Market Access & Value

ARM advances specific proposals to enable coverage, coding, and payment policies that facilitate the development of and patient access to regenerative medicine and advanced therapy products.

ARM advances specific proposals to enable coverage, coding, and payment policies that facilitate the development of and patient access to regenerative medicine and advanced therapy products.

The Need for Innovation in Reimbursement

Reimbursement refers to how a healthcare provider is paid by private insurers or government payers, including Centers for Medicare and Medicaid Services (CMS) in the U.S. and the National Healthcare System (NHS) in the U.K., for example. Under the current, decades-old reimbursement system, if a patient has a severe or chronic disease or disability, payers (both private and public) typically expect to pay for each treatment or interaction with a health care provider over the course of many years—potentially throughout the patient’s entire lifetime.

Gene and cell therapies and other regenerative medicine products are different. Many are designed to durably and even permanently address the underlying cause of a disease. They may be given in just a few administrations, or even a single dose. While these therapies can provide significant direct and indirect savings in medical costs over time, their potentially high upfront cost can create a significant burden on existing reimbursement systems. While reimbursement systems have begun to change to accommodate these new treatments, they still have a way to go to catch up with the immense value provided by advanced therapies.

In the United States, CMS typically sets the standard for reimbursement through its decisions regarding coverage and payment through the Medicare program. In the European Union, individual countries regulate their own respective healthcare systems, with the European Commission encouraging coordinated efforts in cross-border healthcare. ARM works with these and other public payers as well as with commercial insurers to promote reimbursement and payment policies that enable innovation in regenerative medicine.

Our Role in Reimbursement

  • Build and promote a strong value story for regenerative medicine products through evidence collection, including case studies, framework development, coverage criteria, and external stakeholder engagement.
  • Secure supportive coverage and payment policies for cell and gene therapies and other regenerative medicine products.
  • Analyze current and potential payment and financing models to facilitate and improve access and adoption.
  • Break down barriers to the adoption of new, innovative payment and financing models, drive value-based payment reform, and address core challenges to enable payments over time.


ARM’s EU Market Access Report, Published July 2019
“Getting Ready: Recommendations for Timely Access to ATMPs in Europe”
Recommendations Read the Full Report


ARM’s Three-Part White Paper Series Published November 2016 in IN VIVO,
“Curative Regenerative Medicines: Preparing Health Care Systems for the Coming Wave”
Subscribers Non-Subscribers


Published July 2017 in IN VIVO,
“New Payment and Financing Models for Curative Therapies”Subscribers Non-Subscribers


Published July 2018 in IN VIVO,
“Moving From Chronic Therapies To Cures – Creating A Pathway To Enable New Payment Models”Subscribers Non-Subscribers

Current Areas of Focus
In collaboration with members active in ARM's Market Access & Value Committee

  • Value Framework

    Developing principles of an ARM-endorsed value framework, which will be used to evaluate and influence those of key organizations and payers.

  • Payment Model Barrier Mitigation

    Developing and executing strategies to remove or mitigate new payment model barriers in Medicare and Medicaid, including “Best Price” requirements and application of the Anti-Kickback Statute

  • Medicare Technology Reform

    Working with CMS to reform Medicare’s program to cover new technologies in the Medicare Inpatient Prospective Payment System, enabling patient access to advanced therapy products, including CAR T-cell therapies.

  • ATMP Access and Uptake

    Defining the key challenges and opportunities for advanced therapy medicinal product (ATMP) access and uptake in the five major EU countries (France, Germany, Italy, Spain, UK), developing consensus recommendations by country to improve access to ATMPs.