ARM and NAMCP Publish Recommendations to Increase Patient Access in Joint Study, “Roadmap for Navigating the Provider Side of Cell and Gene Therapy (CGT) Patient Access in US Managed Care.”

Washington, DC – October 12, 2020

Reducing payment and reimbursement barriers is the most important factor in driving provider uptake of cell and gene therapies, the Alliance for Regenerative Medicine (ARM) and the National Association of Managed Care Physicians (NAMCP) Medical Directors Institute concluded in a joint study announced today.

The study – “Roadmap for Navigating the Provider Side of Cell and Gene Therapy Patient Access in U.S. Managed Care” – characterizes steps for payers and therapeutic developers to consider when introducing transformative and potentially curative therapies in the U.S. The findings focus on increasing patient access to transformative therapies from the perspective of physicians and health systems, whose views on the adoption of these technologies are less commonly explored than those of payers and developers.

“The provider-side of cell and gene therapy access and uptake is complex and every bit as critical to product success as the payer-side, and not to be underestimated,” said Eric Faulkner, Vice President, Precision and Transformative Medicine at Evidera and lead author for the publication. “It is imperative we do the key research to address provider-side acceptance drivers of cell and gene therapy so we can design the appropriate infrastructure, reimbursement and payment foundation. An integrated approach to clinical development that takes into account provider requirements beyond the evidence can optimize patients’ ability to receive these therapies, along with innovation in the sector.”

The limits of existing coding and payment systems, lack of models for transformative – and potentially curative – therapies, and the challenges associated with establishing multi-year value-based payment agreements are the most formidable hurdles to provider adoption of cell and gene therapies, the study found. All of the above drive concern among providers that they will not be properly reimbursed when administering these therapies.

“This study provides a much-needed compass point highlighting that significant upfront collaboration is needed with providers to ensure that patients will continue to have access to these truly innovative therapies,” said Janet Lambert, CEO of the Alliance for Regenerative Medicine. “This will require us to potentially rethink some aspects of traditional care delivery.”

The study concludes with several other key findings for therapeutic developers and payers:

  • Early engagement with providers is a foundational element in the successful launch of novel cell and gene therapies. Early engagement models that look beyond clinical trials and seek involvement in the pre-clinical stage to alleviate operational, reimbursement and other hurdles are a critical success factor for the advancement of transformative therapies.
  •  Developers and other stakeholders should partner with providers to support appropriate data collection around cell and gene therapies. This will help ensure that provider costs for administering the therapy are accurately recorded and support long-term patient follow-up requirements associated with cell and gene therapies.
  • Addressing affordability will require rethinking and updating various elements of health delivery. While affordability was noted as the key concern for future acceptance and use of cell and gene therapies, stakeholders have yet to fully envision a new model where transformative therapies may be the norm. 

The findings are based on a survey of 42 medical director members of the NAMCP – from health systems, provider organizations, and managed care organizations – and a face-to-face workshop with payers and cell and gene therapy developers.

“Appropriate provider infrastructure and incentives for offering cell and gene therapies is a fundamental piece of the puzzle in today’s U.S. managed care environment. By better understanding how providers have handled the initial wave of cell and gene therapies, we are in a better position to develop solutions that provide efficiencies for all stakeholders,” said Bill Williams, MD, Executive Vice President of the NAMCP Medical Directors Institute.

This study, available for download here, is the second of three studies conducted by ARM and NAMCP exploring how collaboration among therapeutic developers, payers, and providers can ensure patient access to transformative therapies. The first study, released in September 2019, identified how the stakeholders should partner to demonstrate the value of cell and gene therapies and create evidence to facilitate reimbursement.


About the Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory and reimbursement initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 11-year history, ARM has become the voice of the sector, representing the interests of 360+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. To learn more about ARM or to become a member, visit


About the NAMCP Medical Directors Institute

The NAMCP Medical Directors Institute is a non-profit membership association, which was established to provide tools, education, and resources to medical directors, practicing physicians, and other healthcare professionals. NAMCP Medical Directors Institute’s mission is to help Medical Directors from purchasers, health plans, and provider systems make effective and informed decisions, respond to opportunities and challenges in managed care, while helping improve healthcare outcomes, and ultimately the lives of members and patients.  To learn more about the NAMCP Medical Directors Institute or to become a member, visit