Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the United States,1 affecting 15.7 million adults1 and causing nearly 700 000 hospitalizations and 1.7 million emergency department visits in 2012.2 Much of the burden of COPD falls heavily on Medicare, with 1 in 9 Medicare beneficiaries diagnosed as having COPD3 and Medicare paying 51% of all US direct health care costs for COPD.4 Inhaled medications are key to relieving symptoms and improving health outcomes. However, up to 31% of Medicare beneficiaries using COPD inhalers have reported nonadherence owing to cost.5 COPD inhaler costs increased dramatically in 2008, when a ban on chlorofluorocarbon propellants phased out generic inhalers, leaving only brand-name options.6 We examined coverage and cost-sharing for COPD inhalers in Medicare Part D plans, which covered 39 million beneficiaries in 2015.
We analyzed the June 2015 Centers for Medicare and Medicaid Services Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files for all Part D plans nationwide, except special-needs plans that serve specific populations (eg, long-term care) and may have specialized formularies. The study received an institutional review board waiver from the University of Hawaii Office of Research Compliance. We focused on 21 inhalers in 7 treatment classes, including short-acting rescue inhalers and longer-acting or preventive inhalers. For each inhaler, we averaged coverage and required out-of-pocket costs across all plans by counties and states, including Washington, DC. For the most widely covered inhaler in each class, we projected yearly cost-sharing under a standard 2015 Part D benefit with a $320 deductible and whether beneficiaries would reach the coverage gap where cost-sharing increases after total drug expenditures exceed a set threshold. Because COPD often causes costly hospitalizations,2 we explored whether Part D plans that provide both medical and drug benefits (Medicare Advantage Prescription Drug Plans [MA-PDs]), offered better inhaler coverage than stand-alone Part D plans (Prescription Drug Plans [PDPs]).
Our national analysis included 2652 plans (1639 MA-PDs, 1013 PDPs). Between 93% to 100% of plans covered at least 1 inhaler in each class. Mean out-of-pocket costs ranged from $30 to $105 per inhaler, depending on the inhaler selected (Table). The projected annual out-of-pocket cost under a standard 2015 Part D benefit ranged from $494 to $1197 for the most widely covered inhaler in each class (Figure). For 5 of 7 classes, using a single inhaler each month would have produced annual out-of-pocket costs of at least $900 and caused beneficiaries to reach the coverage gap even without other medications. Patients with moderate to severe COPD requiring 2 or 3 inhalers per month (acute rescue and/or multiple preventive classes) would have had projected annual out-of-pocket expenses of $1622 to $2811, reaching the coverage gap by August or earlier.
Most MA-PD and PDP plans (≥92%) covered at least 1 inhaler per class, although MA-PD plans covered specific inhalers more frequently (Table); for 20 of 21 inhalers, the percentage of MA-PD plans providing coverage was 2% to 39% greater than PDP plans. However, MA-PD plans required higher out-of-pocket costs than PDP plans for 14 of 21 inhalers, with cost-sharing ranging from $2 to $46 higher per inhaler.
In our nationwide analysis of Medicare Part D plans, COPD inhalers were nearly universally covered but required high cost-sharing by beneficiaries. For many acute rescue and preventive inhalers, using a single inhaler each month had projected annual out-of-pocket costs of at least $900 under a standard 2015 Part D plan even without other medications.
Our study limitations include projecting annual cost-sharing for each inhaler based on using 1 inhaler per month and no other prescriptions. We did not examine actual out-of-pocket costs, which reflect a beneficiary’s coverage phase when filling an inhaler prescription, which in turn is influenced by their non-COPD medication costs.
Our findings call into question whether Part D continues to adequately support beneficiaries in the face of rapidly rising drug prices. Part D plans and Medicare policy should reassess whether this high cost-sharing adversely affects inhaler adherence and health for beneficiaries with COPD.
Corresponding Author: Chien-Wen Tseng, MD, MS, MPH, Department of Family Medicine and Community Health, University of Hawaii John A. Burns School of Medicine, 677 Ala Moana Blvd, Ste 815, Honolulu, HI 96813 (cwtseng@hawaii.edu).
Published Online: February 20, 2017. doi:10.1001/jamainternmed.2016.9386
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was funded by Agency for Healthcare Research and Quality (AHRQ) grant R03HS016772 and the Hawaii Medical Services Association Endowed Chair in Health Services and Quality Research. Dr Yazdany is supported by AHRQ grant R01 HS024412 and the Russell/Engleman Medical Research Center for Arthritis at the University of California, San Francisco. Dr Lin is supported by AHRQ grant K08HS017723.
Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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