Closure of Medicare Part D coverage gap by the Affordable Care Act (ACA) and use of oral anti-myeloma agents.

Abstract

6522 Background: Medicare Part D pays for oral anti-myeloma immunomodulatory drugs (IMiDs, lenalidomide and thalidomide), but has a coverage gap resulting in an out-of-pocket (OOP) expense of > $ 3000 for the 1st prescription (Rx). Patients (pts) eligible for Low Income Subsidies (LIS) are exempt from cost sharing, and LIS is associated with IMiD receipt ( Olszewski, ASH 2016). In 2011, the ACA partly closed the coverage gap with a 50% manufacturer discount on the price of brand-name drugs within the gap. We examined effects of this policy on IMiD use. Methods: From the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, we selected Part D enrollees who started anti-myeloma chemotherapy in 2008-2012. We identified IMiD use in periods pre-ACA (2008-10) and post-ACA (2011-12), among pts with or without LIS. After confirming parallel trends in IMiD use before the ACA, we examined the effect of ACA discount on IMiD use in a difference-in-differences (DiD) model, using LIS recipients as controls whose OOP costs were not influenced by the ACA. Results: Among 3,313 Part D enrollees (of whom 31% received LIS), 41% received IMiDs as part of their anti-myeloma regimen. Compared with the pre-ACA period, in the post-ACA period the median gross IMiD cost of the 1st Rx increased for all pts (Table). OOP costs for the 1st Rx, and for the 1st year of IMiD therapy, decreased for LIS non-recipients. Proportion of pts entering catastrophic coverage with their 1st IMiD Rx decreased from 71% to 49%. However, there was no statistically significant effect of the ACA discount on the proportion of pts treated with IMiDs (DiD estimator, 3% [95%CI, -4 to 10]; P=.40), or on the time from diagnosis to 1st Rx (median 1.5 mo. in all groups). Conclusions: The ACA-mandated partial closure of coverage gap lowered the OOP costs for Part D enrollees treated with IMiDs. As the median OOP cost remains > $2400 for the 1st Rx, and > $4900 for the 1st year of therapy, the policy may be insufficient to overcome the financial barrier for beneficiaries who do not receive the LIS. [Table: see text]