long interprofessional intervention. Putting aside the reality that this isn’t scalable time-wise or cost-wise to reach even a fraction of the roughly 15 million US children with obesity, there is also the issue of service provision. Because when it comes to obesity, if the intervention is purely educational, even if you want to believe there is a syllabus out there that would have a dramatic impact, its impact will vary wildly depending on the skill and approach of the service providers. This inconvenient truth is also the one that makes it impossible to meaningfully compare program outcomes even when they share the same content.

The USPSTF’s draft recommendations also explicitly avoid what the American Academy of Pediatrics has rightly embraced: the use where appropriate of medications or surgery. While opponents of the use of pharmacotherapy for childhood obesity tend to point to a lack of long-term data as rationale for its denial, something that the USPSTF has done, again, we have long-term data demonstrating a lack of scalable, clinically meaningful efficacy for service only based programs.

Childhood obesity is a flood and its ongoing current is relentless. Given its tremendous impact, especially at its extremes, on both physical and mental health, this is yet another example of systemic weight bias in action — it’s as if the USPSTF is recommending a swimming lesson–only approach while actively fearmongering, despite an absence of plausible mechanistic risk, about the long-term use of life jackets.

Dr. Freedhoff is associate professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. Dr. Freedhoff has disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.

A version of this article appeared on Medscape.com.

Primary aldosteronism (PA) is a frequently overlooked yet common cause of secondary hypertension, presenting significant risk for cardiovascular morbidity and mortality.

But fewer than 4% of at-risk patients receive the recommended screening for PA, leaving a substantial gap in early detection and management, according to Adina F. Turcu, MD, MS, associate professor in endocrinology and internal medicine at University of Michigan Health in Ann Arbor. 

In response to this clinical challenge, Dr. Turcu and her colleagues developed a best-practice advisory (BPA) to identify patients who were at risk for PA and embedded it into electronic health record at University of Michigan ambulatory clinics. Her team found that use of the tool led to increased rates of screening for PA, particularly among primary care physicians.

Over a 15-month period, Dr. Turcu and her colleagues tested the BPA through a quality improvement study, identifying 14,603 unique candidates for PA screening, with a mean age of 65.5 years and a diverse representation of ethnic backgrounds. 

Notably, 48.1% of these candidates had treatment-resistant hypertension, 43.5% exhibited hypokalemia, 10.5% were younger than 35 years, and 3.1% had adrenal nodules. Of these candidates, 14.0% received orders for PA screening, with 70.5% completing the recommended screening within the system, and 17.4% receiving positive screening results. 

The study, conducted over 6 months in 2023, targeted adults with hypertension and at least one of the following: Those who took four or more antihypertensive medications, exhibited hypokalemia, were younger than age 35 years, or had adrenal nodules. Patients previously tested for PA were excluded from the analysis. 

The noninterruptive BPA was triggered during outpatient visits with clinicians who specialized in hypertension. The advisory would then offer an order set for PA screening and provide a link to interpretation guidance for results. Clinicians had the option to use, ignore, or decline the BPA.

“Although we were hoping for broader uptake of this EHR-embedded BPA, we were delighted to see an increase in PA screening rates to 14% of identified candidates as compared to an average of less than 3% in retrospective studies of similar populations, including in our own institution prior to implementing this BPA,” Dr. Turcu told this news organization.

Physician specialty played a crucial role in the utilization of the BPA. Internists and family medicine physicians accounted for the majority of screening orders, placing 40.0% and 28.1% of these, respectively. Family practitioners and internists predominantly used the embedded order set (80.3% and 68.9%, respectively).

“Hypertension often gets treated rather than screening for [causes of] secondary hypertension prior to treatment,” said Kaniksha Desai, MD, clinical associate professor and endocrinology quality director at Stanford University School of Medicine, Stanford, California, who was not involved in the research. But “primary hyperaldosteronism is a condition that can be treated surgically and has increased long term cardiovascular consequences if not identified. While guidelines recommend screening at-risk patients, this often can get lost in translation in clinical practice due to many factors, including time constraints and volume of patients.” 

Patients who did vs did not undergo screening were more likely to be women, Black, and younger than age 35 years. Additionally, the likelihood of screening was higher among patients with obesity and dyslipidemia, whereas it was lower in those with chronic kidney disease and established cardiovascular complications.

According to Dr. Turcu, the findings from this study suggest that noninterruptive BPAs, especially when integrated into primary care workflows, hold promise as effective tools for PA screening.

When coupled with artificial intelligence to optimize detection yield, these refined BPAs could significantly contribute to personalized care for hypertension, the investigators said. 

“Considering that in the United States almost one in two adults has hypertension, such automatized tools become instrumental to busy clinicians, particularly those in primary care,” Dr. Turcu said. “Our results indicate a promising opportunity to meaningfully improve PA awareness and enhance its diagnosis.” 

Dr. Turcu reported receiving grants from the National Heart, Lung, and Blood Institute and Doris Duke Foundation, served as an investigator in a CinCor Pharma clinical trial, and received financial support to her institution during the conduct of the study. Dr. Desai reported no relevant financial disclosures. 
 

A version of this article appeared on Medscape.com.

Primary aldosteronism (PA) is a frequently overlooked yet common cause of secondary hypertension, presenting significant risk for cardiovascular morbidity and mortality.

But fewer than 4% of at-risk patients receive the recommended screening for PA, leaving a substantial gap in early detection and management, according to Adina F. Turcu, MD, MS, associate professor in endocrinology and internal medicine at University of Michigan Health in Ann Arbor. 

In response to this clinical challenge, Dr. Turcu and her colleagues developed a best-practice advisory (BPA) to identify patients who were at risk for PA and embedded it into electronic health record at University of Michigan ambulatory clinics. Her team found that use of the tool led to increased rates of screening for PA, particularly among primary care physicians.

Over a 15-month period, Dr. Turcu and her colleagues tested the BPA through a quality improvement study, identifying 14,603 unique candidates for PA screening, with a mean age of 65.5 years and a diverse representation of ethnic backgrounds. 

Notably, 48.1% of these candidates had treatment-resistant hypertension, 43.5% exhibited hypokalemia, 10.5% were younger than 35 years, and 3.1% had adrenal nodules. Of these candidates, 14.0% received orders for PA screening, with 70.5% completing the recommended screening within the system, and 17.4% receiving positive screening results. 

The study, conducted over 6 months in 2023, targeted adults with hypertension and at least one of the following: Those who took four or more antihypertensive medications, exhibited hypokalemia, were younger than age 35 years, or had adrenal nodules. Patients previously tested for PA were excluded from the analysis. 

The noninterruptive BPA was triggered during outpatient visits with clinicians who specialized in hypertension. The advisory would then offer an order set for PA screening and provide a link to interpretation guidance for results. Clinicians had the option to use, ignore, or decline the BPA.

“Although we were hoping for broader uptake of this EHR-embedded BPA, we were delighted to see an increase in PA screening rates to 14% of identified candidates as compared to an average of less than 3% in retrospective studies of similar populations, including in our own institution prior to implementing this BPA,” Dr. Turcu told this news organization.

Physician specialty played a crucial role in the utilization of the BPA. Internists and family medicine physicians accounted for the majority of screening orders, placing 40.0% and 28.1% of these, respectively. Family practitioners and internists predominantly used the embedded order set (80.3% and 68.9%, respectively).

“Hypertension often gets treated rather than screening for [causes of] secondary hypertension prior to treatment,” said Kaniksha Desai, MD, clinical associate professor and endocrinology quality director at Stanford University School of Medicine, Stanford, California, who was not involved in the research. But “primary hyperaldosteronism is a condition that can be treated surgically and has increased long term cardiovascular consequences if not identified. While guidelines recommend screening at-risk patients, this often can get lost in translation in clinical practice due to many factors, including time constraints and volume of patients.” 

Patients who did vs did not undergo screening were more likely to be women, Black, and younger than age 35 years. Additionally, the likelihood of screening was higher among patients with obesity and dyslipidemia, whereas it was lower in those with chronic kidney disease and established cardiovascular complications.

According to Dr. Turcu, the findings from this study suggest that noninterruptive BPAs, especially when integrated into primary care workflows, hold promise as effective tools for PA screening.

When coupled with artificial intelligence to optimize detection yield, these refined BPAs could significantly contribute to personalized care for hypertension, the investigators said. 

“Considering that in the United States almost one in two adults has hypertension, such automatized tools become instrumental to busy clinicians, particularly those in primary care,” Dr. Turcu said. “Our results indicate a promising opportunity to meaningfully improve PA awareness and enhance its diagnosis.” 

Dr. Turcu reported receiving grants from the National Heart, Lung, and Blood Institute and Doris Duke Foundation, served as an investigator in a CinCor Pharma clinical trial, and received financial support to her institution during the conduct of the study. Dr. Desai reported no relevant financial disclosures. 
 

A version of this article appeared on Medscape.com.

Primary aldosteronism (PA) is a frequently overlooked yet common cause of secondary hypertension, presenting significant risk for cardiovascular morbidity and mortality.

But fewer than 4% of at-risk patients receive the recommended screening for PA, leaving a substantial gap in early detection and management, according to Adina F. Turcu, MD, MS, associate professor in endocrinology and internal medicine at University of Michigan Health in Ann Arbor. 

In response to this clinical challenge, Dr. Turcu and her colleagues developed a best-practice advisory (BPA) to identify patients who were at risk for PA and embedded it into electronic health record at University of Michigan ambulatory clinics. Her team found that use of the tool led to increased rates of screening for PA, particularly among primary care physicians.

