RWE, HEOR & Evidence Synthesis

The Inflation Reduction Act and Its Implications on Real-World Evidence

The Inflation Reduction Act (IRA), passed in August 2022, targets reducing prescription drug prices for Medicare beneficiaries in the US. It introduces three major reforms:

Medicare Part D Changes: This affects how prescription drugs are covered under Medicare Part D.
Inflationary Caps in Medicare Part B: Sets limits on price increases for Medicare Part B services.
Medicare Price Negotiation: Allows Medicare to negotiate drug prices directly, impacting how pharmaceutical companies present evidence.

The Medicare Drug Pricing Negotiation Program (DPNP) establishes maximum fair price (MFP) guidelines for specific drugs, starting with ten drugs in 2026. Pharmaceutical companies must collect robust RWE to support efficacy, safety, and economic impact for effective price negotiations. The sponsor’s proficiency in data analysis is crucial for handling quick turnarounds of RWE. To secure favorable negotiated prices, manufacturers need robust evidence highlighting how the treatment addresses an unmet medical need. By applying innovative methods like causal inference to large real-world databases, we can gain valuable insights into comparative long-term benefits of multiple competing interventions. The integrated approach to evidence generation, including RWE’s pivotal role, is crucial for informed pricing discussions. Axtria's POV discusses the implications of IRA on RWE.

Drug pricing Inflation Reduction Act Medicare Real-World Evidence RWE & HEOR