Pulmonology

Click to view more from Pulmonology Data Trends 2024. 

Click to view more from Pulmonology Data Trends 2024. 

Click to view more from Pulmonology Data Trends 2024. 

TOPLINE:

In patients with pulmonary oligometastases from colorectal cancer (CRC), both stereotactic body radiotherapy (SBRT) and surgery led to similar overall survival rates at 5 years. However, those who received surgery had significantly better progression-free and disease-free survival rates, as well as a longer time to intrathoracic progression.
 

METHODOLOGY:

• SBRT has been shown to provide effective local control and improve short-term survival for patients with pulmonary oligometastases from CRC and has become an alternative for these patients who are ineligible or reluctant to undergo surgery. It’s unclear, however, whether SBRT should be prioritized over surgery in patients with CRC pulmonary metastases, largely because of a lack of prospective data.
• In the current analysis, researchers compared outcomes among 335 patients (median age, 61 years) with lung metastases from CRC who underwent surgery or SBRT, using data from the Peking University Cancer Hospital and Institute between March 2011 and September 2022.
• A total of 251 patients were included in the final analysis after propensity score matching, 173 (68.9%) underwent surgery and 78 (31.1%) received SBRT. The median follow-up was 61.6 months in the surgery group and 54.4 months in the SBRT group.
• The study outcomes were freedom from intrathoracic progression, progression-free survival, and overall survival.

TAKEAWAY:

• At 5 years, rates of freedom from intrathoracic progression were more than twofold higher in the surgery group than in the SBRT group (53% vs 23.4%; hazard ratio [HR], 0.46; P < .001). Progression-free survival rates were also more than twofold higher in the surgery group vs the SBRT group (43.8% vs 18.5%; HR, 0.47; P < .001), respectively. In the SBRT group, a higher percentage of patients had a disease-free interval of less than 12 months compared with the surgery group, with rates of 48.7% and 32.9%, respectively (P = 0.025). 
• Overall survival, however, was not significantly different between the two groups at 5 years (72.5% in the surgery group vs 63.7% in the SBRT group; P = .260). The number of pulmonary metastases (HR, 1.87; 95% CI, 1.11-3.14, P = .019 and tumor size (HR, 1.03; 95% CI, 1.00-1.05, P = .023) were significant prognostic factors for overall survival.
• Local recurrence was more prevalent after SBRT (33.3%) than surgery (16.9%), while new intrathoracic tumors occurred more frequently after surgery than SBRT (71.8% vs 43.1%). Repeated local treatments were common among patients with intrathoracic progression, which might have contributed to favorable survival outcomes in both groups.
• Both treatments were well-tolerated with no treatment-related mortality or grade ≥ 3 toxicities. In the surgery group, 14 patients experienced complications, including atrial fibrillation (n = 4) and prolonged air leaks (n = 7). In the SBRT group, radiation pneumonitis was the most common adverse event (n = 21).

IN PRACTICE:

SBRT yielded overall survival benefits similar to surgery despite a “higher likelihood of prior extrapulmonary metastases, a shorter disease-free interval, and a greater number of metastatic lesions,” the authors wrote. Still, SBRT should be regarded as an “effective alternative in cases in which surgical intervention is either unviable or declined by the patient,” the authors concluded.
 

SOURCE:

The study was co-led by Yaqi Wang and Xin Dong, Peking University Cancer Hospital & Institute, Beijing, China, and was published online in the International Journal of Radiation Oncology, Biology, Physics.
 

LIMITATIONS:

This single-center retrospective study had an inherent selection bias. The lack of balanced sample sizes of the surgery and SBRT groups might have affected the robustness of the statistical analyses. Detailed data on adverse events were not available.
 

DISCLOSURES:

The study was supported by grants from the National Natural Science Foundation of China, Beijing Natural Science Foundation, and Beijing Municipal Administration of Hospital’s Ascent Plan. The authors did not declare any conflicts of interest.

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

TOPLINE:

In patients with pulmonary oligometastases from colorectal cancer (CRC), both stereotactic body radiotherapy (SBRT) and surgery led to similar overall survival rates at 5 years. However, those who received surgery had significantly better progression-free and disease-free survival rates, as well as a longer time to intrathoracic progression.
 

METHODOLOGY:

• SBRT has been shown to provide effective local control and improve short-term survival for patients with pulmonary oligometastases from CRC and has become an alternative for these patients who are ineligible or reluctant to undergo surgery. It’s unclear, however, whether SBRT should be prioritized over surgery in patients with CRC pulmonary metastases, largely because of a lack of prospective data.
• In the current analysis, researchers compared outcomes among 335 patients (median age, 61 years) with lung metastases from CRC who underwent surgery or SBRT, using data from the Peking University Cancer Hospital and Institute between March 2011 and September 2022.
• A total of 251 patients were included in the final analysis after propensity score matching, 173 (68.9%) underwent surgery and 78 (31.1%) received SBRT. The median follow-up was 61.6 months in the surgery group and 54.4 months in the SBRT group.
• The study outcomes were freedom from intrathoracic progression, progression-free survival, and overall survival.

TAKEAWAY:

• At 5 years, rates of freedom from intrathoracic progression were more than twofold higher in the surgery group than in the SBRT group (53% vs 23.4%; hazard ratio [HR], 0.46; P < .001). Progression-free survival rates were also more than twofold higher in the surgery group vs the SBRT group (43.8% vs 18.5%; HR, 0.47; P < .001), respectively. In the SBRT group, a higher percentage of patients had a disease-free interval of less than 12 months compared with the surgery group, with rates of 48.7% and 32.9%, respectively (P = 0.025). 
• Overall survival, however, was not significantly different between the two groups at 5 years (72.5% in the surgery group vs 63.7% in the SBRT group; P = .260). The number of pulmonary metastases (HR, 1.87; 95% CI, 1.11-3.14, P = .019 and tumor size (HR, 1.03; 95% CI, 1.00-1.05, P = .023) were significant prognostic factors for overall survival.
• Local recurrence was more prevalent after SBRT (33.3%) than surgery (16.9%), while new intrathoracic tumors occurred more frequently after surgery than SBRT (71.8% vs 43.1%). Repeated local treatments were common among patients with intrathoracic progression, which might have contributed to favorable survival outcomes in both groups.
• Both treatments were well-tolerated with no treatment-related mortality or grade ≥ 3 toxicities. In the surgery group, 14 patients experienced complications, including atrial fibrillation (n = 4) and prolonged air leaks (n = 7). In the SBRT group, radiation pneumonitis was the most common adverse event (n = 21).

IN PRACTICE:

SBRT yielded overall survival benefits similar to surgery despite a “higher likelihood of prior extrapulmonary metastases, a shorter disease-free interval, and a greater number of metastatic lesions,” the authors wrote. Still, SBRT should be regarded as an “effective alternative in cases in which surgical intervention is either unviable or declined by the patient,” the authors concluded.
 

SOURCE:

The study was co-led by Yaqi Wang and Xin Dong, Peking University Cancer Hospital & Institute, Beijing, China, and was published online in the International Journal of Radiation Oncology, Biology, Physics.
 

LIMITATIONS:

This single-center retrospective study had an inherent selection bias. The lack of balanced sample sizes of the surgery and SBRT groups might have affected the robustness of the statistical analyses. Detailed data on adverse events were not available.
 

