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Review

Personalized medicine policy challenges: measuring clinical utility at point of care

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Pages 289-295 | Published online: 09 Jan 2014

References

  • Evans WE, McLeod HL. Pharmacogenomics – drug disposition, drug targets, and side effects. N. Engl. J. Med. 348(6), 538–549 (2003).
  • Marsh S, van Rooij T. Challenges of incorporating pharmacogenomics into clinical practice. Gastrointest. Cancer Res. 3(5), 206–207 (2009).
  • van Rooij T, Marsh S. Improving oncology outcomes through targeted therapeutics will require electronic delivery systems. Future Oncol. 7(5), 649–656 (2011).
  • de la Calle G, van Mulligen EM, Molero E et al. Education and research in INFOBIOMED, the European Network of Excellence in Biomedical Informatics. AMIA Annu. Symp. Proc. 11, 927 (2007).
  • Maojo V, Crespo J, de la Calle G, Barreiro J, Garcia-Remesal M. Using web services for linking genomic data to medical information systems. Methods Inf. Med. 46(4), 484–492 (2007).
  • Epstein RS, Teagarden JR. Comparative effectiveness research and personalized medicine: catalyzing or colliding? Pharmacoeconomics 28(10), 905–913 (2010).
  • Issa AM. Personalized medicine and the practice of medicine in the 21st century. Mcgill J. Med. 10(1), 53–57 (2007).
  • Frueh FW. Back to the future: why randomized controlled trials cannot be the answer to pharmacogenomics and personalized medicine. Pharmacogenomics 10(7), 1077–1081 (2009).
  • Titler MG. Translation science and context. Res. Theory Nurs. Pract. 24(1), 35–55 (2010).
  • Al Mallah A, Guelpa P, Marsh S, van Rooij T. Integrating genomic-based clinical decision support into electronic health records. Pers. Med. 7, 163–170 (2010).
  • Gurwitz D, Zika E, Hopkins MM, Gaisser S, Ibarreta D. Pharmacogenetics in Europe: barriers and opportunities. Public Health Genomics 12(3), 134–141 (2009).
  • Yin RK. Enhancing the quality of case studies in health services research. Health Serv. Res. 34(5 Pt 2), 1209–1224 (1999).
  • Ullman-Cullere MH, Mathew JP. Emerging landscape of genomics in the Electronic Health Record for personalized medicine. Hum. Mutat. 32(5), 512–516 (2011).
  • Bouffard M, Phillips MS, Brown AM, Marsh S, Tardif JC, van Rooij T. Damming the genomic data flood using a comprehensive analysis and storage data structure. Database (Oxford) 2010, article ID: baq029 (2010).
  • Finkelman BS, Gage BF, Johnson JA, Brensinger CM, Kimmel SE. Genetic warfarin dosing: tables versus algorithms. J. Am. Coll. Cardiol. 57(5), 612–618 (2011).
  • Kawamoto K, Lobach DF, Willard HF, Ginsburg GS. A national clinical decision support infrastructure to enable the widespread and consistent practice of genomic and personalized medicine. BMC Med. Inform. Decis. Mak. 9, 17 (2009).
  • van Rooij T. Behind the PGx challenge: Biofx. Genome Technol. July/August, 19–20 (2007).
  • Saito Y, Oshitanai R, Terao M et al. Post-marketing safety evaluation of S-1 in patients with inoperable or recurrent breast cancer: especially in patients treated with S-1 + trastuzumab. Jpn. J. Clin. Oncol. 41(9), 1051–1058 (2011).
  • Obradovic M, Mrhar A, Kos M. Market uptake of biologic and small-molecule-targeted oncology drugs in Europe. Clin. Ther. 31(12), 2940–2952 (2009).