Over a 15-month period, Dr. Turcu and her colleagues tested the BPA through a quality improvement study, identifying 14,603 unique candidates for PA screening, with a mean age of 65.5 years and a diverse representation of ethnic backgrounds. 

Notably, 48.1% of these candidates had treatment-resistant hypertension, 43.5% exhibited hypokalemia, 10.5% were younger than 35 years, and 3.1% had adrenal nodules. Of these candidates, 14.0% received orders for PA screening, with 70.5% completing the recommended screening within the system, and 17.4% receiving positive screening results. 

The study, conducted over 6 months in 2023, targeted adults with hypertension and at least one of the following: Those who took four or more antihypertensive medications, exhibited hypokalemia, were younger than age 35 years, or had adrenal nodules. Patients previously tested for PA were excluded from the analysis. 

The noninterruptive BPA was triggered during outpatient visits with clinicians who specialized in hypertension. The advisory would then offer an order set for PA screening and provide a link to interpretation guidance for results. Clinicians had the option to use, ignore, or decline the BPA.

“Although we were hoping for broader uptake of this EHR-embedded BPA, we were delighted to see an increase in PA screening rates to 14% of identified candidates as compared to an average of less than 3% in retrospective studies of similar populations, including in our own institution prior to implementing this BPA,” Dr. Turcu told this news organization.

Physician specialty played a crucial role in the utilization of the BPA. Internists and family medicine physicians accounted for the majority of screening orders, placing 40.0% and 28.1% of these, respectively. Family practitioners and internists predominantly used the embedded order set (80.3% and 68.9%, respectively).

“Hypertension often gets treated rather than screening for [causes of] secondary hypertension prior to treatment,” said Kaniksha Desai, MD, clinical associate professor and endocrinology quality director at Stanford University School of Medicine, Stanford, California, who was not involved in the research. But “primary hyperaldosteronism is a condition that can be treated surgically and has increased long term cardiovascular consequences if not identified. While guidelines recommend screening at-risk patients, this often can get lost in translation in clinical practice due to many factors, including time constraints and volume of patients.” 

Patients who did vs did not undergo screening were more likely to be women, Black, and younger than age 35 years. Additionally, the likelihood of screening was higher among patients with obesity and dyslipidemia, whereas it was lower in those with chronic kidney disease and established cardiovascular complications.

According to Dr. Turcu, the findings from this study suggest that noninterruptive BPAs, especially when integrated into primary care workflows, hold promise as effective tools for PA screening.

When coupled with artificial intelligence to optimize detection yield, these refined BPAs could significantly contribute to personalized care for hypertension, the investigators said. 

“Considering that in the United States almost one in two adults has hypertension, such automatized tools become instrumental to busy clinicians, particularly those in primary care,” Dr. Turcu said. “Our results indicate a promising opportunity to meaningfully improve PA awareness and enhance its diagnosis.” 

Dr. Turcu reported receiving grants from the National Heart, Lung, and Blood Institute and Doris Duke Foundation, served as an investigator in a CinCor Pharma clinical trial, and received financial support to her institution during the conduct of the study. Dr. Desai reported no relevant financial disclosures. 
 

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with locally advanced rectal cancer fare better with standard preoperative chemoradiation followed by surgery than with primary surgery and adjuvant chemoradiation, demonstrating better disease-free survival and lower recurrence rates.

METHODOLOGY:

• The standard treatment of locally advanced rectal cancer is chemoradiation followed by surgery, which is known to reduce the likelihood of local recurrence; however, it is also linked to adverse effects including  and bowel/sexual dysfunction.
• A previous trial found that preoperative MRI could delineate tumor involvement of the mesorectal fascia (MRF).
• This Chinese, noninferiority trial tested whether patients with locally advanced rectal cancer with MRI-predicted negative MRF can skip preoperative chemoradiation.
• The study included 275 patients with T3-4aN0 or T1-4aN1-2 rectal adenocarcinoma, an inferior tumor edge 6-12 cm from the anal verge, and gross primary or nodal disease > 1 mm from the MRF — all based on preoperative MRI.
• Patients in the intervention group, 140, were assigned to neoadjuvant chemoradiation (50.4 Gy in 28 fractions with  followed by capecitabine/ started 4 weeks after surgery) and the remaining 135 to upfront surgery followed by adjuvant chemo/chemoradiation when there was tumor within 1 mm of circumferential margins.

TAKEAWAY:

• After a median follow-up of 34.6 months, there were six (4.4%) local recurrences in the intervention group and none in the control group.
• In the intention-to-treat population, the 3-year disease-free survival rate was 81.8% in the intervention group vs 85.4% in the control group (hazard ratio [HR], 1.76).
• In the per protocol dataset, the 3-year disease-free survival rate was 81.1% in the primary surgery group vs 86.6% in the preoperative chemoradiation group — a difference of −5.4% (HR, 2.02), prompting the researchers to stop the trial early.

IN PRACTICE:

“This trial was shut down earlier due to an excessive number of [disease-free survival] and local recurrence events observed in the interventional group of primary surgery. Based on our findings, in [locally advanced rectal cancer] patients with high risk though negative MRF, primary surgery would potentially compromise their [disease-free survival] rates. Therefore, primary surgery is an inferior strategy, compared to preoperative [chemoradiation] followed by surgery, and cannot be recommended for [locally advanced rectal cancer] patients in clinical practice,” the authors concluded.

SOURCE:

The study, with first author Jun Li, MD, Department of Colorectal Surgery and Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China, was published online in the International Journal of Radiation Oncology, Biology, Physics.

LIMITATIONS:

The limited sample size will result in compromises in stratified randomization and lower the power for survival analysis. A relatively high proportion of patients (n = 32) crossed over from the neoadjuvant (chemoradiation) group to the primary surgery group. Follow-up time was relatively short, with only 43% of patients completing 3 years of follow-up.

DISCLOSURES:

The study received no commercial funding. The authors had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with locally advanced rectal cancer fare better with standard preoperative chemoradiation followed by surgery than with primary surgery and adjuvant chemoradiation, demonstrating better disease-free survival and lower recurrence rates.

METHODOLOGY:

• The standard treatment of locally advanced rectal cancer is chemoradiation followed by surgery, which is known to reduce the likelihood of local recurrence; however, it is also linked to adverse effects including  and bowel/sexual dysfunction.
• A previous trial found that preoperative MRI could delineate tumor involvement of the mesorectal fascia (MRF).
• This Chinese, noninferiority trial tested whether patients with locally advanced rectal cancer with MRI-predicted negative MRF can skip preoperative chemoradiation.
• The study included 275 patients with T3-4aN0 or T1-4aN1-2 rectal adenocarcinoma, an inferior tumor edge 6-12 cm from the anal verge, and gross primary or nodal disease > 1 mm from the MRF — all based on preoperative MRI.
• Patients in the intervention group, 140, were assigned to neoadjuvant chemoradiation (50.4 Gy in 28 fractions with  followed by capecitabine/ started 4 weeks after surgery) and the remaining 135 to upfront surgery followed by adjuvant chemo/chemoradiation when there was tumor within 1 mm of circumferential margins.

TAKEAWAY:

• After a median follow-up of 34.6 months, there were six (4.4%) local recurrences in the intervention group and none in the control group.
• In the intention-to-treat population, the 3-year disease-free survival rate was 81.8% in the intervention group vs 85.4% in the control group (hazard ratio [HR], 1.76).
• In the per protocol dataset, the 3-year disease-free survival rate was 81.1% in the primary surgery group vs 86.6% in the preoperative chemoradiation group — a difference of −5.4% (HR, 2.02), prompting the researchers to stop the trial early.

IN PRACTICE:

“This trial was shut down earlier due to an excessive number of [disease-free survival] and local recurrence events observed in the interventional group of primary surgery. Based on our findings, in [locally advanced rectal cancer] patients with high risk though negative MRF, primary surgery would potentially compromise their [disease-free survival] rates. Therefore, primary surgery is an inferior strategy, compared to preoperative [chemoradiation] followed by surgery, and cannot be recommended for [locally advanced rectal cancer] patients in clinical practice,” the authors concluded.

SOURCE:

The study, with first author Jun Li, MD, Department of Colorectal Surgery and Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China, was published online in the International Journal of Radiation Oncology, Biology, Physics.

LIMITATIONS:

The limited sample size will result in compromises in stratified randomization and lower the power for survival analysis. A relatively high proportion of patients (n = 32) crossed over from the neoadjuvant (chemoradiation) group to the primary surgery group. Follow-up time was relatively short, with only 43% of patients completing 3 years of follow-up.

DISCLOSURES:

The study received no commercial funding. The authors had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with locally advanced rectal cancer fare better with standard preoperative chemoradiation followed by surgery than with primary surgery and adjuvant chemoradiation, demonstrating better disease-free survival and lower recurrence rates.

METHODOLOGY:

• The standard treatment of locally advanced rectal cancer is chemoradiation followed by surgery, which is known to reduce the likelihood of local recurrence; however, it is also linked to adverse effects including  and bowel/sexual dysfunction.
• A previous trial found that preoperative MRI could delineate tumor involvement of the mesorectal fascia (MRF).
• This Chinese, noninferiority trial tested whether patients with locally advanced rectal cancer with MRI-predicted negative MRF can skip preoperative chemoradiation.
• The study included 275 patients with T3-4aN0 or T1-4aN1-2 rectal adenocarcinoma, an inferior tumor edge 6-12 cm from the anal verge, and gross primary or nodal disease > 1 mm from the MRF — all based on preoperative MRI.
• Patients in the intervention group, 140, were assigned to neoadjuvant chemoradiation (50.4 Gy in 28 fractions with  followed by capecitabine/ started 4 weeks after surgery) and the remaining 135 to upfront surgery followed by adjuvant chemo/chemoradiation when there was tumor within 1 mm of circumferential margins.

