title: 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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  Pharmacy claims for albuterol inhalers, as well 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
  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.
authors.affiliation: Department of Medicine, Massachusetts General Hospital, Boston2National Bureau of Economic Research, Cambridge, Massachusetts3Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts.
authors.forename: Anupam B
authors.initials: AB
authors.lastname: Jena
authors.affiliation: Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts.
authors.forename: Oliver
authors.initials: O
authors.lastname: Ho
authors.affiliation: National Bureau of Economic Research, Cambridge, Massachusetts4Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles.
authors.forename: Dana P
authors.initials: DP
authors.lastname: Goldman
authors.affiliation: National Bureau of Economic Research, Cambridge, Massachusetts5Division of Health Policy and Management, School of Public Health, University of Minnesota, Minneapolis.
authors.forename: Pinar
authors.initials: P
authors.lastname: Karaca-Mandic
mesh_terms: D000280:Administration, Inhalation; D000420:Albuterol / Q000008:administration & dosage / Q000191:economics*; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000191:economics*; D002648:Child; D017402:Chlorofluorocarbons; D005260:Female; D005102:Health Expenditures; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers / Q000191:economics* / Q000706:statistics & numerical data
chemical_list: D001993:Bronchodilator Agents; D017402:Chlorofluorocarbons; D000420:Albuterol