Lessons From History: Gauging Part D Plan Access Restrictions of Protected Class Drugs as a Harbinger for Coverage of Negotiated Drugs

OBJECTIVES: To explore whether there is a disconnect between the Inflation Reduction Act (IRA) of 2022’s Drug Price Negotiation Program (DPNP) and patient access by analyzing the utilization management (UM) of antineoplastic drugs with protected class status on formularies of Medicare Advantage prescription drug (MA-PD) plans and standalone prescription drug plans (PDPs) from 2019 to 2023. To show whether negotiated drugs encounter access limitations, thereby undermining the legislative objective of ensuring their availability to patients.

METHODS: Coverage and UM of branded antineoplastics (n=82) with the USP classification of molecular target inhibitors were assessed from Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary and Pharmacy Network Information October files (2019 to 2023). The analysis was restricted to MA-PD plans and PDPs with the most common specialty formulary structure (ie, 5-tier formulary structure). UM was categorized as prior authorization (PA), quantity limits (QLs), and step edits. Findings are weighted by plan enrollment.

RESULTS: Of the 82 branded antineoplastic regimens, ~80% were covered by MA-PD plans and PDP plans in 2024. Over time, antineoplastics covered on formularies increased (~50 in 2020 to ~66 in 2024). All covered antineoplastics received some form of UM. Ninety-eight percent or more of covered antineoplastic agents were placed in specialty tiers. The most common forms of UM were PAs and step edits. Among antineoplastics on formulary, QL of ≤30 days was the most common limit applied and use of QLs has steadily increased year over year (~59% of covered antineoplastics in 2020 to ~83% in 2024).

CONCLUSIONS: The legislative intent to reduce patient access barriers may not be fully realized with selected drugs under the IRA DPNP. As patient access hurdles like those observed with drugs having protected class status may persist. Creating access challenges for patients, leading to adverse health outcomes and financial strain.