DISCLOSURES:

The study was supported by grants from the National Natural Science Foundation of China, Beijing Natural Science Foundation, and Beijing Municipal Administration of Hospital’s Ascent Plan. The authors did not declare any conflicts of interest.

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

TOPLINE:

In patients with pulmonary oligometastases from colorectal cancer (CRC), both stereotactic body radiotherapy (SBRT) and surgery led to similar overall survival rates at 5 years. However, those who received surgery had significantly better progression-free and disease-free survival rates, as well as a longer time to intrathoracic progression.
 

METHODOLOGY:

• SBRT has been shown to provide effective local control and improve short-term survival for patients with pulmonary oligometastases from CRC and has become an alternative for these patients who are ineligible or reluctant to undergo surgery. It’s unclear, however, whether SBRT should be prioritized over surgery in patients with CRC pulmonary metastases, largely because of a lack of prospective data.
• In the current analysis, researchers compared outcomes among 335 patients (median age, 61 years) with lung metastases from CRC who underwent surgery or SBRT, using data from the Peking University Cancer Hospital and Institute between March 2011 and September 2022.
• A total of 251 patients were included in the final analysis after propensity score matching, 173 (68.9%) underwent surgery and 78 (31.1%) received SBRT. The median follow-up was 61.6 months in the surgery group and 54.4 months in the SBRT group.
• The study outcomes were freedom from intrathoracic progression, progression-free survival, and overall survival.

TAKEAWAY:

• At 5 years, rates of freedom from intrathoracic progression were more than twofold higher in the surgery group than in the SBRT group (53% vs 23.4%; hazard ratio [HR], 0.46; P < .001). Progression-free survival rates were also more than twofold higher in the surgery group vs the SBRT group (43.8% vs 18.5%; HR, 0.47; P < .001), respectively. In the SBRT group, a higher percentage of patients had a disease-free interval of less than 12 months compared with the surgery group, with rates of 48.7% and 32.9%, respectively (P = 0.025). 
• Overall survival, however, was not significantly different between the two groups at 5 years (72.5% in the surgery group vs 63.7% in the SBRT group; P = .260). The number of pulmonary metastases (HR, 1.87; 95% CI, 1.11-3.14, P = .019 and tumor size (HR, 1.03; 95% CI, 1.00-1.05, P = .023) were significant prognostic factors for overall survival.
• Local recurrence was more prevalent after SBRT (33.3%) than surgery (16.9%), while new intrathoracic tumors occurred more frequently after surgery than SBRT (71.8% vs 43.1%). Repeated local treatments were common among patients with intrathoracic progression, which might have contributed to favorable survival outcomes in both groups.
• Both treatments were well-tolerated with no treatment-related mortality or grade ≥ 3 toxicities. In the surgery group, 14 patients experienced complications, including atrial fibrillation (n = 4) and prolonged air leaks (n = 7). In the SBRT group, radiation pneumonitis was the most common adverse event (n = 21).

IN PRACTICE:

SBRT yielded overall survival benefits similar to surgery despite a “higher likelihood of prior extrapulmonary metastases, a shorter disease-free interval, and a greater number of metastatic lesions,” the authors wrote. Still, SBRT should be regarded as an “effective alternative in cases in which surgical intervention is either unviable or declined by the patient,” the authors concluded.
 

SOURCE:

The study was co-led by Yaqi Wang and Xin Dong, Peking University Cancer Hospital & Institute, Beijing, China, and was published online in the International Journal of Radiation Oncology, Biology, Physics.
 

LIMITATIONS:

This single-center retrospective study had an inherent selection bias. The lack of balanced sample sizes of the surgery and SBRT groups might have affected the robustness of the statistical analyses. Detailed data on adverse events were not available.
 

DISCLOSURES:

The study was supported by grants from the National Natural Science Foundation of China, Beijing Natural Science Foundation, and Beijing Municipal Administration of Hospital’s Ascent Plan. The authors did not declare any conflicts of interest.

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

The US Food and Drug Administration (FDA) has approved lazertinib (Lazcluze) in combination with amivantamab-vmjw (Rybrevant) for upfront treatment of adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) who have EGFR exon 19 deletions or exon 21 L858R substitution mutations as detected by an FDA-approved test. 

This marks the first approval for lazertinib. Amivantamab was initially approved by the FDA in 2021 and carries a few indications for locally advanced or metastatic NSCLC. Both drugs are manufactured by Janssen Biotech Inc.

“Patients will now have the option of a potential new first-line standard of care with significant clinical benefits over osimertinib,” study investigator Alexander Spira, MD, PhD, director, Virginia Cancer Specialists Research Institute, said in a news release from Johnson & Johnson . 

Lazertinib is an oral, highly selective, third-generation EGFR tyrosine kinase inhibitor that can penetrate the brain and amivantamab is a bispecific antibody targeting EGFR and MET.

The approval was based on results from the phase 3 MARIPOSA trial, which showed that the combination reduced the risk of disease progression or death by 30% compared with osimertinib.

The MARIPOSA trial randomly allocated 1074 patients with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic NSCLC and no prior systemic therapy for advanced disease to amivantamab plus lazertinib, osimertinib alone, or lazertinib alone.

Lazertinib plus amivantamab demonstrated a statistically significant improvement in progression-free survival compared with osimertinib (hazard ratio, 0.70; P < .001). Median progression-free survival was 23.7 months with the combination vs 16.6 months osimertinib alone and 18.5 months with lazertinib alone.

The median duration of response was 9 months longer with the combination compared with osimertinib (25.8 months vs 16.7 months).

The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reactions (amivantamab), musculoskeletal pain, edema, stomatitis, venous thromboembolism, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity. 

“A serious safety signal of venous thromboembolic events was observed with lazertinib in combination with amivantamab and prophylactic anticoagulation should be administered for the first four months of therapy,” the FDA noted in a statement announcing the approval.

Results from MARIPOSA were first presented at the European Society for Medical Oncology 2023 Congress and published in The New England Journal of Medicine in June. Longer-term follow-up data from MARIPOSA will be presented at the International Association for the Study of Lung Cancer 2024 World Congress on Lung Cancer in September.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved lazertinib (Lazcluze) in combination with amivantamab-vmjw (Rybrevant) for upfront treatment of adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) who have EGFR exon 19 deletions or exon 21 L858R substitution mutations as detected by an FDA-approved test. 

This marks the first approval for lazertinib. Amivantamab was initially approved by the FDA in 2021 and carries a few indications for locally advanced or metastatic NSCLC. Both drugs are manufactured by Janssen Biotech Inc.

“Patients will now have the option of a potential new first-line standard of care with significant clinical benefits over osimertinib,” study investigator Alexander Spira, MD, PhD, director, Virginia Cancer Specialists Research Institute, said in a news release from Johnson & Johnson . 

Lazertinib is an oral, highly selective, third-generation EGFR tyrosine kinase inhibitor that can penetrate the brain and amivantamab is a bispecific antibody targeting EGFR and MET.

The approval was based on results from the phase 3 MARIPOSA trial, which showed that the combination reduced the risk of disease progression or death by 30% compared with osimertinib.

The MARIPOSA trial randomly allocated 1074 patients with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic NSCLC and no prior systemic therapy for advanced disease to amivantamab plus lazertinib, osimertinib alone, or lazertinib alone.