TAKEAWAY:

• After a median follow-up of 34.6 months, there were six (4.4%) local recurrences in the intervention group and none in the control group.
• In the intention-to-treat population, the 3-year disease-free survival rate was 81.8% in the intervention group vs 85.4% in the control group (hazard ratio [HR], 1.76).
• In the per protocol dataset, the 3-year disease-free survival rate was 81.1% in the primary surgery group vs 86.6% in the preoperative chemoradiation group — a difference of −5.4% (HR, 2.02), prompting the researchers to stop the trial early.

IN PRACTICE:

“This trial was shut down earlier due to an excessive number of [disease-free survival] and local recurrence events observed in the interventional group of primary surgery. Based on our findings, in [locally advanced rectal cancer] patients with high risk though negative MRF, primary surgery would potentially compromise their [disease-free survival] rates. Therefore, primary surgery is an inferior strategy, compared to preoperative [chemoradiation] followed by surgery, and cannot be recommended for [locally advanced rectal cancer] patients in clinical practice,” the authors concluded.

SOURCE:

The study, with first author Jun Li, MD, Department of Colorectal Surgery and Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China, was published online in the International Journal of Radiation Oncology, Biology, Physics.

LIMITATIONS:

The limited sample size will result in compromises in stratified randomization and lower the power for survival analysis. A relatively high proportion of patients (n = 32) crossed over from the neoadjuvant (chemoradiation) group to the primary surgery group. Follow-up time was relatively short, with only 43% of patients completing 3 years of follow-up.

DISCLOSURES:

The study received no commercial funding. The authors had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

New data link smoking and heavy drinking with an increased risk for diverticulitis, with the greatest risk seen in adults who smoke and consume two or more drinks daily.

METHODOLOGY:

• Researchers studied 84,232 women in the Nurses’ Health Study II who were 39-52 years old and without known diverticulitis at baseline in 2003. 
• In 2015 and 2017, participants were asked via questionnaire whether they had been diagnosed with diverticulitis requiring antibiotic therapy or hospitalization. Diverticulitis was defined as a computed tomography scan or pathology report of diverticulitis or a provider diagnosis with a clinical presentation consistent with diverticulitis. 
• Smoking was assessed every 2 years and alcohol consumption every 4 years using standard questionnaires. 
• Consistent with prior studies on risk factors for diverticulitis, multivariable models adjusted for age, menopausal hormone status and hormone use, body mass index, physical activity, aspirin/nonsteroidal anti-inflammatory drug use, intake of fiber and red/processed meat, and other factors were used. 

TAKEAWAY:

• During more than 1 million person-years of follow-up, 3018 incident cases of diverticulitis were identified. 
• Both current and past smoking were associated with increased risk for diverticulitis (hazard ratio [HR], 1.2) compared with never smoking, although no dose-response relationship was evident. In an analysis restricted to participants who had surgery for diverticulitis, the magnitude of the association was strengthened (HR, 1.48 for current smokers and 1.46 for past smokers vs never smokers). 
• Consumption of ≥ 30 g/d of alcohol (2+ drinks/day) was associated with an increased risk for incident diverticulitis (HR, 1.26) compared with not drinking. 
• A joint analysis of smoking and alcohol found that individuals who ever smoked and consumed ≥ 30 g/d of alcohol were at the highest risk for diverticulitis (multivariate HR, 1.53) compared with individuals who never smoked and reported no alcohol use. 

IN PRACTICE:

“As there are currently no medical means to prevent diverticulitis other than dietary and lifestyle interventions, counseling patients about the avoidance of smoking and alcohol may help lower the risk for developing diverticulitis,” the authors concluded.

SOURCE:

The study, with first author Sara Gunby, MD, University of Washington School of Medicine, Seattle, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

Diverticulitis diagnoses were self-reported, although a review of a subset of medical records confirmed the diagnosis in more than 90% of cases establishing the validity of self-report in this population. The study was limited to female nurses, so it is possible the findings may not be generalizable to men or other populations. Residual confounding may have impacted the results.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health. The authors declared no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

New data link smoking and heavy drinking with an increased risk for diverticulitis, with the greatest risk seen in adults who smoke and consume two or more drinks daily.

METHODOLOGY:

• Researchers studied 84,232 women in the Nurses’ Health Study II who were 39-52 years old and without known diverticulitis at baseline in 2003. 
• In 2015 and 2017, participants were asked via questionnaire whether they had been diagnosed with diverticulitis requiring antibiotic therapy or hospitalization. Diverticulitis was defined as a computed tomography scan or pathology report of diverticulitis or a provider diagnosis with a clinical presentation consistent with diverticulitis. 
• Smoking was assessed every 2 years and alcohol consumption every 4 years using standard questionnaires. 
• Consistent with prior studies on risk factors for diverticulitis, multivariable models adjusted for age, menopausal hormone status and hormone use, body mass index, physical activity, aspirin/nonsteroidal anti-inflammatory drug use, intake of fiber and red/processed meat, and other factors were used. 

TAKEAWAY:

• During more than 1 million person-years of follow-up, 3018 incident cases of diverticulitis were identified. 
• Both current and past smoking were associated with increased risk for diverticulitis (hazard ratio [HR], 1.2) compared with never smoking, although no dose-response relationship was evident. In an analysis restricted to participants who had surgery for diverticulitis, the magnitude of the association was strengthened (HR, 1.48 for current smokers and 1.46 for past smokers vs never smokers). 
• Consumption of ≥ 30 g/d of alcohol (2+ drinks/day) was associated with an increased risk for incident diverticulitis (HR, 1.26) compared with not drinking. 
• A joint analysis of smoking and alcohol found that individuals who ever smoked and consumed ≥ 30 g/d of alcohol were at the highest risk for diverticulitis (multivariate HR, 1.53) compared with individuals who never smoked and reported no alcohol use. 

IN PRACTICE:

“As there are currently no medical means to prevent diverticulitis other than dietary and lifestyle interventions, counseling patients about the avoidance of smoking and alcohol may help lower the risk for developing diverticulitis,” the authors concluded.

SOURCE:

The study, with first author Sara Gunby, MD, University of Washington School of Medicine, Seattle, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

Diverticulitis diagnoses were self-reported, although a review of a subset of medical records confirmed the diagnosis in more than 90% of cases establishing the validity of self-report in this population. The study was limited to female nurses, so it is possible the findings may not be generalizable to men or other populations. Residual confounding may have impacted the results.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health. The authors declared no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

New data link smoking and heavy drinking with an increased risk for diverticulitis, with the greatest risk seen in adults who smoke and consume two or more drinks daily.

METHODOLOGY:

• Researchers studied 84,232 women in the Nurses’ Health Study II who were 39-52 years old and without known diverticulitis at baseline in 2003. 
• In 2015 and 2017, participants were asked via questionnaire whether they had been diagnosed with diverticulitis requiring antibiotic therapy or hospitalization. Diverticulitis was defined as a computed tomography scan or pathology report of diverticulitis or a provider diagnosis with a clinical presentation consistent with diverticulitis. 
• Smoking was assessed every 2 years and alcohol consumption every 4 years using standard questionnaires. 
• Consistent with prior studies on risk factors for diverticulitis, multivariable models adjusted for age, menopausal hormone status and hormone use, body mass index, physical activity, aspirin/nonsteroidal anti-inflammatory drug use, intake of fiber and red/processed meat, and other factors were used. 

TAKEAWAY:

• During more than 1 million person-years of follow-up, 3018 incident cases of diverticulitis were identified. 
• Both current and past smoking were associated with increased risk for diverticulitis (hazard ratio [HR], 1.2) compared with never smoking, although no dose-response relationship was evident. In an analysis restricted to participants who had surgery for diverticulitis, the magnitude of the association was strengthened (HR, 1.48 for current smokers and 1.46 for past smokers vs never smokers). 
• Consumption of ≥ 30 g/d of alcohol (2+ drinks/day) was associated with an increased risk for incident diverticulitis (HR, 1.26) compared with not drinking. 
• A joint analysis of smoking and alcohol found that individuals who ever smoked and consumed ≥ 30 g/d of alcohol were at the highest risk for diverticulitis (multivariate HR, 1.53) compared with individuals who never smoked and reported no alcohol use. 

IN PRACTICE:

“As there are currently no medical means to prevent diverticulitis other than dietary and lifestyle interventions, counseling patients about the avoidance of smoking and alcohol may help lower the risk for developing diverticulitis,” the authors concluded.

SOURCE:

The study, with first author Sara Gunby, MD, University of Washington School of Medicine, Seattle, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

Diverticulitis diagnoses were self-reported, although a review of a subset of medical records confirmed the diagnosis in more than 90% of cases establishing the validity of self-report in this population. The study was limited to female nurses, so it is possible the findings may not be generalizable to men or other populations. Residual confounding may have impacted the results.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health. The authors declared no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

France did it 5 years ago and now, from January 1, the Dutch have followed suit, banning devices such as mobile phones and tablets in classrooms unless needed during lessons, for medical reasons, or by students with disabilities. The ban aims to limit distractions during the school day. 

