Oncology monoclonal antibodies expenditure trends and reimbursement projections in the emerging Balkan market
DOI:
https://doi.org/10.7175/fe.v15i1.909Keywords:
Monoclonal antibodies, Pharmaceutical expenditure, ReimbursementAbstract
Monoclonal antibodies applied in clinical oncology present a therapeutic promise for many patients with cancer. Nevertheless these expensive protocols are associated with extremely high acquisition and administration costs. The issue of societal affordability of such treatment options is particularly at stake among middle income European economies. Medicines Agency of Serbia issues regular annual reports on public expenditure on pharmaceuticals since 2004. According to these official data total public expenditure on drugs doubled from 2004-2012 (from € 339,279,304 to € 742,013,976). During the same nine years public expenditure on antineoplastic pharmaceuticals was rising at much faster pace, approximately five times from € 10,297,616 in 2004 to € 51,223,474 in 2012. Absolutely record growth belongs to the value of turnover of monoclonal antibodies indicated in diverse malignancies. These costs became almost twenty times higher in 2012 compared to 2004 (€ 19,687,454 towards € 1,033,313 in the past). National pharmaceutical expenditure trend projections in this country show strong recovery in 2012 after severe blow to the overall health care market imposed by the worldwide crisis. Universal health insurance coverage and sustainable health care financing provision will remain difficult issues for Balkan economies in years to come. Although monoclonal antibodies exhibit undisputed therapeutic efficiency in certain malignant disorders, cost-effectiveness estimates must be taken into consideration by policy makers deciding on reimbursement.
References
Ess SM, Schneeweiss S, Szucs TD. European healthcare policies for controlling drug expenditure. Pharmacoeconomics 2003; 21: 89-103; http://dx.doi.org/10.2165/00019053-200321020-00002
Ferlay J, Autier P, Boniol M, et al. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol 2007; 18: 581-92; http://dx.doi.org/10.1093/annonc/mdl498
Grossman M. The human capital model. In: Culyer AJ, Newhouse JP, editors. Handbook of health economics. Vol. 1A. Amsterdam: Elsevier, 2000; 347-408
Uyl-de Groot CA, de Groot S, Steenhoek A. The economics of improved cancer survival rates: better outcomes, higher costs. Expert Rev Pharmacoecon Outcomes Res 2010; 10: 283-92; http://dx.doi.org/10.1586/erp.10.27
Jakovljevic M, Rankovic A, Racic N, et al. Radiology Services Costs and Utilization Patterns estimates in Southeastern Europe – A Retrospective Analysis from Serbia. ViHRI 2013; 2: 218-25
Ranković A, Rancić N, Jovanovic M, et al. Impact of imaging diagnostics on the budget--are we spending too much? Vojnosanit Pregl 2013; 70: 709-11
von Mehren M, Adams GP, Weiner LM. Monoclonal antibody therapy for cancer. Annu Rev Med 2003; 54: 343-69; http://dx.doi.org/10.1146/annurev.med.54.101601.152442
Farid SS. Process economics of industrial monoclonal antibody manufacture. J Chromatogr B Analyt Technol Biomed Life Sci 2007; 848: 8-18; http://dx.doi.org/10.1016/j.jchromb.2006.07.037
Scolnik PA. mAbs: a business perspective. MAbs 2009; 1: 179-84; http://dx.doi.org/10.4161/mabs.1.2.7736
Ziegelbauer K, Light RD. Monoclonal antibody therapeutics: Leading companies to maximise sales and market share. J Commerc Biotechnol 2008; 14: 65-72; http://dx.doi.org/10.1057/palgrave.jcb.3050081
Tirelli U, Berretta M, Bearz A, et al. Grouping of molecularly targeted anti-cancer agents based on cost-effectiveness analysis. Eur Rev Med Pharmacol Sci 2011; 15: 1355-6
Wild F. Increases in pharmaceutical expenditures of PHI by monoclonal antibodies. Versicherungsmedizin 2013; 65: 91-3
Neyt MJ, Albrecht JA, Clarysse B, et al. Cost-effectiveness of Herceptin:a standard cost model for breast-cancer treatment in a Belgian university hospital. Int J Technol Assess Health Care 2005; 21: 132-7; http://dx.doi.org/10.1017/S0266462305050178
Brodszky V, Orlewska E, Pentek M, et al. Challenges in economic evaluation of new drugs: experience with rituximab in Hungary. Med Sci Monit 2010; 16: SR1-5
Kos M, Obradovic M, Mrhar A. Accessibility to targeted oncology drugs in Slovenia and selected European countries. Eur J Cancer 2008; 44: 408-18; http://dx.doi.org/10.1016/j.ejca.2007.11.020
Jakovljevic MB. Resource allocation strategies in Southeastern European health policy. Eur J Health Econ 2013; 14: 153-9; http://dx.doi.org/10.1007/s10198-012-0439-y
Jakovljevic M, Jovanovic M, Lazic Z, et al. Current efforts and proposals to reduce healthcare costs in Serbia. Ser J Exp Clin Res 2011; 12: 161-3; http://dx.doi.org/10.5937/sjecr1104161J