Lazertinib plus amivantamab demonstrated a statistically significant improvement in progression-free survival compared with osimertinib (hazard ratio, 0.70; P < .001). Median progression-free survival was 23.7 months with the combination vs 16.6 months osimertinib alone and 18.5 months with lazertinib alone.

The median duration of response was 9 months longer with the combination compared with osimertinib (25.8 months vs 16.7 months).

The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reactions (amivantamab), musculoskeletal pain, edema, stomatitis, venous thromboembolism, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity. 

“A serious safety signal of venous thromboembolic events was observed with lazertinib in combination with amivantamab and prophylactic anticoagulation should be administered for the first four months of therapy,” the FDA noted in a statement announcing the approval.

Results from MARIPOSA were first presented at the European Society for Medical Oncology 2023 Congress and published in The New England Journal of Medicine in June. Longer-term follow-up data from MARIPOSA will be presented at the International Association for the Study of Lung Cancer 2024 World Congress on Lung Cancer in September.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved lazertinib (Lazcluze) in combination with amivantamab-vmjw (Rybrevant) for upfront treatment of adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) who have EGFR exon 19 deletions or exon 21 L858R substitution mutations as detected by an FDA-approved test. 

This marks the first approval for lazertinib. Amivantamab was initially approved by the FDA in 2021 and carries a few indications for locally advanced or metastatic NSCLC. Both drugs are manufactured by Janssen Biotech Inc.

“Patients will now have the option of a potential new first-line standard of care with significant clinical benefits over osimertinib,” study investigator Alexander Spira, MD, PhD, director, Virginia Cancer Specialists Research Institute, said in a news release from Johnson & Johnson . 

Lazertinib is an oral, highly selective, third-generation EGFR tyrosine kinase inhibitor that can penetrate the brain and amivantamab is a bispecific antibody targeting EGFR and MET.

The approval was based on results from the phase 3 MARIPOSA trial, which showed that the combination reduced the risk of disease progression or death by 30% compared with osimertinib.

The MARIPOSA trial randomly allocated 1074 patients with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic NSCLC and no prior systemic therapy for advanced disease to amivantamab plus lazertinib, osimertinib alone, or lazertinib alone.

Lazertinib plus amivantamab demonstrated a statistically significant improvement in progression-free survival compared with osimertinib (hazard ratio, 0.70; P < .001). Median progression-free survival was 23.7 months with the combination vs 16.6 months osimertinib alone and 18.5 months with lazertinib alone.

The median duration of response was 9 months longer with the combination compared with osimertinib (25.8 months vs 16.7 months).

The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reactions (amivantamab), musculoskeletal pain, edema, stomatitis, venous thromboembolism, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity. 

“A serious safety signal of venous thromboembolic events was observed with lazertinib in combination with amivantamab and prophylactic anticoagulation should be administered for the first four months of therapy,” the FDA noted in a statement announcing the approval.

Results from MARIPOSA were first presented at the European Society for Medical Oncology 2023 Congress and published in The New England Journal of Medicine in June. Longer-term follow-up data from MARIPOSA will be presented at the International Association for the Study of Lung Cancer 2024 World Congress on Lung Cancer in September.
 

A version of this article appeared on Medscape.com.

As more data show potentially dangerous effects of climate and weather on individuals with chronic medical conditions, CVS Health has introduced an initiative that uses technology to provide weather alerts and targeted outreach to those at increased risk, according to a press release from the company. Ultimately, the goals of the initiative are to improve health, reduce emergency department visits, hospital stays, and medical costs, according to the press release.

Extreme weather events such as heat waves are becoming more frequent and severe, but most heat-related deaths are preventable with outreach and intervention, Dan Knecht, MD, vice president and chief clinical innovation officer for CVS Caremark, a division of CVS Health, said in an interview. The approach will combine the company’s services, including care managers, health centers, and data, to aid patients vulnerable to severe weather.

The initiative is starting with a focus on extreme heat events and will expand this fall with alerts about high levels of air pollution for individuals with vulnerability to reduced lung function, asthma, and cardiac problems as a result of exposure to high air-pollution levels, according to Dr. Knecht.

For now, the initiative is available to members of Aetna Medicare, according to Dr. Knecht. “Our goal is to expand to other consumers, including those who visit MinuteClinic and CVS Pharmacy locations, where we can provide timely environment-related recommendations at time of care,” he said.

The alert system uses environmental data analytics to pair highly localized forecasts and real-time insights about air quality, wildfires, and high heat with medical and pharmacy data for high-risk patients in areas affected by extreme weather.

For example, for individuals who are at risk and living in areas facing extreme heat, “registered nurse care managers proactively reach out to vulnerable patients up to several days in advance of an extreme weather event and provide them personalized tips and resources,” said Dr. Knecht.

In addition, he added, “we talk to patients about how to manage their medications during periods of extreme heat and, when delivering medications, take weather data into account to determine appropriate packaging materials for shipments.”

These interventions direct patients to CVS Health–linked resources, such as Oak Street Health clinics available as cooling centers, health services provided at MinuteClinic locations, and medication management at CVS pharmacies. Other interventions include virtual or in-person mental health counseling through MinuteClinic.

Dr. Knecht offered additional guidance for clinicians and patients to help manage heat waves. “Heat and certain medications can impair heat tolerance and the ability to regulate body temperature,” he told this news organization. Extreme heat may affect the performance of some medications and their devices, such as inhalers and diabetes supplies, he added.
 

Health Alerts Have Potential, But Comprehensive Approach is Needed

“Patients with chronic lung conditions are highly susceptible to the impact of climate change,” MeiLan K. Han, MD, a pulmonologist and professor of internal medicine at the University of Michigan, Ann Arbor, said in an interview. “Increasing dust, hotter temperatures, and higher levels of air pollution make it more difficult for patients to breathe,” she said. Data also suggest that higher levels of air pollution may not only cause chronic lung disease but also cause worsening symptoms among those with existing disease, she added.

A weather-related health alert could be useful for patients so they can be prepared, Dr. Han told this news organization.

“For a patient with chronic lung disease, a hot weather alert may mean that it will be harder for patients to breathe, and [they] may [be] more susceptible to heat stroke and dehydration if they do not have access to air conditioning,” she said. “At a minimum, patients should ensure they are on their controller medications, which often means a daily inhaler for patients with conditions such as asthma and chronic obstructive pulmonary disease (COPD). However, patients also should have access to their short-term reliever medications so they can be prepared for increased shortness of breath that may accompany a hot weather day,” Dr. Han explained.

However, not all patients have access to technology such as smartphones or other devices that will alert them to impending weather events, such as heat waves, said Dr. Han. “For these patients, a standard phone call may be beneficial,” she said.

Looking ahead, “programs for weather-related health alerts will need to be comprehensive, focusing not only on access to needed medications but also climate-controlled settings for temporary relief of heat,” said Dr. Han. “For some of our most vulnerable patients, while they may have air conditioning, they may not be able to afford to run it, so this needs to be considered in developing a comprehensive program,” she emphasized.

