Payers Report Taking Varied Steps to Manage Cell and Gene Therapies

The FDA recently approved the two newest cell and gene therapies, with one of them earning the distinction of being the first of its kind approved by the FDA. As more of these products launch onto the U.S. market — the agency previously predicted that it would be approving 10 to 20 of the treatments by 2025 — payers are taking a variety of approaches to managing the therapies.

Dec. 8 saw the newest approvals, both for the treatment of sickle cell disease in people at least 12 years old: bluebird bio, Inc’s Lyfgenia (lovotibeglogene autotemcel; lovo-cel) and Vertex Pharmaceuticals Inc. and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel; exa-cel). The latter agent is the first CRISPR/Cas9 genome-edited cell therapy that the FDA has approved. The one-time treatments come with hefty price tags: Lyfgenia is priced at $3.1 million and Casgevy at $2.2 million.

Each agent is available through its manufacturer’s national network of treatment centers.

For the Managed Care Biologics & Injectables Index: Q3 2023, from Aug. 13, 2023, to Sept. 21, 2023, Zitter Insights polled 35 commercial payers covering 117.8 million lives and 28 Medicare payers representing 43.6 million lives about their management of gene therapies. Slightly less than half of payers — 49% — said that managing branded products is a very high priority for them while 40% say they take a moderately aggressive approach to management of the agents.

Both AIS Health and Zitter Insights are divisions of MMIT.

Payers said they take a variety of steps to increase their level of aggression in managing these products. The top approach is mandating submission of genetic testing results for initial authorization, done by 69% of respondents, followed by engaging with manufacturers in alternative methods of contracting, such as outcomes-based contracts, which 60% of respondents reported doing. Other common approaches include requiring patients to step through agents with different mechanisms of action before they can access gene therapies, managing the agents separately from others within a therapeutic area, placing them at higher cost-sharing tiers and requiring genetic testing results for continued access.

Almost three-quarters of all payers said that their organization allows for coverage of an FDA-approved gene therapy that is not on formulary through a medical exception request. Among the reimbursement models that survey respondents reported using, outcomes-based contracts were most common (see chart).

For more information on the Zitter Insights data, contact Jill Brown Kettler at

© 2024 MMIT
Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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