Evidera congratulates Eric Faulkner, MPH, Vice President, Precision and Transformative Medicine, on his recent collaboration with the Alliance for Regenerative Medicine (ARM) and the National Association of Managed Care Physicians (NAMCP) on a study of medical director and manufacturer perspectives on value demonstration and reimbursement for cell- and gene-based regenerative and advanced therapies.

The study publication, “Roadmap for Navigating Cell and Gene Therapy Value Demonstration and Reimbursement in U.S. Managed Care,” was announced in a joint ARM and NAMCP press release on September 24. The study 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 these therapies at a pivotal time for the industry when several products have reached the market, with many more currently in late-stage clinical trials.

As lead author for the publication, Eric Faulkner commented, “The initial wave of cell and gene therapies has launched into an environment that was not built with transformative or curative therapies in mind. It’s crucial for payers, providers, patients, and other stakeholders to align on expectations on value demonstration to ensure sustainable access.”

The study highlights Evidera’s recognition of this critical point in the evolution of cell and gene therapies and commitment to help bring new treatment options to patients.  Evidera’s scientific teams understand the concerted effort it takes between healthcare authorities, regulators and drug developers to increase patient access to these potentially curative therapies and can navigate this challenging process.

Learnings for drug developers and payers also highlighted in the study include:

  • Reducing barriers to coverage will be critical for equitable patient access to cell and gene therapies
  • Improving stakeholder alignment on evidence requirements and a value framework for cell and gene therapies is key to support more rapid coverage and access decisions
  • Lack of appropriate fit into existing coding and payment systems creates significant risks for provider adoption and patient access
  • Cell and gene therapy manufacturers must think comprehensively and not take anything for granted in developing a value demonstration strategy
  • It is critical for commercial payers to actively engage in solutions for making truly transformative therapies available to patients in an affordable manner

Read the full press release for a more detailed overview or download the study results for more information.

Contact us here to learn more about the study or to find out how we can help you with your value demonstration and access challenges.