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Value and affordability of CAR T-cell therapy in the United States

Bone Marrow Transplantation volume 55, pages 1706–1715 (2020)Cite this article

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Abstract

In the United States the increasing number of Food and Drug Administration (FDA)-approved, innovative, and potentially effective commercial cancer therapies pose a significant financial burden on public and private payers. Chimeric antigen receptor (CAR) T cells are prototypical of this challenge. In 2017 and 2018, tisagenlecleucel (Kymriah, Novartis) and axicabtagene ciloleucel (Yescarta, Kite) were approved by the FDA for use after showing groundbreaking results in relapsed/refractory B-cell malignancies. In 2020 and 2021, four further submissions to the FDA are expected for CAR T-cell therapies for indolent and aggressive B-cell malignancies and plasma cell myeloma. Yet, with marketed prices of over $350,000 per infusion for the two FDA-approved therapies and similar price tags expected for the coming products, serious concerns are raised over value and affordability. In this review we summarize recent, peer-reviewed cost-effectiveness studies of tisagenlecleucel and axicabtagene ciloleucel in the United States; discuss key issues concerning the health plan budget impact of CAR T-cell therapy; and review policy, payment and scientific approaches that may improve the value and affordability of CAR T-cell therapy.

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Fig. 1: Cost-effectiveness plane summarizing peer reviewed studies of tisagenlecleucel (tisa) and axicabtagene ciloleucel (axi-cel) with willingness-to-pay (WTP) thresholds.
Fig. 2: Variability in calculated incremental cost-effectiveness ratios (ICER) from peer reviewed studies.

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Acknowledgements

We thank Dr Stefanie Kalfas and Dr Jordan Gauthier for valuable discussions, critical reading, and editing of the manuscript. We thank Dr Lindsie Goss for consultations regarding CAR T-cell patenting.

Funding

This study was supported in part by funds from the Fred Hutchinson Cancer Research Center Integrated Immunotherapy Research Center (PI: Roth JA).

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Authors and Affiliations

  1. Clinical Research Division and Integrated Immunotherapy Research Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    Salvatore Fiorenza & Cameron J. Turtle

  2. Department of Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC, Australia

    David S. Ritchie

  3. Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, VIC, Australia

    David S. Ritchie

  4. Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    Scott D. Ramsey & Joshua A. Roth

  5. Comparative Health Outcomes, Policy and Economics Institute, School of Pharmacy, University of Washington, Seattle, WA, USA

    Scott D. Ramsey & Joshua A. Roth

  6. Department of Medicine, University of Washington, Seattle, WA, USA

    Cameron J. Turtle

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Correspondence to Joshua A. Roth.

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Conflict of interest

SF and DSR declare no conflicts of interest. CJT is an inventor on patents licensed or pending to Juno Therapeutics (a Bristol-Myers Squibb company) and Nektar Therapeutics; receives research funding from Juno Therapeutics (a Bristol-Myers Squibb company) and Nektar Therapeutics; has equity options in Precision Biosciences, Caribou Biosciences, and Eureka Therapeutics; and has served as an advisor for Juno Therapeutics (a Bristol-Myers Squibb company), Nektar Therapeutics, Precision Biosciences, Caribou Biosciences, Eureka Therapeutics, Allogene, Kite Pharma (a Gilead company), Novartis, Humanigen, Aptevo, and Allogene. JAR and SDR have served as consultants for Kite Pharma (a Gilead company).

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Fiorenza, S., Ritchie, D.S., Ramsey, S.D. et al. Value and affordability of CAR T-cell therapy in the United States. Bone Marrow Transplant 55, 1706–1715 (2020). https://doi.org/10.1038/s41409-020-0956-8

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