NEW YORK – Contrary to what the flurry of recent headlines might suggest, FDA approvals of the first gene and cell therapies didn't lead to the invention of value-based pricing. The model has circulated in the U.S. health care system over the years in various forms – risk-sharing arrangements and managed entry agreements, for example – but the introduction of potentially curative treatments, combined with accelerated approvals based on limited durability data, is putting the pressure on companies to reconsider how they view product launches and reimbursement.