LAST OF A SERIES
BY DR. RICHARD MCFARLAND
CHIEF REGULATORY OFFICER, ARMI | BIOFABUSA
The RACER Blueprint is comprised of Five key factors, in addition to manufacturing, that are essential to a good idea making it from an academic achievement to part of a clinician’s armamenterium. They are as important as the scientific and engineering foundations of a TEMP (or other advanced therapy) with respect to full commercialization.
- Realistic Clinical Targets
- Accessible Capital
- Conducive Regulatory Strategy
- Expanding the Available Workforce
- Rational Reimbursement Environment
This blog post takes a deeper dive into the R of RACER – Rational Reimbursement Environment
Given the early stage of regenerative medicine as an industry, and based on the number of available, approved products, some might think that it is too early to spend much time thinking about a rational reimbursement strategy.
However, many of the TEMPs that will be manufactured at scale will result in cures of diseases or conditions rather than just treating symptoms. This fact will challenge existing payment models that are designed to reimburse for treatments and not one-time cures. This is true of TEMPS that will replace traditional pharmacological treatments. It is also true of renal replacement therapies that will compete with the established standard of care for end stage kidney disease, in-center hemodialysis.
The recently approved CAR-T and gene therapies that potentially provide curative therapies are spurring widespread policy and practical discussions about how to develop reimbursement strategies for curative therapies. These approaches are likely to influence how TEMPs, including engineered organs, are reimbursed when they hit the market. Therefore, it behooves the TEMPS and regenerative medicine community to follow these discussions closely.