  • Becla L, Lunshof JE, Gurwitz D et al. Health technology assessment in the era of personalized health care. Int. J. Technol. Assess. Health Care 27(2), 118–126 (2011).
  • Marsh S. Impact of pharmacogenomics on clinical practice in oncology. Mol. Diagn. Ther. 11(2), 79–82 (2007).
  • Chiang A, Million RP. Personalized medicine in oncology: next generation. Nat. Rev. Drug Discov. 10(12), 895–896 (2011).
  • Kung S, Allen JD. Patients and clinicians report higher-than-average satisfaction with psychiatric genotyping for depressed inpatients. J. Clin. Psychiatr. 71, 745–753 (2011).
  • Newman WG, Payne K, Tricker K et al.; TARGET study recruitment team. A pragmatic randomized controlled trial of thiopurine methyltransferase genotyping prior to azathioprine treatment: the TARGET study. Pharmacogenomics 12(6), 815–826 (2011).
  • Payne K, Fargher EA, Roberts SA et al. Valuing pharmacogenetic testing services: a comparison of patients’ and health care professionals’ preferences. Value Health 14(1), 121–134 (2011).
  • Gage BF, Eby C, Johnson JA et al. Use of pharmacogenetic and clinical factors to predict the therapeutic dose of warfarin. Clin. Pharmacol. Ther. 84(3), 326–331 (2008).
  • Phillips MS, Hihi AK, van Rooij T et al. Génome Québec & Montreal Heart Institute Pharmacogenomics Centre: a translational pharmacogenomics platform – from R&D to the clinic. Pharmacogenomics 9(10), 1391–1396 (2008).
  • American Pharmacists Association. Integrating pharmacogenomics into pharmacy practice via medication therapy management. J. Am. Pharm. Assoc. 51, e64–e74 (2011).
  • Epstein RS, Moyer TP, Aubert RE et al. Warfarin genotyping reduces hospitalization rates results from the MM-WES (Medco–Mayo Warfarin Effectiveness study). J. Am. Coll. Cardiol. 55(25), 2804–2812 (2010).
  • Khoury MJ, Rich EC, Randhawa G, Teutsch SM, Niederhuber J. Comparative effectiveness research and genomic medicine: an evolving partnership for 21st century medicine. Genet. Med. 11(10), 707–711 (2009).
  • Dodson C. Knowledge and attitudes concerning pharmacogenomics among healthcare professionals. Pers. Med. 8, 421–428 (2011).
  • Bonter K, Desjardins C, Currier N, Pun J, Ashbury FD. Personalised medicine in Canada: a survey of adoption and practice in oncology, cardiology and family medicine. BMJ Open 1(1), e000110 (2011).
  • Roederer MW, McLeod H, Juliano JJ. Can pharmacogenomics improve malaria drug policy? Bull. World Health Organ. 89(11), 838–845 (2011).
  • Johnson JA, Gong L, Whirl-Carrillo M et al. Clinical Pharmacogenetics Implementation Consortium Guidelines for CYP2C9 and VKORC1 genotypes and warfarin dosing. Clin. Pharmacol. Ther. 90(4), 625–629 (2011).
  • Ferrusi IL, Marshall DA, Kulin NA, Leighl NB, Phillips KA. Looking back at 10 years of trastuzumab therapy: what is the role of HER2 testing? A systematic review of health economic analyses. Pers. Med. 6(2), 193–215 (2009).
  • Gage BF, Lesko LJ. Pharmacogenetics of warfarin: regulatory, scientific, and clinical issues. J. Thromb. Thrombolysis 25(1), 45–51 (2008).
  • Rieder MJ, Reiner AP, Gage BF et al. Effect of VKORC1 haplotypes on transcriptional regulation and warfarin dose. N. Engl. J. Med. 352(22), 2285–2293 (2005).
  • Plosker GL, Keam SJ. Trastuzumab: a review of its use in the management of HER2-positive metastatic and early-stage breast cancer. Drugs 66(4), 449–475 (2006).
