Are health technology assessments of pharmacogenetic tests feasible? A case study of CYP2D6 testing in the treatment of breast cancer with tamoxifen

Personalized Medicine
Nigel FleemanRumona Dickson

Abstract

This paper reports the process and experience of the design and conduct of a UK-based health technology assessment (HTA) of CYP2D6 pharmacogenetic testing to inform the targeted use of tamoxifen for the treatment of breast cancer. Examples of particular challenges for conducting a HTA are highlighted. It is clear from the HTA process described here that a common finding of similar future HTAs will have gaps in the evidence base, particularly in relation to evidence to inform cost-effectiveness. The lack of evidence is likely to be sufficiently large to result in extreme uncertainty and possibly decisions not to recommend a pharmacogenetic test for use in clinical practice. This has clear negative implications, which may hamper moving pharmacogenetic tests from the research environment into clinical practice and requires attention from both manufacturers of pharmacogenetic tests and key decision-makers responsible for market authorization and reimbursement.

References

Jun 11, 2002·International Journal of Technology Assessment in Health Care·Kent Woods
Jun 11, 2002·International Journal of Technology Assessment in Health Care·Marcial VelascoClaudia Wild
Apr 2, 2004·Nature·Wen-Hung ChungYuan-Tsong Chen
May 12, 2007·International Journal of Technology Assessment in Health Care·Kirsten F L DoumaWim H van Harten
Nov 1, 2007·Clinical Pharmacology and Therapeutics·A GaedigkJ S Leeder
Nov 24, 2007·Pharmacogenomics·David Gurwitz, Arno G Motulsky
Feb 8, 2008·The New England Journal of Medicine·Simon MallalUNKNOWN PREDICT-1 Study Team
Sep 25, 2008·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Steven M TeutschUNKNOWN EGAPP Working Group
Oct 7, 2008·Statistics in Medicine·Andrea L Jorgensen, Paula R Williamson
Feb 11, 2009·Public Health Genomics·D GurwitzD Ibarreta
Mar 21, 2009·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Jaekyu ShinTaimour Y Langaee
Dec 10, 2009·Journal of Clinical Epidemiology·Nita A Limdi, David L Veenstra
Jan 21, 2010·Medical Decision Making : an International Journal of the Society for Medical Decision Making·Rena ContiScott D Grosse
Sep 3, 2010·Genetics in Medicine : Official Journal of the American College of Medical Genetics·David L VeenstraWylie Burke
Sep 9, 2010·Maternal and Child Health Journal·Pierre Buekens, Perrine Humblet
Oct 27, 2010·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Muin J KhouryJames P Evans
Oct 29, 2010·Clinical Pharmacology and Therapeutics·M Pirmohamed
Mar 25, 2011·Clinical Pharmacology and Therapeutics·L MadlenskyJ P Pierce
Mar 8, 2012·Journal of the National Cancer Institute·James M RaeUNKNOWN ATAC trialists
Mar 8, 2012·Journal of the National Cancer Institute·Meredith M ReganUNKNOWN Breast International Group (BIG) 1-98 Collaborative Group
Aug 17, 2012·Medical Decision Making : an International Journal of the Society for Medical Decision Making·Tracy MerlinPhilip Ryan

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BETA
genotyping

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