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Published in: Applied Health Economics and Health Policy 2/2017

01-04-2017 | Original Research Article

Budget Impact Analysis of Biosimilar Trastuzumab for the Treatment of Breast Cancer in Croatia

Authors: August Cesarec, Robert Likić

Published in: Applied Health Economics and Health Policy | Issue 2/2017

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Abstract

Background and Objective

Breast cancer is the most common cancer in women and has considerable impact on healthcare budgets and patients’ quality of life. Trastuzumab (Herceptin®) is a monoclonal antibody directed against the human epidermal growth factor receptor (HER2) for the treatment of breast cancer. Several trastuzumab biosimilars are currently in development. In 2015, trastuzumab was the drug with the highest financial consumption among all drugs in Croatia. This model estimates the 1-year budget impact of the introduction of biosimilar trastuzumab in Croatia.

Methods

A budget impact model, based on approvals for trastuzumab treatment in 2015, was developed for the introduction of biosimilars. Two biosimilar scenarios were developed: biosimilar scenario 1, based on all approvals in 2015, and biosimilar scenario 2, based on approvals after February 2015 and the reimbursement of the subcutaneous formulation of trastuzumab in Croatia. Only trastuzumab-naïve patients and drug-acquisition costs were used in the model. Uptake of biosimilar was assumed at 50 %. Scenarios were calculated with price discounts of 15, 25 and 35 %. The robustness of the model was tested by extensive sensitivity analyses.

Results

The projected drug cost savings from the introduction of biosimilar trastuzumab range from €0.26 million (scenario 2, 15 % price discount) to €0.69 million (scenario 1, 35 % price discount). If budget savings were reinvested to treat additional patients with trastuzumab, 14 (scenario 2, 15 % price discount) to 47 (scenario 1, 35 % price discount) additional patients could be treated. Sensitivity analyses showed that the incidence of breast cancer had the highest impact on the model, with a 10 % decrease in incidence leading to an 11.3 % decrease in projected savings.

