Inflation Reduction Act

In 2025, Medicare Part D will be reconfigured to include an annual $2000 out-of-pocket spending cap. Beneficiaries may opt-in to a program to spread the $2000 payment throughout the year (“smoothing”). Also, patient cost-sharing in the catastrophic phase will be eliminated and shifted to payers and manufacturers. While patients may experience meaningful relief from affordability concerns, payers may respond with additional exclusions and restrictions leading to increased contracting activity for manufacturers.

Lumanity can help you with:

• Analyzing and quantifying brand and competitor impacts of Part D redesign
• Assessing risk for contracting strategy
• Refining forecasting based on changes to manufacturer risk-share
• Identifying geographies with Part D opportunities to assist patients

For the first time CMS is empowered to negotiate national-level pricing for select Part D products with the highest expenditures. To thrive in the context of this new legislation manufacturers must sharpen their ability to incorporate clinical evidence and create strategic frameworks to communicate the value of their drugs.

Our value and access experts know the right questions to assess products and portfolios and improve strategic decision-making. Lumanity can help you with:

• Understanding the evolution of CMS as a new negotiating entity and how they operate
• Evaluating your product’s evidence dossier and value narrative
• Developing an integrated plan to strengthen your evidence package
• Generating relevant and impactful real-world evidence that directly addresses CMS’ evolving evidence demands
• Synthesizing and translating evidence for negotiation readiness
• Driving compliance with activity timeline monitoring, internal education, and tactical implementation

There’s increased pressure to select lead indications and multi-indication strategies come with new tradeoffs. Compressed timelines may convert “fast to market” to “fast to discount”. An earlier view of life cycle management, including data-driven market sizing and trial design optimization, is needed to optimize product strategies.

Lumanity can help you with:

• Optimizing asset strategy to align to the new time horizons in the IRA
• Evaluating portfolio strategy to create long-term success strategies for early-stage products to model future impacts of the IRA
• Reimagining life cycle management to take into account the IRA