Institute issues draft scoping plan for review of anti-BCMA therapies for multiple myeloma
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The Institute for Clinical and Economic Review has completed a draft scoping document for its planned assessment of chimeric antigen receptor T-cell therapies for the treatment of multiple myeloma.
The institute will compare the clinical effectiveness and value of two CAR T-cell therapies: idecabtagene vicleucel (Bristol Myers Squibb, bluebird bio) and ciltacabtagene autoleucel (Johnson & Johnson, Legend Biotech Corp.).
The review also will focus on belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), an antibody-drug conjugate. All three therapies target the B-cell maturation antigen on the surface of blood cancer cells.
The FDA granted priority review status to idecabtagene vicleucel on Sept. 22; however, neither CAR T-cell therapy has been approved by the FDA for any indication. The FDA approved belantamab mafodotin-blmf in August for treatment of patients with relapsed or refractory multiple myeloma who underwent at least four previous lines of treatment.
The draft scoping document outlines the methods and definitions that will be used during the analysis. The resulting report will be reviewed in April during a public meeting of the Midwest Comparative Effectiveness Public Advisory Council.
“[The institute] also welcomes submissions from stakeholders on examples of low-value care practices within these clinical areas,” a press release from the institute stated. “These submissions will inform sections in each report on strategies to reduce waste and preserve resources for high-value, potentially higher-cost treatments.”
Interested stakeholders may submit comments and suggestion on changes to the draft scoping document via email to publiccomments@icer-review.org by 5 p.m. Eastern on Oct. 13. Comments should be submitted according to the institute’s formatting specifications.
A revised scoping document will be made available on Oct. 21.
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