Personalized medicine: Factors influencing reimbursement
AbstractObjectives 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.
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Bibliographic InfoArticle provided by Elsevier in its journal Health Policy.
Volume (Year): 94 (2010)
Issue (Month): 2 (February)
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Web page: http://www.elsevier.com/locate/healthpol
Personalized medicine Pharmacogenetics Pharmacogenomics Diagnostic tests Reimbursement Genetic tests;
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- 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.
- 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.
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