The impact of the US food and drug administration chlorofluorocarbon ban on out-of-pocket costs and use of albuterol inhalers among individuals with asthma

Anupam B. Jena, Oliver Ho, Dana P. Goldman, Pinar Karaca-Mandic

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

IMPORTANCE The US Clean Air Act prohibits use of nonessential ozone-depleting substances. In 2005, the US Food and Drug Administration announced the ban of chlorofluorocarbon (CFC) albuterol inhalers by December 31, 2008. The policy resulted in the controversial replacement of generic CFC inhalers by more expensive, branded hydrofluoroalkane inhalers. The policy's impact on out-of-pocket costs and utilization of albuterol is unknown. OBJECTIVE To study the impact of the US Food and Drug Administration's CFC ban on out-of-pocket costs and utilization of albuterol inhalers. DESIGN, SETTING, AND PARTICIPANTS Using private insurance data from January 1, 2004, to December 31, 2010, we investigated the effect of the CFC ban on out-of-pocket costs and utilization of albuterol inhalers among individuals with asthma (109 428 adults; 37 281 children), as well as asthma-related hospitalizations, emergency department visits, and outpatient visits.We estimated multivariable models adjusted for age, sex, comorbidities, and mean out-of-pocket costs of albuterol inhalers in an individual's drug plan.We analyzed whether effects varied between adults vs children and those with persistent vs nonpersistent asthma. MAIN OUTCOMES AND MEASURES Pharmacy claims for albuterol inhalers, aswell as asthma-related hospitalizations, emergency department visits, and outpatient visits. RESULTS The mean out-of-pocket albuterol cost rose from $13.60 (95%CI, $13.40-$13.70) per prescription in 2004 to $25.00 (95%CI, $24.80-$25.20) immediately after the 2008 ban. By the end of 2010, costs had lowered to $21.00 (95%CI, $20.80-$21.20) per prescription. Overall albuterol inhaler use steadily declined from 2004 to 2010. 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. In multivariable analyses, a $10 increase in out-of-pocket albuterol prescription costs was estimated to lower utilization by 0.92 percentage points (95%CI, -1.39 to -0.44; P < .001) for adults and 0.54 percentage points (95%CI, -0.84 to -0.24; P = .001) for children, with no difference between adults vs children and patients with persistent vs nonpersistent asthma and with no impact on asthma-related hospitalizations, emergency department visits, and outpatient visits. CONCLUSIONS AND RELEVANCE The Federal ban of CFC inhalers led to large relative increases in out-of-pocket albuterol costs among privately insured individuals with asthma and modest declines in utilization. The policy's impact on individuals without insurance, who faced greater cost increases, is unknown.

Original languageEnglish (US)
Pages (from-to)1171-1179
Number of pages9
JournalJAMA internal medicine
Volume175
Issue number7
DOIs
StatePublished - Jul 1 2015

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Chlorofluorocarbons
Albuterol
Nebulizers and Vaporizers
United States Food and Drug Administration
Health Expenditures
Asthma
HFA 134a
Prescriptions
Hospital Emergency Service
Hospitalization
Outpatients
Insurance
Costs and Cost Analysis
Ozone
Comorbidity

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The impact of the US food and drug administration chlorofluorocarbon ban on out-of-pocket costs and use of albuterol inhalers among individuals with asthma. / Jena, Anupam B.; Ho, Oliver; Goldman, Dana P.; Karaca-Mandic, Pinar.

In: JAMA internal medicine, Vol. 175, No. 7, 01.07.2015, p. 1171-1179.

Research output: Contribution to journalArticle

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abstract = "IMPORTANCE The US Clean Air Act prohibits use of nonessential ozone-depleting substances. In 2005, the US Food and Drug Administration announced the ban of chlorofluorocarbon (CFC) albuterol inhalers by December 31, 2008. The policy resulted in the controversial replacement of generic CFC inhalers by more expensive, branded hydrofluoroalkane inhalers. The policy's impact on out-of-pocket costs and utilization of albuterol is unknown. OBJECTIVE To study the impact of the US Food and Drug Administration's CFC ban on out-of-pocket costs and utilization of albuterol inhalers. DESIGN, SETTING, AND PARTICIPANTS Using private insurance data from January 1, 2004, to December 31, 2010, we investigated the effect of the CFC ban on out-of-pocket costs and utilization of albuterol inhalers among individuals with asthma (109 428 adults; 37 281 children), as well as asthma-related hospitalizations, emergency department visits, and outpatient visits.We estimated multivariable models adjusted for age, sex, comorbidities, and mean out-of-pocket costs of albuterol inhalers in an individual's drug plan.We analyzed whether effects varied between adults vs children and those with persistent vs nonpersistent asthma. MAIN OUTCOMES AND MEASURES Pharmacy claims for albuterol inhalers, aswell as asthma-related hospitalizations, emergency department visits, and outpatient visits. RESULTS The mean out-of-pocket albuterol cost rose from $13.60 (95{\%}CI, $13.40-$13.70) per prescription in 2004 to $25.00 (95{\%}CI, $24.80-$25.20) immediately after the 2008 ban. By the end of 2010, costs had lowered to $21.00 (95{\%}CI, $20.80-$21.20) per prescription. Overall albuterol inhaler use steadily declined from 2004 to 2010. 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. In multivariable analyses, a $10 increase in out-of-pocket albuterol prescription costs was estimated to lower utilization by 0.92 percentage points (95{\%}CI, -1.39 to -0.44; P < .001) for adults and 0.54 percentage points (95{\%}CI, -0.84 to -0.24; P = .001) for children, with no difference between adults vs children and patients with persistent vs nonpersistent asthma and with no impact on asthma-related hospitalizations, emergency department visits, and outpatient visits. CONCLUSIONS AND RELEVANCE The Federal ban of CFC inhalers led to large relative increases in out-of-pocket albuterol costs among privately insured individuals with asthma and modest declines in utilization. The policy's impact on individuals without insurance, who faced greater cost increases, is unknown.",
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AU - Goldman, Dana P.

