Clinical and economic challenges facing pharmacogenomics

Pharmacogenomics Journal

Volumn 13, Issue 4, 2013, Pages 378-388

  Cohen, J ^a   Wilson, A ^a   Manzolillo, K ^a  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Companion diagnostic; Personalized medicine; Reimbursement

Indexed keywords

ABACAVIR; CETUXIMAB; ERLOTINIB; GEFITINIB; IMATINIB; IRINOTECAN; TRASTUZUMAB; WARFARIN;

ARTICLE; CLINICAL EFFECTIVENESS; COMPANION DIAGNOSTIC; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DECISION MAKING; DRUG COST; ECONOMIC EVALUATION; FOOD AND DRUG ADMINISTRATION; HUMAN; INVESTIGATIVE PROCEDURES; LIMIT OF QUANTITATION; MEDICAL SOCIETY; ORGANIZATIONAL DOWNSIZING; ORGANIZATIONAL EFFICIENCY; PATIENT ASSESSMENT; PERSONALIZED MEDICINE; PHARMACOGENOMICS; PHYSICIAN ATTITUDE; PRESCRIPTION; PRIORITY JOURNAL; PUBLICATION; REIMBURSEMENT;

EID: 84881191075     PISSN: 1470269X     EISSN: 14731150     Source Type: Journal    
DOI: 10.1038/tpj.2011.63     Document Type: Article

References (43)