We could all surely do with some device detox, but the question remains whether too much screen time has an impact on child development. Karen Mansfield, PhD, a postdoctoral researcher on adolescent well-being in the digital age at Oxford University, told this news organization, “The evidence is definitely not set in stone. There have been some recent reviews of screen time effects on children, demonstrating very mixed findings.”

The latest research, said Dr. Mansfield, is still young, lacking consistency in findings, and rife with misinterpretation.

Tiziana Metitieri, a cognitive neuropsychologist at the Meyer Hospital in Florence, Italy, echoed these sentiments, suggesting that the sheer quantity of screen time is an insufficient metric for understanding its impact on cognitive and psychological development. “There are two main reasons for this,” she explained to this news organization. “Firstly, because the current measurements of screen time rely on self-report data, which can be affected by an overestimation or underestimation of objective usage due to social desirability bias. Secondly, because digital experiences differ in terms of content, device used, context, location, and individuals involved.”
 

Are Politicians in Too Much of a Rush?

UNESCO’s most recent report on technology in education highlighted a correlation between excessive mobile phone use and reduced educational performance and emotional stability.

The OECD report “Empowering Young Children in the Digital Age,” rightly suggested there is a need to improve protection in digital environments, bridge the digital divide, and educate parents and teachers on safe digital practices.

But Dr. Mansfield said, “Currently, policy implementation is racing far ahead of the evidence, with similar suggestions to ban smartphones in schools in the United Kingdom and Canada. However, there is no available evidence on the long-term benefits of banning smartphones. Much of the research behind the OECD and UNESCO policies is observational in nature, which limits causal interpretation more than with interventions.”

While most governments are not pursuing restrictive practices, Dr. Metitieri said that “their approaches are based on their political ideology, often using moral panic as a means to rally support, showing their heartfelt commitment to defending against the invasions of digital technology ruining human civilizations.” 

Sakshi Ghai, PhD, Dr. Mansfield’s fellow postdoctoral researcher at Oxford University, reiterated Dr. Metitieri’s concerns, “Screen time as a concept has limitations, and policy guidance needs to be careful when drawing insights from such limited evidence. What do we mean by screen time? How can time spent on different activities be clearly delineated? An oversimplistic focus on screen time may overlook the nuances and complexity of digital media use.”
 

The Key Is the What and Where

Digital screens can be productive for children, such as when used for educational purposes, be it to join a class over Zoom or partake in extracurricular educational activities. However, Dr. Ghai emphasized the importance of identifying what constitutes reasonable consumption of digital media. “Screens can help disadvantaged children achieve positive educational outcomes, particularly those with learning difficulties,” said Dr. Ghai. “Using media to interact with other children can also bring positive social connections to racially diverse children or those from the LGBTQ community, which reiterates why finding the balance that allows children to reap the benefits of digital technology while safeguarding their mental, physical, and social health, is crucial.”

On the other hand, Dr. Metitieri explained that there is evidence that passive exposure to educational content does not necessarily lead to growth benefits. “The key is the relational environment in which these digital experiences occur,” she said. 

Dr. Mansfield said a lot of research describes excessive use of digital media as a form of addiction. “Some studies have attempted to validate and test ‘smartphone addiction’ scales for adolescent. Besides pathologizing an increasingly common activity, such self-report scales are highly subjective, implying serious limitations when attempting to define ‘cut offs’ or diagnostic thresholds.”

Previous efforts to determine benchmarks for screen time usage, focusing on the relationship between historical screen usage and present mental well-being, have overlooked the nature of the digital interaction and the social and technological backdrop. “Effects of screen time on children is a continuously changing, rapidly developing research field, and other contextual factors have been shown to play a greater role on mental health,” explained Dr. Mansfield.
 

Are School Bans Too Restrictive?

Implementing nationwide policies that warrant a dramatic shift in how we approach activities that have become second nature, such as using a mobile phone, is profoundly difficult, particularly as evidence is inconclusive and inconsistent. “The long-term effects of different types of digital content on children’s learning are yet to be clear, and most education-related research so far has been carried out with college students,” said Dr. Mansfield.

For concerned parents and schools, Dr. Metitieri advised against overly restrictive approaches. “Children and adolescents can find ways around restrictions at home and school, meaning that an overly restrictive approach is limited in its effectiveness,” she said. “The best way to adapt to the changes happening in education, relationships, work, and leisure is through a combination of experiences offline and digital education.”

Mirroring Dr. Metitieri’s outlook, Dr. Mansfield suggested, “Restricting the use of smartphones and other personal devices is one method to reduce distraction, but ultimately, children will need to learn to optimize their use of digital devices.”

Recent Dutch media reports cited government ministers’ consultations with neuropsychiatrist Theo Compernolle, MD, PhD, who compared children’s current smartphone usage patterns to addiction and suggested that such habits may hinder the development of the prefrontal cortex. However, Dr. Mansfield said, “There is no evidence to back up this claim.” Although she acknowledged the potential short-term benefits of a screen time ban in enhancing classroom concentration, she said, “One study directly tested this hypothesis and found no association between social media use and brain development, meaning that any claims of long-term effects remain purely speculative.”

The issue of children’s screen time is complex. Understanding the content and context of screen time, educating parents and teachers, and integrating digital experiences with offline activities seem to be the way forward. While governments contend with the complexities of managing this rather modern challenge, the balance between digital engagement and cognitive development remains a critical topic for continued research and thoughtful policymaking. Dr. Metitieri summed it up, “As adult members of the digital society, it is important for us to educate ourselves on how to effectively use online platforms before sharing our experiences and concerns about the online world with children and adolescents.”

A version of this article appeared on Medscape.com.

France did it 5 years ago and now, from January 1, the Dutch have followed suit, banning devices such as mobile phones and tablets in classrooms unless needed during lessons, for medical reasons, or by students with disabilities. The ban aims to limit distractions during the school day. 

We could all surely do with some device detox, but the question remains whether too much screen time has an impact on child development. Karen Mansfield, PhD, a postdoctoral researcher on adolescent well-being in the digital age at Oxford University, told this news organization, “The evidence is definitely not set in stone. There have been some recent reviews of screen time effects on children, demonstrating very mixed findings.”

The latest research, said Dr. Mansfield, is still young, lacking consistency in findings, and rife with misinterpretation.

Tiziana Metitieri, a cognitive neuropsychologist at the Meyer Hospital in Florence, Italy, echoed these sentiments, suggesting that the sheer quantity of screen time is an insufficient metric for understanding its impact on cognitive and psychological development. “There are two main reasons for this,” she explained to this news organization. “Firstly, because the current measurements of screen time rely on self-report data, which can be affected by an overestimation or underestimation of objective usage due to social desirability bias. Secondly, because digital experiences differ in terms of content, device used, context, location, and individuals involved.”
 

Are Politicians in Too Much of a Rush?

UNESCO’s most recent report on technology in education highlighted a correlation between excessive mobile phone use and reduced educational performance and emotional stability.

The OECD report “Empowering Young Children in the Digital Age,” rightly suggested there is a need to improve protection in digital environments, bridge the digital divide, and educate parents and teachers on safe digital practices.

But Dr. Mansfield said, “Currently, policy implementation is racing far ahead of the evidence, with similar suggestions to ban smartphones in schools in the United Kingdom and Canada. However, there is no available evidence on the long-term benefits of banning smartphones. Much of the research behind the OECD and UNESCO policies is observational in nature, which limits causal interpretation more than with interventions.”

While most governments are not pursuing restrictive practices, Dr. Metitieri said that “their approaches are based on their political ideology, often using moral panic as a means to rally support, showing their heartfelt commitment to defending against the invasions of digital technology ruining human civilizations.” 

Sakshi Ghai, PhD, Dr. Mansfield’s fellow postdoctoral researcher at Oxford University, reiterated Dr. Metitieri’s concerns, “Screen time as a concept has limitations, and policy guidance needs to be careful when drawing insights from such limited evidence. What do we mean by screen time? How can time spent on different activities be clearly delineated? An oversimplistic focus on screen time may overlook the nuances and complexity of digital media use.”
 

The Key Is the What and Where

Digital screens can be productive for children, such as when used for educational purposes, be it to join a class over Zoom or partake in extracurricular educational activities. However, Dr. Ghai emphasized the importance of identifying what constitutes reasonable consumption of digital media. “Screens can help disadvantaged children achieve positive educational outcomes, particularly those with learning difficulties,” said Dr. Ghai. “Using media to interact with other children can also bring positive social connections to racially diverse children or those from the LGBTQ community, which reiterates why finding the balance that allows children to reap the benefits of digital technology while safeguarding their mental, physical, and social health, is crucial.”

On the other hand, Dr. Metitieri explained that there is evidence that passive exposure to educational content does not necessarily lead to growth benefits. “The key is the relational environment in which these digital experiences occur,” she said. 

Dr. Mansfield said a lot of research describes excessive use of digital media as a form of addiction. “Some studies have attempted to validate and test ‘smartphone addiction’ scales for adolescent. Besides pathologizing an increasingly common activity, such self-report scales are highly subjective, implying serious limitations when attempting to define ‘cut offs’ or diagnostic thresholds.”

Previous efforts to determine benchmarks for screen time usage, focusing on the relationship between historical screen usage and present mental well-being, have overlooked the nature of the digital interaction and the social and technological backdrop. “Effects of screen time on children is a continuously changing, rapidly developing research field, and other contextual factors have been shown to play a greater role on mental health,” explained Dr. Mansfield.
 

Are School Bans Too Restrictive?

