The Institute for Clinical and Economic Review (ICER) is planning to assess the comparative clinical effectiveness and value of two CAR T-cell therapies in the works to treat multiple myeloma – idecabtagene vicleucel (Bristol Myers Squibb Co., Bluebird Bio Inc.) and ciltacabtagene autoleucel (Johnson & Johnson, Legend Biotech Corp.). An FDA decision on idecabtagene vicleucel is expected early next year, and the biologic license application for ciltacabtagene autoleucel is expected to be submitted by the end of this year. Comments on development of the evidence report are due by Sept. 17. ICER said it plans to review the report at a public meeting in April 2021.
ICER posted its draft scoping document outlining its planned review of the health and economic outcomes of Aurinia Pharmaceuticals Inc.’s voclosporin and Glaxosmithkline plc’s (GSK) Benlysta (belimumab) for treating lupus nephritis. Voclosporin has a Jan. 22, 2021, PDUFA date, and GSK is expecting an FDA decision early next year on a label expansion for Benlysta, which already is approved to treat lupus erythematosus. Comments on the scoping document should be submitted by Sept. 21, 2020. In addition to those comments, ICER said it would like examples from stakeholders of low-value care practices in treating lupus nephritis.