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Privately insured patients with asthma faced an 81% rise in out-of-pocket costs for albuterol and used slightly less of the medication after the Food and Drug Administration banned chlorofluorocarbon-based inhalers, researchers reported online in JAMA Internal Medicine.
But the ban did not appear to affect rates of hospitalization or emergency department or outpatient visits for asthma, said Dr. Anupam Jena of Massachusetts General Hospital in Boston and his associates. “The impact of the FDA policy on individuals without insurance who faced greater increases in out-of-pocket costs warrants further exploration,” the researchers emphasized.
Concerns about ozone depletion led the FDA in 2005 to announce a ban on CFC inhalers that became effective at the end of 2008. Patients were left with pricier branded hydrofluoroalkane albuterol inhalers, Dr. Jena and his associates noted (JAMA Intern. Med. 2015 May 11 [doi:10.1001/jamainternmed.2015.1665]).
To investigate the economic and clinical effects of this shift, the researchers analyzed private insurance data from 2004 to 2010 on 109,428 adults and 37,281 children with asthma.
The average out-of-pocket cost of an albuterol prescription rose from $13.60 (95% confidence interval, $13.40-$13.70) in 2004 to $25.00 (95% CI, $24.80-$25.20) in 2008, just after the ban went into effect, the researchers reported. By 2010, the average cost of a prescription had dropped to $21.00 (95% CI, $20.80-$21.20). “Steep declines in use of generic CFC inhalers occurred after the fourth quarter of 2006 and were almost fully offset by increases in use of hydrofluoroalkane inhalers,” added the researchers. Furthermore, every $10 increase in out-of-pocket albuterol prescription costs was tied to about a 0.92 percentage point decline in use of the inhalers (95% CI, −1.39 to −0.44; P < .001) in adults, and a 0.54 percentage point in children (95% CI, −0.84 to −0.24; P = .001), they said. Usage did not vary significantly between adults and children or among patients with persistent or nonpersistent asthma, they added.
The National Institutes of Health, National Institute on Aging, and University of Minnesota funded the study. The investigators declared no relevant conflicts of interest.
The 2008 FDA ban on albuterol inhalers containing chlorofluorocarbons was questioned at the time because the CFCs emitted from inhalers have an insignificant effect on ozone and because of the anticipated costs of transitioning to hydrofluoroalkane inhalers for patients with respiratory disease.
Whether banning chlorofluorocarbon inhalers will lead to any improvement in the environment is unclear. It is clear that the ban has increased health care costs and improved the bottom line of pharmaceutical companies that are making hydrofluoroalkane-based inhalers. Although albuterol inhalers have been in use for more than 30 years, pharmaceutical companies have used the chlorofluorocarbon ban as an opportunity to raise the price on inhalers from approximately $13 for a generic formulation to more than $50 today. … In this unique situation, it would have made more sense to not ban chlorofluorocarbon inhalers until hydrofluoroalkane inhalers were available in generic formulations. This would have balanced the best interests of society and the best interests of individuals with respiratory disease, allowing the FDA to protect the environment without making inhalers expensive and unaffordable for many.
Joseph Ross, M.D., M.H.S. is at the Yale University School of Medicine in New Haven, Conn., and disclosed FDA research funding related to medical device surveillance and clinical trial data sharing. Rita Redberg, M.D., M.Sc., is at the University of California, San Francisco, and made no relevant disclosures. These comments are based on their accompanying editorial (JAMA Intern. Med. 2015 May 11 [doi:10.1001/jamainternmed.2015.1696]).
The 2008 FDA ban on albuterol inhalers containing chlorofluorocarbons was questioned at the time because the CFCs emitted from inhalers have an insignificant effect on ozone and because of the anticipated costs of transitioning to hydrofluoroalkane inhalers for patients with respiratory disease.
Whether banning chlorofluorocarbon inhalers will lead to any improvement in the environment is unclear. It is clear that the ban has increased health care costs and improved the bottom line of pharmaceutical companies that are making hydrofluoroalkane-based inhalers. Although albuterol inhalers have been in use for more than 30 years, pharmaceutical companies have used the chlorofluorocarbon ban as an opportunity to raise the price on inhalers from approximately $13 for a generic formulation to more than $50 today. … In this unique situation, it would have made more sense to not ban chlorofluorocarbon inhalers until hydrofluoroalkane inhalers were available in generic formulations. This would have balanced the best interests of society and the best interests of individuals with respiratory disease, allowing the FDA to protect the environment without making inhalers expensive and unaffordable for many.
Joseph Ross, M.D., M.H.S. is at the Yale University School of Medicine in New Haven, Conn., and disclosed FDA research funding related to medical device surveillance and clinical trial data sharing. Rita Redberg, M.D., M.Sc., is at the University of California, San Francisco, and made no relevant disclosures. These comments are based on their accompanying editorial (JAMA Intern. Med. 2015 May 11 [doi:10.1001/jamainternmed.2015.1696]).
The 2008 FDA ban on albuterol inhalers containing chlorofluorocarbons was questioned at the time because the CFCs emitted from inhalers have an insignificant effect on ozone and because of the anticipated costs of transitioning to hydrofluoroalkane inhalers for patients with respiratory disease.
