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Open Access 01-09-2019 | Acute Lymphoblastic Leukemia | Original Research Article

Cost Effectiveness of Blinatumomab Versus Inotuzumab Ozogamicin in Adult Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia in the United States

Authors: Thomas E. Delea, Xinke Zhang, Jordan Amdahl, Diana Boyko, Franziska Dirnberger, Marco Campioni, Ze Cong

Published in: PharmacoEconomics | Issue 9/2019

Abstract

Background and Objective

The TOWER and INO-VATE-ALL trials demonstrated the efficacy and safety of blinatumomab and inotuzumab ozogamicin (inotuzumab), respectively, versus standard-of-care (SOC) chemotherapy in adults with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL). The cost effectiveness of blinatumomab versus inotuzumab has not previously been examined.

Methods

Cost effectiveness of blinatumomab versus inotuzumab in R/R B-cell precursor ALL patients with one or no prior salvage therapy from a United States (US) payer perspective was estimated using a partitioned survival model. Health outcomes were estimated based on published aggregate data from INO-VATE-ALL and individual patient data from TOWER weighted to match patients in INO-VATE-ALL using matching adjusted indirect comparison (MAIC). Analyses were conducted using five approaches relating to use of anchored versus unanchored comparisons of health outcomes and, for the anchored comparisons, the reference treatment to which treatment effects on health outcomes were applied. Estimates from TOWER including the probabilities of complete remission and allogeneic stem-cell transplant (allo-SCT), overall and event-free survival, utilities, duration of therapy, and use of subsequent therapies were MAIC adjusted to match INO-VATE-ALL. Costs of treatment, adverse events, allo-SCT, subsequent therapies, and terminal care were from published sources. A 50-year time horizon and 3% annual discount rate were used.

Results

Incremental costs for blinatumomab versus inotuzumab ranged from US$7023 to US$36,244, depending on the approach used for estimating relative effectiveness. Incremental quality-adjusted life-years (QALYs) ranged from 0.54 to 1.78. Cost effectiveness for blinatumomab versus inotuzumab ranged from US$4006 to US$20,737 per QALY gained.

Conclusions

Blinatumomab is estimated to be cost effective versus inotuzumab in R/R B-cell precursor ALL adults who have received one or no prior salvage therapy from a US payer perspective.

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Terwilliger T, Abdul-Hay M. Acute lymphoblastic leukemia: a comprehensive review and 2017 update. Blood cancer journal. 2017;7(6):e577.CrossRefPubMedPubMedCentral

National Cancer Institute Surveillance Epidemiology and End Results Program. SEER Cancer Stat Facts: Acute Lymphocytic Leukemia. National Cancer Institute. Bethesda, MD. https://seer.cancer.gov/statfacts/html/alyl.html. Accessed 29 June 2018.

European Medicines Agency. Blincyto (blinatumomab) European Public Assessment Report. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003731/WC500198227.pdf. Accessed 22 June 2018. 2015.

Frey NV, Luger SM. How I treat adults with relapsed or refractory Philadelphia chromosome-negative acute lymphoblastic leukemia. Blood. 2015;126(5):589–96.CrossRefPubMed

National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Acute Lymphoblastic Leukemia. Version 1.2018—March 12, 2018. https://www.nccn.org/professionals/physician_gls/default.aspx#all. Accessed 18 Apr 2018.

Gokbuget N, Dombret H, Ribera JM, Fielding AK, Advani A, Bassan R, et al. International reference analysis of outcomes in adults with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia. Haematologica. 2016;101(12):1524–33.CrossRefPubMedPubMedCentral

Kantarjian H, Stein A, Gokbuget N, Fielding AK, Schuh AC, Ribera JM, et al. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia. N Engl J Med. 2017;376(9):836–47.CrossRefPubMedPubMedCentral

Food and Drug Administration. FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425549.htm. Accessed 22 Dec 2015.

Amgen. BLINCYTO^® (blinatumomab) for injection, for intravenous use [full prescribing information]. Initial U.S. Approval: 2014. Revised: 5/2018. http://pi.amgen.com/united_states/blincyto/blincyto_pi_hcp_english.pdf. Accessed 30 May 2018.

10.

Topp MS, Zimmerman Z, Cannell P, Dombret H, Maertens J, Stein A, et al. Health-related quality of life in adults with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab. Blood. 2018;131(26):2906–14.CrossRefPubMedPubMedCentral

11.

Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, et al. Inotuzumab ozogamicin versus standard therapy for acute lymphoblastic leukemia. N Engl J Med. 2016;375:1–14.CrossRef

12.

National Cancer Institute. FDA Approves Inotuzumab for Adults with B-Cell Acute Lymphoblastic Leukemia. https://www.cancer.gov/news-events/cancer-currents-blog/2017/fda-inotuzumab-leukemia. Accessed: 11 Apr 2018.

13.

U.S. Food & Drug Administration. FDA approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572133.htm. Accessed 11 Apr 2018.

14.

BESPONSA (inotuzumab ozogamicin) for injection, for intravenous use [full prescribing information]. Initial U.S. Approval: 2017. Revised: 03/2018. Pfizer, New York, NY. http://labeling.pfizer.com/ShowLabeling.aspx?id=9503&format=PDF. Accessed 1 June 2018.

15.

European Medicines Agency. BESPONSA Assessment Report. https://www.ema.europa.eu/documents/assessment-report/besponsa-epar-public-assessment-report_en.pdf. Accessed 28 Jan 2019. 2017.

16.

Kantarjian H, DeAngelo D, Stelljes M, Liedtke M, Stock W, Gokbuget N, et al. Inotuzumab ozogamicin vs standard of care in patients with relapsed/refractory acute lymphoblastic leukemia: long-term results of the phase 3 INO-VATE study. American Society of Hematology (ASH) Annual Meeting & Exposition. 2017. p. 59.

17.

Song J, Ma Q, Gao W, Cong Z, Xie J, Zimmerman Z, et al. Matching-adjusted indirect comparison of blinatumomab vs. inotuzumab ozogamicin for adults with relapsed/refractory acute lymphoblastic leukemia. Adv Ther. 2018;36:1–12.

18.

Signorovitch JE, Sikirica V, Erder MH, Xie J, Lu M, Hodgkins PS, et al. Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research. Value Health. 2012;15(6):940–7.

19.

Delea TE, Amdahl J, Boyko D, Hagiwara M, Zimmerman ZF, Franklin JL, et al. Cost-effectiveness of blinatumomab versus salvage chemotherapy in relapsed or refractory Philadelphia-chromosome-negative b-precursor acute lymphoblastic leukemia from a US payer perspective. J Med Econ. 2017;20:1–23.CrossRef

20.

Weinstein MC, O’Brien B, Hornberger J, Jackson J, Johannesson M, McCabe C, et al. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices–Modeling Studies. Value Health. 2003;6(1):9–17.

21.

US Bureau of Labor Statistics. CPI-All Urban Consumers (Current Series). Medical care in U.S. city average, all urban consumers, not seasonally adjusted. https://data.bls.gov/timeseries/CUUR0000SAM?output_view=pct_12mths. Accessed 27 Nov 2018.

22.

Guyot P, Ades AE, Ouwens MJ, Welton NJ. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves. BMC Med Res Methodol. 2012;1(12):9.CrossRef

23.

Schoenfeld D. Residuals for the proportional hazards regresssion model. Biometrika. 1982;69(1):239–41.CrossRef

24.

Phillippo DM, Ades AE, Dias S, Palmer S, Abrams KR, Welton NJ. Methods for population-adjusted indirect comparisons in health technology appraisal. Med Decis Making. 2018;38(2):200–11.CrossRefPubMed

25.

Amdahl J. Package ‘flexsurvcure’ July 17, 2017. https://cran.r-project.org/web/packages/flexsurvcure/flexsurvcure.pdf. Accessed 30 June 2018.

26.

Jackson C. Package ‘flexsurv’. Flexible Parametric Survival and Multi-State Models. May 11, 2016. https://cran.r-project.org/web/packages/flexsurv/flexsurv.pdf. Accessed 30 Jan 2016.

27.

Lambert PC, Thompson JR, Weston CL, Dickman PW. Estimating and modeling the cure fraction in population-based cancer survival analysis. Biostatistics. 2007;8(3):576–94.CrossRefPubMed

28.

Rowen D, Brazier J, Young T, Gaugris S, Craig BM, King MT, et al. Deriving a preference-based measure for cancer using the EORTC QLQ-C30. Value Health. 2011;14(5):721–31.

