Document Detail


Payer perspectives on pharmacogenomics testing and drug development.
MedLine Citation:
PMID:  19102724     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Robert S Epstein; Felix W Frueh; Dawn Geren; Doris Hummer; Scott McKibbin; Susan O'Connor; Gurvaneet Randhawa; Benjamin Zelman
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Pharmacogenomics     Volume:  10     ISSN:  1744-8042     ISO Abbreviation:  Pharmacogenomics     Publication Date:  2009 Jan 
Date Detail:
Created Date:  2008-12-23     Completed Date:  2009-03-23     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100897350     Medline TA:  Pharmacogenomics     Country:  England    
Other Details:
Languages:  eng     Pagination:  149-51     Citation Subset:  IM    
Affiliation:
Medco Health Solutions, Inc., 100 Parsons Pond Drive, Franklin Lakes, NJ 07417, USA. robert_epstein@medco.com
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MeSH Terms
Descriptor/Qualifier:
Cost-Benefit Analysis
Diagnostic Techniques and Procedures / economics*,  standards
Drug Design*
Humans
Pharmaceutical Preparations / economics*,  standards
Pharmacogenetics / economics*,  standards
Predictive Value of Tests
Reimbursement Mechanisms*
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/Pharmaceutical Preparations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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