Strengthening Evidence Packages for IRA Drug Price Negotiation

Before CMS issued guidance providing details on IRA drug price negotiations, life sciences manufacturers needed to prepare “evidence about alternative treatments” in an unclear environment. One manufacturer, anticipating that one or more of its drugs may be selected, sought to determine how its evidence might be evaluated during the IRA negotiation process, how it might strengthen its negotiation position by refining, augmenting, and presenting its evidence packages, and how CMS’s evaluation of these packages may translate to MFP setting for selected drugs.

We completed a three-phase project to help the client anticipate how CMS would evaluate its evidence packages during potential IRA negotiations and create strategies to strengthen those packages before negotiations began.

First, we evaluated evidence dossiers for two products selected as case studies, producing complex “evidence footprint” visualizations for each, which facilitated identification of evidence gaps. We then developed an evidence prioritization scheme to model the evidence standards CMS may employ by analyzing how government organizations (that we deemed “analogous” to CMS in some respect), and prominent value assessment methodologies weigh different forms of evidence. We layered this prioritization scheme with the evidence footprints to assess alignment with potential IRA negotiation evidence standards and determine how heavily we expected CMS to weigh each evidence type during the negotiation process.

Second, we used the insights gained from phase one to simulate expected evidence review by CMS. We emulated CMS’s approach to evidence collection and review for both case study products, and generated detailed insights into how CMS might gauge the value of each product based on evidence quality and study results. This exercise’s outcomes enabled us to develop a strategy for strengthening the evidence package of each product and mitigating risks associated with IRA negotiation.

Third, we leveraged outputs from phases one and two to facilitate a mock IRA negotiation for an at-risk product. These mock negotiations, which included an external panel of objective reviewers, helped the client select studies for submission to evidence review, forecast reviewer reactions and disagreements, and prioritize evidence gaps for resolution.

This project enabled the client to anticipate likely features of the IRA drug negotiation evidence review process and prepare to engage with CMS to optimize negotiation positioning for its products.