Dr. Knecht had no financial conflicts to disclose. Dr. Han disclosed ties with Aerogen, Altesa BioSciences, American Lung Association, Amgen, Apreo Health, AstraZeneca, Biodesix, Boehringer Ingelheim, Chiesi, Cipla, COPD Foundation, DevPro, Gala Therapeutics, Genentech, GlaxoSmithKline, Integrity, MDBriefcase, Medscape, Medtronic, Medwiz, Meissa Vaccines, Merck, Mylan, NACE, National Institutes of Health, Novartis, Nuvaira, Polarian, Pulmonx, Regeneron, Roche, RS Biotherapeutics, Sanofi, Sunovion, Teva, UpToDate, and Verona..
 

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

As more data show potentially dangerous effects of climate and weather on individuals with chronic medical conditions, CVS Health has introduced an initiative that uses technology to provide weather alerts and targeted outreach to those at increased risk, according to a press release from the company. Ultimately, the goals of the initiative are to improve health, reduce emergency department visits, hospital stays, and medical costs, according to the press release.

Extreme weather events such as heat waves are becoming more frequent and severe, but most heat-related deaths are preventable with outreach and intervention, Dan Knecht, MD, vice president and chief clinical innovation officer for CVS Caremark, a division of CVS Health, said in an interview. The approach will combine the company’s services, including care managers, health centers, and data, to aid patients vulnerable to severe weather.

The initiative is starting with a focus on extreme heat events and will expand this fall with alerts about high levels of air pollution for individuals with vulnerability to reduced lung function, asthma, and cardiac problems as a result of exposure to high air-pollution levels, according to Dr. Knecht.

For now, the initiative is available to members of Aetna Medicare, according to Dr. Knecht. “Our goal is to expand to other consumers, including those who visit MinuteClinic and CVS Pharmacy locations, where we can provide timely environment-related recommendations at time of care,” he said.

The alert system uses environmental data analytics to pair highly localized forecasts and real-time insights about air quality, wildfires, and high heat with medical and pharmacy data for high-risk patients in areas affected by extreme weather.

For example, for individuals who are at risk and living in areas facing extreme heat, “registered nurse care managers proactively reach out to vulnerable patients up to several days in advance of an extreme weather event and provide them personalized tips and resources,” said Dr. Knecht.

In addition, he added, “we talk to patients about how to manage their medications during periods of extreme heat and, when delivering medications, take weather data into account to determine appropriate packaging materials for shipments.”

These interventions direct patients to CVS Health–linked resources, such as Oak Street Health clinics available as cooling centers, health services provided at MinuteClinic locations, and medication management at CVS pharmacies. Other interventions include virtual or in-person mental health counseling through MinuteClinic.

Dr. Knecht offered additional guidance for clinicians and patients to help manage heat waves. “Heat and certain medications can impair heat tolerance and the ability to regulate body temperature,” he told this news organization. Extreme heat may affect the performance of some medications and their devices, such as inhalers and diabetes supplies, he added.
 

Health Alerts Have Potential, But Comprehensive Approach is Needed

“Patients with chronic lung conditions are highly susceptible to the impact of climate change,” MeiLan K. Han, MD, a pulmonologist and professor of internal medicine at the University of Michigan, Ann Arbor, said in an interview. “Increasing dust, hotter temperatures, and higher levels of air pollution make it more difficult for patients to breathe,” she said. Data also suggest that higher levels of air pollution may not only cause chronic lung disease but also cause worsening symptoms among those with existing disease, she added.

A weather-related health alert could be useful for patients so they can be prepared, Dr. Han told this news organization.

“For a patient with chronic lung disease, a hot weather alert may mean that it will be harder for patients to breathe, and [they] may [be] more susceptible to heat stroke and dehydration if they do not have access to air conditioning,” she said. “At a minimum, patients should ensure they are on their controller medications, which often means a daily inhaler for patients with conditions such as asthma and chronic obstructive pulmonary disease (COPD). However, patients also should have access to their short-term reliever medications so they can be prepared for increased shortness of breath that may accompany a hot weather day,” Dr. Han explained.

However, not all patients have access to technology such as smartphones or other devices that will alert them to impending weather events, such as heat waves, said Dr. Han. “For these patients, a standard phone call may be beneficial,” she said.

Looking ahead, “programs for weather-related health alerts will need to be comprehensive, focusing not only on access to needed medications but also climate-controlled settings for temporary relief of heat,” said Dr. Han. “For some of our most vulnerable patients, while they may have air conditioning, they may not be able to afford to run it, so this needs to be considered in developing a comprehensive program,” she emphasized.

Dr. Knecht had no financial conflicts to disclose. Dr. Han disclosed ties with Aerogen, Altesa BioSciences, American Lung Association, Amgen, Apreo Health, AstraZeneca, Biodesix, Boehringer Ingelheim, Chiesi, Cipla, COPD Foundation, DevPro, Gala Therapeutics, Genentech, GlaxoSmithKline, Integrity, MDBriefcase, Medscape, Medtronic, Medwiz, Meissa Vaccines, Merck, Mylan, NACE, National Institutes of Health, Novartis, Nuvaira, Polarian, Pulmonx, Regeneron, Roche, RS Biotherapeutics, Sanofi, Sunovion, Teva, UpToDate, and Verona..
 

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

As more data show potentially dangerous effects of climate and weather on individuals with chronic medical conditions, CVS Health has introduced an initiative that uses technology to provide weather alerts and targeted outreach to those at increased risk, according to a press release from the company. Ultimately, the goals of the initiative are to improve health, reduce emergency department visits, hospital stays, and medical costs, according to the press release.

Extreme weather events such as heat waves are becoming more frequent and severe, but most heat-related deaths are preventable with outreach and intervention, Dan Knecht, MD, vice president and chief clinical innovation officer for CVS Caremark, a division of CVS Health, said in an interview. The approach will combine the company’s services, including care managers, health centers, and data, to aid patients vulnerable to severe weather.

The initiative is starting with a focus on extreme heat events and will expand this fall with alerts about high levels of air pollution for individuals with vulnerability to reduced lung function, asthma, and cardiac problems as a result of exposure to high air-pollution levels, according to Dr. Knecht.

For now, the initiative is available to members of Aetna Medicare, according to Dr. Knecht. “Our goal is to expand to other consumers, including those who visit MinuteClinic and CVS Pharmacy locations, where we can provide timely environment-related recommendations at time of care,” he said.

The alert system uses environmental data analytics to pair highly localized forecasts and real-time insights about air quality, wildfires, and high heat with medical and pharmacy data for high-risk patients in areas affected by extreme weather.

For example, for individuals who are at risk and living in areas facing extreme heat, “registered nurse care managers proactively reach out to vulnerable patients up to several days in advance of an extreme weather event and provide them personalized tips and resources,” said Dr. Knecht.

In addition, he added, “we talk to patients about how to manage their medications during periods of extreme heat and, when delivering medications, take weather data into account to determine appropriate packaging materials for shipments.”

These interventions direct patients to CVS Health–linked resources, such as Oak Street Health clinics available as cooling centers, health services provided at MinuteClinic locations, and medication management at CVS pharmacies. Other interventions include virtual or in-person mental health counseling through MinuteClinic.

Dr. Knecht offered additional guidance for clinicians and patients to help manage heat waves. “Heat and certain medications can impair heat tolerance and the ability to regulate body temperature,” he told this news organization. Extreme heat may affect the performance of some medications and their devices, such as inhalers and diabetes supplies, he added.
 