Implementing nationwide policies that warrant a dramatic shift in how we approach activities that have become second nature, such as using a mobile phone, is profoundly difficult, particularly as evidence is inconclusive and inconsistent. “The long-term effects of different types of digital content on children’s learning are yet to be clear, and most education-related research so far has been carried out with college students,” said Dr. Mansfield.

For concerned parents and schools, Dr. Metitieri advised against overly restrictive approaches. “Children and adolescents can find ways around restrictions at home and school, meaning that an overly restrictive approach is limited in its effectiveness,” she said. “The best way to adapt to the changes happening in education, relationships, work, and leisure is through a combination of experiences offline and digital education.”

Mirroring Dr. Metitieri’s outlook, Dr. Mansfield suggested, “Restricting the use of smartphones and other personal devices is one method to reduce distraction, but ultimately, children will need to learn to optimize their use of digital devices.”

Recent Dutch media reports cited government ministers’ consultations with neuropsychiatrist Theo Compernolle, MD, PhD, who compared children’s current smartphone usage patterns to addiction and suggested that such habits may hinder the development of the prefrontal cortex. However, Dr. Mansfield said, “There is no evidence to back up this claim.” Although she acknowledged the potential short-term benefits of a screen time ban in enhancing classroom concentration, she said, “One study directly tested this hypothesis and found no association between social media use and brain development, meaning that any claims of long-term effects remain purely speculative.”

The issue of children’s screen time is complex. Understanding the content and context of screen time, educating parents and teachers, and integrating digital experiences with offline activities seem to be the way forward. While governments contend with the complexities of managing this rather modern challenge, the balance between digital engagement and cognitive development remains a critical topic for continued research and thoughtful policymaking. Dr. Metitieri summed it up, “As adult members of the digital society, it is important for us to educate ourselves on how to effectively use online platforms before sharing our experiences and concerns about the online world with children and adolescents.”

A version of this article appeared on Medscape.com.

France did it 5 years ago and now, from January 1, the Dutch have followed suit, banning devices such as mobile phones and tablets in classrooms unless needed during lessons, for medical reasons, or by students with disabilities. The ban aims to limit distractions during the school day. 

We could all surely do with some device detox, but the question remains whether too much screen time has an impact on child development. Karen Mansfield, PhD, a postdoctoral researcher on adolescent well-being in the digital age at Oxford University, told this news organization, “The evidence is definitely not set in stone. There have been some recent reviews of screen time effects on children, demonstrating very mixed findings.”

The latest research, said Dr. Mansfield, is still young, lacking consistency in findings, and rife with misinterpretation.

Tiziana Metitieri, a cognitive neuropsychologist at the Meyer Hospital in Florence, Italy, echoed these sentiments, suggesting that the sheer quantity of screen time is an insufficient metric for understanding its impact on cognitive and psychological development. “There are two main reasons for this,” she explained to this news organization. “Firstly, because the current measurements of screen time rely on self-report data, which can be affected by an overestimation or underestimation of objective usage due to social desirability bias. Secondly, because digital experiences differ in terms of content, device used, context, location, and individuals involved.”
 

Are Politicians in Too Much of a Rush?

UNESCO’s most recent report on technology in education highlighted a correlation between excessive mobile phone use and reduced educational performance and emotional stability.

The OECD report “Empowering Young Children in the Digital Age,” rightly suggested there is a need to improve protection in digital environments, bridge the digital divide, and educate parents and teachers on safe digital practices.

But Dr. Mansfield said, “Currently, policy implementation is racing far ahead of the evidence, with similar suggestions to ban smartphones in schools in the United Kingdom and Canada. However, there is no available evidence on the long-term benefits of banning smartphones. Much of the research behind the OECD and UNESCO policies is observational in nature, which limits causal interpretation more than with interventions.”

While most governments are not pursuing restrictive practices, Dr. Metitieri said that “their approaches are based on their political ideology, often using moral panic as a means to rally support, showing their heartfelt commitment to defending against the invasions of digital technology ruining human civilizations.” 

Sakshi Ghai, PhD, Dr. Mansfield’s fellow postdoctoral researcher at Oxford University, reiterated Dr. Metitieri’s concerns, “Screen time as a concept has limitations, and policy guidance needs to be careful when drawing insights from such limited evidence. What do we mean by screen time? How can time spent on different activities be clearly delineated? An oversimplistic focus on screen time may overlook the nuances and complexity of digital media use.”
 

The Key Is the What and Where

Digital screens can be productive for children, such as when used for educational purposes, be it to join a class over Zoom or partake in extracurricular educational activities. However, Dr. Ghai emphasized the importance of identifying what constitutes reasonable consumption of digital media. “Screens can help disadvantaged children achieve positive educational outcomes, particularly those with learning difficulties,” said Dr. Ghai. “Using media to interact with other children can also bring positive social connections to racially diverse children or those from the LGBTQ community, which reiterates why finding the balance that allows children to reap the benefits of digital technology while safeguarding their mental, physical, and social health, is crucial.”

On the other hand, Dr. Metitieri explained that there is evidence that passive exposure to educational content does not necessarily lead to growth benefits. “The key is the relational environment in which these digital experiences occur,” she said. 

Dr. Mansfield said a lot of research describes excessive use of digital media as a form of addiction. “Some studies have attempted to validate and test ‘smartphone addiction’ scales for adolescent. Besides pathologizing an increasingly common activity, such self-report scales are highly subjective, implying serious limitations when attempting to define ‘cut offs’ or diagnostic thresholds.”

Previous efforts to determine benchmarks for screen time usage, focusing on the relationship between historical screen usage and present mental well-being, have overlooked the nature of the digital interaction and the social and technological backdrop. “Effects of screen time on children is a continuously changing, rapidly developing research field, and other contextual factors have been shown to play a greater role on mental health,” explained Dr. Mansfield.
 

Are School Bans Too Restrictive?

Implementing nationwide policies that warrant a dramatic shift in how we approach activities that have become second nature, such as using a mobile phone, is profoundly difficult, particularly as evidence is inconclusive and inconsistent. “The long-term effects of different types of digital content on children’s learning are yet to be clear, and most education-related research so far has been carried out with college students,” said Dr. Mansfield.

For concerned parents and schools, Dr. Metitieri advised against overly restrictive approaches. “Children and adolescents can find ways around restrictions at home and school, meaning that an overly restrictive approach is limited in its effectiveness,” she said. “The best way to adapt to the changes happening in education, relationships, work, and leisure is through a combination of experiences offline and digital education.”

Mirroring Dr. Metitieri’s outlook, Dr. Mansfield suggested, “Restricting the use of smartphones and other personal devices is one method to reduce distraction, but ultimately, children will need to learn to optimize their use of digital devices.”

Recent Dutch media reports cited government ministers’ consultations with neuropsychiatrist Theo Compernolle, MD, PhD, who compared children’s current smartphone usage patterns to addiction and suggested that such habits may hinder the development of the prefrontal cortex. However, Dr. Mansfield said, “There is no evidence to back up this claim.” Although she acknowledged the potential short-term benefits of a screen time ban in enhancing classroom concentration, she said, “One study directly tested this hypothesis and found no association between social media use and brain development, meaning that any claims of long-term effects remain purely speculative.”

The issue of children’s screen time is complex. Understanding the content and context of screen time, educating parents and teachers, and integrating digital experiences with offline activities seem to be the way forward. While governments contend with the complexities of managing this rather modern challenge, the balance between digital engagement and cognitive development remains a critical topic for continued research and thoughtful policymaking. Dr. Metitieri summed it up, “As adult members of the digital society, it is important for us to educate ourselves on how to effectively use online platforms before sharing our experiences and concerns about the online world with children and adolescents.”

A version of this article appeared on Medscape.com.

A recent alert posted on the Asthma and Allergy Foundation of America (AAFA) website blog announced, “Flovent HFA and Flovent Diskus Asthma Medicine Being Discontinued.” A further heading positioned next to images of the two red inhaler devices stated: “Generic versions of the same medicines and devices are available but you need to check your insurance.” While few, it is generally thought, will have trouble finding suitable alternatives, the warning captured the reality descending upon some individual asthma sufferers whose insurance coverage may need tweaking at the very least, or at worst may be lacking.

The AAFA blog included a GSK (GlaxoSmithKline) November 2023 statement to AAFA regarding the brand name FLOVENT discontinuation. It noted the launch of an authorized Flovent HFA (fluticasone propionate inhalation aerosol) generic in May 2022 and a planned (October 2023) launch of an authorized generic for Flovent Diskus (fluticasone propionate inhalation powder) as “part of our commitment to be ambitious for patients.” The GSK statement continues: “These GSK manufactured authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products. We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”

GSK will continue to manufacture the authorized generics, but they will be distributed by Prasco LLC.
 

Medicaid Rebate Cap Removed

As a Forbes article on January 3, 2024, by Joshua Cohen (“New Medicaid Rebate Rule Causes Problems For Asthma Patients On Flovent”) points out, the Flovent January 1, 2024, discontinuation coincided with the removal of the Medicaid rebate cap (American Rescue Plan Medicaid Drug Rebate Program) targeting manufacturers who had previously raised medication prices at rates higher than the inflation rate. The Forbes story notes GoodRx data showing a 47% increase in Flovent price since 2014. The implication is that drug manufacturers could be forced to sell such a drug to Medicaid at a loss because of the rebate cap removal. An authorized generic introduced to the market at a lower price under a private label with no price history, however, would not be subject to the higher Medicaid rebates.

