Coverage of genetic therapies for spinal muscular atrophy across fee-for-service Medicaid programs.

BACKGROUND: Genetic therapies are a promising treatment for children born with spinal muscular atrophy (SMA); however, their high price tags can evoke coverage restrictions. OBJECTIVE: To assess variation in coverage guidelines across fee-for-service state Medicaid programs for 2 novel genetic therapies, nusinersen and onasemnogene abeparvovec, that treat SMA. We also assessed the association of these coverage guidelines with use of the 2 genetic therapies. METHODS: We evaluated fee-for-service Medicaid coverage policies for nusinersen and onasemnogene abeparvovec from publicly available websites for the period February 2020-March 2020. We then documented areas of agreement and disagreement across 4 key coverage domains. We used 2018 and 2019 state Medicaid drug utilization data to calculate the use of nusinersen across Medicaid programs and assessed that use against the restrictiveness of the coverage guidelines. RESULTS: We identified 19 state Medicaid coverage guidelines for nusinersen. Most states agreed on diagnostics requirements; however, there were disagreements based on ventilator status. We identified 17 state Medicaid coverage guidelines for onasemnogene abeparvovec. There was more discordance in these coverage guidelines compared with nusinersen, notably in domains of SMN2 gene count and ventilator status. When comparing utilization of nusinersen with coverage restrictions, we found that the more restrictive states had considerably lower utilization of nusinersen. CONCLUSIONS: There was significant variation across fee-for-service Medicaid coverage policies for nusinersen and onasemnogene abeparvovec. Although states can impose individual coverage guidelines for each drug, we presented policy options that could reduce variation and potentially decrease the cost burden of these drugs. DISCLOSURES: This study was funded by Arnold Ventures. The authors have no conflicts of interest to disclose.

Biosimilar formulary placement in Medicare Part D prescription drug plans: A case study of infliximab.

PURPOSE: Biosimilars can generate competition and provide cost savings over reference biologics for the Medicare program and beneficiaries. The extent to which these benefits can be realized in the Medicare Part D program depends on how biosimilars and biologics are placed in the formulary. We conducted a study to examine Medicare formulary placement of the first biologic to have 2 biosimilars on the market-infliximab and its biosimilars infliximab-dyyb and infliximab-abda. METHODS: All standalone and Medicare Advantage (MA) prescription drug plans (PDPs) offered in Medicare Part D were examined between September 2016 (ie, at the end of the last quarter before the launch of the first infliximab biosimilar) and September 2018, at which time a second biosimilar had been on the market for about 14 months. When PDPs covered both the reference biologic and a biosimilar, we compared the cost-sharing tier and the frequency of prior authorization and step therapy requirements for each drug. RESULTS: Nearly all PDPs covered infliximab throughout the study period. By September 2018, 31.7% of MA plans and 14.9% of standalone PDPs were covering a biosimilar on the market. Nearly all plans that covered a biosimilar also covered the reference product. Most plans (98% of standalone PDPs and 89% of MA plans) had placed prior authorization restrictions on both the biologic and the biosimilar. All plans covering both products placed them in the same cost-sharing tier. No plan required step therapy for either product. CONCLUSION: Formulary placement of infliximab biologic and biosimilars in Medicare Part D is not optimized to generate cost savings for the Medicare program and beneficiaries, whose cost sharing is often based on the drug's list price. The Medicare program should provide incentives for PDPs to expand biosimilar coverage.