Specialty Drug Access Laws: Impacts on Patient and Plan Financial Burden across the Distribution

Tuesday, June 25, 2019: 2:00 PM
Coolidge - Mezzanine Level (Marriott Wardman Park Hotel)

Presenter: Kai Yeung

Co-Authors: Douglas Barthold; Stacie Dusetzina; Anirban Basu

Discussant: Martin Andersen


Specialty drugs, high-priced treatments used for complex and life-threatening conditions, often represent important therapeutic advances in effectiveness. However, patient access may be limited by high out-of-pocket spending requirements by health insurance plans. Since 2014, three states have enacted policies to cap out-of-pocket payments for specialty drugs at $150 per 30 days supply among employer-sponsored plans. While promising for improving access, the caps may also increase plan spending which could raise future insurance premiums, thereby reducing overall insurance affordability. The federal legislature and other state legislatures are currently considering, or have previously considered similar prescription drug cost-sharing protection bills. The objective of this study is to estimate impact of the caps on out-of-pocket and health plan spending and specialty drug utilization, focusing on patients with the highest levels of specialty drug spending.


We compared the outcomes in the three states (Louisiana, Maryland, and Delaware) that capped out-of-pocket spending for specialty drugs with the outcomes in neighboring states that did not enact the caps. Our sample included individuals aged 0-64 with diagnoses for rheumatoid arthritis, multiple sclerosis, hepatitis C, psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis in fully-insured employer-sponsored plans from 2011-2016 administered by three large nationwide insurers.

Our outcomes of interest were mean patient out-of-pocket and health plan spending for specialty drug, non-specialty drug and total cost of care minus specialty drug spending. Because we hypothesized that the caps would differentially affect patient out-of-pocket spending depending where patients were in the distribution, we measured out-of-pocket specialty drug spending for the 95th quantile of specialty drug users (our primary outcome) and the 50th quantile of specialty drug users.


Our study included approximately 28,895 persons (582,561 person-months) of observation in the intervention and control states. Out-of-pocket costs decreased by $351 (95% confidence interval, $-554 to $-148) per specialty drug user per month at the 95th quantile of specialty drug spending. There were no statistically significant changes in any other variables of interest.


The caps were associated with substantial reductions in out-of-pocket spending for high-priced specialty drugs for the highest spenders without increasing health plan spending, a proxy for future insurance premiums.