Motivation considerations aside, the fallout for patients may or may not include a lower cost alternative. The authorized generic versions of Flovent HFA and Flovent Diskus are identical to the branded products with respect to the drugs and the devices. The GSK statement expressed hope that most insurance plans will replace the brand name with the authorized generic. The possibility persists, however, that there may be some that do not — resulting in a need to find the right substitute and/or higher out-of-pocket costs.

“Even though some patients may experience some disruption initially in their prescriptions,” Diego J. Maselli, MD, professor and chief, division of pulmonary diseases and critical care, UT Health at San Antonio, Texas, said in an interview, “fortunately, there are quite a few alternatives, and we don’t anticipate significant problems. It will be a wrinkle for some of the patients with regard to coverage, but there are definitely many alternatives that can provide good enough treatment for them.”
 

Similar alternative inhalers?

The alternatives have their specific properties and qualities, but the vast majority of experts, Dr. Maselli said, consider them to be very similar.

For CAREMARK CVS, a major pharmaceutical benefits manager, the preferred Flovent substitute is Pulmicort Flexhaler, a dry-powder inhaler that contains budesonide rather than fluticasone. While Flovent HF is a metered dose inhaler with a propellant, the Pulmicort device contains budesonide as a dry powder and requires activation through inhalation, which can be problematic for young children, AAFA CEO Kenneth Mendez said in an interview. To address that issue, he said, CVS Caremark is covering the authorized fluticasone metered dose inhaler generic for children under 6 years old. “Those individuals 6 years and older with severe asthma who can’t breathe deeply enough to get the medicine into their lungs will have to work with their doctors to apply for a formulary exception. And that’s a complicated process,” Mr. Mendez observed. “And it can take some time,” he added.

Another key issue highlighted here, he emphasized, is “how complicated this system is.” The U.S. drug pricing ecosystem involves multiple manufacturers, pharmacy benefit managers, insurance companies and their various plans, and federal policies potentially creating situations that may reduce access to critical medicines for patients, Mr. Mendez said. “Some people will be scurrying and scrambling to try to get coverage. The scope of the impact is actually unknown, but we’re going to find out now. As a nonprofit, we monitor social media and we’re listening closely.”

AAFA’s further concern is the rising costs of asthma medications. “It’s the number one thing we hear about as a patient organization,” Mr. Mendez said. On January 9, 2024, AAFA issued a press release praising the previous day’s news item from the U.S. Senate Committee on Health, Education, Labor & Pensions (“Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of Asthma Inhalers). In it, Senator Bernie Sanders pointed to the more than 12-fold higher cost in the United States compared with the United Kingdom for GSK’s inhaler combining fluticasone and a beta2 agonist. The Senate HELP Committee has sent letters to the CEOs of the four major inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GSK, and Teva), stating: “These prices force patients, especially the uninsured and underinsured, to ration doses or abandon their prescriptions altogether. The results are predictable and devastating.”
 

High costs of inhalers could lead to rationing

AAFA research, the AAFA press release states, confirms that when asthma medicine costs become a barrier to treatment, people with asthma ration or discontinue medication use. The release also includes Mr. Mendez’s plea for a broad national conversation. “We are hopeful the HELP Committee investigation will lead to a national conversation about asthma drug costs and produce action that breaks down barriers to affordable treatment for people with asthma. The bottom line is that cost drives access. We understand the barriers, now it is important to move toward solutions.”

AAFA’s blog advises that when an individual’s insurance plan does not cover the authorized generic and does not offer a formulary exception, other inhaler options include ArmonAir Digihaler and Arnuity Ellipta. Because these are not identical to the authorized generics, individuals should check with their doctors regarding available doses and inhaler types and, if necessary, request training on inhaler use.

“It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season.” AAFA urges individuals with asthma who are currently Flovent users to check with their doctors or pharmacists about the best next steps for them.

A recent alert posted on the Asthma and Allergy Foundation of America (AAFA) website blog announced, “Flovent HFA and Flovent Diskus Asthma Medicine Being Discontinued.” A further heading positioned next to images of the two red inhaler devices stated: “Generic versions of the same medicines and devices are available but you need to check your insurance.” While few, it is generally thought, will have trouble finding suitable alternatives, the warning captured the reality descending upon some individual asthma sufferers whose insurance coverage may need tweaking at the very least, or at worst may be lacking.

The AAFA blog included a GSK (GlaxoSmithKline) November 2023 statement to AAFA regarding the brand name FLOVENT discontinuation. It noted the launch of an authorized Flovent HFA (fluticasone propionate inhalation aerosol) generic in May 2022 and a planned (October 2023) launch of an authorized generic for Flovent Diskus (fluticasone propionate inhalation powder) as “part of our commitment to be ambitious for patients.” The GSK statement continues: “These GSK manufactured authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products. We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”

GSK will continue to manufacture the authorized generics, but they will be distributed by Prasco LLC.
 

Medicaid Rebate Cap Removed

As a Forbes article on January 3, 2024, by Joshua Cohen (“New Medicaid Rebate Rule Causes Problems For Asthma Patients On Flovent”) points out, the Flovent January 1, 2024, discontinuation coincided with the removal of the Medicaid rebate cap (American Rescue Plan Medicaid Drug Rebate Program) targeting manufacturers who had previously raised medication prices at rates higher than the inflation rate. The Forbes story notes GoodRx data showing a 47% increase in Flovent price since 2014. The implication is that drug manufacturers could be forced to sell such a drug to Medicaid at a loss because of the rebate cap removal. An authorized generic introduced to the market at a lower price under a private label with no price history, however, would not be subject to the higher Medicaid rebates.

Motivation considerations aside, the fallout for patients may or may not include a lower cost alternative. The authorized generic versions of Flovent HFA and Flovent Diskus are identical to the branded products with respect to the drugs and the devices. The GSK statement expressed hope that most insurance plans will replace the brand name with the authorized generic. The possibility persists, however, that there may be some that do not — resulting in a need to find the right substitute and/or higher out-of-pocket costs.

“Even though some patients may experience some disruption initially in their prescriptions,” Diego J. Maselli, MD, professor and chief, division of pulmonary diseases and critical care, UT Health at San Antonio, Texas, said in an interview, “fortunately, there are quite a few alternatives, and we don’t anticipate significant problems. It will be a wrinkle for some of the patients with regard to coverage, but there are definitely many alternatives that can provide good enough treatment for them.”
 

Similar alternative inhalers?

The alternatives have their specific properties and qualities, but the vast majority of experts, Dr. Maselli said, consider them to be very similar.

For CAREMARK CVS, a major pharmaceutical benefits manager, the preferred Flovent substitute is Pulmicort Flexhaler, a dry-powder inhaler that contains budesonide rather than fluticasone. While Flovent HF is a metered dose inhaler with a propellant, the Pulmicort device contains budesonide as a dry powder and requires activation through inhalation, which can be problematic for young children, AAFA CEO Kenneth Mendez said in an interview. To address that issue, he said, CVS Caremark is covering the authorized fluticasone metered dose inhaler generic for children under 6 years old. “Those individuals 6 years and older with severe asthma who can’t breathe deeply enough to get the medicine into their lungs will have to work with their doctors to apply for a formulary exception. And that’s a complicated process,” Mr. Mendez observed. “And it can take some time,” he added.

Another key issue highlighted here, he emphasized, is “how complicated this system is.” The U.S. drug pricing ecosystem involves multiple manufacturers, pharmacy benefit managers, insurance companies and their various plans, and federal policies potentially creating situations that may reduce access to critical medicines for patients, Mr. Mendez said. “Some people will be scurrying and scrambling to try to get coverage. The scope of the impact is actually unknown, but we’re going to find out now. As a nonprofit, we monitor social media and we’re listening closely.”

AAFA’s further concern is the rising costs of asthma medications. “It’s the number one thing we hear about as a patient organization,” Mr. Mendez said. On January 9, 2024, AAFA issued a press release praising the previous day’s news item from the U.S. Senate Committee on Health, Education, Labor & Pensions (“Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of Asthma Inhalers). In it, Senator Bernie Sanders pointed to the more than 12-fold higher cost in the United States compared with the United Kingdom for GSK’s inhaler combining fluticasone and a beta2 agonist. The Senate HELP Committee has sent letters to the CEOs of the four major inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GSK, and Teva), stating: “These prices force patients, especially the uninsured and underinsured, to ration doses or abandon their prescriptions altogether. The results are predictable and devastating.”
 

High costs of inhalers could lead to rationing

AAFA research, the AAFA press release states, confirms that when asthma medicine costs become a barrier to treatment, people with asthma ration or discontinue medication use. The release also includes Mr. Mendez’s plea for a broad national conversation. “We are hopeful the HELP Committee investigation will lead to a national conversation about asthma drug costs and produce action that breaks down barriers to affordable treatment for people with asthma. The bottom line is that cost drives access. We understand the barriers, now it is important to move toward solutions.”

AAFA’s blog advises that when an individual’s insurance plan does not cover the authorized generic and does not offer a formulary exception, other inhaler options include ArmonAir Digihaler and Arnuity Ellipta. Because these are not identical to the authorized generics, individuals should check with their doctors regarding available doses and inhaler types and, if necessary, request training on inhaler use.

“It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season.” AAFA urges individuals with asthma who are currently Flovent users to check with their doctors or pharmacists about the best next steps for them.

A recent alert posted on the Asthma and Allergy Foundation of America (AAFA) website blog announced, “Flovent HFA and Flovent Diskus Asthma Medicine Being Discontinued.” A further heading positioned next to images of the two red inhaler devices stated: “Generic versions of the same medicines and devices are available but you need to check your insurance.” While few, it is generally thought, will have trouble finding suitable alternatives, the warning captured the reality descending upon some individual asthma sufferers whose insurance coverage may need tweaking at the very least, or at worst may be lacking.

