Skip to Main Content
HBS Home
  • About
  • Academic Programs
  • Alumni
  • Faculty & Research
  • Baker Library
  • Giving
  • Harvard Business Review
  • Initiatives
  • News
  • Recruit
  • Map / Directions
Faculty & Research
  • Faculty
  • Research
  • Featured Topics
  • Academic Units
  • …→
  • Harvard Business School→
  • Faculty & Research→
Publications
Publications
  • November 2012 (Revised January 2013)
  • Case
  • HBS Case Collection

Companion Diagnostics: Uncertainties for Approval and Reimbursement

By: Richard G. Hamermesh, Norman C. Selby and Phillip Andrews
  • Format:Print
  • | Language:English
  • | Pages:20
ShareBar

Abstract

The FDA approvals of novel therapeutics were seen as signs in the personalized medicine community of real progress in the growth of personalized medicine. The FDA's approval of such drugs, along with companion diagnostics, suggested a shift in thinking and regulatory practices at the agency. Beyond the regulatory questions, many considered the reimbursement system archaic, dispersed, unpredictable, and unnecessarily time consuming. Many questioned whether the traditional models of reimbursement were relevant in the era of personalized medicine, and who should be covering the cost of tests needed to identify the sometimes small number of patients who could benefit from expensive targeted drugs. This case focuses on the array of possibilities and the ambiguity surrounding these regulatory and reimbursement issues.

Keywords

Models Of Reimbursement; Personalized Medicine; Regulation; Healthcare Reform; Health Care and Treatment; Health Industry; United States

Citation

Hamermesh, Richard G., Norman C. Selby, and Phillip Andrews. "Companion Diagnostics: Uncertainties for Approval and Reimbursement." Harvard Business School Case 813-037, November 2012. (Revised January 2013.)
  • Educators
  • Purchase

About The Author

Richard G. Hamermesh

→More Publications

Related Work

    • November 2012 (Revised January 2013)
    • Faculty Research

    Companion Diagnostics: Uncertainties for Approval and Reimbursement

    By: Richard G. Hamermesh, Norman C. Selby and Phillip Andrews
Related Work
  • Companion Diagnostics: Uncertainties for Approval and Reimbursement By: Richard G. Hamermesh, Norman C. Selby and Phillip Andrews
ǁ
Campus Map
Harvard Business School
Soldiers Field
Boston, MA 02163
→Map & Directions
→More Contact Information
  • Make a Gift
  • Site Map
  • Jobs
  • Harvard University
  • Trademarks
  • Policies
  • Accessibility
  • Digital Accessibility
Copyright © President & Fellows of Harvard College