Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 Jul;175(7):1171-9.
doi: 10.1001/jamainternmed.2015.1665.

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

Affiliations
Free PMC article

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 et al. JAMA Intern Med. .
Free PMC article

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, 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 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.

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1
Figure 1
Trends in Out-of-Pocket Costs and Utilization of Albuterol Inhalers A, The mean out-of-pocket costs per quarter (Q) are shown with associated 95% CIs. The dotted line reflects the date when the Food and Drug Administration mandated that all chlorofluorocarbon (CFC) albuterol inhalers must be withdrawn from the US market. However, phaseout of CFC inhalers occurred gradually in the 2 years prior, as shown in B. B, The percentages of patients filling an albuterol inhaler prescription per quarter are shown with associated 95% CIs. HFA indicates hydrofluoroalkane.
Figure 2
Figure 2
Change in the Mean Out-of-Pocket Costs for Albuterol Inhalers Across Plans After the Elimination of Generic Chlorofluorocarbon Albuterol From the US Market Each point reflects a drug plan that was present in 2004 to 2006 and 2009 to 2010 (32 plans total). The horizontal axis shows each plan’s mean out-of-pocket cost for a 30-day equivalent albuterol inhaler prescription from 2004 to 2006 computed across all individuals in a plan who filled an albuterol prescription during those years. The vertical axis shows the dollar change in the mean out-of-pocket albuterol inhaler cost for a given plan between 2004 to 2006 and 2009 to 2010.

Comment in

Similar articles

See all similar articles

Cited by 3 articles

Publication types

Feedback