Health Alerts Have Potential, But Comprehensive Approach is Needed

“Patients with chronic lung conditions are highly susceptible to the impact of climate change,” MeiLan K. Han, MD, a pulmonologist and professor of internal medicine at the University of Michigan, Ann Arbor, said in an interview. “Increasing dust, hotter temperatures, and higher levels of air pollution make it more difficult for patients to breathe,” she said. Data also suggest that higher levels of air pollution may not only cause chronic lung disease but also cause worsening symptoms among those with existing disease, she added.

A weather-related health alert could be useful for patients so they can be prepared, Dr. Han told this news organization.

“For a patient with chronic lung disease, a hot weather alert may mean that it will be harder for patients to breathe, and [they] may [be] more susceptible to heat stroke and dehydration if they do not have access to air conditioning,” she said. “At a minimum, patients should ensure they are on their controller medications, which often means a daily inhaler for patients with conditions such as asthma and chronic obstructive pulmonary disease (COPD). However, patients also should have access to their short-term reliever medications so they can be prepared for increased shortness of breath that may accompany a hot weather day,” Dr. Han explained.

However, not all patients have access to technology such as smartphones or other devices that will alert them to impending weather events, such as heat waves, said Dr. Han. “For these patients, a standard phone call may be beneficial,” she said.

Looking ahead, “programs for weather-related health alerts will need to be comprehensive, focusing not only on access to needed medications but also climate-controlled settings for temporary relief of heat,” said Dr. Han. “For some of our most vulnerable patients, while they may have air conditioning, they may not be able to afford to run it, so this needs to be considered in developing a comprehensive program,” she emphasized.

Dr. Knecht had no financial conflicts to disclose. Dr. Han disclosed ties with Aerogen, Altesa BioSciences, American Lung Association, Amgen, Apreo Health, AstraZeneca, Biodesix, Boehringer Ingelheim, Chiesi, Cipla, COPD Foundation, DevPro, Gala Therapeutics, Genentech, GlaxoSmithKline, Integrity, MDBriefcase, Medscape, Medtronic, Medwiz, Meissa Vaccines, Merck, Mylan, NACE, National Institutes of Health, Novartis, Nuvaira, Polarian, Pulmonx, Regeneron, Roche, RS Biotherapeutics, Sanofi, Sunovion, Teva, UpToDate, and Verona..
 

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

An estimated 450,000 US deaths are expected this year from conditions attributed to cigarette smoking. Although the percentage of adults who smoke declined from 21% in 2005 to 11% in 2022, the annual death toll has been stable since 2005 and isn’t expected to decline until 2030, owing to an aging population of current and former smokers.

In 2022, based on a national survey, two thirds of the 28.8 million US adult smokers wanted to quit, and more than half tried quitting on their own or with the help of clinicians, but less than 9% succeeded in kicking the habit. The health benefits of quitting, summarized in a patient education handout from the American Cancer Society, include a lower risk for cancer, diabetes, and cardiovascular disease. Furthermore, the handout states, “quitting smoking can add as much as 10 years to your life, compared to if you continued to smoke.”

For my patients older than age 50 who are lifelong smokers, the qualifier “as much as” can be a sticking point. Although most recognize that continuing to smoke exposes them to greater health risks and are willing to undergo lung cancer screening and receive pneumococcal vaccines, a kind of fatalism frequently sets in. I’ve heard more times than I can recall some version of the declaration, “It’s too late for quitting to make much difference for me.” Many smokers think that once they reach middle age, gains in life expectancy will be too small to be worth the intense effort and multiple failed attempts that are typically required to quit permanently. Until recently, there were few data I could call on to persuade them they were wrong.

In February 2024, Dr. Eo Rin Cho and colleagues pooled data from four national cohort studies (United States, United Kingdom, Norway, and Canada) to calculate mortality differences among current, former, and never smokers aged 20-79 years. Compared with never smokers, lifelong smokers died an average of 12-13 years earlier. However, quitting before age 50 nearly eliminated the excess mortality associated with smoking, and in the 50- to 59-year-old age group, cessation eventually reduced excess mortality by 92%-95%. Better yet, more than half of the benefits occurred within the first 3 years after cessation.

At first glance, these estimates may seem too good to be true. A few months later, though, a different research group, using data from a large cancer prevention study and 2018 US population census and mortality rates, largely confirmed their findings. Dr. Thuy Le and colleagues found that quitting at age 35, 45, 55, 65, or 75 years resulted in average life gains of 8, 5.6, 3.5, 1.7, and 0.7 years, respectively, relative to continuing to smoke. Because no patient is average, the analysis also presented some helpful probabilities. For example, a smoker who quits at age 65 has about a 1 in 4 chance of gaining at least 1 full year of life and a 1 in 6 chance of gaining at least 4 years. In other words, from a life expectancy perspective alone, it’s almost never too late to quit smoking.

Dr. Lin is a family physician and Associate Director, Family Medicine Residency Program, Lancaster General Hospital, Lancaster, Pennsylvania. He blogs at Common Sense Family Doctor. He has disclosed no relevant financial relationships.

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

An estimated 450,000 US deaths are expected this year from conditions attributed to cigarette smoking. Although the percentage of adults who smoke declined from 21% in 2005 to 11% in 2022, the annual death toll has been stable since 2005 and isn’t expected to decline until 2030, owing to an aging population of current and former smokers.

In 2022, based on a national survey, two thirds of the 28.8 million US adult smokers wanted to quit, and more than half tried quitting on their own or with the help of clinicians, but less than 9% succeeded in kicking the habit. The health benefits of quitting, summarized in a patient education handout from the American Cancer Society, include a lower risk for cancer, diabetes, and cardiovascular disease. Furthermore, the handout states, “quitting smoking can add as much as 10 years to your life, compared to if you continued to smoke.”

For my patients older than age 50 who are lifelong smokers, the qualifier “as much as” can be a sticking point. Although most recognize that continuing to smoke exposes them to greater health risks and are willing to undergo lung cancer screening and receive pneumococcal vaccines, a kind of fatalism frequently sets in. I’ve heard more times than I can recall some version of the declaration, “It’s too late for quitting to make much difference for me.” Many smokers think that once they reach middle age, gains in life expectancy will be too small to be worth the intense effort and multiple failed attempts that are typically required to quit permanently. Until recently, there were few data I could call on to persuade them they were wrong.

In February 2024, Dr. Eo Rin Cho and colleagues pooled data from four national cohort studies (United States, United Kingdom, Norway, and Canada) to calculate mortality differences among current, former, and never smokers aged 20-79 years. Compared with never smokers, lifelong smokers died an average of 12-13 years earlier. However, quitting before age 50 nearly eliminated the excess mortality associated with smoking, and in the 50- to 59-year-old age group, cessation eventually reduced excess mortality by 92%-95%. Better yet, more than half of the benefits occurred within the first 3 years after cessation.

At first glance, these estimates may seem too good to be true. A few months later, though, a different research group, using data from a large cancer prevention study and 2018 US population census and mortality rates, largely confirmed their findings. Dr. Thuy Le and colleagues found that quitting at age 35, 45, 55, 65, or 75 years resulted in average life gains of 8, 5.6, 3.5, 1.7, and 0.7 years, respectively, relative to continuing to smoke. Because no patient is average, the analysis also presented some helpful probabilities. For example, a smoker who quits at age 65 has about a 1 in 4 chance of gaining at least 1 full year of life and a 1 in 6 chance of gaining at least 4 years. In other words, from a life expectancy perspective alone, it’s almost never too late to quit smoking.

