FOR IMMEDIATE RELEASE
CONTACT: Macey Kostbar
WASHINGTON, DC (June 18, 2020) – Below is a statement from the Institute for Gene Therapies (IGT) Chairman Congressman Erik Paulsen regarding the Centers for Medicare and Medicaid Services (CMS) Proposed Rule Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements:
“The Institute for Gene Therapies commends CMS for releasing its much-anticipated proposed rule on changes to the Medicaid Drug Rebate Program (MDRP) to facilitate value-based purchasing (VBP) arrangements for drugs. VBP arrangements are of significant interest to gene therapy stakeholders. For gene therapies to realize their potential for long-lasting benefit to patients with serious diseases, we need clear pathways for enabling development of innovative payment mechanisms, including those that link payment and outcomes.
“We applaud the Administration's support for VBP and its acknowledgement of the unique nature of each VBP arrangement. CMS has given careful consideration to several new proposals for revising MDRP price reporting, specifically Best Price, for purposes of facilitating manufacturers' ability to provide VBP arrangements. Medicaid Best Price rules, which were instituted decades before gene therapies were on the market in the United States, have posed a hurdle to VBP development. We also recognize the operational challenges that may be presented by the proposed price reporting framework.
IGT is assessing the new proposals in further detail and looks forward to providing comments to CMS as part of the rulemaking cycle.”
About the Institute for Gene Therapies
The Institute for Gene Therapies (IGT) works with stakeholders across the healthcare system to advocate for a modernized regulatory and reimbursement framework that encourages the development of transformative gene therapies and promotes patient access. Members of our advisory councils include American Autoimmune Related Diseases Association (AARDA), AVROBIO, Bladder Cancer Advocacy Network, CMT Research Foundation, Cure Duchenne, Cure SMA, EveryLife Foundation, FerGene, Foundation Fighting Blindness, Friedrich’s Ataxia Research Alliance, Gaucher Community Alliance, Jenn McNary (Founder of One Rare), Johnson & Johnson, Khrystal Davis (Founder of Texas Rare Alliance), National Patient Advocate Foundation, PTC Therapeutics, Rett Syndrome Research Fund, Rolf Benirschke (Patient Advocate for Crohn’s disease, ulcerative colitis, colorectal and bladder cancer), Seth Rotberg (Co-Founder and Head of Strategy & Engagement of Our Odyssey), Soft Bones, Spark Therapeutics, Vertex.