Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • News & Views
  • Published:

Immunotherapy

Tisagenlecleucel — the first approved CAR-T-cell therapy: implications for payers and policy makers

Nature Reviews Clinical Oncology volume 15, pages 11–12 (2018)Cite this article

Subjects

On 30th August 2017, tisagenlecleucel became the first chimeric antigen receptor (CAR)-T-cell therapy to be approved by the FDA. This approval has important implications for health-care systems because the use of this promising treatment presents considerable logistical, toxicological, and financial challenges. Moreover, the high price tag of US$475,000 is questionable, considering the major role of US taxpayers in covering the development, delivery, and supportive-care costs of this treatment.

This is a preview of subscription content, access via your institution

Relevant articles

Open Access articles citing this article.

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. US Food and Drug Administration. FDA approves tisagenlecleucel for B-cell ALL and tocilizumab for cytokine release syndrome. FDA https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm574154.htm (2017).

  2. US Food and Drug Administration. FDA briefing document: Oncologic Drugs Advisory Committee meeting; BLA 125646; Tisagenlecleucel, Novartis Pharmaceuticals Corporation. FDA https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566166.pdf (2017).

  3. Court, E. Novartis' CAR-T gene therapy, the first approved by FDA, to cost $475,000. Market Watch http://www.marketwatch.com/story/novartis-car-t-gene-therapy-the-first-approved-by-fda-to-be-priced-based-on-cancer-patients-outcomes-2017-08-30 (31 Aug 2017).

  4. Herman, B. The cancer drug pricing firestorm. Axios https://www.axios.com/the-car-t-drug-pricing-firestorm-2479635241.html (31 Aug 2017).

  5. Mitchell, D. Patients For Affordable Drugs launches campaign demanding fair pricing of new Novartis cancer drug. Patients For Affordable Drugs http://www.patientsforaffordabledrugs.org/2017/08/17/patients-for-affordable-drugs-launches-campaign-demanding-fair-pricing-of-new-cancer-drug/ (17 Aug 2017).

    Google Scholar 

  6. Singhroy, D. Total federal funding to organizations for projects related to chimeric antigen receptors. Knowledge Ecology International for Patients For Affordable Drugs https://docs.google.com/document/d/1ie5HJk_8NV_VMnOzAcx1ojCs1dRIJ4Jv-zMQr-GOqdQ/edit (2017).

    Google Scholar 

  7. Prasad, V. & Mailankody, S. Research and development spending to bring a single cancer drug to market and revenues after approval. JAMA Int. Med. http://dx.doi.org/10.1001/jamainternmed.2017.3601 (2017).

  8. US Securities and Exchange Commission. FORM 10-K: Annual report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, Kite Pharma, Inc. (US Securities and Exchange Commission, 2016).

  9. Gilead Sciences, Inc. Gilead Sciences to acquire Kite Pharma for $11.9 billion. Gilead Sciences, Inc. http://www.gilead.com/news/press-releases/2017/8/gilead-sciences-to-acquire-kite-pharma-for-119-billion (28 Aug 2017).

  10. Grady, D. In girl's last hope, altered immune cells beat leukemia. The New York Times (10 Dec 2012).

  11. Novartis. Novartis pivotal CTL019 6-month follow-up data show durable remission rates in children, young adults with r/r B-cell ALL. Novartis https://www.novartis.com/news/media-releases/novartis-pivotal-ctl019-6-month-follow-data-show-durable-remission-rates (23 Jun 2017).

  12. Majhail, N. S., Mau, L. W., Denzen, E. M. & Arneson, T. J. Costs of autologous and allogeneic hematopoietic cell transplantation in the United States: a study using a large national private claims database. Bone Marrow Transplant. 48, 294–300 (2013).

    Article  CAS  Google Scholar 

  13. US Food and Drug Administration. Prescribing information for tisagenlecleucel. FDA https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM573941.pdf (2017).

  14. Stein, R. FDA approves first gene therapy for leukemia. NPR Shots http://www.npr.org/Sections/Health-Shots/2017/08/30/547293551/fda-Approves-First-Gene-Therapy-Treatment-for-Cancer (30 Aug 2017).

    Google Scholar 

  15. Food and Drug Administration Center for Drug Evaluation and Research. Oncologic Drugs Advisory Committee (ODAC); morning session; Wednesday, July 12, 2017. FDA https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM573720.pdf (2017).

  16. Lamont, E. B. et al. Is patient travel distance associated with survival on phase II clinical trials in oncology? J. Natl Cancer Inst. 95, 1370–1375 (2003).

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Vinay Prasad is at the Division of Hematology and Medical Oncology, Knight Cancer Institute; Department of Preventive Medicine and Public Health; and Center for Health Care Ethics, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, Portland, Oregon 97239, USA.,

    Vinay Prasad

  2. Department of Preventive Medicine and Public Health,

    Vinay Prasad

Authors
  1. Vinay Prasad
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Vinay Prasad.

Ethics declarations

Competing interests

The work of the author is funded by the Laura and John Arnold Foundation. The author also receives royalties from his book Ending Medical Reversal: Improving Outcomes, Saving Lives.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Prasad, V. Tisagenlecleucel — the first approved CAR-T-cell therapy: implications for payers and policy makers. Nat Rev Clin Oncol 15, 11–12 (2018). https://doi.org/10.1038/nrclinonc.2017.156

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/nrclinonc.2017.156

This article is cited by

Search

Advanced search

Quick links

Nature Briefing: Translational Research

Sign up for the Nature Briefing: Translational Research newsletter — top stories in biotechnology, drug discovery and pharma.

Get what matters in translational research, free to your inbox weekly. Sign up for Nature Briefing: Translational Research