Cost-effectiveness of rituximab in addition to fludarabine and cyclophosphamide (R-FC) for the first-line treatment of chronic lymphocytic leukemia

Leukemia and Lymphoma

Volumn 57, Issue 5, 2016, Pages 1130-1139

  Müller, Dirk ^a   Fischer, Kirsten ^a   Kaiser, Peter ^a   Eichhorst, Barbara ^a   Walshe, Ronald ^b   Reiser, Marcel ^c   Kellermann, Lenka ^d   Borsi, Lisa ^a   Civello, Daniele ^a   Mensch, Alexander ^a   Bahlo, Jasmin ^a   Hallek, Michael ^a   Stock, Stephanie ^a   Fingerle Rowson, Günter ^e  

^a UNIVERSITY OF COLOGNE   (Germany)

^b SVA Zurich   (Switzerland)

^c PIOH   (Germany)

^d Oncology Information Service   (Germany)

^e F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

chronic lymphocytic leukemia; pharmacoeconomic analysis; Rituximab

Indexed keywords

CYCLOPHOSPHAMIDE; FILGRASTIM; FLUDARABINE; LENOGRASTIM; PEGFILGRASTIM; RITUXIMAB; ANTINEOPLASTIC AGENT; VIDARABINE;

ADD ON THERAPY; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CHRONIC LYMPHATIC LEUKEMIA; COST EFFECTIVENESS ANALYSIS; DRUG COST; FOLLOW UP; HEALTH INSURANCE; HEALTH STATUS; HUMAN; LEUKOPENIA; MAJOR CLINICAL STUDY; MULTICENTER STUDY (TOPIC); NEUTROPENIA; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; RANDOMIZED CONTROLLED TRIAL (TOPIC); SENSITIVITY ANALYSIS; AGED; ANALOGS AND DERIVATIVES; COST BENEFIT ANALYSIS; ECONOMICS; FEMALE; HEALTH CARE COST; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; MIDDLE AGED; MORTALITY; PATHOLOGY; STATISTICAL MODEL; TREATMENT OUTCOME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COST-BENEFIT ANALYSIS; CYCLOPHOSPHAMIDE; FEMALE; FOLLOW-UP STUDIES; HEALTH CARE COSTS; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; MIDDLE AGED; MODELS, STATISTICAL; QUALITY-ADJUSTED LIFE YEARS; RITUXIMAB; TREATMENT OUTCOME; VIDARABINE;

EID: 84947781314     PISSN: 10428194     EISSN: 10292403     Source Type: Journal    
DOI: 10.3109/10428194.2015.1070151     Document Type: Article

References (41)

