Harvard Pilgrim's Michael Sherman and Cigna's Steve Miller advise gene therapy developers to consider the burden of high cost treatments on Medicaid programs when setting list prices.
Medicaid programs will be on the front lines in the struggle to afford high-cost gene therapies and treatment developers should be mindful of how pricing decisions will play out in the states, warned Harvard Pilgrim Health Care chief medical officer Michael Sherman.
“I believe as we see more of these coming to market, we will see more pressure, not just with commercial...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.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.