Conclusion

The introduction of biosimilar trastuzumab could lead to significant drug cost savings in Croatia.
Literature
1.
go back to reference Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015;136(5):E359–86. doi:10.1002/ijc.29210.CrossRefPubMed Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015;136(5):E359–86. doi:10.​1002/​ijc.​29210.CrossRefPubMed
5.
go back to reference Zheng Z, Yabroff KR, Guy GP Jr, Han X, Li C, Banegas MP, et al. Annual medical expenditure and productivity loss among colorectal, female breast, and prostate cancer survivors in the United States. J Natl Cancer Inst. 2016;. doi:10.1093/jnci/djv382. Zheng Z, Yabroff KR, Guy GP Jr, Han X, Li C, Banegas MP, et al. Annual medical expenditure and productivity loss among colorectal, female breast, and prostate cancer survivors in the United States. J Natl Cancer Inst. 2016;. doi:10.​1093/​jnci/​djv382.
8.
go back to reference Nahta R, Yu D, Hung MC, Hortobagyi GN, Esteva FJ. Mechanisms of disease: understanding resistance to HER2-targeted therapy in human breast cancer. Nat Clin Pract Oncol. 2006;3(5):269–80. doi:10.1038/ncponc0509.CrossRefPubMed Nahta R, Yu D, Hung MC, Hortobagyi GN, Esteva FJ. Mechanisms of disease: understanding resistance to HER2-targeted therapy in human breast cancer. Nat Clin Pract Oncol. 2006;3(5):269–80. doi:10.​1038/​ncponc0509.CrossRefPubMed
9.
go back to reference Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987;235(4785):177–82.CrossRefPubMed Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987;235(4785):177–82.CrossRefPubMed
15.
go back to reference Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659–72. doi:10.1056/NEJMoa052306.CrossRefPubMed Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659–72. doi:10.​1056/​NEJMoa052306.CrossRefPubMed
17.
go back to reference Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783–92. doi:10.1056/NEJM200103153441101.CrossRefPubMed Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783–92. doi:10.​1056/​NEJM200103153441​101.CrossRefPubMed
21.
go back to reference Jakovljevic M, Gutzwiller F, Schwenkglenks M, Milovanovic O, Rancic N, Varjacic M, et al. Costs differences among monoclonal antibodies-based first-line oncology cancer protocols for breast cancer, colorectal carcinoma and non-Hodgkin’s lymphoma. J BUON. 2014;19(4):1111–20.PubMed Jakovljevic M, Gutzwiller F, Schwenkglenks M, Milovanovic O, Rancic N, Varjacic M, et al. Costs differences among monoclonal antibodies-based first-line oncology cancer protocols for breast cancer, colorectal carcinoma and non-Hodgkin’s lymphoma. J BUON. 2014;19(4):1111–20.PubMed
31.
go back to reference Im Y-H, Odarchenko P, Grecea D, Komov D, Anatoliy CV, Gupta S, et al., editors. Double-blind, randomized, parallel group, phase III study to demonstrate equivalent efficacy and comparable safety of CT-P6 and trastuzumab, both in combination with paclitaxel, in patients with metastatic breast cancer (MBC) as first-line treatment. In: ASCO Annual Meeting Proceedings; 2013. Im Y-H, Odarchenko P, Grecea D, Komov D, Anatoliy CV, Gupta S, et al., editors. Double-blind, randomized, parallel group, phase III study to demonstrate equivalent efficacy and comparable safety of CT-P6 and trastuzumab, both in combination with paclitaxel, in patients with metastatic breast cancer (MBC) as first-line treatment. In: ASCO Annual Meeting Proceedings; 2013.
35.
go back to reference Voncina L, Strizrep T. Croatia: 2009/2010 pharmaceutical pricing and reimbursement reform. Eurohealth. 2011;16(4):20–2. Voncina L, Strizrep T. Croatia: 2009/2010 pharmaceutical pricing and reimbursement reform. Eurohealth. 2011;16(4):20–2.
37.
go back to reference Montserrat M, Leveque D, Barthelemy P, Bergerat JP. Duration of adjuvant trastuzumab treatment in routine practice. Anticancer Res. 2012;32(10):4585–8.PubMed Montserrat M, Leveque D, Barthelemy P, Bergerat JP. Duration of adjuvant trastuzumab treatment in routine practice. Anticancer Res. 2012;32(10):4585–8.PubMed
38.
go back to reference Pivot X, Gligorov J, Muller V, Curigliano G, Knoop A, Verma S, et al. Patients’ preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol. 2014;25(10):1979–87. doi:10.1093/annonc/mdu364.CrossRefPubMed Pivot X, Gligorov J, Muller V, Curigliano G, Knoop A, Verma S, et al. Patients’ preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol. 2014;25(10):1979–87. doi:10.​1093/​annonc/​mdu364.CrossRefPubMed
39.
go back to reference Ismael G, Hegg R, Muehlbauer S, Heinzmann D, Lum B, Kim SB, et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012;13(9):869–78. doi:10.1016/S1470-2045(12)70329-7.CrossRefPubMed Ismael G, Hegg R, Muehlbauer S, Heinzmann D, Lum B, Kim SB, et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012;13(9):869–78. doi:10.​1016/​S1470-2045(12)70329-7.CrossRefPubMed
47.
go back to reference Godman B, Kwon H-Y, Brkičić LS, Bogut M, Sršen M, Tabain T et al. Pharmaceutical pricing in Croatia: a comparison of ordinances in 2013 versus 2009 and their potential savings to provide future guidance. Generics Biosimilars Initiat J (GaBI J). 2015;4(2):79–89. doi:10.5639/gabij.2015.0402.017.CrossRef Godman B, Kwon H-Y, Brkičić LS, Bogut M, Sršen M, Tabain T et al. Pharmaceutical pricing in Croatia: a comparison of ordinances in 2013 versus 2009 and their potential savings to provide future guidance. Generics Biosimilars Initiat J (GaBI J). 2015;4(2):79–89. doi:10.​5639/​gabij.​2015.​0402.​017.CrossRef
48.
go back to reference Brodszky V, Baji P, Balogh O, Pentek M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ. 2014;15(Suppl 1):S65–71. doi:10.1007/s10198-014-0595-3.CrossRefPubMed Brodszky V, Baji P, Balogh O, Pentek M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ. 2014;15(Suppl 1):S65–71. doi:10.​1007/​s10198-014-0595-3.CrossRefPubMed
54.
go back to reference Jackisch C, Kim SB, Semiglazov V, Melichar B, Pivot X, Hillenbach C, et al. Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study. Ann Oncol. 2015;26(2):320–5. doi:10.1093/annonc/mdu524.CrossRefPubMed Jackisch C, Kim SB, Semiglazov V, Melichar B, Pivot X, Hillenbach C, et al. Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study. Ann Oncol. 2015;26(2):320–5. doi:10.​1093/​annonc/​mdu524.CrossRefPubMed
58.
go back to reference Mack A. Norway, biosimilars in different funding systems. What works. 2015:90-2. Mack A. Norway, biosimilars in different funding systems. What works. 2015:90-2.
59.
go back to reference Yin D, Barker KB, Li R, Meng X, Reich SD, Ricart AD, et al. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01). Br J Clin Pharmacol. 2014;78(6):1281–90. doi:10.1111/bcp.12464.CrossRefPubMedPubMedCentral Yin D, Barker KB, Li R, Meng X, Reich SD, Ricart AD, et al. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01). Br J Clin Pharmacol. 2014;78(6):1281–90. doi:10.​1111/​bcp.​12464.CrossRefPubMedPubMedCentral
62.
go back to reference Lammers P, Criscitiello C, Curigliano G, Jacobs I. Barriers to the use of trastuzumab for HER2+ breast cancer and the potential impact of biosimilars: a physician survey in the United States and emerging markets. Pharmaceuticals 2014;7(9):943–53.CrossRefPubMedPubMedCentral Lammers P, Criscitiello C, Curigliano G, Jacobs I. Barriers to the use of trastuzumab for HER2+ breast cancer and the potential impact of biosimilars: a physician survey in the United States and emerging markets. Pharmaceuticals 2014;7(9):943–53.CrossRefPubMedPubMedCentral
Metadata
Title
Budget Impact Analysis of Biosimilar Trastuzumab for the Treatment of Breast Cancer in Croatia
Authors
August Cesarec
Robert Likić
Publication date
01-04-2017
Publisher
Springer International Publishing
Published in
Applied Health Economics and Health Policy / Issue 2/2017
Print ISSN: 1175-5652
Electronic ISSN: 1179-1896
DOI
https://doi.org/10.1007/s40258-016-0285-7

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