Payer perspectives on pharmacogenomics testing and drug development.
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.
Epstein
Robert S
RS
Medco Health Solutions, Inc., 100 Parsons Pond Drive, Franklin Lakes, NJ 07417, USA. robert_epstein@medco.com
Frueh
Felix W
FW
Geren
Dawn
D
Hummer
Doris
D
McKibbin
Scott
S
O'Connor
Susan
S
Randhawa
Gurvaneet
G
Zelman
Benjamin
B
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
D004364:Pharmaceutical Preparations