Dr. Lin is a family physician and Associate Director, Family Medicine Residency Program, Lancaster General Hospital, Lancaster, Pennsylvania. He blogs at Common Sense Family Doctor. He has disclosed no relevant financial relationships.

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

An estimated 450,000 US deaths are expected this year from conditions attributed to cigarette smoking. Although the percentage of adults who smoke declined from 21% in 2005 to 11% in 2022, the annual death toll has been stable since 2005 and isn’t expected to decline until 2030, owing to an aging population of current and former smokers.

In 2022, based on a national survey, two thirds of the 28.8 million US adult smokers wanted to quit, and more than half tried quitting on their own or with the help of clinicians, but less than 9% succeeded in kicking the habit. The health benefits of quitting, summarized in a patient education handout from the American Cancer Society, include a lower risk for cancer, diabetes, and cardiovascular disease. Furthermore, the handout states, “quitting smoking can add as much as 10 years to your life, compared to if you continued to smoke.”

For my patients older than age 50 who are lifelong smokers, the qualifier “as much as” can be a sticking point. Although most recognize that continuing to smoke exposes them to greater health risks and are willing to undergo lung cancer screening and receive pneumococcal vaccines, a kind of fatalism frequently sets in. I’ve heard more times than I can recall some version of the declaration, “It’s too late for quitting to make much difference for me.” Many smokers think that once they reach middle age, gains in life expectancy will be too small to be worth the intense effort and multiple failed attempts that are typically required to quit permanently. Until recently, there were few data I could call on to persuade them they were wrong.

In February 2024, Dr. Eo Rin Cho and colleagues pooled data from four national cohort studies (United States, United Kingdom, Norway, and Canada) to calculate mortality differences among current, former, and never smokers aged 20-79 years. Compared with never smokers, lifelong smokers died an average of 12-13 years earlier. However, quitting before age 50 nearly eliminated the excess mortality associated with smoking, and in the 50- to 59-year-old age group, cessation eventually reduced excess mortality by 92%-95%. Better yet, more than half of the benefits occurred within the first 3 years after cessation.

At first glance, these estimates may seem too good to be true. A few months later, though, a different research group, using data from a large cancer prevention study and 2018 US population census and mortality rates, largely confirmed their findings. Dr. Thuy Le and colleagues found that quitting at age 35, 45, 55, 65, or 75 years resulted in average life gains of 8, 5.6, 3.5, 1.7, and 0.7 years, respectively, relative to continuing to smoke. Because no patient is average, the analysis also presented some helpful probabilities. For example, a smoker who quits at age 65 has about a 1 in 4 chance of gaining at least 1 full year of life and a 1 in 6 chance of gaining at least 4 years. In other words, from a life expectancy perspective alone, it’s almost never too late to quit smoking.

Dr. Lin is a family physician and Associate Director, Family Medicine Residency Program, Lancaster General Hospital, Lancaster, Pennsylvania. He blogs at Common Sense Family Doctor. He has disclosed no relevant financial relationships.

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

Like many diseases, whooping cough reached record low levels during the early days of the COVID pandemic. Also known as pertussis, it’s back with a vengeance and could even threaten people who are vaccinated against the disease, since protection fades over time.

More than 10,000 cases of whooping cough have been reported in the United States so far this year, and weekly reports say cases have more than tripled 2023 levels as of June, according to the Centers for Disease Control and Prevention (CDC). In 2023, there were 2815 cases reported during the entire year.

“The number of reported cases this year is close to what was seen at the same time in 2019, prior to the pandemic,” the CDC reported. There were 18,617 cases of whooping cough in 2019.

There were 259 cases reported nationwide for the week ending Aug. 3, with nearly half occurring in the mid-Atlantic region. Public health officials believe the resurgence of whooping cough is likely due to declining vaccination rates, mainly due to the missed vaccines during the height of the COVID pandemic. The diphtheria, tetanus, and pertussis vaccines (DTaP) have been given together since the 1940s, typically during infancy and again during early childhood. In 1941, there were more than 220,000 cases of whooping cough.

Whooping cough is caused by the bacteria Bordetella pertussis. The bacteria attach to tiny, hair-like extensions in the upper respiratory system called cilia, and toxins released by them damage the cilia and cause airways to swell. Early symptoms are similar to the common cold, but the condition eventually leads to coughing fits and a high-pitched “whoop” sound made when inhaling after a fit subsides. Coughing fits can be so severe that people can fracture a rib.

Vaccinated people may get a less severe illness, compared to unvaccinated people, the CDC says. Babies and children are particularly at risk for severe and even potentially deadly complications. About one in three babies under age 1 who get whooping cough will need to be hospitalized, and among those hospitalized babies, 1 in 100 die from complications.
 

A version of this article appeared on WebMD.com.

Like many diseases, whooping cough reached record low levels during the early days of the COVID pandemic. Also known as pertussis, it’s back with a vengeance and could even threaten people who are vaccinated against the disease, since protection fades over time.

More than 10,000 cases of whooping cough have been reported in the United States so far this year, and weekly reports say cases have more than tripled 2023 levels as of June, according to the Centers for Disease Control and Prevention (CDC). In 2023, there were 2815 cases reported during the entire year.

“The number of reported cases this year is close to what was seen at the same time in 2019, prior to the pandemic,” the CDC reported. There were 18,617 cases of whooping cough in 2019.

There were 259 cases reported nationwide for the week ending Aug. 3, with nearly half occurring in the mid-Atlantic region. Public health officials believe the resurgence of whooping cough is likely due to declining vaccination rates, mainly due to the missed vaccines during the height of the COVID pandemic. The diphtheria, tetanus, and pertussis vaccines (DTaP) have been given together since the 1940s, typically during infancy and again during early childhood. In 1941, there were more than 220,000 cases of whooping cough.

Whooping cough is caused by the bacteria Bordetella pertussis. The bacteria attach to tiny, hair-like extensions in the upper respiratory system called cilia, and toxins released by them damage the cilia and cause airways to swell. Early symptoms are similar to the common cold, but the condition eventually leads to coughing fits and a high-pitched “whoop” sound made when inhaling after a fit subsides. Coughing fits can be so severe that people can fracture a rib.

Vaccinated people may get a less severe illness, compared to unvaccinated people, the CDC says. Babies and children are particularly at risk for severe and even potentially deadly complications. About one in three babies under age 1 who get whooping cough will need to be hospitalized, and among those hospitalized babies, 1 in 100 die from complications.
 

A version of this article appeared on WebMD.com.

Like many diseases, whooping cough reached record low levels during the early days of the COVID pandemic. Also known as pertussis, it’s back with a vengeance and could even threaten people who are vaccinated against the disease, since protection fades over time.

More than 10,000 cases of whooping cough have been reported in the United States so far this year, and weekly reports say cases have more than tripled 2023 levels as of June, according to the Centers for Disease Control and Prevention (CDC). In 2023, there were 2815 cases reported during the entire year.

“The number of reported cases this year is close to what was seen at the same time in 2019, prior to the pandemic,” the CDC reported. There were 18,617 cases of whooping cough in 2019.

