Value-based contracting (VBC) has been difficult to execute in the pharmaceutical arena, especially in the gene therapy space. This has been driven by several factors, including the lack of long-term data, the imbalance of upside and downside risk between manufacturers and payers, and difficulties with implementation.
However, gene therapy manufacturers should prepare for VBC given the evolving policy and market access landscape in the US, driven largely by the Medicaid Cell and Gene Therapy (CGT) Access Model. Manufacturers should be strategic in designing and utilizing long-term outcomes studies, as the data will be central to contract terms that impact reimbursement amounts and timelines under the CGT Access Model.