  • Dent S, Verma Sh, Latreille J et al. The role of HER2-targeted therapies in women with HER2-overexpressing metastatic breast cancer. Curr. Oncol. 16(4), 25–35 (2009).
  • Bange J, Zwick E, Ullrich A. Molecular targets for breast cancer therapy and prevention. Nat. Med. 7(5), 548–552 (2001).
  • Engel RH, Kaklamani VG. HER2-positive breast cancer: current and future treatment strategies. Drugs 67(9), 1329–1341 (2007).
  • Romond EH, Perez EA, Bryant J et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N. Engl. J. Med. 353(16), 1673–1684 (2005).
  • Nahta R, Esteva FJ. Trastuzumab: triumphs and tribulations. Oncogene 26(25), 3637–3643 (2007).
  • Ameyaw MM, Tayeb M, Thornton N et al. Ethnic variation in the HER-2 codon 655 genetic polymorphism previously associated with breast cancer. J. Hum. Genet. 47(4), 172–175 (2002).
  • Nahta R, Yuan LX, Du Y, Esteva FJ. Lapatinib induces apoptosis in trastuzumab-resistant breast cancer cells: effects on insulin-like growth factor I signaling. Mol. Cancer Ther. 6(2), 667–674 (2007).
  • Marsh S, Hoskins JM. Irinotecan pharmacogenomics. Pharmacogenomics 11(7), 1003–1010 (2010).
  • Hoskins JM, Goldberg RM, Qu P, Ibrahim JG, McLeod HL. UGT1A1*28 genotype and irinotecan-induced neutropenia: dose matters. J. Natl Cancer Inst. 99(17), 1290–1295 (2007).
  • Cecchin E, Innocenti F, D’Andrea M et al. Predictive role of the UGT1A1, UGT1A7, and UGT1A9 genetic variants and their haplotypes on the outcome of metastatic colorectal cancer patients treated with fluorouracil, leucovorin, and irinotecan. J. Clin. Oncol. 27(15), 2457–2465 (2009).
  • Hoskins JM, Marcuello E, Altes A et al. Irinotecan pharmacogenetics: influence of pharmacodynamic genes. Clin. Cancer Res. 14(6), 1788–1796 (2008).
  • de Jong FA, Scott-Horton TJ, Kroetz DL et al. Irinotecan-induced diarrhea: functional significance of the polymorphic ABCC2 transporter protein. Clin. Pharmacol. Ther. 81(1), 42–49 (2007).
  • Millar JA, Millward MJ. Cost effectiveness of trastuzumab in the adjuvant treatment of early breast cancer: a lifetime model. Pharmacoeconomics 25(5), 429–442 (2007).
  • Matter-Walstra KW, Dedes KJ, Schwenkglenks M, Brauchli P, Szucs TD, Pestalozzi BC. Trastuzumab beyond progression: a cost–utility analysis. Ann. Oncol. 21(11), 2161–2168 (2010).
  • Neyt M, Huybrechts M, Hulstaert F, Vrijens F, Ramaekers D. Trastuzumab in early stage breast cancer: a cost–effectiveness analysis for Belgium. Health Policy 87(2), 146–159 (2008).
  • Lee JY, Garnett CE, Gobburu JV et al. Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008. Clin. Pharmacokinet. 50(10), 627–635 (2011).
  • Haas JS, Phillips KA, Liang SY et al. Genomic testing and therapies for breast cancer in clinical practice. J. Oncol. Pract. 7(Suppl. 3), e1s–e7s (2011).
  • Ferrusi IL, Leighl NB, Kulin NA, Marshall DA. Do economic evaluations of targeted therapy provide support for decision makers? J. Oncol. Pract. 7(Suppl. 3), S36–S45 (2011).
  • Grutters JP, Seferina SC, Tjan-Heijnen VC, van Kampen RJ, Goettsch WG, Joore MA. Bridging trial and decision: a checklist to frame health technology assessments for resource allocation decisions. Value Health 14(5), 777–784 (2011).

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