(207) Examining the Impact of Specialty Drug Rebates on Health Plan Coverage Decisions

Background: : Manufacturers offer rebates to secure preferred coverage for specialty drugs, but the extent of their influence remains unclear. Current policy discussions often cite list prices, overlooking rebates and negotiated discounts between manufacturers, PBMs, and payers. Understanding how rebates affect coverage decisions is critical for improving patient access.

Objective: : To evaluate how net prices and rebates affect payer coverage of specialty drugs.

Methods: : We analyzed 161 specialty drugs with pricing and commercial health plan coverage information in the SSR Health US Brand Rx Net Pricing Tool and the Specialty Drug Evidence and Coverage (SPEC) Database for all four quarters of 2023. We conducted a multivariate logistic regression analysis to identify factors influencing payer coverage decision-making. We classified coverage decisions as: unrestricted—covering the full FDA-approved population—or restricted—imposing additional access requirements such as clinical criteria or step therapy protocols. Variables included rebate size, net price, drug type (e.g., oncology, orphan), route of administration, number of indications, competition, FDA approval pathway, and time since FDA approval.

Results: : The median estimated net price was $48,700 (IQR: $20,800 to $166,400) with a median rebate of $29,400 (IQR: $16,000–$47,900), reflecting a median discount of 28% off list price (IQR: 16%–67%). Among 6,688 coverage decisions analyzed, 54% included at least one restriction. Drugs with higher net prices (≥$166,400) were more likely to face restrictions compared to lower-priced drugs ( <$20,800) (OR: 2.56 (p < 0.001). In contrast, drugs with higher rebates (≥$47,900) were less likely to face restrictions than those with lower rebates ( <$16,000) (OR 0.56, p< 0.001). Oncology drugs, orphan drugs, drugs with expedited approval, self-administered drugs and those FDA designated as second-line or later use were less likely to face restrictions. Older drugs and those in highly competitive therapeutic classes were more likely to be restricted.

Conclusions: : Net prices and rebates significantly influence health plan coverage decisions for specialty drugs. Greater transparency in rebate and pricing negotiations is needed to promote equitable access and manage affordability challenges for patients.

Sponsorship:: argenx, inc.