Prepare for IRA negotiations with a robust evidence package submission

The Inflation Reduction Act of 2022 (IRA) empowers Medicare to negotiate prices of some products, impacting drug manufacturers’ pre-launch and post-launch commercial strategies.

IRA impacts:

  • Clinical development and business development strategy/asset evaluation  
  • Evidence development
  • Portfolio optimization 
  • Pricing strategy 

As part of pricing negotiations, Centers for Medicare and Medicaid Services (CMS) will offer a maximum fair price (MFP) to the drug manufacturer. The MFP is based on nine parameters:

Manufacturer-specific data: Evidence about alternative treatments:
  • R&D costs
  • Unit costs
  • Federal financing 
  • Patent/exclusivity
  • US revenue and sales volume 
  • Comparative effectiveness
  • Unmet medical need
  • Comparative therapeutic advancement 
  • Prescribing information  


MFP offers could be 40 – 75% lower than list price, based on the parameters above. 

Prepare for IRA negotiations with a robust evidence package submission, including independent determination of MFP

To bring transparency and a focus on value to both the launch price determination process and a basis for post-launch MFP negotiations, Parexel can provide an independent determination of MFP to serve as a foundational reference.

Parexel's framework for MFP determination sequence.png

Parexel’s framework for MFP determination sequence


Our bespoke solution is built on expertise in HEOR modeling and payer/HTA interactions and supported by technical experts.  Our Access Consulting team is always available for a conversation to support your preparation for IRA negotiations, including independent determination of MFP.