The Alliance for Regenerative Medicine (ARM) is the preeminent international organization focused specifically on the issues facing regenerative medicine and advanced therapies. We are advocates for progress in gene therapy, cell therapy, and tissue engineering.
Working with our members and policymakers, we foster investment, research & development, and successful commercialization of safe, effective, and transformational therapies for patients around the world.
2020 Priorities:
2020 Priorities:
2020 Priorities:
ARM is the leading voice in the regenerative medicine sector educating stakeholders on policy issues affecting the development of and patient access to regenerative medicines. For a full list of ARM’s presentations and publications, click here.
Produced by the Marwood Institute and funded by ARM, this report uses a “Transformative Therapy Value Model,” and demonstrates that durable cell or gene therapies for multiple myeloma, sickle cell disease, and hemophilia A could provide cumulative cost-savings of $33B over the next ten years.
New cell and gene therapies are changing the face of medicine – and raising questions on how to pay for durable and potentially curative new treatments. Watch this webinar playback to gain insights from experts in the developer, payor, and policy spheres.
ARM CEO Janet Lambert presented at ASGCT’s 2020 Virtual Conference on value demonstration for cell & gene therapy. The presentation cites findings from ARM’s library of original policy analyses.
The Alliance for Regenerative Medicine (ARM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Rule on Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (the “Proposed Rule”).
The Alliance for Regenerative Medicine (ARM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Rule on Ensuring Access to Medicaid Services (the “Proposed Rule”).
The Alliance for Regenerative Medicine (ARM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed payment updates to the fiscal year 2024 Hospital Inpatient Prospective Payment System (Proposed Rule).
ARM appreciates this opportunity to comment on the Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program proposed rule (the “Proposed Rule”).
ARM thanks Representatives Anna Eshoo and Brett Guthrie for their leadership championing policies to ensure patients can benefit from durable, potentially curative cell and gene therapies.
ARM asks the chair of the House Committee on Energy Commerce to support policies that ensure patients with healthcare coverage through state Medicaid programs can access emerging cell and gene therapies (CGTs).
ARM offers the following comments detailing the challenges of the New Technology Add-on Program (NTAP).
ARM is grateful to Senators Grassley and Bennet, and Representatives Trahan and Miller Meeks for their leadership championing policies to ensure children with medically complex conditions enrolled in Medicaid can access specialized care across state lines.
To promote appropriate access to cell and gene therapies and support the patients receiving these treatments, ARM urges CMS to adopt several recommendations stated within our comment letter.
Comments
ARM applauds ICER for addressing needed updates regarding patient engagement, clinical trial diversity, and real-world evidence priorities; however, ARM raises critical concerns with ICERs approach for assessing the value of cell and gene therapies, particularly as is relates to timing of their assessments and considerations around health benefit price benchmarks.