4:46 PM
May 16, 2018
 |  BC Extra  |  Politics & Policy

CMS initiates national coverage analysis of CAR T therapies

CMS began a national coverage analysis Wednesday to review the use of CAR T cell therapies to treat cancer.

An NCA is the first step in the path to developing a National Coverage Decision that would impose a uniform national coverage policy. In February, UnitedHealth Group Inc. (NYSE:UNH) requested that CMS issue an NCD for the two FDA-approved CAR T therapies -- Kymriah tisagenlecleucel from Novartis AG (NYSE:NVS; SIX:NOVN) and Yescarta axicabtagene ciloleucel from the Kite Pharma Inc. unit of Gilead Sciences Inc. (NASDAQ:GILD).

CMS noted that both therapies include boxed warnings and require REMS and that adverse events including cytokine release syndrome and neurologic effects have been reported in the majority of patients who received CAR T cell therapy. The agency added that few Medicare patients have been studied, with limited follow-up, and that initial studies were confined to the inpatient hospital setting.

CMS is accepting public comments until June 15 and plans to hold a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) on Aug. 22. The agency's proposed decision memo is due Feb. 16, 2019.

FDA approved Kymriah to treat pediatric relapsed, refractory acute lymphoblastic leukemia (ALL) in August and Yescarta to treat relapsed or refractory large B cell lymphoma in October. Earlier this month, FDA expanded Kymriah's label to include adults with relapsed or refractory diffuse large B cell lymphoma (DLBCL) (see BioCentury Extra, May 1).

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