Jeff Sharman, MD, discusses policies and procedures, such as FACT accreditation and the REMS program, for setting up an outpatient CAR T center for patients with R/R NHL.
Jeff Sharman, MD: One of the distinctions that’s going to be interesting moving forward with policy makers and payers is who can be credentialed to administer this therapy. In the past, cellular therapy was governed by FACT [Foundation for the Accreditation of Cellular Therapy] accreditation. FACT accreditation is the governing organization that looks at cellular therapies for stem cell transplant, both autologous and allogeneic. But now we have immune effector cell programs, and the question is whether that requires FACT accreditation or if that could be governed more by the REMS [Risk Evaluation and Mitigation Strategy] program. There are many sophisticated oncology practices that are comfortable with REMS programs. This is something that has been done for quite a while.
However, FACT accreditation does represent a significant barrier for those centers that aren’t already FACT accredited. You have to do cellular therapy and present your cases to get FACT accredited, but if you can’t do the cases because you’re not FACT accredited in the first place, there’s a chicken-and-egg phenomena regarding whether you can take this on. I understand how this is likely to roll out. The product by Juno [Therapeutics, Inc] is going to be available to those programs that satisfy the REMS program and not the FACT accreditation standard. Whether payers are willing to follow that, of course, is going to have a profound impact on access.