Application of cost-effectiveness ana lysis to demonstrate the potential value of companion diagnostics in chronic myeloid leukemia

Pharmacogenomics

Volumn 12, Issue 3, 2011, Pages 411-421

  Gaultney, Jennifer G ^a   Sanhueza, Enrique ^b   Janssen, Jeroen J ^c   Redekop, William K ^a   Uyl De Groot, Carin A ^a  

^a ERASMUS UNIVERSITY ROTTERDAM   (Netherlands)

^b PONTIFICIA UNIVERSIDAD CATÓLICA DE CHILE   (Chile)

^c VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

companion diagnostics; cost effectiveness ana lysis; dasatinib; hronic myeloid leukemia; nilotinib; tyrosine kinase inhibitors

Indexed keywords

ALPHA INTERFERON; CYTARABINE; DASATINIB; NILOTINIB;

ARTICLE; CANCER GROWTH; CANCER SURVIVAL; CHRONIC MYELOID LEUKEMIA; COMPANION DIAGNOSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DIAGNOSIS; DIAGNOSTIC ACCURACY; DIAGNOSTIC VALUE; DRUG COST; DRUG EFFICACY; HEALTH CARE COST; HEALTH CARE QUALITY; HUMAN; LOW DRUG DOSE; NETHERLANDS; PROGRESSION FREE SURVIVAL;

COST-BENEFIT ANALYSIS; DECISION SUPPORT TECHNIQUES; HUMANS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; MICROARRAY ANALYSIS; NETHERLANDS; PROTEIN KINASES; PYRIMIDINES; THIAZOLES; TUMOR MARKERS, BIOLOGICAL;

EID: 79953254548     PISSN: 14622416     EISSN: 17448042     Source Type: Journal    
DOI: 10.2217/pgs.10.187     Document Type: Article

References (45)

