Economic opportunities and challenges for pharmacogenomics

Annual Review of Pharmacology and Toxicology

Volumn 50, Issue , 2010, Pages 423-437

  Deverka, Patricia A ^a   Vernon, John ^a   McLeod, Howard L ^a  

^a IL   (United States)

Author keywords

Costs and cost analysis; Health policy; Outcomes assessments (health care); Public policy

Indexed keywords

GEFITINIB; IRINOTECAN;

COST; COST BENEFIT ANALYSIS; DECISION MAKING; DRUG EFFICACY; DRUG INDUSTRY; HEALTH CARE POLICY; HEALTH CARE SYSTEM; HEALTH ECONOMICS; HUMAN; PHARMACOGENOMICS; PRIORITY JOURNAL; REVIEW; TREATMENT OUTCOME; DRUG DEVELOPMENT; ECONOMICS; HEALTH CARE DELIVERY; PHARMACOGENETICS;

COST-BENEFIT ANALYSIS; DELIVERY OF HEALTH CARE; DRUG DISCOVERY; HUMANS; PHARMACOGENETICS;

EID: 77949502656     PISSN: 03621642     EISSN: 15454304     Source Type: Book Series    
DOI: 10.1146/annurev.pharmtox.010909.105805     Document Type: Review

References (46)

1. Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, et al. 2001. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N. Engl. J. Med. 344:783-792
2. Deverka PA, Doksum T, Carlson RJ. 2007. Integrating molecular medicine into the US health care system: opportunities, barriers and policy challenges. Clin. Pharmacol. Ther. 82:427-434
3. DiMasi JA, Hansen RW, Grabowski HG. 2003. The price of innovation: new estimates of drug development costs. J. Health Econ. 22:151-185
4. Food and Drug Administration. 2004. Innovation or stagnation: challenges and opportunity on the critical path to new medical products. http://www. fda. gov/oc/initiatives/criticalpath/whitepaper. html
5. Kola I, Landis J. 2004. Can the pharmaceutical industry reduce attrition rates? Nat. Rev. Drug Discov. 3:711-715
6. Moore TJ, Cohen MR, Furberg CD. 2007. Serious adverse drug events reported to the Food and Drug Administration, 1998-2005. Arch. Int. Med. 167:1752-1759
7. Andersson T, Flockhart DA, Goldstein DB, Huang SM, Kroetz DL, et al. 2005. Drug-metabolizing enzymes: evidence for clinical utility of pharmacogenomic tests. Clin. Pharmacol. Ther. 78:559-581
8. Ginsburg GS, Konstance RP, Allsbrook JS, Schulman KA. 2005. Implications of pharmacogenomics for drug development and clinical practice. Arch. Int. Med. 165:2331-2336
9. Phillips KA, Van Bebber SL. Measuring the value of pharmacogenomics. Nat. Rev. Drug Discov. 4:500-510
10. Orszag PR, Ellis P. 2007. The challenge of rising health care costs: a view from the Congressional Budget Office. N. Engl. J. Med. 357:1793-1795 (Pubitemid 350044798)
11. Newhouse JP. 1992. Medical care costs: how much welfare loss? J. Econ. Perspect. 6:3-21
12. Chernew ME, Jacobson PD, Hofer TP, Aaronson KD, Fendrick AM. 2004. Barriers to constraining health care cost growth. Health Aff. 23:122-128
13. Catlin A, Cowan C, Hartman M, Heffler S, National Health Expenditure Accounts Team. 2008. National health spending in 2006: a year of change for prescription drugs. Health Aff. 27:14-29
14. Phillips KA, Veenstra D, VanBebber S, Sakowski J. 2003. An introduction to cost-effectiveness and cost-benefit analysis of pharmacogenomics. Pharmacogenomics 4:231-239
15. Drummond MF, Schwartz JS, Jonsson B, Luce BR, Neumann PJ, et al. 2008. Key principles for the improved conduct of health technology assessments for resource allocation decisions. Int. J. Tech. Assess. Health Care 24:244-258
16. International Pharmacogenetics Warfarin Consortium, Klein TE, Altman RB, Eriksson N, Gage BF, et al. Estimation of the warfarin dose with clinical and pharmacogenetic data. N. Engl. J. Med. 360:753-764
17. Eckman MH, Rosand J, Greenberg SM, Gage BF. 2009. Cost-effectiveness of using pharmacogenetic information in warfarin dosing for patients with nonvalvular atrial fibrillation. Ann. Int. Med. 150:73-83
18. Vernon JA, Johnson SJ, Hughen WK, Trujillo A. 2006. Economic and developmental considerations for pharmacogenomic technology. Pharmacogenomics 24:335-343
19. Veenstra DL. 2007. The cost-effectiveness of warfarin pharmacogenomics. Int. Soc. Thromb. Haemost. 5:1974-1975
20. Cook J, Hunter G, Vernon J. 2009. The future costs, risks, and rewards of drug development. Pharma-coeconomics 27:355-363
21. Press M, Seelig S. 2004. Lessons learned from the development of a diagnostic to predict response to Herceptin: targeted medicine\from concept to clinic. Thomson Financial Street Events, Conference Report on Targeted Medicine, November 11, pp. 10-11
22. Trusheim MR, Berndt ER, Douglas FL. 2007. Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers. Nat. Rev. Drug. Discov. 6:287-293
23. Garrison LP, Carlson RJ, Carlson JJ, Kuszler PC, Meckley LM, Veenstra DL. 2008. A review of public policy issues in promoting the development and commercialization of pharmacogenomic applications: challenges and implications. Drug Metab. Rev. 40:377-401
24. Mallal S, Phillips E, Carosi G, Molina JM, Workman C, et al. 2008. HLA-B5701 screening for hyper-sensitivity to avacavir. N. Engl. J. Med. 358:568-579
25. DiMasi JA, Hansen RW, Grabowski HG. 2003. The price of innovation: new estimates of drug development costs. J. Health Econ. 22:151-185
26. Vernon J, Hughen K, Trujillo A. 2008. The future of drug development: the economics of pharmacoge-nomics. Exp. Rev. Clin. Pharm. 1:49-59
27. Murphy KM, Topel RH. 2006. The value of health and longevity. J. Polit. Econ. 114:871-904
28. Flowers CR, Veenstra D. 2004. The role of cost-effectiveness analysis in the era of pharmacogenomics. Pharmacogenomics 22:481-493
29. Weinstein MC, Siegel JE, Gold MR, Damlet MS, Russell LB. 1996. Recommendations of the Panel on Cost-Effectiveness in Health and Medicine. JAMA 276:1253-1258
30. Neumann PJ, Rosen AB, Weinstein MC. 2005. Medicare and cost-effectiveness analysis. N. Engl. J. Med. 353:1516-1522
31. Limdi NA, Veenstra DL. 2008. Warfarin pharmacogenetics. Pharmacotherapy 28:1084-1097
32. Flockhart DA, O'Kane D, Williams MS, Watson MS, Gage B, et al. 2008. Pharmacogenetic testing of CYP2C9 and VKORC1 alleles for warfarin. Genet. Med. 10:139-150
33. McWilliam A, Lutter R, Nardinelli C. 2008. Healthcare impact of personalized medicine using genetic testing: an exploratory analysis for warfarin. Personal. Med. 5:279-284
34. Eckman MH, Rosand J, Greenberg SM, Gage BF. 2009. Cost-effectiveness of using pharmacogenetic information in warfarin dosing for patients with nonvalvular atrial fibrillation. Ann. Intern. Med. 150:73-83
35. Centers for Medicare & Medicaid Services. 2009. Proposed Decision Memo for Pharmacogenomic Testing for Warfarin Response (CAG-00400N). http://www. cms. hhs. gov/mcd/viewdraftdecisionmemo. asp?from2=viewdraftdecisionmemo. asp&id=224&
36. Flockhart DA, Skaar T, Berlin DS, Klein TE, Nguyen AT. 2009. Clinically available pharmacogenomics tests. Clin. Pharmacol. Ther. 86:109-113
37. Katsanis SH, Javitt G, Hudson K. 2008. A case studyofpersonalized medicine. Science 320: 53-54 (erratum post 18 April 2008)
38. Phillips KA, Van Bebber SL. 2004. Asystematic reviewofcost-effectiveness analysesofpharmacogenomic interventions. Pharmacogenomics 5:1139-1149
39. Vegter S, Boersma C, Rozenbaum M, Wilffert B, Navis G, Postma MJ. 2008. Pharmacoeco-nomic evaluations of pharmacogenetic and genomic screening programmes. Pharmacoeconomics 26:569-587
40. Schackman BR, Scott CA, Salensky RP, Losina E, Freedberg KA, Sax PE. 2008. The cost-effectiveness of HLA-B5701 genetic screening to guide initial antiretroviral therapy for HIV. AIDS 22:2025-2037
41. Carlson JJ, Garrison LP, Ramsey SD, Veenstra DL. 2009. The potential clinical and economic outcomes of pharmacogenomic approaches to EGFR-tyrosine kinase inhibitor therapy in non-small-cell lung cancer. Value Health 12:20-27
42. Moses H, Dorsey ER, Matheson DHM, Thier SO. 2005. Financial anatomy of biomedical research. JAMA 294:1333-1342
43. Garrison LP, Neumann PJ, Erickson P, Marshall D, Mullins CD. 2007. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health 10:326-335
44. Sung NS, Crowley WF, Genel M, Salber P, Sandy L, et al. 2003. Central challenges facing the national clinical research enterprise. JAMA 289:1278-1287
45. Wilensky GR. 2006. Developing a center for comparative effectiveness information. Health Aff. 25:2572-2585
46. Garber AM, Tunis SR. 2009. Does comparative-effectiveness research threaten personalized medicine? N. Eng. J. Med. 360:1525-1527