Variation in market access decisions for cell and gene therapies across the United States, Canada, and Europe

  • Transformative cell and gene therapies have now launched worldwide, and many potentially curative cell and gene therapies are in development, offering the prospect of significant health gains for patients. Access to these therapies depend on decisions made by health technology assessment (HTA) and payer organizations. We sought to describe the emerging cell and gene therapies market access landscape by analyzing 17 US commercial payer medical policies, and HTA reports from five European countries and Canada. We found that some US health plans applied coverage restrictions more often than others (four plans applied restrictions in all decisions, while four plans applied restrictions in <30% of decisions). The European and Canadian HTA bodies recommend access to fewer therapies than US health plans, reflecting a more stringent approach in the context of limited evidence and high scientific uncertainty that is commonly associated with these treatments. Our findings suggest that patient access to approved cell and gene therapies isTransformative cell and gene therapies have now launched worldwide, and many potentially curative cell and gene therapies are in development, offering the prospect of significant health gains for patients. Access to these therapies depend on decisions made by health technology assessment (HTA) and payer organizations. We sought to describe the emerging cell and gene therapies market access landscape by analyzing 17 US commercial payer medical policies, and HTA reports from five European countries and Canada. We found that some US health plans applied coverage restrictions more often than others (four plans applied restrictions in all decisions, while four plans applied restrictions in <30% of decisions). The European and Canadian HTA bodies recommend access to fewer therapies than US health plans, reflecting a more stringent approach in the context of limited evidence and high scientific uncertainty that is commonly associated with these treatments. Our findings suggest that patient access to approved cell and gene therapies is restricted in all regions studied, though the nature of these restrictions differs between US health plans and the European/Canada HTA recommendations. Payers, HTA groups, pharmaceutical companies, and other stakeholders should collaborate to more clearly define the "uncertainties" and develop market access policies that balance benefits of early access with ongoing data collection to close evidence gaps over time.show moreshow less

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Author:Sean Tunis, Eve Hanna, Peter J. Neumann, Mondher Toumi, Omar Dabbous, Michael Drummond, Frank-Ulrich Fricke, Sean D. Sullivan, Daniel C. Malone, Ulf Persson, James D. Chambers
DOI:https://doi.org/10.1016/j.healthpol.2021.10.003
ISSN:0168-8510
Parent Title (English):Health Policy
Publisher:Elsevier BV
Document Type:Article
Language:English
Reviewed:Begutachtet/Reviewed
Release Date:2024/11/27
Tag:Cell and gene therapies; Health technology assessment; Market access; Payers
Volume:125
Issue:12
Pagenumber:7
First Page:1550
Last Page:1556
institutes:Fakultät Betriebswirtschaft
Licence (German):Creative Commons - CC BY - Namensnennung 4.0 International
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