1. Phillips K. The intersection of biotechnology and pharmacogenomics: health policy implications. Health Aff 2006; 25: 1271-1280.
2. Deverka P, Vernon J, McLeod H. Economic opportunities and challenges for pharmacogenomics. Annu Rev Pharmacol Toxicol 2010; 50: 423-437.
3. Shah J. Economic and regulatory consideration in pharmacogenomics for drug licensing and healthcare. Nat Biotechnol 2003; 21: 747-753.
4. Gold H, Hall M, Blinder V, Schackman B. Cost-effectiveness of pharmacogenomics testing for UGT1A1 before irinotecan administration for metastatic colorectal cancer. Cancer 2009; 115: 3858-3867.
5. Deverka P. Pharmacogenomics, evidence, and the role of payers. Pub Health Gen 2009; 12: 149-157.
6. Bodenheimer T, Chen E, Bennett H. Confronting the growing burden of chronic disease: can the US healthcare workforce do the job? Health Aff 2009; 28: 64-74.
7. Piccart-Gebhart M, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I. Trastuzumab after adjuvant chemotherapy in HER-2 positive breast cancer. N Engl J Med 2005; 352: 1659-1672.
8. Romond E, Perez E, Bryant J, Suman V, Geyer C, Davidson J et al. Trastuzumab plus adjuvant chemotherapy for operable HER2 positive breast cancer. N Engl J Med 2005; 353: 1673-1684.
9. Frueh F, Amur S, Mummaneni M, Epstein R, Aubert R, DeLuca T et al. Pharmacogenomic biomarker information in drug labels approved by the United States Food and Drug Administration: Prevalence of related drug use. Pharmacotherapy 2008; 28: 992-998.
10. Lièvre A, Bachet J, Le Corre D, Boige V, Landi B, Emile J et al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res 2006; 6: 3992-3995.
11. Brown B, Diamantopoulos A, Bernier J, Schoffski P, Hieke K, Mantovani L et al. An economic evaluation of cetuximab combined with radiotherapy for patients with locally advanced head and neck cancer in Belgium, France, Italy, Switzerland, and the United Kingdom. Val Health 2008; 1: 791-799.
12. Starling N, Tilden D, White J, Cunningham D. Cost-effectiveness analysis of cetuximab/irinotecan vs. active/best supportive care for the treatment of metastatic colorectal cancer patients who have failed previous chemotherapy treatment. Brit J Cancer 2007; 6: 206-212.
13. Rogowski W, Grosse S, Khoury M. Challenges of translating genetic tests into clinical and public health practice. Nat Rev Gen 2009; 10: 489-495.
14. Carver K. Companion diagnostics: evolving FDA regulation and issues for resolution. In: Danzis S, Flannery E (eds). In Vitro Diagnostics: The Complete Regulatory Guide. Food and Drug Law Institute: Washington, DC, 2010 pp 149-184.
15. Lesko L. Personalized medicine: elusive dream or imminent reality? Clin Pharm Ther 2007; 81: 807-816.
16. US Food and Drug Administration. Table of valid biomarkers in the context of approved drug labels. http://www.fda.gov/cder/genomics/genomics-biomarkers- table.htm Accessed 1 September 2010.
17. Giaccone G. The role of gefitinib in lung cancer treatment. Clin Canc Res 2004; 10: 4233s-4237s.
18. Lesko L, Woodcock J. Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective. Nat Rev Drug Disc 2004; 3: 763-769.
19. Department of Health and Human Services: coverage and reimbursement of genetic tests and services: Report of the secretary's advisory committee on genetics, health, and society (2006) http://www4. od.nih.gov/oba/sacghs/reports/ CR-report.pdf Accessed 8 October 2010.
20. Higashi M, Veenstra D, Midori Kondo L, McDonell M, Martin D, Wittkowsky A et al. Association between CYP2C9 genetic variants and anticoagulation-related outcomes during warfarin therapy. JAMA 2002; 287: 1690-1697.
21. Centers for Medicare and Medicaid Services: decision on Warfarin Testing. http://www.cms.gov/mcd/viewdraftdecisionmemo.asp?from21/4 viewdraftdecisionmemo.asp&id1/4224&Accessed 8 October 2010.
22. Pollack A. Gene test for dosage of warfarin rebuffed. NY Times 2009.
23. Thomson Reuters Drug Points http://online.statref.com/Document/Document. aspx?docAddress1/4n3XOOXDHK6e6-NjdPTXpRw%3d%3-d&offset1/47&SessionId1/ 4122622AROANINSLO Accessed 1 April 2011.
24. Center for the Evaluation of Value and Risk in Health: CEA Registry https://research.tufts-nemc.org/cear/Default.aspx accessed 30 May 2010.
25. Pharmacy Benefit Management Institute: PBM Directory http://www.pbmi.com/ pbmdir.asp accessed 3 June 2010.
26. Centers for Medicare and Medicaid Services: Medicare Prescription Drug Plan Finder http://www.medicare.gov/MPDPF/Public/Include/DataSection/Questions/ MPDPFIntro.asp accessed 5 November 2010.
27. Centers for Medicare and Medicaid Services: Medicare Coverage Database. http://www.cms.gov/mcd/search.asp?clickon1/4search accessed 5. November 2010.
28. Deverka P. Pharmacogenomics, evidence, and the role of payers. Pub Health Gen 2009; 12: 149-157.
29. Khoury M, Berg A, Coates R, Evans J, Teutsch, Bradley L et al. The evidence dilemma in genomic medicine. Health Aff 2008; 27: 1600-1611.
30. Ridge J. Reimbursement and coverage challenges associated with bringing emerging molecular diagnostics into the personalized medicine paradigm. Pers Med 2006; 3: 45-46.
31. Gerber A, Tunis S. Does comparative-effectiveness research threaten personalized medicine? N Engl J Med 2009; 360: 1925-1927.
32. Dendukuri N, Khetani K, McIsaac M, Brophy J. Testing for HER2-positive breast cancer: a systematic review and cost-effectiveness analysis. Can Med Assoc J 2007; 176: 1429-1434.
33. Phillips K, Van Bebber S. A systematic review of cost-effectiveness analyses of pharmacogenomic interventions. Pharmacogenomics 2004; 5: 1139-1149.
34. Hamburg M, Collins F. The path to personalized medicine. N Engl J Med 2010; 363: 301-304.
35. Hallberg B, Palmer R. Crizotinib - latest champion in the cancer wars? N Engl J Med 2010; 363: 1760-1762.
36. Jenkins A. A dying wish. Forbes Mag 2011.
37. Meckley L, Neumann P. Personalized medicine: factors influencing reimbursement. Health Pol 2010; 94: 91-100.
38. Phillips K. The intersection of biotechnology and pharmacogenomics: health policy implications. Health Aff 2006; 5: 1271-1280.
39. Paci D, Ibarreta D. Economic and cost-effectiveness considerations for pharmacogenetics tests: an integral part of translational research and innovation uptake in personalized medicine. Curr Pharmacogen Pers Med 2009; 7: 284-296.
40. Epstein R, Russell Teagarden J. Comparative effectiveness research and personalized medicine. Pharmacoeconomics 2010; 8: 905-913.
41. Hughes B. Novel risk-sharing scheme puts the spotlight on biomarkers. Nat Rev Drug Disc 2007; 6: 417-420.
42. Carlson J, Garrison L, Sullivan S. Paying for outcomes: innovative coverage and reimbursement schemes for pharmaceuticals. J Manag Care Pharm 2009; 15: 683-687.
43. Tanisha C, Reginald D, Williams II A, Bridger P. Medicare's coverage of colorectal cancer drugs: a case study in evidence development and policy. Health Aff 2009; 25: 1231-1239.