The AAFA blog included a GSK (GlaxoSmithKline) November 2023 statement to AAFA regarding the brand name FLOVENT discontinuation. It noted the launch of an authorized Flovent HFA (fluticasone propionate inhalation aerosol) generic in May 2022 and a planned (October 2023) launch of an authorized generic for Flovent Diskus (fluticasone propionate inhalation powder) as “part of our commitment to be ambitious for patients.” The GSK statement continues: “These GSK manufactured authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products. We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”

GSK will continue to manufacture the authorized generics, but they will be distributed by Prasco LLC.
 

Medicaid Rebate Cap Removed

As a Forbes article on January 3, 2024, by Joshua Cohen (“New Medicaid Rebate Rule Causes Problems For Asthma Patients On Flovent”) points out, the Flovent January 1, 2024, discontinuation coincided with the removal of the Medicaid rebate cap (American Rescue Plan Medicaid Drug Rebate Program) targeting manufacturers who had previously raised medication prices at rates higher than the inflation rate. The Forbes story notes GoodRx data showing a 47% increase in Flovent price since 2014. The implication is that drug manufacturers could be forced to sell such a drug to Medicaid at a loss because of the rebate cap removal. An authorized generic introduced to the market at a lower price under a private label with no price history, however, would not be subject to the higher Medicaid rebates.

Motivation considerations aside, the fallout for patients may or may not include a lower cost alternative. The authorized generic versions of Flovent HFA and Flovent Diskus are identical to the branded products with respect to the drugs and the devices. The GSK statement expressed hope that most insurance plans will replace the brand name with the authorized generic. The possibility persists, however, that there may be some that do not — resulting in a need to find the right substitute and/or higher out-of-pocket costs.

“Even though some patients may experience some disruption initially in their prescriptions,” Diego J. Maselli, MD, professor and chief, division of pulmonary diseases and critical care, UT Health at San Antonio, Texas, said in an interview, “fortunately, there are quite a few alternatives, and we don’t anticipate significant problems. It will be a wrinkle for some of the patients with regard to coverage, but there are definitely many alternatives that can provide good enough treatment for them.”
 

Similar alternative inhalers?

The alternatives have their specific properties and qualities, but the vast majority of experts, Dr. Maselli said, consider them to be very similar.

For CAREMARK CVS, a major pharmaceutical benefits manager, the preferred Flovent substitute is Pulmicort Flexhaler, a dry-powder inhaler that contains budesonide rather than fluticasone. While Flovent HF is a metered dose inhaler with a propellant, the Pulmicort device contains budesonide as a dry powder and requires activation through inhalation, which can be problematic for young children, AAFA CEO Kenneth Mendez said in an interview. To address that issue, he said, CVS Caremark is covering the authorized fluticasone metered dose inhaler generic for children under 6 years old. “Those individuals 6 years and older with severe asthma who can’t breathe deeply enough to get the medicine into their lungs will have to work with their doctors to apply for a formulary exception. And that’s a complicated process,” Mr. Mendez observed. “And it can take some time,” he added.

Another key issue highlighted here, he emphasized, is “how complicated this system is.” The U.S. drug pricing ecosystem involves multiple manufacturers, pharmacy benefit managers, insurance companies and their various plans, and federal policies potentially creating situations that may reduce access to critical medicines for patients, Mr. Mendez said. “Some people will be scurrying and scrambling to try to get coverage. The scope of the impact is actually unknown, but we’re going to find out now. As a nonprofit, we monitor social media and we’re listening closely.”

AAFA’s further concern is the rising costs of asthma medications. “It’s the number one thing we hear about as a patient organization,” Mr. Mendez said. On January 9, 2024, AAFA issued a press release praising the previous day’s news item from the U.S. Senate Committee on Health, Education, Labor & Pensions (“Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of Asthma Inhalers). In it, Senator Bernie Sanders pointed to the more than 12-fold higher cost in the United States compared with the United Kingdom for GSK’s inhaler combining fluticasone and a beta2 agonist. The Senate HELP Committee has sent letters to the CEOs of the four major inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GSK, and Teva), stating: “These prices force patients, especially the uninsured and underinsured, to ration doses or abandon their prescriptions altogether. The results are predictable and devastating.”
 

High costs of inhalers could lead to rationing

AAFA research, the AAFA press release states, confirms that when asthma medicine costs become a barrier to treatment, people with asthma ration or discontinue medication use. The release also includes Mr. Mendez’s plea for a broad national conversation. “We are hopeful the HELP Committee investigation will lead to a national conversation about asthma drug costs and produce action that breaks down barriers to affordable treatment for people with asthma. The bottom line is that cost drives access. We understand the barriers, now it is important to move toward solutions.”

AAFA’s blog advises that when an individual’s insurance plan does not cover the authorized generic and does not offer a formulary exception, other inhaler options include ArmonAir Digihaler and Arnuity Ellipta. Because these are not identical to the authorized generics, individuals should check with their doctors regarding available doses and inhaler types and, if necessary, request training on inhaler use.

“It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season.” AAFA urges individuals with asthma who are currently Flovent users to check with their doctors or pharmacists about the best next steps for them.

A1c level strongly predicts the risk of developing type 2 diabetes among adolescents with overweight or obesity, new data suggested.

In a large California healthcare database over a 10-year period, the incidence of type 2 diabetes was relatively low overall among adolescents with overweight and obesity. However, the risk increased with baseline A1c levels above 6.0% as well as in those with more severe obesity, women, and Asian or Pacific Islanders.

The new findings were published online in JAMA Network Open by pediatric endocrinologist Francis M. Hoe, MD, of Kaiser Permanente Roseville Medical Center, Roseville, California, and colleagues.

Previous studies have examined the incidence of type 2 diabetes among all youth, regardless of weight class. This is one of the first large population studies to examine the incidence and risk for type 2 diabetes by incremental level of A1c in a racially and ethnically diverse group of youth with overweight and obesity, Dr. Hoe told this news organization in an interview.

“This study was only possible to do because Kaiser Permanente Northern California has nearly 1 million pediatric members. The biggest thing we learned is that risk for type 2 diabetes is low in overweight and obese youth, especially those with an HbA1c less than 5.9%,” he said.
 

Zeroing in on Those at Greatest Risk for Type 2 Diabetes

Currently, the American Diabetes Association (ADA) recommends screening for type 2 diabetes in adolescents with overweight (body mass index [BMI], 85th percentile or greater) or obesity (≥ 95th) who have at least one additional risk factor, including family history of type 2 diabetes and Native American, Black, or Hispanic ethnicity. About one in four US adolescents qualify by those criteria, the authors noted in the paper.

And, as for adults, ADA recommends subsequent annual diabetes screening in youth identified as having “prediabetes,” that is, a A1c level between 5.7% and 6.5%.

The new study confirmed that adolescents with A1c in the upper end of the prediabetes range were at a greater risk for type 2 diabetes. But those individuals were the minority. Adolescents with overweight/obesity who had baseline A1c levels in the lower end of the prediabetes range, 5.7%-5.8%, accounted for two thirds of those with prediabetes in the study population and had a very low incidence of type 2 diabetes compared with those with higher A1c levels.

“Specifically, we found an annual type 2 diabetes incidence of 0.2% for HbA1c of 5.7%-5.8%, which is much lower than adults. These adolescents will likely benefit from lifestyle intervention. But because their risk of developing type 2 diabetes is lower, they probably don’t need to be screened annually, as currently recommended by the ADA,” Dr. Hoe said.

Similarly, he added, “since obesity severity was associated with a higher risk for type 2 diabetes, increases in BMI percentile should also prompt consideration of repeat diabetes screening.”
 

Large Database Allows for Detailed Findings

The study population was 74,552 adolescents aged 10-17 years with overweight or obesity, of whom 49.4% were male, 64.6% were younger than 15 years, and 73.1% had obesity. Only 21.6% were White, while 43.6% were Hispanic, 11.1% Black, and 17.6% Asian or Pacific Islander.

Nearly a quarter, 22.9%, had baseline A1c in the prediabetes range of 5.7%-6.4%. Mean A1c rose with BMI category from overweight to moderate to severe obesity (P < .001 for each comparison). Baseline A1c was highest (5.53%) in Black adolescents and lowest in White teens (5.38%), also significant differences by group (P < .001).

Of the total 698 who developed diabetes during the follow-up, 89.7% were classified as having type 2 diabetes, with a median 3.8 years from baseline to diagnosis.

The overall incidence rate of type 2 diabetes during the follow-up was 2.1 per 1000 person-years. As the baseline A1c rose from less than 5.5% to 6.0%, from 6.1% to 6.2%, and from 6.3% to 6.4%, those incidence rates were 0.8, 8.1, 21.8, and 68.9 per 1000 person-years, respectively.

In a multivariate analysis, compared to baseline A1c below 5.5%, increased risk was ninefold for A1c 5.9%-6.0%, 23-fold for 6.1%-6.2%, and 72-fold for 6.3%-6.4%.

The incidence rates were higher in female than in male adolescents (2.4 vs 1.8 per 1000 person-years) and increased by BMI category from 0.6 to 1.3 to 4.3 for those with overweight, moderate obesity, and severe obesity, respectively.

Type 2 diabetes incidence per 1000 person-years also varied by race and ethnicity, ranging from 1.3 for White adolescents to 3.0 for Asian or Pacific Islanders.

