Situation
In 2023, a top 20 pharmaceutical manufacturer anticipated that their blockbuster drug would be selected for Cycle 1 of the Medicare Drug Price Negotiation Program. Their objective was to achieve the highest Maximum Fair Price (MFP) across four indications, compared to multiple branded and generic therapeutic alternatives. The client faced unprecedented negotiations with ambiguous and evolving guidance, significant unknowns, and demanding timelines. They reached out to a strategic services partner with integrated, deep specialisms across strategy, evidence, engagement, and technology and AI—Lumanity.
Approach
To navigate these challenges, Lumanity aligned and rapidly deployed a team of over 40 market access, pricing, medical, HTA, and HEOR experts in partnership with the client. The strategy was to enable effective planning and expedient responses with Centers for Medicare and Medicaid Services (CMS). Lumanity developed a novel submission strategy and prepared for negotiations where no prior frameworks existed.
Submission Strategy (2023)
- Conducted comparative effectiveness of therapeutic alternatives
- Submitted “Section I” Information Collection Request (ICR) form
- Developed a comprehensive pricing tool and analytics
Negotiation Readiness & Execution (2024)
- Evaluated the initial offer
- Prepared a written counter-offer response
- Provided strategic support for three live CMS meetings
Impact
The client’s medicine achieved a higher Maximum Fair Price (MFP) compared to its direct competitor. Following this successful outcome, the client requested continued support from Lumanity in market access, policy, and HEOR, underscoring the value of Lumanity’s comprehensive and strategic approach.
Read more about Lumanity’s learnings and advice from the first two rounds of the MDPN program here.
Learn more about Lumanity’s IRA offerings here.