1. Surveillance Epidemiology and End Results (SEER) Stat Fact Sheets: chronic lymphocytic leukemia, May 2013 (internet). Available from: http://seer.cancer.gov/statfacts/html/clyl.html. Accessed September 30, 2014.
2. Robert-Koch-Institute. Cancer in Germany: Leukemia, 2013. Available from: http://www.krebsdaten.de/Krebs/DE/Content/Publikationen/Krebs-in-Deutschland/kid-2013/krebs-in-deutschland-2013.pdf?-blob=publicationFile. Available from: http://seer.cancer.gov/statfacts/html/clyl.html. Accessed September 30, 2014.
3. Blankart CR, Koch T, Linder R, et al. Cost of illness and economic burden of chronic lymphocytic leukemia. Orphanet L Rare Dis 2013; 8: 32-41.
4. Byrd JC, Kitada S, Flinn IW, et al. The mechanism of tumor cell clearance by rituximab in vivo in patients with B-cell chronic lymphocytic leukemia: evidence of caspase activation and apoptosis induction. Blood 2002; 99: 1038-1043.
5. OBrien SM, Kantarjian H, Thomas DA, et al. Rituximab dose-escalation trial in chronic lymphocytic leukemia. J Clin Oncol 2001; 19: 2165-2170.
6. Keating MJ, O'Brien S, Albitar M, et al. Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia. J Clin Oncol 2005; 23: 4079-4088.
7. Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet 2010; 376: 1164-1174.
8. Bauer K, Rancea M, Roloff V, et al. Rituximab, ofatumumab and other monoclonal anti-CD20 antibodies for chronic lymphocytic leukaemia. Cochrane Database Syst Rev 2012; 14: 11.
9. Bryan J, Borthakur G. Role of rituximab in first-line treatment of chronic lymphocytic leukemia. Ther Clin Risk Manag 2010; 22: 1-11.
10. European Medicines Agency. MabThera® (Rituximab), 2015. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000165/human-med-000897.jsp&mid=WC0b01ac058001d124. Accessed April 30, 2015.
11. Byrd JC, Jones JJ, Woyach JA., et al. Entering the era of targeted therapy for chronic lymphocytic leukemia: impact on the practicing clinician. J Clin Oncol. 2014; 32: 3039-3047.
12. Goede V, Fischer K, Busch R, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med 2014; 370: 1101-1110.
13. Hillmen P, Robak T, Janssens A, et al. Ofatumumab + chlorambucil versus chlorambucil alone in patients with untreated chronic lymphocytic leukemia (CLL): results of the Phase III Study Complement 1 (OMB110911). Blood 2013; 122: 528.
14. Hornberger J, Reyes C, Shewade A, et al. Cost-effectiveness of adding rituximab to fludarabine and cyclophosphamide for the treatment of previously untreated chronic lymphocytic leukemia. Leuk Lymphoma 2012; 53: 225-234.
15. Casado LF, Garciá Marco JA, Gilsanz F, et al. Economic evaluation of rituximab added to fludarabine plus cyclophosphamide versus fludarabine plus cyclophosphamide for the treatment of chronic lymphocytic leukemia. Gac Sanit 2011; 25: 274-281.
16. Fischer K, Bahlo J, Fink AM, et al. Extended follow up of the CLL8 protocol, a Randomized Phase-III Trial of the German CLL Study Group (GCLLSG) comparing Fludarabine and Cyclophosphamide (FC) to FC Plus Rituximab (FCR) for previously untreated patients with Chronic Lymphocytic Leukemia (CLL): results on survival, progression-free survival, delayed neutropenias and secondary malignancies confirm superiority of the FCR Regimen (ASH Annual Meeting Abstracts). Blood 2012; 120(Suppl): 435.
17. Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood (Suppl) 2008; 111: 5446-5456.
18. Institute for Quality and Efficiency in Health Care. General Methods for the assessment of the relation of benefits to costs, 2014. Available from: https://www.iqwig.de/download/General-Methods-for-the-Assessment-of-the-Relation-of-Benefits-to-Costs.pdf. Accessed September 30, 2014.
19. The Federal Statistics Office (Destatis). Life expectancy 2009/2011, 2014. Available from: https://www.destatis.de/DE/Publikationen/Thematisch/Bevoelkerung/Bevoelkerungsbewegung/PeriodensterbetafelnBundeslaender5126204117004.pdf?-blob=publicationFile. Accessed September 30, 2014.
20. Gold MR, Siegel JE, Russell LB, et al. Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996.
21. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365-376.
