SITUATION
A global cell and gene therapy manufacturer was preparing for commercial scale-up of its autologous therapy across North America and Europe. While the therapy showed strong clinical data, manufacturing complexity remained a key barrier, both for operational scalability and payer confidence.
The company had recently invested in a next-generation, automated manufacturing platform that reduced process time and contamination risks. However, they struggled to frame this operational leap in a way that would resonate with payers and HTA bodies during upcoming reimbursement submissions.
CHALLENGE
Advanced therapies often face payer hesitation due to high treatment costs, site limitations, and manufacturing unpredictability. In this case, the client's internal teams had limited experience translating manufacturing innovation into clear access value narratives.
Key challenges included:
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Difficulty connecting technical process improvements with outcomes that matter to payers
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Lack of reference cases for automation as a cost or reliability argument in cell therapy reimbursement
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Internal misalignment between manufacturing, market access, and medical affairs teams
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Concerns about over-promising efficiency benefits before real-world data was available
Without a credible, data-informed value communication strategy, there was a risk of weak access outcomes — regardless of innovation quality.
APPROACH
ConsaInsights was brought in to help frame manufacturing innovation as a strategic advantage for payers, HTA reviewers, and hospital budget holders. We focused on translating operational progress into value pillars that could support pricing, reimbursement, and adoption.
Cross-Therapy Manufacturing Benchmarking
We analyzed 9 approved cell and gene therapies to assess how manufacturing complexity, processing time, and site readiness had impacted payer decisions and pricing negotiations. This helped identify both risks and best practices.
Internal Innovation Value Audit
We worked with the client’s technical and operations teams to document quantifiable benefits of the new automation platform. This included processing time reduction, contamination risk decrease, reduced operator training requirements, and batch-to-batch consistency improvements.
Stakeholder Relevance Mapping
We conducted structured interviews with former payers and HTA reviewers to understand how they interpret value in cell therapy manufacturing. Their feedback helped refine messaging to focus on predictability, sustainability, and reduced hospital burden — not just cost.