29.

Liang KY, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73:13–22.CrossRef

30.

Sullivan PW, Ghushchyan V. Preference-Based EQ-5D index scores for chronic conditions in the United States. Med Decis Making. 2006;26(4):410–20.

31.

Barlev A, Lin VW, Song X. Burden of hospitalization in relapsed acute lymphoblastic leukemia. Curr Med Res Opin. 2016;32(7):1209–12.CrossRefPubMed

32.

Blue Cross and Blue Shield of Michigan. Medicare Advantage PPO Enhanced Benefits. Fee Schedule. https://www.bcbsm.com/content/dam/public/Providers/Documents/help/medicare-advantage-fee-schedule.pdf. Accessed 27 Nov 2018.

33.

Center for Medicare and Medicaid Services. Physician Fee Schedule Search. https://www.cms.gov/apps/physician-fee-schedule/search/search-results.aspx?Y=0&T=0&HT=0&CT=3&H1=96521&M=5. Accessed on 27 Nov 2018.

34.

National Institute for Health and Care Excellence. Single Technology Appraisal. Inotuzumab ozogamicin for treating relapsed or refracotry B-cell acute lymphoblastic leukaemia [ID893]. Committee Papers. 2017. https://www.nice.org.uk/guidance/gid-ta10091/documents/committee-papers-2. Accessed 15 June 2017.

35.

IBM Corporation. IBM Micromedex RED BOOK. http://www.micromedexsolutions.com/home/dispatch. Accessed 27 Nov 2018.

36.

Dasta JF, McLaughlin TP, Mody SH, Piech CT. Daily cost of an intensive care unit day: the contribution of mechanical ventilation. Crit Care Med. 2005;33(6):1266–71.CrossRefPubMed

37.

Zhang X, Song X, Lopez-Gonzalez L, Jariwala-Parikh K, Romanov V, Cong Z. Economic Burden of veno-occlusive disease (VOD) in patients with acute lymphoblastic leukemia (ALL) in the US. Blood. 2017;130(Suppl 1):5611.

38.

Zhang X, Song X, Lopez-Gonzalez L, Jariwala-Parikh K, Cong Z. Economic burden of hematopoietic stem cell transplantation (HSCT) in patients with acute lymphoblastic leukemia (ALL) in the US. Blood. 2017;130(Suppl 1):3376.

39.

Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, et al. Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine. JAMA. 2016;316(10):1093–103.CrossRefPubMed

40.

Martin PJ, Counts GW Jr, Appelbaum FR, Lee SJ, Sanders JE, Deeg HJ, et al. Life expectancy in patients surviving more than 5 years after hematopoietic cell transplantation. J Clin Oncol. 2010;28(6):1011–6.CrossRefPubMedPubMedCentral

41.

Stelljes M, Su Y, Fahrbach K, Vandendries E, Page V, Onyekwere U, et al. Indirect Treatment Comparison (ITC) of Inotuzumab Ozogamicin (InO) and Blinatumomab (Blina) for Relapsed or Refractory (RR) Acute Lymphoblastic Leukemia (ALL). Blood. 2017;130:2558.

42.

Chastek B, Harley C, Kallich J, Newcomer L, Paoli CJ, Teitelbaum AH. Health care costs for patients with cancer at the end of life. J Oncol Pract. 2012;8(6):75s–80s.CrossRefPubMedPubMedCentral

Title: Cost Effectiveness of Blinatumomab Versus Inotuzumab Ozogamicin in Adult Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia in the United States
Authors: Thomas E. Delea
Xinke Zhang
Jordan Amdahl
Diana Boyko
Franziska Dirnberger
Marco Campioni
Ze Cong
Publication date: 01-09-2019
Publisher: Springer International Publishing
Keywords: Acute Lymphoblastic Leukemia
Blinatumomab
Inotuzumab Ozogamicin
Published in: PharmacoEconomics / Issue 9/2019
Print ISSN: 1170-7690
Electronic ISSN: 1179-2027
DOI: https://doi.org/10.1007/s40273-019-00812-6

At a glance: The STEP trials

Springer Medicine

Cost Effectiveness of Blinatumomab Versus Inotuzumab Ozogamicin in Adult Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia in the United States

Abstract

Background and Objective

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background and Objective

Methods

Results

Conclusions

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