ARTICLE | Politics, Policy & Law
PROs in prime time
How CMS focus on PROs for CAR Ts complements work by FDA and others
September 29, 2018 2:01 AM UTC
A recommendation by CMS’s MEDCAC catapults the collection of PRO data to the postmarket setting from their more familiar spot in clinical development. CAR T leaders Novartis AG and Gilead Sciences Inc., however, are not on board.
The companies argue the requirement for patient reported outcomes (PROs) could make patient access to the CAR Ts even harder by narrowing the already restricted number of hospitals capable of administering the therapies. ...