6D-06 - Inequities in the Use of Orally-administered Antimyeloma Therapies Granted Accelerated Approval

Background: The US FDA Accelerated Approval pathway has helped expedite the availability of treatments for serious or life-threatening conditions; however, approved drugs have typically demonstrated improvements of surrogate endpoints, meaning their clinical benefit is less clear upon market entry. To date, no studies have evaluated whether the use of accelerated approval products are equitable.

Objectives: To assess inequities in the initiation of accelerated approval products among older adults with multiple myeloma – a cancer, in which a dozen therapies have received accelerated approval.

Methods: In this cohort study, we used the SEER-Medicare linked database to identify older adults (>65 years old) who were diagnosed with multiple myeloma from 2008 to 2019 and continuously enrolled in Medicare Part D in the 12 months before and after diagnosis. Using the FDA’s Drug and Biologic Accelerated Approvals report, we categorized orally-administered antimyeloma medications as accelerated approval products during the period after accelerated approval until conversion to traditional approval or withdrawal from the market. We used a multivariable Cox proportional hazards model to assess time to treatment initiation.

Results: Among the 24,456 beneficiaries diagnosed with multiple myeloma, 6.4% filled a prescription for an accelerated approval product. Most beneficiaries (93.9%) used an accelerated approval product that was later converted to traditional approval, while 6.1% filled a prescription for a product that was eventually withdrawn from the market. We observed inequities in the initiation of accelerated approval products. Compared to non-Hispanic White beneficiaries, non-Hispanic Black and Hispanic beneficiaries had a lower likelihood of experiencing earlier treatment initiation (adjusted hazard ratio [aHR] 0.86, 95% confidence limit [CL] 0.74-1.00 and aHR 0.73, 95% CL 0.61-0.87, respectively). Additionally, beneficiaries residing in the South were 25% less likely to fill a prescription for an accelerated approval product relative to those residing in the Northeast (aHR 0.75, 95% CL 0.64-0.87). We did not observe differences in the initiation of accelerated approval products by biological sex, urbanicity, or socioeconomic status.

Conclusions: Beneficiaries of color and those residing in the South were less likely to fill a prescription for antimyeloma therapy granted accelerated approval. Given that most accelerated approval products confirmed clinical benefit in required postmarketing studies and were converted to traditional approval, future research is needed to understand how inequitable use of accelerated approval products impacts clinical outcomes and health service use.