Whether banning chlorofluorocarbon inhalers will lead to any improvement in the environment is unclear. It is clear that the ban has increased health care costs and improved the bottom line of pharmaceutical companies that are making hydrofluoroalkane-based inhalers. Although albuterol inhalers have been in use for more than 30 years, pharmaceutical companies have used the chlorofluorocarbon ban as an opportunity to raise the price on inhalers from approximately $13 for a generic formulation to more than $50 today. … In this unique situation, it would have made more sense to not ban chlorofluorocarbon inhalers until hydrofluoroalkane inhalers were available in generic formulations. This would have balanced the best interests of society and the best interests of individuals with respiratory disease, allowing the FDA to protect the environment without making inhalers expensive and unaffordable for many.
Joseph Ross, M.D., M.H.S. is at the Yale University School of Medicine in New Haven, Conn., and disclosed FDA research funding related to medical device surveillance and clinical trial data sharing. Rita Redberg, M.D., M.Sc., is at the University of California, San Francisco, and made no relevant disclosures. These comments are based on their accompanying editorial (JAMA Intern. Med. 2015 May 11 [doi:10.1001/jamainternmed.2015.1696]).
Privately insured patients with asthma faced an 81% rise in out-of-pocket costs for albuterol and used slightly less of the medication after the Food and Drug Administration banned chlorofluorocarbon-based inhalers, researchers reported online in JAMA Internal Medicine.
But the ban did not appear to affect rates of hospitalization or emergency department or outpatient visits for asthma, said Dr. Anupam Jena of Massachusetts General Hospital in Boston and his associates. “The impact of the FDA policy on individuals without insurance who faced greater increases in out-of-pocket costs warrants further exploration,” the researchers emphasized.
Concerns about ozone depletion led the FDA in 2005 to announce a ban on CFC inhalers that became effective at the end of 2008. Patients were left with pricier branded hydrofluoroalkane albuterol inhalers, Dr. Jena and his associates noted (JAMA Intern. Med. 2015 May 11 [doi:10.1001/jamainternmed.2015.1665]).
To investigate the economic and clinical effects of this shift, the researchers analyzed private insurance data from 2004 to 2010 on 109,428 adults and 37,281 children with asthma.
The average out-of-pocket cost of an albuterol prescription rose from $13.60 (95% confidence interval, $13.40-$13.70) in 2004 to $25.00 (95% CI, $24.80-$25.20) in 2008, just after the ban went into effect, the researchers reported. By 2010, the average cost of a prescription had dropped to $21.00 (95% CI, $20.80-$21.20). “Steep declines in use of generic CFC inhalers occurred after the fourth quarter of 2006 and were almost fully offset by increases in use of hydrofluoroalkane inhalers,” added the researchers. Furthermore, every $10 increase in out-of-pocket albuterol prescription costs was tied to about a 0.92 percentage point decline in use of the inhalers (95% CI, −1.39 to −0.44; P < .001) in adults, and a 0.54 percentage point in children (95% CI, −0.84 to −0.24; P = .001), they said. Usage did not vary significantly between adults and children or among patients with persistent or nonpersistent asthma, they added.
The National Institutes of Health, National Institute on Aging, and University of Minnesota funded the study. The investigators declared no relevant conflicts of interest.
Privately insured patients with asthma faced an 81% rise in out-of-pocket costs for albuterol and used slightly less of the medication after the Food and Drug Administration banned chlorofluorocarbon-based inhalers, researchers reported online in JAMA Internal Medicine.
But the ban did not appear to affect rates of hospitalization or emergency department or outpatient visits for asthma, said Dr. Anupam Jena of Massachusetts General Hospital in Boston and his associates. “The impact of the FDA policy on individuals without insurance who faced greater increases in out-of-pocket costs warrants further exploration,” the researchers emphasized.
Concerns about ozone depletion led the FDA in 2005 to announce a ban on CFC inhalers that became effective at the end of 2008. Patients were left with pricier branded hydrofluoroalkane albuterol inhalers, Dr. Jena and his associates noted (JAMA Intern. Med. 2015 May 11 [doi:10.1001/jamainternmed.2015.1665]).
To investigate the economic and clinical effects of this shift, the researchers analyzed private insurance data from 2004 to 2010 on 109,428 adults and 37,281 children with asthma.
The average out-of-pocket cost of an albuterol prescription rose from $13.60 (95% confidence interval, $13.40-$13.70) in 2004 to $25.00 (95% CI, $24.80-$25.20) in 2008, just after the ban went into effect, the researchers reported. By 2010, the average cost of a prescription had dropped to $21.00 (95% CI, $20.80-$21.20). “Steep declines in use of generic CFC inhalers occurred after the fourth quarter of 2006 and were almost fully offset by increases in use of hydrofluoroalkane inhalers,” added the researchers. Furthermore, every $10 increase in out-of-pocket albuterol prescription costs was tied to about a 0.92 percentage point decline in use of the inhalers (95% CI, −1.39 to −0.44; P < .001) in adults, and a 0.54 percentage point in children (95% CI, −0.84 to −0.24; P = .001), they said. Usage did not vary significantly between adults and children or among patients with persistent or nonpersistent asthma, they added.
The National Institutes of Health, National Institute on Aging, and University of Minnesota funded the study. The investigators declared no relevant conflicts of interest.
FROM JAMA INTERNAL MEDICINE
Key clinical point: The FDA ban on chlorofluorocarbon-based albuterol inhalers sharply increased out-of-pocket costs and slightly decreased inhaler usage.
Major finding: Average out-of-pocket cost of albuterol inhalers rose by 50% after the ban was passed.
Data source: Analysis of private insurance data from 109,428 adults and 37,281 children with asthma from 2004 through 2010.
Disclosures: The National Institutes of Health, National Institute on Aging, and University of Minnesota funded the study. The investigators declared no relevant conflicts of interest.
