The Centers for Medicare and Medicaid Services (CMS), Center for Medicare and Medicaid Innovation (CMMI)’s Cell and Gene Therapy (CGT) Access Model aims to improve health outcomes for people with Medicaid living with rare and severe diseases. The model’s first targeted CGT is gene therapy for sickle cell disease (SCD). As part of the model, CMS negotiates outcomes-based agreements with participating gene therapy manufacturers on behalf of the states to reduce administrative burden for the states and enable access for patients. A clinical stage company with a gene therapy product that treats SCD, engaged ADVI to develop a strategy to approach CMMI about the model and considerations for potential future participation.

The Challenge

The manufacturer needed to engage with CMMI to discuss their view of the current state and future considerations of the model and outline their priorities and concerns vis a vis their specific and the class of therapies coming to market. Ultimately, ADVI’s client needed to demonstrate their support for CMMI’s aim in improving access to care, their interest in partnership with CMMI, and gauge CMMI’s point of view on key model topics.

The Strategy

ADVI’s cell and gene market access team, in addition to ADVI’s numerous Medicaid directors and Medicaid managed care medical director advisors, developed a strategy for the client that included engagement with CMMI and CMS. ADVI worked with the life sciences manufacturer by leading the client’s team in internal working sessions to define potential issues and areas of concern for the manufacturer, prepared slides for the CMMI meeting, secured a meeting with the CMMI project team focused on the CGT Access Model, and provided a comprehensive summary of the engagement with recommendations for next steps and an opportunity to workshop a roadmap to the company’s launch and beyond.

The Results

ADVI facilitated a successful meeting with CMMI with the manufacturer. Internally, the company lauded ADVI for its advice, insight, and strategy. ADVI’s input enabled a successful client dialogue with CMMI, shaped a roadmap for their management and board, and contributed to the important discussion that will improve patient access to gene therapies.

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