There were 259 cases reported nationwide for the week ending Aug. 3, with nearly half occurring in the mid-Atlantic region. Public health officials believe the resurgence of whooping cough is likely due to declining vaccination rates, mainly due to the missed vaccines during the height of the COVID pandemic. The diphtheria, tetanus, and pertussis vaccines (DTaP) have been given together since the 1940s, typically during infancy and again during early childhood. In 1941, there were more than 220,000 cases of whooping cough.

Whooping cough is caused by the bacteria Bordetella pertussis. The bacteria attach to tiny, hair-like extensions in the upper respiratory system called cilia, and toxins released by them damage the cilia and cause airways to swell. Early symptoms are similar to the common cold, but the condition eventually leads to coughing fits and a high-pitched “whoop” sound made when inhaling after a fit subsides. Coughing fits can be so severe that people can fracture a rib.

Vaccinated people may get a less severe illness, compared to unvaccinated people, the CDC says. Babies and children are particularly at risk for severe and even potentially deadly complications. About one in three babies under age 1 who get whooping cough will need to be hospitalized, and among those hospitalized babies, 1 in 100 die from complications.
 

A version of this article appeared on WebMD.com.

Ensifentrine (Ohtuvayre), a novel medication for the treatment of chronic obstructive pulmonary disease (COPD) recently approved by the US Food and Drug Administration, has been shown to reduce COPD exacerbations and may improve the quality of life for patients, but these potential benefits come at a high annual cost, authors of a cost-effectiveness analysis say.

Ensifentrine is a first-in-class selective dual inhibitor of both phosphodiesterase 3 (PDE-3) and PDE-4, combining both bronchodilator and nonsteroidal anti-inflammatory effects in a single molecule. The drug is delivered through a standard jet nebulizer.

In the phase 3 ENHANCE 1 and 2 trials, ensifentrine significantly improved lung function based on the primary outcome of average forced expiratory volume in 1 second (FEV1) within 0-12 hours of administration compared with placebo. In addition, patients were found to tolerate the inhaled treatment well, with similar proportions of ensifentrine- and placebo-assigned patients reporting treatment-emergent adverse events. The most common treatment-emergent adverse events were nasopharyngitis, hypertension, and back pain, reported in < 3% of the ensifentrine group.
 

High Cost Barrier

But as authors of the analysis from the Boston-based Institute for Clinical and Economic Review (ICER) found, the therapeutic edge offered by ensifentrine is outweighed by the annual wholesale acquisition cost that its maker, Verona Pharma, has established: $35,400, which far exceeds the estimated health-benefit price of $7500 to $12,700, according to ICER. ICER is an independent, nonprofit research institute that conducts evidence-based reviews of healthcare interventions, including prescription drugs, other treatments, and diagnostic tests. 

“Current evidence shows that ensifentrine decreases COPD exacerbations when used in combination with some current inhaled therapies, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments,” said David Rind, MD, chief medical officer of ICER, in a statement.

In an interview, Dr. Rind noted that the high price of ensifentrine may lead payers to restrict access to an otherwise promising new therapy. “Obviously many drugs in the US are overpriced, and this one, too, looks like it is overpriced. That causes ongoing financial toxicity for individual patients and it causes problems for the entire US health system, because when we pay too much for drugs we don’t have money for other things. So I’m worried about the fact that this price is too high compared to the benefit it provides,” he said.

As previously reported, as many as 1 in 6 persons with COPD in the United States miss or delay COPD medication doses owing to high drug costs. “I think that the pricing they chose is going to cause lots of barriers to people getting access and that insurance companies will throw up barriers. Primary care physicians like me won’t even try to get approval for a drug like this given the hoops we will be made to jump through, and so fewer people will get this drug,” Dr. Rind said. He pointed out that a lower wholesale acquisition cost could encourage higher volume sales, affording the drug maker a comparable profit to the higher cost but lower volume option.
 

Good Drug, High Price

An independent appraisal committee for ICER determined that “current evidence is adequate to demonstrate a net health benefit for ensifentrine added to maintenance therapy when compared to maintenance therapy alone.”

But ICER also issued an access and affordability alert “to signal to stakeholders and policymakers that the amount of added health care costs associated with a new service may be difficult for the health system to absorb over the short term without displacing other needed services.” ICER recommends that payers should include coverage for smoking cessation therapies, and that drug manufacturers “set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments.”

“This looks like a pretty good drug,” Dr. Rind said. “It looks quite safe, and I think there will be a lot of patients, particularly those who are having frequent exacerbations, who this would be appropriate for, particularly once they’ve maxed out existing therapies, but maybe even earlier than that. And if the price comes down to the point that patients can really access this and providers can access it, people really should look at this as a potential therapy.”
 

Drug Not Yet Available? 

However, providers have not yet had experience to gauge the new medication. “We haven’t been able to prescribe it yet,” said Corinne Young, MSN, FNP-C, FCCP, director of advance practice provider and clinical services for Colorado Springs Pulmonary Consultants and president and founder of the Association of Pulmonary Advanced Practice Providers. She learned that “they were going to release it to select specialty pharmacies in the third quarter of 2024. But all the ones we call do not have it, and no one knows who does. They haven’t sent any reps into the field in my area, so we don’t have any points of contact either,” she said. 

Verona Pharma stated it anticipates ensifentrine to be available in the third quarter of 2024 “through an exclusive network of accredited specialty pharmacies.” 

Funding for the ICER report came from nonprofit foundations. No funding came from health insurers, pharmacy benefit managers, or life science companies. Dr. Rind had no disclosures relevant to ensifentrine or Verona Pharma. Ms. Young is a member of the CHEST Physician Editorial Board.

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

Ensifentrine (Ohtuvayre), a novel medication for the treatment of chronic obstructive pulmonary disease (COPD) recently approved by the US Food and Drug Administration, has been shown to reduce COPD exacerbations and may improve the quality of life for patients, but these potential benefits come at a high annual cost, authors of a cost-effectiveness analysis say.

Ensifentrine is a first-in-class selective dual inhibitor of both phosphodiesterase 3 (PDE-3) and PDE-4, combining both bronchodilator and nonsteroidal anti-inflammatory effects in a single molecule. The drug is delivered through a standard jet nebulizer.

In the phase 3 ENHANCE 1 and 2 trials, ensifentrine significantly improved lung function based on the primary outcome of average forced expiratory volume in 1 second (FEV1) within 0-12 hours of administration compared with placebo. In addition, patients were found to tolerate the inhaled treatment well, with similar proportions of ensifentrine- and placebo-assigned patients reporting treatment-emergent adverse events. The most common treatment-emergent adverse events were nasopharyngitis, hypertension, and back pain, reported in < 3% of the ensifentrine group.
 

High Cost Barrier

But as authors of the analysis from the Boston-based Institute for Clinical and Economic Review (ICER) found, the therapeutic edge offered by ensifentrine is outweighed by the annual wholesale acquisition cost that its maker, Verona Pharma, has established: $35,400, which far exceeds the estimated health-benefit price of $7500 to $12,700, according to ICER. ICER is an independent, nonprofit research institute that conducts evidence-based reviews of healthcare interventions, including prescription drugs, other treatments, and diagnostic tests. 

