title: Payer perspectives on pharmacogenomics testing and drug development.
abstract: A series of questions about hypothetical drugs and pharmacogenomic tests was posed to a panel of representatives from the health plan, government and employer sectors in order to elicit suggestions for input on data or study design considerations important for coverage determination. The panel suggested seven areas for drug developers to strongly consider. These areas were to include comparative information on new tests versus usual care, assess the negative predictive value of new tests, measure and report on cost offsets, balance relative risk improvement with absolute risk, consider the policy implications of the products or tests, report percentage responders in addition to group mean improvements, and to include specific pharmacogenomic information in US FDA approved labels. The panel was generally enthusiastic about the promise of the field to improve drug selection or dosing.
authors.affiliation: Medco Health Solutions, Inc., 100 Parsons Pond Drive, Franklin Lakes, NJ 07417, USA. robert_epstein@medco.com
authors.forename: Robert S
authors.initials: RS
authors.lastname: Epstein
authors.forename: Felix W
authors.initials: FW
authors.lastname: Frueh
authors.forename: Dawn
authors.initials: D
authors.lastname: Geren
authors.forename: Doris
authors.initials: D
authors.lastname: Hummer
authors.forename: Scott
authors.initials: S
authors.lastname: McKibbin
authors.forename: Susan
authors.initials: S
authors.lastname: O'Connor
authors.forename: Gurvaneet
authors.initials: G
authors.lastname: Randhawa
authors.forename: Benjamin
authors.initials: B
authors.lastname: Zelman
mesh_terms: D003362:Cost-Benefit Analysis; D019937:Diagnostic Techniques and Procedures / Q000191:economics* / Q000592:standards; D015195:Drug Design; D006801:Humans; D004364:Pharmaceutical Preparations / Q000191:economics* / Q000592:standards; D010597:Pharmacogenetics / Q000191:economics* / Q000592:standards; D011237:Predictive Value of Tests; D012051:Reimbursement Mechanisms; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations