ARM and NAMCP Publish Study of Managed Care Medical Director Perspectives, “Ensuring Patient Access to Regenerative and Advanced Therapies in Managed Care: How Do We Get There?”

WASHINGTON, D.C. – January 25, 2018

The Alliance for Regenerative Medicine (ARM) and the National Association of Managed Care Physicians (NAMCP) Medical Directors Institute announced today the joint release of their recent study of medical director perspectives on value demonstration and reimbursement for regenerative and advanced therapies.

The study, entitled “Ensuring Patient Access to Regenerative and Advanced Therapies in Managed Care: How Do We Get There?” identifies various challenges and posits possible solutions to ensure the appropriate integration of these high-value therapies into the current U.S. health care system. The study also takes a look at various proposed alternative payment and financing models to enable sustainable patient access to these products.

“This is a critical time for dialogue between regenerative and advanced therapy manufacturers, managed care, and other stakeholders,” said Eric Faulkner, Vice President, Precision and Transformative Technology Solutions at Evidera and lead author for the publication. “Our health system is continuously seeking innovations that have the potential to transform patient outcomes and truly ‘move the needle.’ Regenerative and advanced therapies have such potential, but they will enter global health systems that are ill-prepared to receive truly transformative therapies. This paper is part of the vanguard of early global dialogue to help bridge this gap and help prepare us for novel technologies that may alter our expectations for therapy development and patient care.”

“With hundreds of regenerative and advanced therapies in the pipeline, and several poised for near-commercialization, this is a pivotal moment for our sector and for patients in need,” said Janet Lynch Lambert, CEO for the Alliance for Regenerative Medicine. “Addressing the significant value assessment and reimbursement challenges is vital to ensuring these potentially transformative products reach patients as soon as possible.”

“Potential to transform patient outcomes in high unmet need areas is something that has value for all health stakeholders,” said Bill Williams, MD, Executive Vice President of the NAMCP Medical Directors Institute.  “A foundational focus of our organization is bringing together payers, providers, manufacturers and others to address novel technologies and healthcare management issues in an open, solution-focused environment. Many of the challenges our health system faces cannot be tackled by a single stakeholder. This important effort aligns closely with our Genomics Biotech and Medical Technology Institute’s (GBEMTI) mission of helping managed care prepare for current and future innovations that benefit patients and improve managed care practice. Regenerative and advanced therapies hold significant promise for improving the human condition in ways we are only beginning to realize.”

As complex as our U.S. healthcare environment is, this is absolutely essential for addressing challenges and embracing opportunities to constantly improve managed care practice, appropriate patient access and outcomes. Getting stakeholders around the table is a key reason we established our Genomics Biotech and Emerging Medical Technologies Institute.

The study illuminates the complexity inherent in commercializing regenerative and advanced therapies, owing to sector’s range of technology types, platform approaches, and immensely promising clinical potential. Active engagement and collaboration between the managed care community and regenerative and advanced therapy developers will therefore be essential to addressing the study’s identified challenges: measuring pricing value; defining what makes a product “transformative” or even “curative”; identifying and implementing the appropriate reimbursement models; among others.

The study concludes with several key learnings for therapeutic developers:

  • Prepare for education and market preparation to be a journey, not a destination. Consistent stakeholder education is vital, as these technologies offer longer-lasting, even permanent effects that differ significantly from other pharmaceutical products currently on the market.
  • Lead with value and think transformative impact. Study participants emphasized the need for regenerative and advanced therapy developers to demonstrate compelling evidence of value, focusing not only on superior outcomes, but on the products transformational nature and patient benefits.
  • Existing value frameworks are sufficient, but there are some exceptions.  Study respondents indicated that existing processes accommodate the magnitude of even a transformative product’s effect, with two key exceptions: a) expectations for demonstrating the effect’s duration and b) demonstrating curative effect.
  • Anticipate heterogeneity in reimbursement models. Although existing reimbursement systems were not built with these therapies in mind, study participants did confirm that commercial payers would likely have the potential to develop new case rates to cover the costs of these therapies, providing the therapy were viewed as transformative.
  • Prepare for today’s market realities while working towards introducing novel reimbursement models. Existing U.S. systems are not geared to absorb the financial impact of single administration model therapies. Study respondents anticipated that without innovative payment and financing models, some regenerative and advanced therapies could face challenges in obtaining coverage.

The study results are available to download here.

About The Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 275 members and is the leading global advocacy organization in this field. 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