EU, US and Japan payer research for a novel immunotherapy in advanced RCC

Challenge:

Our client was developing novel, precision immunotherapy, delivering individualized treatments that recognized each patient’s disease. Its lead product was in Phase III clinical development and the client was preparing for commercialization in key markets. Unlike other cellular immunotherapies, the clients platform entailed the manufacture of multiple cryopreserved doses of individualized therapeutic product, therefore the supply chain was complex. The client had conducted limited analysis of the payer landscapes in the key markets and therefore required this urgently to inform the detailed commercial strategy and tactical marketing plans. Furthermore, its clinical trials to date had not collected any Quality of Life (QOL) data, and we proposed this to be an issue to be addressed as well.

Solution:

Alacrita provided support through:

• Developing a target therapeutic profile (TPP) suited for a payer audience;
• Conducted 30 primary payer research in the EU, US and Japan;
• Assessed gaps in the evidence generation program versus payer ‘value drivers’.

We provided a written report summarising payer feedback, specifically:

• Payers’ level of focus on the indication, perceived budget impact and cost tracking;
• Payers’ view of the level of unmet need in the indication;
• The assessment process for coverage and reimbursement;
• Impact of labeling scenarios on pricing and reimbursement;
• Key payer value elements (based on reaction to product profile);
• Open and closed pricing analysis;
• The evidence required to support the targeted price range;
• Perception of existing cell and gene therapies.

New Product Planning

The payer environment for innovative therapies is becoming increasingly competitive. Leverage our team’s industry experience in pharmaceutical market access, market research and strategic planning. We will work with you to map a clear path towards optimized access and value-based pricing for your new products. Alacrita’s expert network also offers you access to senior Medical Affairs experience, which we have used to help clients drive alignment at the commercial and medical interface.