Key Considerations for Assessing Real-World Comparative Effectiveness in the Context of the Drug Price Negotiation Program: A Case Study of Pembrolizumab.

ABSTRACT:

Background and objective

The Centers for Medicare and Medicaid Services increasingly rely on real-world evidence to inform drug price negotiations under the Inflation Reduction Act. This study aims to evaluate methodological decisions that impact real-world comparative effectiveness outcomes using a case example of first-line pembrolizumab versus therapeutic alternatives in advanced non-small cell lung cancer among the Medicare population.

Methods

This study used a deidentified, electronic health record-derived, advanced non-small cell lung cancer dataset (2011-23) to analyze Medicare-eligible stage IV patients in three indications: (1) non-squamous, epidermal growth factor receptor, and anaplastic lymphoma kinase negative; (2) squamous; and (3) epidermal growth factor recep

SUBMITTER: Zemplenyi AT 

PROVIDER: S-EPMC12370795 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature