Measuring the value of pharmacogenomics

Nature Reviews Drug Discovery

Volumn 4, Issue 6, 2005, Pages 500-509

  Phillips, Kathryn A ^a   Van Bebber, Stephanie L ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMITRIPTYLINE; AMPHETAMINE; ATOMOXETINE; CARVEDILOL; CELECOXIB; CHLORPHENIRAMINE; CODEINE; CYTOCHROME P450 2D6; FLECAINIDE ACETATE; FLUOXETINE; FLUVOXAMINE; HALOPERIDOL; HYDROCODONE; IMIPRAMINE; METOCLOPRAMIDE; METOPROLOL; METOPROLOL SUCCINATE; NORTRIPTYLINE; ONDANSETRON; PAROXETINE; PROMETHAZINE; PROPAFENONE; PROPRANOLOL; RISPERIDAL; RISPERIDONE; ROFECOXIB; TAMOXIFEN; TRAMADOL; TRASTUZUMAB; VENLAFAXINE;

ALLELE; BREAST CANCER; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; COST MINIMIZATION ANALYSIS; COST OF ILLNESS; COST UTILITY ANALYSIS; COUGHING; DEPRESSION; DRUG BIOAVAILABILITY; DRUG COST; DRUG EFFICACY; DRUG INDICATION; DRUG METABOLISM; DRUG RESPONSE; DRUG SAFETY; DRUG UTILIZATION; ECONOMIC ASPECT; FOOD AND DRUG ADMINISTRATION; GENE MUTATION; GENETIC ANALYSIS; GENETIC VARIABILITY; HEART DISEASE; HUMAN; HYPERTENSION; MENTAL DISEASE; PAIN; PHARMACOGENETICS; PHARMACOGENOMICS; PRESCRIPTION; PRIORITY JOURNAL; RESOURCE ALLOCATION; REVIEW; SIDE EFFECT; TREATMENT OUTCOME;

HUMANS; PHARMACOGENETICS;

EID: 20844434680     PISSN: 14741776     EISSN: None     Source Type: Journal    
DOI: 10.1038/nrd1749     Document Type: Review

References (85)

1. Collins, F. S. Shattuck lecture - Medical and societal consequences of the human genome project. N. Engl. J. Med. 341, 28-37 (1999).
2. Collins, F. S. & McKusick, V. A. Implications of the human genome project for medical science. JAMA 285, 540-544 (2001).
3. Varmus, H. Getting ready for gene-based medicine. N. Engl. J. Med. 347, 1526-1527 (2002).
4. Khoury, M. J., McCabe, L. L. & McCabe, E. R. Population screening in the age of genomic medicine. N. Engl. J. Med. 348, 50-58 (2003).
5. Phillips, K. A. & Van Bebber, S. L. Regulatory perspectives on pharmacogenomics: a review of the literature on key issues faced by the United States Food and Drug Administration. Med. Care Res. Rev. (in the press).
6. Phillips, K. A., Van Bebber, S. L., Veenstra, D. & Sakowski, J. The economics of pharmacogenomics. Curr. Pharmacogenomics 1, 277-284 (2003).
7. Phillips, K. A., Veenstra, D., Van Bebber, S. L. & Sakowski, J. An introduction to cost-effectiveness and cost-benefit analysis of pharmacogenomics. Pharmacogenomics 4, 231-239 (2003).
8. Phillips, K. A., Veenstra, D. L., Oren, E., Lee, J. K. & Sadee, W. Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. JAMA 286, 2270-2279 (2001).
9. Phillips, K. A., Veenstra, D. L., Ramsey, S. D., Van Bebber, S. L. & Sakowski, J. Genetic testing and pharmacogenomics: issues for determining the impact to health care delivery and costs. Am. J. Manag. Care 10, 425-432 (2004).
10. Veenstra, D. L., Higashi, M. K. & Phillips, K. A. Assessing the cost-effectiveness of pharmacogenomics. Pharm. Sci. 2 [online], http://www.aapspharmsci.org/articles/ps0203/ps020329/ps020329.pdf (2000).
11. Danzon, P. & Towse, A. The economics of gene therapy and of pharmacogenetics. Value Health 5, 5-13 (2002).
12. Robertson, J. A., Brody, B., Buchanan, A., Kahn, J. & McPherson, E. Pharmacogenetic challenges for the health care system. Health Affairs 21, 155-167 (2002).
13. Roses, A. D. Pharmacogenetics and the practice of medicine. Nature 405, 857-895 (2000).
14. Ingelman-Sundberg, M. Pharmacogenetics: an opportunity for a safer and more efficient pharmacotherapy. J. Intern. Med. 250, 186-200 (2001).
15. Fishbain, D. A. et al. Genetic testing for enzymes of drug metabolism: does it have clinical utility for pain medicine at the present time? A structured review. Pain Medicine 5, 81-93 (2004).
16. Shah, J. Economic and regulatory considerations in pharmacogenomics for drug licensing and healthcare. Nature Biotechnol. 21, 747-753 (2003).
17. Evans, W. & Relling, M. Pharmacogenomics: translating functional genomics into rational therapeutics. Science 286, 487-491 (1999).
18. Holtzman, N. & Marteau, T. Will genetics revolutionize medicine? N. Engl. J. Med. 343, 141-144 (2000).
19. Holtzman, N. A. & Marteau, T. M. Will genetics revolutionalize medicine? Author response. N. Engl. J. Med. 343, 1498 (2000).
20. Lindpaintner, K. Pharmacogenetics and the future of medical practice. J. Mol. Med. 81, 141-153 (2003).
21. Issa, A. M. Ethical perspectives on pharmacogenomic profiling in the drug development process. Nature Rev. Drug Discov. 1, 300-308 (2002).
22. Issa, A. M. Ethical considerations in clinical pharmacogenomics research. Trends Pharm. Sci. 21, 247-249 (2000).
23. Clayton, E. W. Ethical, legal, and social implications of genomic medicine. N. Engl. J. Med. 349, 562-569 (2003).
24. Ries Merikangas, K. & Risch, N. Genomic priorities and public health. Science 302, 599-601 (2004).
25. Haga, S. B. & Burke, W. Using pharmacogenetics to improve drug safety and efficacy. JAMA 291, 2869-2871 (2004).
26. Webster, A., Martin, P., Lewis, G. & Smart, A. Integrating pharmacogenetics into society: in search of a model. Nature Rev. Genet. 5, 663-669 (2004).
27. Food and Drug Administration. FDA clears first of kind genetic lab test [online], http://www.fda.gov/bbs/topics/news/2004/new01149.html (2004).
28. Lesko, L. J. & Woodcock, J. Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective. Nature Rev. Drug Discov. 3, 763-769 (2004).
29. Food and Drug Administration. Guidance for industry: pharmacogenomic data submissions [online], http://www.fda.gov/cber/gdIns/pharmdtasub.pdf (2005).
30. Lesko, L. J. et al. Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop. J. Clin. Pharmacol. 43, 342-358 (2003).
31. Salerno, R. A. & Lesko, L. J. Pharmacogenomics in drug development and regulatory decision-making: the Genomic Data Submission (GDS) proposal. Pharmacogenomics 5, 25-30 (2004).
32. FDC Reports. FDA Pharmacogenomics Advisory Committee Will Oversee Data Submission. The Pink Sheet 22 March (2004).
33. US Department of Health and Human Services & Food and Drug Administration. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products [online], http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html (2004).
34. Secretary's Advisory Committee on Genetics Health and Society. Second Meeting, October 22-23 (2003).
35. Gutman, S. OIVD requests a meeting with Roche Diagnostics regarding the AmpliChip CYP450 Microarray. [online], http://www.fda.gov/cdrh/oivd/letter-roche2.html (2003).
36. Kaiser, J. FDA puts the brakes on Roche's gene array Test. Science 302, 1134 (2003).
37. Steimer, W. & Potter, J. M. Pharmacogenetic screening and therapeutic drugs. Clin. Chim. Acta 315, 137-155 (2002).
38. Phillips, K. A., Veenstra, D. L. & Sadee, W. Implications of the genetics revolution for health services research: pharmacogenomics and improvements in drug therapy. Health Services Research 35, 1-12 (2000).
39. Phillips, K. A. & Van Bebber, S. L. Cost-effectiveness of pharmacogenomic interventions: a systematic review of the literature. Pharmacogenomics 5, 1139-1149 (2004).
40. Gold, M., Siegel, J., Russell, L. & Weinstein, M. Cost-Effectiveness in Health And Medicine (Oxford Univ. Press, New York, 1996).
41. Drummond, M. F. Cost-of-illness studies - a major headache. Pharmacoeconomics 2, 1-4 (1992).
42. Rice, D. P. Estimating the cost of illness. (Public Health Service publication, US Gov. Printing Office, 1966).
43. Rice, D. P. Cost of illness studies: what is good about them? Inj. Prev. 6, 177-179 (2000).
44. Varmus, H. Evaluating the burden of disease and spending the research dollars of the National Institutes of Health. N. Engl. J. Med. 340, 1914-15 (1999).
45. Wolf, C. & Smith, G. Pharmacogenetics. Br. Med. Bull. 55, 366-386 (1999).
46. European Society of Human Genetics. Polymorphic sequence variants in medicine: technical, social, legal and ethical issues - pharmacogenomics as an example. Background document. (Draft Version as per June 10, 2004) [online], http://www.eshg.org/ESHG-IPTSPGX.pdf (2004).
47. Food and Drug Administration. Guidance for Industry: Pharmacogenomics Data Submission. Draft Guidance [online], http://www.fda.gov/cder/guidance/5900dft.pdf (2003).
48. Meyer, U. A. Pharmacogenetics - five decades of therapeutic lessons from genetic diversity. Nature Rev. Genet. 5, 669-676 (2004).
49. Cytochrome P450 Drug Interaction Table. [online], http://medicine.iupui.edu/flockhart/table.htm (2004).
50. Drug Topics.com. The top 200 brand-name drugs by unit in 2003 [online], http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=104560 (2003).
51. Drug Topics.com. The top 200 generic drugs by unit in 2003 [online], http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=104565 (2003).
52. Drug Topics.com. The top 200 brand-name drugs by retail sales in 2003 [online], http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=104561 (2003).
53. Drug Topics.com. The top 200 generic drugs by retail sales in 2003 [online], http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=104567 (2003).
54. Elsevier Inc. MD Consult Core Collection [online], http://www.mdconsult.com/ (2004).
55. Klein, T. E. et al. Integrating genotype and phenotype information: an overview of the PharmGKB project. Pharmacogenomics J. 1, 167-170 (2001).
56. Ingelman-Sundberg, M. Human drug metabolising cytochrome P450 enzymes: properties and polymorphisms. Naunyn-Schmiedebergs Arch. Pharmacol. 369, 89-104 (2003).
57. American Heart Association. Heart Disease and Stroke Statistics - 2004 Update [online], http://www.americanheart.org/downloadable/heart/ 1079736729696HDSStats2004UpdateREV3-19-04.pdf (2003).
58. National Institute of Mental Health. NIH Publication No. 01-4584. The numbers count - mental disorders in America: a summary of statistics describing the prevalence of mental disorders in America [online], http://www.nimh. nih.gov/publicat/numbers.cfm (2001).
59. National Academy on an Aging Society. Depression: a treatable disease - challenges for the 21st century: chronic and disabling conditions. Number 9. [online], http://www.agingsociety.org/agingsociety/pdf/depression.pdf (2000).
60. Gibbons, R. J. et al. ACC/AHA 2002 guideline update for the management of patients with chronic stable angina: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for the Management of Patients with Chronic Stable Angina) [online], http://www.acc.org/clinical/guidelines/stable/stable.pdf (2002).
61. American College of Cardiology & American Heart Association Inc. ACC/AHA/ESC Pocket Guidelines for the Management of Patients with Atrial Fibrillation [online], http://www.americanheart.org/downloadable/heart/ 1017094776302AF_pktguideline.pdf (2002).
62. DuPont, R. L., Rice, D. P., Shiraki, S. & Rowland, C. Economic costs of obsessive-compulsive disorder. Cited in Anxiety Disorders: Obsessive-Compulsive Disorder (MDchoice.com) [online], http://mdchoice.com/Pt/consumer/anxOCD.asp (1996).
63. Pfizer. Zoloft OCD fact sheet [online], http://www.zoloft.com/psd/factsheet/ocdfact.pdf (2000).
64. Agency for Healthcare Research and Quality. Evidence Report/Technology Assessment (Number 11): Treatment of Attention-Deficit/Hyperactivity Disorder [online], http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat1.chapter.14677 (1999).
65. Chan, E., Zhan, C. & Homer, C. J. Health care use and costs for children with attention-deficit/hyperactivity disorder: national estimates from the medical expenditure panel survey. Arch. Pediatr. Adolesc. Med. 156, 504-11 (2002).
66. Rice, D. P. The economic impact of schizophrenia. J. Clin. Psychiatry 60 (Suppl. 1), 28-30 (1999).
67. Adams, P. F., Hendershot, G. E. & Marano, M. A. Current estimates from the National Health Interview Survey, 1996. National Center for Health Statistics. Vital Health Stat 10(200) [online], http://www.cdc.gov/nchs/data/series/sr_10/10_200_1.pdf (1999).
68. Fendrick, A. M., Monto, A. S., Nightengale, B. & Sarnes, M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch. Intern. Med. 163, 487-494 (2003).
69. Ospina, M. & Harstall, C. Prevalence of chronic pain: an overview HTA Report 29 [online], http://www.ahfmr.ab.ca/hta/hta-publications/reports/ prevalence_chronicpain.pdf (2002).
70. Stewart, W. F., Ricci, J. A., Chee, E., Morganstein, D. & Lipton, R. Lost productive time and cost due to common pain conditions in the US workforce. JAMA 290, 2443-2454 (2003).
71. Lethbridge-Çejku, M., Schiller, J. S. & Bernadel, L. Summary health statistics for US Adults: National Health Interview Survey, 2002. National Center for Health Statistics. Vital and Health Statistics Series 10 [online], http://www.cdc.gov/ncha/data/series/sr_10/sr10_222.pdf (2004).
72. CDC & US Department of Health and Human Services. Preventing chronic diseases: investing wisely in health. screening to prevent cancer deaths [online], http://www.cdc.gov/nccdphp/pe_factsheets/pefs_cancer.pdf (2003).
73. Altman, R. B. et al. Indexing pharmacogenetic knowledge on the World Wide Web. Pharmacogenetics 13, 3-5 (2003).
74. US Public Health Service. Mental Health: A Report of the Surgeon General [online], http://www.surgeongeneral.gov/library/mentalhealth/home.html (1999).
75. Pirmohamed, M. et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ 329, 15-19 (2004).
76. Gasche, Y. et al. Codeine intoxication associated with ultrarapid CYP2D6 metabolism. N. Engl. J. Med. 351, 2827-2831 (2004).
77. Higashi, M. K. & Veenstra, D. L. Managed care in the genomics era: assessing the cost-effectiveness of genetic tests. Am. J. Manage Care 9, 493-500 (2003).
78. Ingelman-Sundberg, M. Pharmacogenetics of cytochrome P450 and its applications in drug therapy: the past, present and future. Trends Pharmacol Sci. 25, 193-200 (2004).
79. Collins, F. S., Green, E. D., Guttmacher, A. E. & Guyer, M. S. A vision for the future of genomics research. Nature 422, 835-847 (2003).
80. Evans, W. E. & Relling, M. K. Moving towards individualized medicine with pharmacogenomics. Nature 429, 464-468 (2004).
81. Zineh, I. et al. Availability of pharmacogenomics-based prescribing information in currently approved drugs. Pharmacogenomics J. 4, 354-8 (2004).
82. Kirchheiner, J. et al. Pharmacogenetics of antidepressants and antipsychotics: the contribution of allelic variations to the phenotype of drug response. Mol. Psychol. 9, 442-73 (2004).
83. Klein, T. E. & Altman, R. B. PharmGKB: the pharmacogenetics and pharmacogenomics knowledge base. Pharmacogenomics J. 4, 1 (2004).
84. Drug Information Association. Co-Development of Drug, Biological, and Device Products (meeting announcement) [online], http://www.diahome.org (2004).
85. Feigal, D. W. & Gutman, S. in Pharmacogenomics: Social, Ethical, and Clinical Dimensions (ed. Rothstein, M. A.) 99-108 (John Wiley & Sons, Inc, New Jersey, 2003).