Good morning. Elizabeth Cooney here in Boston filling in for Ed Silverman on a balmy August morning. Lots to catch up on today:
The Trump administration on Wednesday finalized long-sought rules for when Medicare will cover CAR-T treatments, often curative therapies that harness patients’ own immune cells against their cancer, STAT reports. Medicare will pay for CAR-T therapies even when used to treat conditions that aren’t FDA-approved. The two approved CAR-T treatments on the market are Yescarta from Gilead Sciences for non-Hodgkin lymphoma and Kymriah from Novartis for acute lymphoblastic leukemia.
After Novartis confirmed that it withheld manipulated data on its gene therapy Zolgensma — the world’s most expensive drug — the Institute for Clinical and Economic Review said it is reconsidering how it determines fair prices for one-time treatments that promise long-term effects, Inside Health Policy notes. In preparation for a wave of expensive gene and cell therapies, ICER requested public input on its so-called value framework, highlighting the uncertainty of the data on which prices for gene therapies are set.