“Current evidence shows that ensifentrine decreases COPD exacerbations when used in combination with some current inhaled therapies, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments,” said David Rind, MD, chief medical officer of ICER, in a statement.

In an interview, Dr. Rind noted that the high price of ensifentrine may lead payers to restrict access to an otherwise promising new therapy. “Obviously many drugs in the US are overpriced, and this one, too, looks like it is overpriced. That causes ongoing financial toxicity for individual patients and it causes problems for the entire US health system, because when we pay too much for drugs we don’t have money for other things. So I’m worried about the fact that this price is too high compared to the benefit it provides,” he said.

As previously reported, as many as 1 in 6 persons with COPD in the United States miss or delay COPD medication doses owing to high drug costs. “I think that the pricing they chose is going to cause lots of barriers to people getting access and that insurance companies will throw up barriers. Primary care physicians like me won’t even try to get approval for a drug like this given the hoops we will be made to jump through, and so fewer people will get this drug,” Dr. Rind said. He pointed out that a lower wholesale acquisition cost could encourage higher volume sales, affording the drug maker a comparable profit to the higher cost but lower volume option.
 

Good Drug, High Price

An independent appraisal committee for ICER determined that “current evidence is adequate to demonstrate a net health benefit for ensifentrine added to maintenance therapy when compared to maintenance therapy alone.”

But ICER also issued an access and affordability alert “to signal to stakeholders and policymakers that the amount of added health care costs associated with a new service may be difficult for the health system to absorb over the short term without displacing other needed services.” ICER recommends that payers should include coverage for smoking cessation therapies, and that drug manufacturers “set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments.”

“This looks like a pretty good drug,” Dr. Rind said. “It looks quite safe, and I think there will be a lot of patients, particularly those who are having frequent exacerbations, who this would be appropriate for, particularly once they’ve maxed out existing therapies, but maybe even earlier than that. And if the price comes down to the point that patients can really access this and providers can access it, people really should look at this as a potential therapy.”
 

Drug Not Yet Available? 

However, providers have not yet had experience to gauge the new medication. “We haven’t been able to prescribe it yet,” said Corinne Young, MSN, FNP-C, FCCP, director of advance practice provider and clinical services for Colorado Springs Pulmonary Consultants and president and founder of the Association of Pulmonary Advanced Practice Providers. She learned that “they were going to release it to select specialty pharmacies in the third quarter of 2024. But all the ones we call do not have it, and no one knows who does. They haven’t sent any reps into the field in my area, so we don’t have any points of contact either,” she said. 

Verona Pharma stated it anticipates ensifentrine to be available in the third quarter of 2024 “through an exclusive network of accredited specialty pharmacies.” 

Funding for the ICER report came from nonprofit foundations. No funding came from health insurers, pharmacy benefit managers, or life science companies. Dr. Rind had no disclosures relevant to ensifentrine or Verona Pharma. Ms. Young is a member of the CHEST Physician Editorial Board.

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

Ensifentrine (Ohtuvayre), a novel medication for the treatment of chronic obstructive pulmonary disease (COPD) recently approved by the US Food and Drug Administration, has been shown to reduce COPD exacerbations and may improve the quality of life for patients, but these potential benefits come at a high annual cost, authors of a cost-effectiveness analysis say.

Ensifentrine is a first-in-class selective dual inhibitor of both phosphodiesterase 3 (PDE-3) and PDE-4, combining both bronchodilator and nonsteroidal anti-inflammatory effects in a single molecule. The drug is delivered through a standard jet nebulizer.

In the phase 3 ENHANCE 1 and 2 trials, ensifentrine significantly improved lung function based on the primary outcome of average forced expiratory volume in 1 second (FEV1) within 0-12 hours of administration compared with placebo. In addition, patients were found to tolerate the inhaled treatment well, with similar proportions of ensifentrine- and placebo-assigned patients reporting treatment-emergent adverse events. The most common treatment-emergent adverse events were nasopharyngitis, hypertension, and back pain, reported in < 3% of the ensifentrine group.
 

High Cost Barrier

But as authors of the analysis from the Boston-based Institute for Clinical and Economic Review (ICER) found, the therapeutic edge offered by ensifentrine is outweighed by the annual wholesale acquisition cost that its maker, Verona Pharma, has established: $35,400, which far exceeds the estimated health-benefit price of $7500 to $12,700, according to ICER. ICER is an independent, nonprofit research institute that conducts evidence-based reviews of healthcare interventions, including prescription drugs, other treatments, and diagnostic tests. 

“Current evidence shows that ensifentrine decreases COPD exacerbations when used in combination with some current inhaled therapies, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments,” said David Rind, MD, chief medical officer of ICER, in a statement.

In an interview, Dr. Rind noted that the high price of ensifentrine may lead payers to restrict access to an otherwise promising new therapy. “Obviously many drugs in the US are overpriced, and this one, too, looks like it is overpriced. That causes ongoing financial toxicity for individual patients and it causes problems for the entire US health system, because when we pay too much for drugs we don’t have money for other things. So I’m worried about the fact that this price is too high compared to the benefit it provides,” he said.

As previously reported, as many as 1 in 6 persons with COPD in the United States miss or delay COPD medication doses owing to high drug costs. “I think that the pricing they chose is going to cause lots of barriers to people getting access and that insurance companies will throw up barriers. Primary care physicians like me won’t even try to get approval for a drug like this given the hoops we will be made to jump through, and so fewer people will get this drug,” Dr. Rind said. He pointed out that a lower wholesale acquisition cost could encourage higher volume sales, affording the drug maker a comparable profit to the higher cost but lower volume option.
 

Good Drug, High Price

An independent appraisal committee for ICER determined that “current evidence is adequate to demonstrate a net health benefit for ensifentrine added to maintenance therapy when compared to maintenance therapy alone.”

But ICER also issued an access and affordability alert “to signal to stakeholders and policymakers that the amount of added health care costs associated with a new service may be difficult for the health system to absorb over the short term without displacing other needed services.” ICER recommends that payers should include coverage for smoking cessation therapies, and that drug manufacturers “set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments.”

“This looks like a pretty good drug,” Dr. Rind said. “It looks quite safe, and I think there will be a lot of patients, particularly those who are having frequent exacerbations, who this would be appropriate for, particularly once they’ve maxed out existing therapies, but maybe even earlier than that. And if the price comes down to the point that patients can really access this and providers can access it, people really should look at this as a potential therapy.”
 

Drug Not Yet Available? 

However, providers have not yet had experience to gauge the new medication. “We haven’t been able to prescribe it yet,” said Corinne Young, MSN, FNP-C, FCCP, director of advance practice provider and clinical services for Colorado Springs Pulmonary Consultants and president and founder of the Association of Pulmonary Advanced Practice Providers. She learned that “they were going to release it to select specialty pharmacies in the third quarter of 2024. But all the ones we call do not have it, and no one knows who does. They haven’t sent any reps into the field in my area, so we don’t have any points of contact either,” she said. 

Verona Pharma stated it anticipates ensifentrine to be available in the third quarter of 2024 “through an exclusive network of accredited specialty pharmacies.” 

Funding for the ICER report came from nonprofit foundations. No funding came from health insurers, pharmacy benefit managers, or life science companies. Dr. Rind had no disclosures relevant to ensifentrine or Verona Pharma. Ms. Young is a member of the CHEST Physician Editorial Board.

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