1. Papadopoulos N, Kinzler KW, Vogelstein B: The role of companion diagnostics in the development and use of mutation-targeted cancer therapies. Nat. Biotechnol. 24(8), 985-995 (2006). (Pubitemid 44215393)
2. Deverka PA, Doksum T, Carlson RJ: Integrating molecular medicine into the US health-care system: opportunities, barriers, and policy challenges. Clin. Pharmacol. Ther. 82(4), 427-434 (2007). (Pubitemid 47414350)
3. Gurwitz D, Zika E, Hopkins MM, Gaisser S, Ibarreta D: Pharmacogenetics in Europe: barriers and opportunities. Pub. Health Genom. 12(3), 134-141 (2009).
4. Drummond MF, Sculpher MJ, Torrance GW, O'Brien B, Stoddart GL: Methods for the Economic Evaluation of Health Care Programmes, 3rd Edition. Oxford Medical Publications, Oxford, UK (2005).
5. Deverka PA, Vernon J, McLeod HL: Economic opportunities and challenges for pharmacogenomics. Annu. Rev. Pharmacol. Toxicol. 50, 423-437 (2010).
6. Hornberger J, Cosier LE, Lyman GH: Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-poskive, early-stage breast cancer. Am. Manag. Care 11(5), 313-324(2005). (Pubitemid 40646936)
7. Phillips KA, Van Bebber SL: A systematic review of cost-effectiveness analyses of pharmacogenomic interventions. Pharmacogenomics 5(8), 1139-1149 (2004). (Pubitemid 40045254)
8. Vegter S, Boersma C, Rozenbaum M et al. Pharmacoeconomic evaluations of pharmacogenetic and genomic screening programmes: a systematic review on content and adherence to guidelines. Pharmacoeconomics 26(7), 569-587 (2008). (Pubitemid 351871553)
9. Deininger MW, Goldman JM, Melo JV The molecular biology of chronic myeloid leukemia. Blood96(10), 3343-3356 (2000).
10. Druker BJ, Guilhot F, O'Brien SG, et al. Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. N. Engl. J. Med. 355(23), 2408-2417 (2006). (Pubitemid 44903745)
11. Gordois A, Scuffham P, Warren E, Ward S: Cost-utilky analysis of imatinib mesilate for the treatment of advanced stage chronic myeloid leukaemia. Br. J. Cancer 89(4), 634-640 (2003). (Pubitemid 37076165)
12. Groot MT, Ossenkoppele GJ, Kramer MH et aL: [Drug treatment of chronic myeloid leukemia: a cost effectiveness analysis of first-and second-line treatment]. Ned. Tijdschr. Geneeskd. 147(30), 1460-1465 (2003). (Pubitemid 37063655)
13. Dalziel K, Round A, Stein K, Garside R, Price A: Effectiveness and cost-effectiveness of imatinib for first-line treatment of chronic myeloid leukaemia in chronic phase: a systematic review and economic analysis. Health Technol. Assess. 8(28), iii, 1-120 (2004).
14. ReedSD, Anstrom KJ, LudmerJA, Glendenning GA, Schulman KA: Cost-effectiveness of imatinib versus interferon-a plus low-dose cytarabine for patients with newly diagnosed chronic-phase chronic myeloid leukemia. Cancer 101(11), 2574-2583 (2004). (Pubitemid 39532287)
15. Warren E, Ward S, Gordois A, Scuffham P: Cost-utilky analysis of imatinib mesylate for the treatment of chronic myelogenous leukemia in the chronic phase. Clin. Ther. 26(11), 1924-1933 (2004). (Pubitemid 40089505)
16. Skrepnek GH, Ballard EE: Cost-efficacy of imatinib versus allogeneic bone marrow transplantation with a matched unrelated donor in the treatment of chronic myelogenous leukemia: a decision-analytic approach. Pharmacotherapy 250), 325-334 (2005). (Pubitemid 40300319)
17. O'Dwyer ME, Mauro MJ, Blasdel C et al.: Clonal evolution and lack of cytogenetic response are adverse prognostic factors for hematologic relapse of chronic phase CML patients treated with imatinib mesylate. Blood 103(2), 451-455 (2004). (Pubitemid 38140072)
18. Soverini S, Martinelli G, Rosti G et al.: ABL mutations in late chronic phase chronic myeloid leukemia patients with up-front cytogenetic resistance to imatinib are associated with a greater likelihood of progression to blast crisis and shorter survival: a study by the GIMEMA Working Party on Chronic Myeloid Leukemia. Clin. Oncol. 23(18), 4100-4109 (2005). (Pubitemid 46211315)
19. Gorre ME, Mohammed M, Ellwood K et al.: Clinical resistance to STI-571 cancer therapy caused by BCR-ABL gene mutation or amplification. Science 293 (5531), 876-880 (2001). (Pubitemid 32743979)
20. Kantarjian HM, Talpaz M, Giles F, O'Brien S, Cortes J: New insights into the pathophysiology of chronic myeloid leukemia and imatinib resistance. Ann. Intern. Med. 145(12), 913-923 (2006). (Pubitemid 351639967)
21. Kantarjian HM, Smith TL, O'Brien S et al.: Prolonged survival in chronic myelogenous leukemia after cytogenetic response to interferon-a therapy. The Leukemia Service. Ann. Intern. Med. 122(4), 254-261 (1995).
22. Kantarjian H, Schiffer C, Jones D, Cortes J: Monitoring the response and course of chronic myeloid leukemia in the modern era of BCR-ABL tyrosine kinase inhibitors: practical advice on the use and interpretation of monitoring methods. Blood 111(4), 1774-1780 (2008). (Pubitemid 351451481)