Bogdanovic L, Savic S, Basta-Jovanovic G, et al. Death caused by undiagnosed primary intracranial neoplasmas-an autopsy study. Rom J Leg Med 2011; 19: 107-10; http://dx.doi.org/10.4323/rjlm.2011.107
Institute of Public Health of Serbia. Health Statistical Yearbook of Republic of Serbia 2011. Belgrade, 2012. Available at: http://www.batut.org.rs/download/publikacije/pub2011.pdf (last accessed February 2014)
Institute of public health of Serbia “Dr Milan Jovanovic Batut”. Cancer incidence and mortality in central Serbia. Report No. XII, Belgrade, 2012. Available at: http://www.batut.org.rs (last accessed February 2014)
Chiesa F, Tradati N, Calabrese L, et al. Thyroid disease in northern Italian children born around the time of the Chernobyl nuclear accident. Ann Oncol 2004; 15: 1842-6; http://dx.doi.org/10.1093/annonc/mdh477
Papathanasiou K, Gianoulis C, Tolikas A, et al. Effect of depleted uranium weapons used in the Balkan war on the incidence of cervical intraepithelial neoplasia (CIN) and invasive cancer of the cervix in Greece. Clin Exp Obstet Gynecol 2005; 32: 58-60
Jakovljevic M, Riegler A, Jovanovic M, et al. Serbian and Austrian alcohol-dependent patients: a comparison of two samples regarding therapeutically relevant clinical features. Alcohol Alcohol 2013; 48: 505-8; http://dx.doi.org/10.1093/alcalc/agt011
Medicines and Medicals Devices Agency of Serbia. Preparation of Professional Publications of the Agency. Belgrade,2014. Available at: http://www.alims.gov.rs/eng/about-agency/publication (last accessed February 2014)
WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index. Available at: http://www.whocc.no/atc_ddd_index/?code=L01XC (last accessed February 2014)
Shih YC, Elting LS, Pavluck AL, et al. Immunotherapy in the initial treatment of newly diagnosed cancer patients: utilization trend and cost projections for non-Hodgkin’s lymphoma, metastatic breast cancer, and metastatic colorectal cancer. Cancer Invest 2010; 28: 46-53; http://dx.doi.org/10.3109/07357900902783187
Tetsuji Y, Chen CC, Hanaoka C, et al. Challenges of healthy lifestyle, health disadvantages, and justice in aging: International comparison. 141st APHA Annual Meeting. Boston, 2013
Jakovljevic M, Matter-Walstra K, Gutzwiller F, et al. Resource use and costs of newly diagnosed cancer initial medical care. Submitted to European Journal of Cancer Care
Jakovljevic M, Gutzwiller F, Schwenkglenks M, et al. Costs differentials among mAbs-based first-line oncology treatment protocols for breast cancer, colorectal Carcinoma and non-Hodgkin’s lymphoma. Submitted to Targeted Oncology
Jelic M, Jovanovic D, Popovic L, et al. Monoclonal antibodies at the Oncology Institute of Vojvodina: 5-year expenditure. Arch Oncol 2012; 20: 53-6; http://dx.doi.org/10.2298/AOO1204053J
Beck E. Global pharma market outlook. IMS Health. Available at: http://www.apteka.ua/wp-content/uploads/2013/09/8-EBeck.pdf (last accessed February 2014)
Radovanovic A, Dagovic A , Jakovljevic M. Economics of cancer related medical care: estimates worldwide and available domestic evidence. Arch Oncol 2011; 19: 59-63; http://dx.doi.org/10.2298/AOO1104059R
Gulácsi L. Future challenges for health economics and health technology assessment of biological drugs. Eur J Health Econ 2010; 11: 235-8; http://dx.doi.org/10.1007/s10198-010-0246-2
Simoens S, Rijdt DT, Declerck P. Monoclonal antibodies: indications, budget impact and use. JPRHC 2010; 1: 123-30
Jakovljevic M, Vukovic M, Chia-Ching C, et al. Do Policy Measures Impact on Cost Consciousness of Health Care Professionals? ISPOR 16th European Meeting. Dublin, 2013
Malik NN. Controlling the cost of innovative cancer therapeutics. Nat Rev Clin Oncol 2009; 6: 550-2; http://dx.doi.org/10.1038/nrclinonc.2009.113
Jakovljevic M, Nakazono S, Ogura S. Contemporary generic market in Japan – key conditions to successful evolution. Expert Rev Pharmacoecon Outcomes Res 2014; 14: 181-94; http://dx.doi.org/10.1586/14737167.2014.881254
Knezevic I, Griffiths E. Biosimilars – global issues, national solutions. Biologicals 2011; 39: 252-5; http://dx.doi.org/10.1016/j.biologicals.2011.09.005
Konski FA. Generic Biologics – A Comparative Analysis of Regulatory Review. BioProcess International 2011; 9: 34-9
Akiyama S. Specific adverse events caused by monoclonal antibodies, focusing on the prophylaxis and management. Nihon Rinsho 2012; 70: 2199-204
Chabot I, Rocchi A. How do cost-effectiveness analyses inform reimbursement decisions for oncology medicines in Canada? The example of sunitinib for first-line treatment of metastatic renal cell carcinoma. Value Health 2010; 13; 837-45; http://dx.doi.org/10.1111/j.1524-4733.2010.00738.x
Tetsuji Y, Chen CC, Tadashi Y, I-Ming Chiu and John D. Worrall Pharmaceutical Price Control Policy, Pharmaceutical Innovation, and Health Durability. TOPHARMEJ 2010; 2: 34-46
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