AU - Karaca-Mandic, Pinar

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N2 - IMPORTANCE The US Clean Air Act prohibits use of nonessential ozone-depleting substances. In 2005, the US Food and Drug Administration announced the ban of chlorofluorocarbon (CFC) albuterol inhalers by December 31, 2008. The policy resulted in the controversial replacement of generic CFC inhalers by more expensive, branded hydrofluoroalkane inhalers. The policy's impact on out-of-pocket costs and utilization of albuterol is unknown. OBJECTIVE To study the impact of the US Food and Drug Administration's CFC ban on out-of-pocket costs and utilization of albuterol inhalers. DESIGN, SETTING, AND PARTICIPANTS Using private insurance data from January 1, 2004, to December 31, 2010, we investigated the effect of the CFC ban on out-of-pocket costs and utilization of albuterol inhalers among individuals with asthma (109 428 adults; 37 281 children), as well as asthma-related hospitalizations, emergency department visits, and outpatient visits.We estimated multivariable models adjusted for age, sex, comorbidities, and mean out-of-pocket costs of albuterol inhalers in an individual's drug plan.We analyzed whether effects varied between adults vs children and those with persistent vs nonpersistent asthma. MAIN OUTCOMES AND MEASURES Pharmacy claims for albuterol inhalers, aswell as asthma-related hospitalizations, emergency department visits, and outpatient visits. RESULTS The mean out-of-pocket albuterol cost rose from $13.60 (95%CI, $13.40-$13.70) per prescription in 2004 to $25.00 (95%CI, $24.80-$25.20) immediately after the 2008 ban. By the end of 2010, costs had lowered to $21.00 (95%CI, $20.80-$21.20) per prescription. Overall albuterol inhaler use steadily declined from 2004 to 2010. 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. In multivariable analyses, a $10 increase in out-of-pocket albuterol prescription costs was estimated to lower utilization by 0.92 percentage points (95%CI, -1.39 to -0.44; P < .001) for adults and 0.54 percentage points (95%CI, -0.84 to -0.24; P = .001) for children, with no difference between adults vs children and patients with persistent vs nonpersistent asthma and with no impact on asthma-related hospitalizations, emergency department visits, and outpatient visits. CONCLUSIONS AND RELEVANCE The Federal ban of CFC inhalers led to large relative increases in out-of-pocket albuterol costs among privately insured individuals with asthma and modest declines in utilization. The policy's impact on individuals without insurance, who faced greater cost increases, is unknown.

AB - IMPORTANCE The US Clean Air Act prohibits use of nonessential ozone-depleting substances. In 2005, the US Food and Drug Administration announced the ban of chlorofluorocarbon (CFC) albuterol inhalers by December 31, 2008. The policy resulted in the controversial replacement of generic CFC inhalers by more expensive, branded hydrofluoroalkane inhalers. The policy's impact on out-of-pocket costs and utilization of albuterol is unknown. OBJECTIVE To study the impact of the US Food and Drug Administration's CFC ban on out-of-pocket costs and utilization of albuterol inhalers. DESIGN, SETTING, AND PARTICIPANTS Using private insurance data from January 1, 2004, to December 31, 2010, we investigated the effect of the CFC ban on out-of-pocket costs and utilization of albuterol inhalers among individuals with asthma (109 428 adults; 37 281 children), as well as asthma-related hospitalizations, emergency department visits, and outpatient visits.We estimated multivariable models adjusted for age, sex, comorbidities, and mean out-of-pocket costs of albuterol inhalers in an individual's drug plan.We analyzed whether effects varied between adults vs children and those with persistent vs nonpersistent asthma. MAIN OUTCOMES AND MEASURES Pharmacy claims for albuterol inhalers, aswell as asthma-related hospitalizations, emergency department visits, and outpatient visits. RESULTS The mean out-of-pocket albuterol cost rose from $13.60 (95%CI, $13.40-$13.70) per prescription in 2004 to $25.00 (95%CI, $24.80-$25.20) immediately after the 2008 ban. By the end of 2010, costs had lowered to $21.00 (95%CI, $20.80-$21.20) per prescription. Overall albuterol inhaler use steadily declined from 2004 to 2010. 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. In multivariable analyses, a $10 increase in out-of-pocket albuterol prescription costs was estimated to lower utilization by 0.92 percentage points (95%CI, -1.39 to -0.44; P < .001) for adults and 0.54 percentage points (95%CI, -0.84 to -0.24; P = .001) for children, with no difference between adults vs children and patients with persistent vs nonpersistent asthma and with no impact on asthma-related hospitalizations, emergency department visits, and outpatient visits. CONCLUSIONS AND RELEVANCE The Federal ban of CFC inhalers led to large relative increases in out-of-pocket albuterol costs among privately insured individuals with asthma and modest declines in utilization. The policy's impact on individuals without insurance, who faced greater cost increases, is unknown.

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