The Alliance for Regenerative Medicine (ARM) today announced the publication of its reimbursement and market-access focused white paper, “Moving From Chronic Therapies To Cures – Creating A Pathway To Enable New Payment Models,” available online today in the journal In Vivo.
Authored by Francesca Cook, REGENXBIO; Ted Slocomb, Audentes Therapeutics; Michael Werner, ARM; Ted Haack, LatticePoint Consulting; Donald Han, Pfizer; and Faraz Ali, REGENXBIO Therapeutics, this white paper, the third and final paper in ARM’s three-part series identifies current logistical, legal, regulatory, and other barriers to widespread adoption of alternative payment and financing models. In addition, it offers detailed market-based policy solutions to overcome specified implementation challenges. As with previous papers in the series, numerous member organizations involved in ARM’s Reimbursement Committee contributed their insights.
“The FDA’s recent cell and gene therapy product approvals are terrific news for patients and for the regenerative and advanced therapies sector overall. Their availability brings commercialization and access issues into distinctly sharper focus,” said Michael Werner, ARM co-founder and senior counsel. “The unique qualities of these transformative products requires key stakeholders to come together to advance policy solutions to accommodate and appropriately prepare our healthcare system to ensure patient access.”
The first paper, published November 2016, provided an overall assessment of the sector landscape, detailing the potential clinical impact, quality of life improvement, healthcare system cost effect and societal benefits these gene, cell and tissue engineered therapies represent, highlighting various potential payment and finance models. The second paper, published July 2017, identified and evaluated potential payment models for cell and gene therapies, and also highlighted key stakeholder perspectives and barriers to implementation.
The white paper will also be featured in the July/August In Vivo print edition.
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 290 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.