Pharmacoeconomics: theory and practice
№3, 2015, Vol.3

Kulikov A.Y., Ugrekhelidze D.T. 5422

Pharmacoeconomic study of different preparations of botulinum toxin type A used for the treatment of cerebral palsy in terms of health of the Russian Federation was conducted. The aim of this study was to determine the most appropriate therapy of cerebral palsy from the pharmacoeconomic point of view. We compared three regimens: botulinum toxin type A - Dysport® in combination with standard therapy, botulinum toxin type A - Botox® in combination with standard therapy and standard therapy without the use of botulinum toxin. It should be noted that centrally acting muscle relaxant (Baclofen) was used in standard therapy, but BTA in this treatment scheme is not used to eliminate unwanted relaxation of the muscles. As a result, it was found that the regimen Dysport®+standard therapy has the lowest cost-effectiveness ratio (11 608 rubles) in comparison with drug therapy Botox®+standard therapy (12 879 rubles) and standard therapy with a centrally acting muscle relaxant without BTA (25 222 rubles) by the end of 2 years of treatment. According to the budget impact analysis at the end of 2 years for 1 patient the scheme Dysport®+standard therapy was the least expensive form of therapy (1 079 500 rubles) in comparison with therapy Botox®+standard therapy (1 159 085 rubles) and standard therapy with a centrally acting muscle relaxant without BTA (1 210 678 rubles).

Melik-Guseynov D.V. 4554

The market entry of modern recombinant blood coagulation factors VIII have brought the quality and safety of medical help for hemophilia A patients to a higher level. Before 2015 only full-length recombinant blood coagulation factor VIII (INN octocog alfa) was available to patients within the framework of the federal reimbursement program “7 Nosologies”, while in 2015 the first B-domain deleted recombinant factor VIII (INN moroctocog alpha) was included in the program for the first time and also became available to patients. During the analysis of clinical and economic characteristics of these drugs it was found that the cost of treatment with full-length factor VIII is lower than with B-domain deleted factor VIII due to lower risk of inhibitor development and clinically-proven reduction in bleeding frequency on prophylaxis in fulllength recombinant factor VIII, as well as to higher consumption of B-domain deleted factors for effective bleeding prophylaxis. As a consequence, clinically unreasonable patient switching from full-length to B-domain deleted factors requires “7 Nosologies” budget increase comparing to 2014.

Abdrashitova G.T., Serpik V.G., Yagudina R.I. 5065

In the framework of the presented study, we have performed a pharmacoeconomic analysis of medical care for chronic kidney disease patients who need renal replacement therapy via peritoneal dialysis and hemodialysis. The study results demonstrates that the aggregate costs of peritoneal dialysis therapy, on the average, are lower than those of hemodialysis by 12 % due to the lower costs of treatment of the chronic kidney disease and renal replacement therapy related complications and lower indirect costs due to longer preservation of the capacity for work. Peritoneal dialysis demonstrated higher clinical effectiveness and lower aggregate costs and, as consequence, lower cost-utility ratio, i.e. demonstrated the advantages over hemodialysis.

Komarov E.A., Kulikov A.Y., Pochuprina A.A. 4616

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease, which, in the cases of high activity, results in extensive damage to various tissues and organs, as well as promotes early patient disability. Most drugs used for the treatment of SLE are currently prescribed off-label, since this specific indication is not reflected in their prescribing information. At the same time, the advent of belimumab (Benlysta®), an innovative biological product for the treatment of SLE, which represents the most severe connective tissue disorder, provided patients with an access to a highly effective targeted therapy, which specifically impacts one of the main mechanisms of the disease. The innovative and proprietary product, Belimumab, has a relatively high cost, which, as the healthcare budget is restricted, requires that a pharmacoeconomic evaluation be completed of combined use of belimumab with standard of care (SoC) versus SoC alone. The present study showed that the use of belimumab combined with SoC in patients with SLE was, clearly, associated with additional costs compared to SoC alone. However, given low incidence of the condition, the overall increase in costs is unlikely to be significant. On the other hand, it was noted that the high belimumab efficacy resulted in lower direct costs of treating the SLE (cardiovascular, cutaneous, and pulmonary) complications, as well as the costs of hospital care. A comparative analysis has demonstrated that the annual cost of treatment with belimumab was similar to the cost of other genetically engineered biological products, which have already been included into the List of Vital and Essential Drugs used for rheumatic diseases, particularly rheumatoid arthritis. In this view, the use of belimumab, which represents the only targeted drug for SLE, could be considered during the review of policy for subsidised drug provision to patients with this condition.

