Another Advocacy Win for Patients: Medicare Finalizes Coverage for Some CAR T-Cell Therapies On August 7, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover FDA-approved Chimeric Antigen Receptor T-cell, or “CAR T-cell” therapy, which is a form of cancer treatment that uses a patient’s own genetically-modified immune cells to fight disease. FDA-approved CAR T-cell therapies are approved to treat some people with specific types of cancer – certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia. CMS approved the NCD (National Coverage Decision) without some of the requirements that had some providers concerned. With the decision, it establishes coverage that increases reimbursement, approves usage in certain FDA-approved healthcare facilities other than hospitals, reduces some reporting requirements that may have discouraged adoption, and supports ongoing monitoring and collaboration in the future between CMS, the FDA, and the NCI. “This decision is great news,” commented Dellann Elliott Mydland, President and CEO of the EndBrainCancer Initiative. “We applaud the CMS for moving this forward and providing expanded coverage for these promising treatments. The EBCI is excited about the research for CAR T-Cell Therapy to treat brain cancer and we hope that research will progresses to the […]

The EndBrainCancer Initiative Urges Support for New FDA Clinical Trial Diversity Guidelines and Proposes Key Amendments Proposed Changes Offer Patients with Brain Cancer and Other Rare Diseases Access to Advocacy Oriented “Patient Partner Navigation Services” Press Release in PDF Format Press Release on PRNEWSWIRE National Distribution Network   SEATTLE, Aug. 1, 2019 /PRNewswire/ — The EndBrainCancer Initiative (EBCI) urges support for the new  guidelines proposed by the FDA entitled “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry.” With the public comment period ending on August 6th, the EBCI also proposes changes to the guidelines that would ensure that brain cancer patients and other rare disease patients are offered the opportunity to interact with advocacy oriented outside “Patient Partners Navigation Services” at the time of diagnosis prior to surgery and as a regular part of clinical trial  participation to increase inclusion, diversity, and enrollment in support of the growth goals of the guidelines (EBCI Letter and Public Comment). Overall, this FDA draft guidance document provides recommendations for inclusive research practices for  industry/drug companies clinical trial sponsors to broaden eligibility criteria and increase enrollment of underrepresented populations, including patients with other diseases […]