22. Kim SH, Jo MW, Kim HJ., et al. Mapping EORTC QLQ-C30 onto EQ-5D for the assessment of cancer patients. Health Qual Life Outcomes 2012; 10: 151-156.
23. Schmidt C, Fetscher S, Görg C, et al. Treatment of indolent lymphoma in Germany-results of a representative population-based survey. Clin Lymphoma Myeloma Leuk 2011; 11: 204-211.
24. WEBAPO® LAUER-Taxe, 2014. Available from: http://www.lauer-fischer.de/lf/Seiten/WEBAPO-Lauer-Taxe/WEBAPO-Lauer-Taxe-demo.aspx. Accessed September 30, 2014.
25. Doctors Fee Scale within the Statutory Health Insurance Scheme for outpatient services (Einheitlicher Bewertungsmaßstab, EBM), 2014. Available from: http://applications.kbv.de/ebm/EBMGesamt.htm. Accessed September 30, 2014.
26. Diagnosis Related Groups (DRG) Research Group-Webgrouper., 2014. Available from: http://drg.uni-muenster.de/index.php?option=com-webgrouper&view=webgrouper&Itemid=26. Accessed September 30, 2014.
27. Frybeck DG, Chinnis JO, Ulvila JW. Bayesian cost effectiveness analysis. An example using the GUSTO trial. Int J Technol Assess Health Care 2001; 17: 83-97.
28. Leunis A, Redekop WK, van Montfort KA., et a. The development and validation of a decision-Analytic model representing the full disease course of acute myeloid leukemia. Pharmacoeconomics 2013; 31: 605-621.
29. Schmidt C, Fingerle-Rowsen G, Boehme A, et al. Changes in the diagnosis and treatment of patients with low grade lymphoma in Germany: years 2006-2009. Leuk Lymphoma 2015; 56: 694-702.
30. Adena M, Houltram J, Mulligan SP, et al. Modelling the cost effectiveness of rituximab in chronic lymphocytic leukaemia in first-line therapy and following relapse. Pharmacoeconomics 2014; 32: 193-207.
31. Main C, Pitt M, Moxham T, et al. The clinical effectiveness and cost-effectiveness of rituximab for the first-line treatment of chronic lymphocytic leukaemia: an evidence review of the submission from Roche. Health Technol Assess 2010; 14 (Suppl. 2): 27-32.
32. Ubel PA, Hirth RA, Chernew ME, et al. What is the price of life and why doesn't it increase at the rate of inflation? Arch Intern Med 2003; 163: 1637-1641.
33. Garrison LP Jr, Wang ST, Huang H, et al. The cost-effectiveness of initial treatment of multiple myeloma in the U.S. with bortezomib plus melphalan and prednisone versus thalidomide plus melphalan and prednisone or lenalidomide plus melphalan and prednisone with continuous lenalidomide maintenance treatment. Oncologist 2013; 18: 27-36.
34. Hillner BE, Ingle JN, Berenson JR, et al. American Society of Clinical Oncology guideline on the role of bisphosphonates in breast cancer. American Society of Clinical Oncology Bisphosphonates Expert Panel. J Clin Oncol 2000; 18: 1378-1391.
35. Cremieux PY, Finkelstein SN, Berndt ER, et al. Cost effectiveness, quality-Adjusted life-years and supportive care. Recombinant human erythropoietin as a treatment of cancer-Associated anaemia. Pharmacoeconomics 1999; 16: 459-472.
36. Zbrozek AS, Cantor SB, Cardenas MP, et al. Pharmacoeconomic analysis of ondansetron versus metoclopramide for cisplatin-induced nausea and vomiting. Am J Hosp Pharm 1994; 51: 1555-1563.
37. Beusterien KM, Davies J, Leach M, et al. Population preference values for treatment outcomes in chronic lymphocytic leukaemia: a cross-sectional utility study. Health Qual Life Outcomes 2010; 8: 50-58.
38. Hay JW, Smeeding J, Carroll NV, et al. Good research practices for measuring drug costs in cost effectiveness analyses: issues and recommendations: the ISPOR Drug Cost Task Force report-Part I. Value Health 2010; 13: 3-7.
39. Garrison LP Jr, Neumann PJ, Erickson P, et al. Using real-world data for coverage and payment decision: the ISPOR Real-World Data Task Force report. Value Health 2007; 10: 326-335.
40. Frenk J, Gómez-Dantés O. Globalization and the challenges to health systems. Health Aff (Millwood) 2002; 21: 160-165.
41. Stilgenbauer S, Schnaiter A, Paschka P, et al. Gene mutations and treatment outcome in chronic lymphocytic leukemia: results from the CLL8 trial. Blood 2014; 123: 3247-3254.