Products from Bristol-Myers Squibb, Gilead and J&J might be eligible for supplemental reimbursement under hospital payment proposed rule that could help promote uptake.
Two recently-approved CAR-T therapies for lymphoma, Bristol Myers Squibb Company’s Breyanzi and Gilead Sciences, Inc.’s Tecartus, face challenges in getting approval for supplemental Medicare reimbursement as novel agents because their indications could be considered the same or similar to older CAR-Ts.
The Centers for Medicare and Medicaid Services discussed applications for new technology add-on payments for Breyanzi (lisocabtagene maraleucel), Tecartus (brexucabtagene...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