23. Boender P, Janssen J, Smk L et al.: Application of kinase activity profiles to predict upcoming TKI resistance in CML-patients. Presented at: the American Society of Hematology Annual Meeting. 4-7 December, FL, USA. 116(21) (2010) (Abstract 3425).
24. Folkvord S, Flatmark K, Dueland S et al.: Prediction of response to preoperative chemoradiotherapy in rectal cancer by multiplex kinase activity profiling. Int. J. Radiat. Oncol. Biol. Phys. 78(2), 555-562 (2010).
25. Hilhorst R, Schaake E, Van Pel R et al.: Application of kinase activity profiles to predict response to erlotinib in a neoadjuvant setting in early stage non-small cell lung cancer (NSCLC). Clin. Oncol. 28(Suppl. 15) (2010) (Abstract 10566).
26. Kantarjian H, Pasquini R, Hamerschlak N et al.: Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia after failure of first-line imatinib: a randomized Phase 2 trial. Blood 109(12), 5143-5150 (2007). (Pubitemid 46890528)
27. Kantarjian HM, Giles F, Gattermann N et al.: Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance. Blood 110(10), 3540-3546 (2007). (Pubitemid 350159618)
28. Lowenberg B, Ossenkoppele GJ, de Witte T, Boogaerts MA: Chronic Myeloid Leukemia. In: Handboek Hematologie. De Tijdstroom, Utrecht, The Netherlands, 489-500 (2008).
29. Giles F, le Coutre P, Bhalla K et al.: A Phase II study of nilotinib, a novel tyrosine kinase inhibitor administered to patients with imatinib resistant or intolerant chronic myelogenous leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast crisis (BC) who have also failed dasatinib therapy. ASH Annual Meeting Abstracts 108(11), 2170 (2006).
30. Quintas-Cardama A, Kantarjian H, Jones D et al.: Dasatinib (BMS-354825) is active in Philadelphia chromosome-positive chronic myelogenous leukemia after imatinib and nilotinib (AMN107) therapy failure. Blood 109(2), 497-499 (2007). (Pubitemid 46105944)
31. Tarn CS, Kantarjian H, Garcia-Manero G et al.: Failure to achieve a major cytogenetic response by 12 months defines inadequate response in patients receiving nilotinib or dasatinib as second or subsequent line therapy for chronic myeloid leukemia. Blood 112(3), 516-518 (2008).
32. GratwohlA, Brand R, Apperley J et al.: Allogeneic hematopoietic stem cell transplantation for chronic myeloid leukemia in Europe 2006: transplant activity, long-term data and current results. An analysis by the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation (EBMT). Haematologica 91(4), 513-521 (2006).
33. O'Brien SG, Guilhot F, Larson RA et al.: Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N. Engl. J. Med. 348(11), 994-1004 (2003). (Pubitemid 36302244)
34. Ross JS, Hatzis C, Symmans WF, Pusztai L, Hortobagyi GN: Commercialized multigene predictors of clinical outcome for breast cancer. Oncologist 13(5), 477-493 (2008). (Pubitemid 351872866)
35. Rix U, Hantschel O, Durnberger G et al.: Chemical proteomic profiles of the BCR-ABL inhibitors imatinib, nilotinib, and dasatinib reveal novel kinase and nonkinase targets. Blood 110(12), 4055-4063 (2007). (Pubitemid 350248462)
36. Kantarjian H, Giles F, Wunderle L et al.: Nilotinib in imatinib-resistant CML, Philadelphia chromosome-positive ALL. N. Engl. J. Med. 354(24), 2542-2551 (2006). (Pubitemid 43882350)
37. Flowers CR, Veenstra D: The role of cost-effectiveness analysis in the era of pharmacogenomics. Pharmacoeconomics 22(8), 481-493 (2004). (Pubitemid 38858292)
38. Deverka PA: Pharmacogenomics, evidence, and the role of payers. Public Health Genomics 12(3), 149-157(2009).
39. Garber AM, Tunis SR: Does comparative-effectiveness research threaten personalized medicine? N. Engl. J. Med. 360(19), 1925-1927(2009).
40. Saglio G, Kim DW, Issaragrisil S et al.: Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N. Engl. J. Med. 362(24), 2251-2259 (2010).
41. Kantarjian H, Shah NP, Hochhaus A et al.: Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N. Engl. J. Med. 362(24), 2260-2270 (2010).
42. Stallings SC, Huse D, Finkelstein SN et al.: A framework to evaluate the economic impact of pharmacogenomics. Pharmacogenomics 7(6), 853-862 (2006). (Pubitemid 44458118)
43. Epstein RS, Frueh FW, Geren D et al.: Payer perspectives on pharmacogenomics testing and drug development. Pharmacogenomics 10(1), 149-151 (2009).
44. Vallejo-Torres L, Steuten LM, Buxton MJ et al.: Integrating health economics modeling in the product development cycle of medical devices: a Bayesian approach. Int. J. Technol. Assess. Health Care 24(4), 459-464 (2008).
45. Gaisser S, Vignola-Gagne E, Husing B, Enzing C, Van der Valk T: EU policies in personalized medicine-related technologies. Pers. Med. 6(1), 93-102 (2009).