“We plan on further exploring the effect of the weight and BMI change over time and how that may affect type 2 diabetes risk,” Dr. Hoe told this news organization.

This study was supported by a grant from the Kaiser Permanente Northern California Community Health program. Dr. Hoe and his coauthors had no further disclosures.

A version of this article appeared on Medscape.com.

A1c level strongly predicts the risk of developing type 2 diabetes among adolescents with overweight or obesity, new data suggested.

In a large California healthcare database over a 10-year period, the incidence of type 2 diabetes was relatively low overall among adolescents with overweight and obesity. However, the risk increased with baseline A1c levels above 6.0% as well as in those with more severe obesity, women, and Asian or Pacific Islanders.

The new findings were published online in JAMA Network Open by pediatric endocrinologist Francis M. Hoe, MD, of Kaiser Permanente Roseville Medical Center, Roseville, California, and colleagues.

Previous studies have examined the incidence of type 2 diabetes among all youth, regardless of weight class. This is one of the first large population studies to examine the incidence and risk for type 2 diabetes by incremental level of A1c in a racially and ethnically diverse group of youth with overweight and obesity, Dr. Hoe told this news organization in an interview.

“This study was only possible to do because Kaiser Permanente Northern California has nearly 1 million pediatric members. The biggest thing we learned is that risk for type 2 diabetes is low in overweight and obese youth, especially those with an HbA1c less than 5.9%,” he said.
 

Zeroing in on Those at Greatest Risk for Type 2 Diabetes

Currently, the American Diabetes Association (ADA) recommends screening for type 2 diabetes in adolescents with overweight (body mass index [BMI], 85th percentile or greater) or obesity (≥ 95th) who have at least one additional risk factor, including family history of type 2 diabetes and Native American, Black, or Hispanic ethnicity. About one in four US adolescents qualify by those criteria, the authors noted in the paper.

And, as for adults, ADA recommends subsequent annual diabetes screening in youth identified as having “prediabetes,” that is, a A1c level between 5.7% and 6.5%.

The new study confirmed that adolescents with A1c in the upper end of the prediabetes range were at a greater risk for type 2 diabetes. But those individuals were the minority. Adolescents with overweight/obesity who had baseline A1c levels in the lower end of the prediabetes range, 5.7%-5.8%, accounted for two thirds of those with prediabetes in the study population and had a very low incidence of type 2 diabetes compared with those with higher A1c levels.

“Specifically, we found an annual type 2 diabetes incidence of 0.2% for HbA1c of 5.7%-5.8%, which is much lower than adults. These adolescents will likely benefit from lifestyle intervention. But because their risk of developing type 2 diabetes is lower, they probably don’t need to be screened annually, as currently recommended by the ADA,” Dr. Hoe said.

Similarly, he added, “since obesity severity was associated with a higher risk for type 2 diabetes, increases in BMI percentile should also prompt consideration of repeat diabetes screening.”
 

Large Database Allows for Detailed Findings

The study population was 74,552 adolescents aged 10-17 years with overweight or obesity, of whom 49.4% were male, 64.6% were younger than 15 years, and 73.1% had obesity. Only 21.6% were White, while 43.6% were Hispanic, 11.1% Black, and 17.6% Asian or Pacific Islander.

Nearly a quarter, 22.9%, had baseline A1c in the prediabetes range of 5.7%-6.4%. Mean A1c rose with BMI category from overweight to moderate to severe obesity (P < .001 for each comparison). Baseline A1c was highest (5.53%) in Black adolescents and lowest in White teens (5.38%), also significant differences by group (P < .001).

Of the total 698 who developed diabetes during the follow-up, 89.7% were classified as having type 2 diabetes, with a median 3.8 years from baseline to diagnosis.

The overall incidence rate of type 2 diabetes during the follow-up was 2.1 per 1000 person-years. As the baseline A1c rose from less than 5.5% to 6.0%, from 6.1% to 6.2%, and from 6.3% to 6.4%, those incidence rates were 0.8, 8.1, 21.8, and 68.9 per 1000 person-years, respectively.

In a multivariate analysis, compared to baseline A1c below 5.5%, increased risk was ninefold for A1c 5.9%-6.0%, 23-fold for 6.1%-6.2%, and 72-fold for 6.3%-6.4%.

The incidence rates were higher in female than in male adolescents (2.4 vs 1.8 per 1000 person-years) and increased by BMI category from 0.6 to 1.3 to 4.3 for those with overweight, moderate obesity, and severe obesity, respectively.

Type 2 diabetes incidence per 1000 person-years also varied by race and ethnicity, ranging from 1.3 for White adolescents to 3.0 for Asian or Pacific Islanders.

“We plan on further exploring the effect of the weight and BMI change over time and how that may affect type 2 diabetes risk,” Dr. Hoe told this news organization.

This study was supported by a grant from the Kaiser Permanente Northern California Community Health program. Dr. Hoe and his coauthors had no further disclosures.

A version of this article appeared on Medscape.com.

A1c level strongly predicts the risk of developing type 2 diabetes among adolescents with overweight or obesity, new data suggested.

In a large California healthcare database over a 10-year period, the incidence of type 2 diabetes was relatively low overall among adolescents with overweight and obesity. However, the risk increased with baseline A1c levels above 6.0% as well as in those with more severe obesity, women, and Asian or Pacific Islanders.

The new findings were published online in JAMA Network Open by pediatric endocrinologist Francis M. Hoe, MD, of Kaiser Permanente Roseville Medical Center, Roseville, California, and colleagues.

Previous studies have examined the incidence of type 2 diabetes among all youth, regardless of weight class. This is one of the first large population studies to examine the incidence and risk for type 2 diabetes by incremental level of A1c in a racially and ethnically diverse group of youth with overweight and obesity, Dr. Hoe told this news organization in an interview.

“This study was only possible to do because Kaiser Permanente Northern California has nearly 1 million pediatric members. The biggest thing we learned is that risk for type 2 diabetes is low in overweight and obese youth, especially those with an HbA1c less than 5.9%,” he said.
 

Zeroing in on Those at Greatest Risk for Type 2 Diabetes

Currently, the American Diabetes Association (ADA) recommends screening for type 2 diabetes in adolescents with overweight (body mass index [BMI], 85th percentile or greater) or obesity (≥ 95th) who have at least one additional risk factor, including family history of type 2 diabetes and Native American, Black, or Hispanic ethnicity. About one in four US adolescents qualify by those criteria, the authors noted in the paper.

And, as for adults, ADA recommends subsequent annual diabetes screening in youth identified as having “prediabetes,” that is, a A1c level between 5.7% and 6.5%.

The new study confirmed that adolescents with A1c in the upper end of the prediabetes range were at a greater risk for type 2 diabetes. But those individuals were the minority. Adolescents with overweight/obesity who had baseline A1c levels in the lower end of the prediabetes range, 5.7%-5.8%, accounted for two thirds of those with prediabetes in the study population and had a very low incidence of type 2 diabetes compared with those with higher A1c levels.

“Specifically, we found an annual type 2 diabetes incidence of 0.2% for HbA1c of 5.7%-5.8%, which is much lower than adults. These adolescents will likely benefit from lifestyle intervention. But because their risk of developing type 2 diabetes is lower, they probably don’t need to be screened annually, as currently recommended by the ADA,” Dr. Hoe said.

Similarly, he added, “since obesity severity was associated with a higher risk for type 2 diabetes, increases in BMI percentile should also prompt consideration of repeat diabetes screening.”
 

Large Database Allows for Detailed Findings

The study population was 74,552 adolescents aged 10-17 years with overweight or obesity, of whom 49.4% were male, 64.6% were younger than 15 years, and 73.1% had obesity. Only 21.6% were White, while 43.6% were Hispanic, 11.1% Black, and 17.6% Asian or Pacific Islander.

Nearly a quarter, 22.9%, had baseline A1c in the prediabetes range of 5.7%-6.4%. Mean A1c rose with BMI category from overweight to moderate to severe obesity (P < .001 for each comparison). Baseline A1c was highest (5.53%) in Black adolescents and lowest in White teens (5.38%), also significant differences by group (P < .001).

Of the total 698 who developed diabetes during the follow-up, 89.7% were classified as having type 2 diabetes, with a median 3.8 years from baseline to diagnosis.

The overall incidence rate of type 2 diabetes during the follow-up was 2.1 per 1000 person-years. As the baseline A1c rose from less than 5.5% to 6.0%, from 6.1% to 6.2%, and from 6.3% to 6.4%, those incidence rates were 0.8, 8.1, 21.8, and 68.9 per 1000 person-years, respectively.

In a multivariate analysis, compared to baseline A1c below 5.5%, increased risk was ninefold for A1c 5.9%-6.0%, 23-fold for 6.1%-6.2%, and 72-fold for 6.3%-6.4%.

The incidence rates were higher in female than in male adolescents (2.4 vs 1.8 per 1000 person-years) and increased by BMI category from 0.6 to 1.3 to 4.3 for those with overweight, moderate obesity, and severe obesity, respectively.

Type 2 diabetes incidence per 1000 person-years also varied by race and ethnicity, ranging from 1.3 for White adolescents to 3.0 for Asian or Pacific Islanders.

“We plan on further exploring the effect of the weight and BMI change over time and how that may affect type 2 diabetes risk,” Dr. Hoe told this news organization.

This study was supported by a grant from the Kaiser Permanente Northern California Community Health program. Dr. Hoe and his coauthors had no further disclosures.

A version of this article appeared on Medscape.com.