The FDA approval of new drugs were seen as a sign in the personalized medicine community real progress in the growth of personalized medicine, the FDA approval of these drugs, along with companion diagnostics, suggested rethinking and regulatory practice in the agency. In addition to the legal issues, as many of the reimbursement system archaic, distributed, unpredictable, and unnecessarily time-consuming. Many wondered whether the traditional models of reimbursement … Read more »

The FDA approval of new drugs were seen as a sign in the personalized medicine community real progress in the growth of personalized medicine, the FDA approval of these drugs, along with companion diagnostics, suggested rethinking and regulatory practice in the agency. In addition to the legal issues, as many of the reimbursement system archaic, distributed, unpredictable, and unnecessarily time-consuming. Many wondered whether the traditional models of reimbursement were relevant in the age of personalized medicine, and who is needed for the cost of testing to the sometimes small number of patients who could benefit from expensive targeted drugs. This case focuses on the range of possibilities and the uncertainty these regulatory and reimbursement issues.
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from
Richard G. Hamermesh,
Norman C. Selby,
Phillip Andrews
Source: Harvard Business School
20 pages.
Release Date: 1 November 2012. Prod #: 813037-PDF-ENG
Companion Diagnostics: Uncertainties for approval and reimbursement HBR case solution