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 and manufacturer perspectives on value demonstration and reimbursement for cell- and gene-based regenerative and advanced therapies.
The study, entitled “Roadmap for Navigating Cell and Gene Therapy Value Demonstration and Reimbursement in U.S. Managed Care,” characterizes step-by-step considerations for achieving appropriate patient access to transformative and potentially curative therapies in the U.S. managed care setting. The findings identify key issues relevant to value demonstration and access to potentially curative therapies at a pivotal time for the industry, as several products have reached the market, with dozens more in late-stage clinical trials.
“The initial wave of cell and gene therapies has launched into an environment that was not built with transformative or curative therapies in mind,” said Eric Faulkner, Vice President, Precision and Transformative Medicine at Evidera and lead author for the publication. “It’s crucial for payers, providers, patients, and other stakeholders to align on expectations on value demonstration to ensure sustainable access.”
“In the next two to three years, the sector expects the number of marketed cell and gene therapies to more than triple,” said Janet Lambert, CEO for the Alliance for Regenerative Medicine. “We will improve patient lives if we ensure patients have timely access to these treatments and value assessment and reimbursement processes have been structured with these unique therapies in mind.”
“Appropriate reimbursement and access to transformative therapies is critical to constantly improve managed care practice, appropriate patient access and outcomes. This effort is one step to achieving that goal by identifying and acknowledging the key acceptance requirements and stakeholder perspectives as these therapies enter the marketplace,” said Bill Williams, MD, Executive Vice President of the NAMCP Medical Directors Institute.
The study concludes with several key learnings for therapeutic developers and payers:
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 350 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit http://www.alliancerm.org.
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 http://www.namcp.org.