Kulikov A.Y., Strunina (Rybchenko) Y.V. 4471

Currently, in treatment of patients with urothelial transitional cell carcinoma resistant to platinum-based regimen, only Javlor (vinflunine) shows the best evidence when using in second-line chemotherapy scheme. Vinflunine shows the advantage over best supportive care during a randomized Phase III study. The aim of this study is to compare Javlor therapy in combination with the best supportive therapy and the best supportive therapy alone in terms of pharmacoeconomic analysis. Budget impact analysis shows that the treatment of urothelial transitional cell carcinoma with Javlor requires additional expenses. Cost-effectiveness analysis shows that the ICER does not exceed “willingness-to-pay” threshold which means that from the point of view of incremental analysis the therapy in patients with urothelial transitional cell carcinoma using Javlor is cost-effective.

Kulikov A.Y., Novikov I.V. 4756

Study purpose: to determine whether canagliflozin is a pharmacoeconomically justified option to be included into therapy for patients with insufficient glycemic control and treated with metformin either as monotherapy administered in the maximum tolerated dose or as a part of a combined therapy with sulfonylurea derivatives taking into account the conditions existing in the Russian Federation.

Tishchenko D.G., Yagudina R.I. 4704

This document represents the results of validation of pharmacoeconomic model of introduction of medicinal product Ibrutinib into chronic lymphatic leukemia therapy practice within the programme of drug provision for patients with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, haematopoietic and related tissues, multiple sclerosis, as well as patients after transplantation of organs and/or tissues (hereafter referred to as ‘7 cost-intensive nosologies (7 CIN) programme’). Budget impact analysis demonstrated the possibility to provide all patients requiring Ibrutinib therapy without budget increase using only a part of savings within the programme during a period of 2016 – 2018.

Kulikov A.Y., Pochuprina A.A. 5670

Recent market entry of disease-modifying anti-rheumatic drugs (DMARDs) for patients with rheumatoid arthritis (RA) who had an inadequate response to methotrexate in Russia has secured patient access to highly effective treatment options. Access to effective treatment options are of particular importance for highly prevalent conditions with early function impairment such as RA. Innovative medicines, such as DMARDs, are however typically characterized by high treatment costs and require pharmacoeconomic assessment as part of the decision making process regarding federal reimbursement. In the present study, adaptation of an Italian health economic model was performed with the aim to compare cost-efficacy of subcutaneous abatacept versus adalimumab from the Russian Federation national health care system perspective. Clinical efficacy data as well as patient characteristics were based on the AMPLE trial patient population, which was a direct headto-head comparison of subcutaneous abatacept and adalimumab in RA. The time horizon was set at 2 years, which corresponds with the length of the AMPLE study. Direct medical costs included pharmaceutical costs based on the registered maximum selling prices, cost of adverse event treatment, outpatient and inpatient treatment, and diagnostic and laboratory monitoring costs (Rubles, 2015). Results showed that the total 2-year costs of treating 100 patients were 143,750,205.87 rubles for abatacept compared with 165,749,479.26 rubles for adalimumab, at a total cost-savings of treating an entire cohort with abatacept equal to 21,999,273.38 rubles or 219,992.73 rubles per patient. The cost-effectiveness ratios across all disease activity measures (ACR 20, 50, 70, 90; DAS-28; HAQ-DI; CDAI; SDAI) demonstrated that abatacept compared to adalimumab had a lower cost per health outcome. Therefore, from a pharmacoeconomic point of view, subcutaneous abatacept is most likely a preferable alternative compared with adalimumab for the treatment of RA patients in the Russian Federation.

Zinchuk I.Y., Kulikov A.Y. 4671

The study established a superior clinical efficacy in bleeding episodes relieving, and the health care resources saving in contrast with the current treatment regimen, when patients with von Willebrand disease Haemate P treatment receive. Thus, Haemate P shows pharmacoeconomic advantage over current treatment regimen of von Willebrand disease, which includes coagulation factor VIII drugs, as well as Wilate pharmacotherapy, as the most effective and cheap treatment scheme.

Kulikov A.Y., Ugrekhelidze D.T., Yagudina R.I. 4780

In this paper, the main methodological aspects of the willingnessto-pay analysis are highlighted. The values of the willingness-to-pay threshold according to the methodology of the World Health Organization are calculated, the ones of the Russian Federation and the countries of the Group of Twenty and the Commonwealth of Independent States were compared. The international experience of the calculation of willingness-to-pay threshold is covered. Advantages and disadvantages of various methods of calculation of the willingness-to-pay threshold are presented.