BioCentury
ARTICLE | Politics & Policy

After MEDCAC vote, CMS CAR T coverage could come down to PROs

August 22, 2018 10:13 PM UTC

CMS's Medicare Evidence Development & Advisory Committee voted that there is sufficient evidence to support the use of four different patient-reported outcome tools that could be used in future studies of CAR T cell therapies. The decision sets up the possibility that gathering information via one of these PROs could be a prerequisite for coverage under a pending National Coverage Determination for Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel.

CMS held the Wednesday meeting to review the evidence specific to PROs across various diseases and to determine how and whether they should be included in future clinical studies, including those for CAR Ts. MEDCAC is part of CMS's NCD process for Kymriah from Novartis AG (NYSE:NVS; SIX:NOVN) and Yescarta from the Kite Pharma Inc. unit of Gilead Sciences Inc. (NASDAQ:GILD). ...