Although regarded as potentially revolutionary additions to modern medicine, cell and gene therapies come with a significant financial cost. Public health care systems’ budgets are already strained by growing and aging populations, and many private insurer’s budgets are equally stretched. The current systems are not structured to absorb a sudden uptake in high-cost prescriptions for a large patient population.Nonetheless, developing an approvable regenerative medicine typically revolves around the needs of regulators, not payers, in order to be compliant throughout clinical development. Given that in the U.S. and Europe many of the Advanced-therapy Medicinal Products that have achieved market authorisation have not been able to secure, it is irresponsible to automatically assume that an approved product will become a reimbursed product. To demonstrate the value proposition of a new product and to facilitate market access for patients, clinical and health economic data is needed which can be generated through certain strategies and approaches throughout clinical development. It is also possible to overcome market access delays and concerns over product uncertainty using performance-based managed entry agreements combined with post-launch evidence. |