title: Personalized medicine: factors influencing reimbursement.
abstract: OBJECTIVE
  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.
authors.affiliation: Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, 800 Washington St., #63, Boston, MA 02111, USA. lmeckley@tuftsmedicalcenter.org
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Meckley
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Neumann
mesh_terms: D020811:Biomedical Technology / Q000191:economics*; D003955:Diagnostic Tests, Routine; D005820:Genetic Testing; D006801:Humans; D010597:Pharmacogenetics; D057285:Precision Medicine; D012051:Reimbursement Mechanisms; D014481:United States