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Personalized medicine: Factors influencing reimbursement

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  • Meckley, Lisa M.
  • Neumann, Peter J.

Abstract

Objectives Personalized medicine (PM) has attracted tremendous interest, but yielded few marketed products. We examined factors influencing the reimbursement of existing PM technologies.Methods We conducted six case studies of the following paired genetic tests and treatments: HER2/neu with trastuzumab (Herceptin); hepatitis C genotyping with ribavirin/pegylated interferon; Oncotype DX with chemotherapy; UGT1A1 with irinotecan (Camptosar); VKORC1/CYP2C9 with warfarin; BRCA1/2 with prophylactic surgical measures; and Oncotype DX with chemotherapy. We developed a framework for categorizing PM technology, and assessed factors influencing reimbursement, including quality of evidence, type of regulatory oversight, presence of clinical guidelines, and cost-effectiveness.Results PM is not a monolithic concept, but rather encompasses different types of technology. The strength of evidence available for existing PM technology varies widely and, along with endorsement of clinical guidelines, appears to be the strongest predictor of reimbursement. In the absence of reimbursement, direct-to-consumer marketing has continued for some PM technology. The type of regulatory oversight and the results of cost-effectiveness analysis do not appear to be associated with reimbursement to date.Conclusions To date, the promise and hype of PM has outpaced its evidentiary support. In order to achieve favorable coverage and reimbursement and to support premium prices for PM, manufacturers will need to bring better clinical evidence to the marketplace and better establish the value of their products.

Suggested Citation

  • Meckley, Lisa M. & Neumann, Peter J., 2010. "Personalized medicine: Factors influencing reimbursement," Health Policy, Elsevier, vol. 94(2), pages 91-100, February.
    • Handle: RePEc:eee:hepoli:v:94:y:2010:i:2:p:91-100
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    Citations

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    Cited by:

    1. Degtiar, Irina, 2017. "A review of international coverage and pricing strategies for personalized medicine and orphan drugs," Health Policy, Elsevier, vol. 121(12), pages 1240-1248.
    2. Leopold, C. & Vogler, S. & Habl, C. & Mantel-Teeuwisse, A.K. & Espin, J., 2013. "Personalised medicine as a challenge for public pricing and reimbursement authorities – A survey among 27 European countries on the example of trastuzumab," Health Policy, Elsevier, vol. 113(3), pages 313-322.
    3. Holloway, Kelly & Miller, Fiona A., 2022. "The Consultant's intermediary role in the regulation of molecular diagnostics in the US," Social Science & Medicine, Elsevier, vol. 304(C).
    4. F. Antoñanzas & C. Juárez-Castelló & R. Rodríguez-Ibeas, 2015. "Some economics on personalized and predictive medicine," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 16(9), pages 985-994, December.
    5. Vokinger, Kerstin N. & Muehlematter, Urs Jakob, 2020. "Accessibility of cancer drugs in Switzerland: Time from approval to pricing decision between 2009 and 2018," Health Policy, Elsevier, vol. 124(3), pages 261-267.
    6. Fernando Antoñanzas & Carmelo A. Juárez-Castelló & Roberto Rodríguez-Ibeas, 2016. "Implementing personalized medicine with asymmetric information on prevalence rates," Health Economics Review, Springer, vol. 6(1), pages 1-8, December.
    7. Marta O. Soares & Simon Walker & Stephen J. Palmer & Mark J. Sculpher, 2018. "Establishing the Value of Diagnostic and Prognostic Tests in Health Technology Assessment," Medical Decision Making, , vol. 38(4), pages 495-508, May.
    8. F. Antoñanzas & C. A. Juárez-Castelló & R. Rodríguez-Ibeas, 2019. "Pre-approval incentives to promote adoption of personalized medicine: a theoretical approach," Health Economics Review, Springer, vol. 9(1), pages 1-10, December.
    9. Veronika Kalouguina & Joël Wagner, 2020. "Challenges and Solutions for Integrating and Financing Personalized Medicine in Healthcare Systems: A Systematic Literature Review," JRFM, MDPI, vol. 13(11), pages 1-22, November.
    10. Fischer, Katharina E. & Leidl, Reiner & Rogowski, Wolf H., 2011. "A structured tool to analyse coverage decisions: Development and feasibility test in the field of cancer screening and prevention," Health Policy, Elsevier, vol. 101(3), pages 290-299, August.
    11. Rositsa Koleva-Kolarova & James Buchanan & Heleen Vellekoop & Simone Huygens & Matthijs Versteegh & Maureen Rutten-van Mölken & László Szilberhorn & Tamás Zelei & Balázs Nagy & Sarah Wordsworth & Apos, 2022. "Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options," Applied Health Economics and Health Policy, Springer, vol. 20(4), pages 501-524, July.
    12. Tracy Merlin & Claude Farah & Camille Schubert & Andrew Mitchell & Janet E. Hiller & Philip Ryan, 2013. "Assessing Personalized Medicines in Australia," Medical Decision Making, , vol. 33(3), pages 333-342, April.

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