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CMS To Make Hospitals Study Patients Who Get CAR-T

By John Wilkerson / February 15, 2019 at 4:21 PM
CMS will require hospitals that administer the expensive new CAR-T gene therapy to participate in a clinical registry or study aimed at determining whether real-world results mirror those from clinical trials used to get the treatments approved, according to a national coverage determination published Friday (Feb. 15) for chimeric antigen receptor (CAR) T-cells therapy. Drug makers were hoping to avoid such requirements, but consultants said the so-called coverage with evidence development plan was expected. CMS hasn’t released the study design,...


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