Colorectal cancer (CRC) is an actual medical problem of the Russian Health Care system due to high morbidity and mortality rates. Despite the arrival of newer anti-cancer agents in the second-line setting for CRC treatment during the last years, no Health Technology Assessments (HTA) were preformed for modern agents. Aim: HTA of second line chemotherapy for metastatic CRC (mCRC) with a new anti-cancer agent afl ibercept in combination with chemotherapy regimen FOLFIRI during the short- and long-term perspectives for the Government Health Care System. Methods. Markov’s modelling has been performed based on published data of VELOUR study with 30-months horizon for two strategies of treatment: afl ibercept+FOLFIRI and FOLFIRI only for prognosis of effi cacy establishing. Overall survival (OS), time to progression (TTP) and QALY were used for effi cacy criteria defi nition. Cost-eff ectiveness analysis, including incremental, has been performed and results were compared with willingness to pay (WTP) parameter. Cost of chemotherapy, side eff ects correction, as well as expenditures for treatment in case of second line failure, have been calculated for both technologies. Costs were allowed by Governmental Health Care System expenditures. Results. It was concluded that afl ibercept+FOLFIRI is more eff ective vs FOLFIRI on all parameters of effi cacy (for OS — by 12%, for TTP — by 16%, for QALY — by 26%). CER`s for OS parameter were RUR 322 348 for afl ibercept+FOLFIRI and RUR 253 685 for FOLFIRI only (NS). For TTP parameter based on 30-months horizon ICER for afl ibercept+FOLFIRI was RUR 994 039, it was 1,35 times less than WTP. ICER for QALY was diff erent from such kind for OS and TTP. Total expenditures for 30-months modelling horizon for FOLFIRI were less by 42% due to add of afl ibercept cost in the calculation. Cost of treatment in case of second line failure was 78% of the total structure of expenditures for FOLFIRI and only 56% for afl ibercept+FOLFIRI. Probabilistic sensitivity analysis has been performed by multiplex changes of effi cacy parameters and costs of afl ibercept+FOLFIRI and FOLFIRI only and has confi rmed that afl ibercept+FOLFIRI is more eff ective and more expensive scheme. Conclusion. Second line strategy of mCRC chemotherapy with afl ibercept+FOLFIRI is more cost-eff ective vs FOLFIRI for OS and TTP criteria. When compared with afl ibercept+FOLFIRI, with FOLFIRI use, the treatment costs rise as a result of decreased effi cacy. Afl ibercept+FOLFIRI meets the criteria of WTP and is reasonable for reimbursement on Governmental level.

Chronic obliterating diseases of lower limb arteries is a large group of socially significant diseases, characterized by persistent chronic progress, high probability of disabling complications as well as the emergence needs for expensive surgical treatment. This disease characterized by the association with other diseases of the cardiovascular system, making the conservative therapy especially relevant. Aim. To perform the pharmacoeconomic analysis (PHe) of the naft idrofuryl in the Russian Federation (RF) in patients aged 66 years and older with peripheral vascular disease, including atherosclerosis of the lower limbs arteries and the clinical picture, corresponding to Stage II of Fontaine. Methodology. Th is PHe is conducted perspective of public health organizations of the RF and considers only direct medical costs. Horizon of PHe adopted for 240 weeks (4.6 years). The source of data on the clinical eff ectiveness was taken from randomized controlled trials and meta-analyzes, which examined the efficacy, safety and tolerability comparable drugs. For criteria of clinical efficacy has been chosen the mean log expression of the maximum distance walk. As a criterion of utility were calculated the quality adjusted life years (QALY). In developed Markov model, the time horizon was broken down into a cycle of length for 1 week. On the basis of existing government standard of care was the assessment of costs in health care system for diagnosis and treatment in simulated groups, taking into consideration the cost of angioplasty. It was conducted cost-eff ectiveness (CEA), cost-utility (CUA), budget impact (BIA) and sensitivity analysis (SA), calculated cost-eff ectiveness threshold. Result. CER per patient at naft idrofuryl was 2,061 rubl., at pentoxifylline — 4,764 rubl. Since naft idrofuryl is not only superior to pentoxifylline in clinical effectiveness, but also was associated with a lower cost, the calculation of the ICER not needed. PHe show that CER per patient did not exceed the «willingness-to-pay ratio» none of the drugs, thus both of the drugs is relevant to reimbursement system. CUA demonstrated superiority naft idrofuryl both in terms of the net impact on the QALY, and in terms of utility costs (CUR), CUR of naft idrofuryl per patient totaled 144,992 rubl., pentoxifylline — 213,854 rubl. SA confi rmed the stability of these results. Analysis of BIA shows that the fi scal burden associated with naft idrofuryl, is lower by 183,9 million rubl. per year for every 3,000 treated patients on pentoxifylline, which can allow one to treat 1,321 patients more via a naft idrofuryl based therapeutic strategy. Conclusion. Excellence naft idrofuryl over pentoxifylline confi rmed in this pharmacoeconomic study. Naft idrofuryl dominates in terms of CER, CUR and reduce budget impact.

Rheumatoid arthritis (RA) is an autoimmune disease with unknown etiology that is characterized by chronic, erosive arthritis (synovitis), usually affecting more than five joints, and systemic impairment of internal organs. It usually leads to irreversible functional impairment of affected joints, and systemic inflammatory changes. The main goal of therapeutic strategies for RA focuses on preserving quality of life by suppressing the inflammation, preventing structural alteration of joints and other clinical manifestations, normalization of patient’s social functioning. Genetically engineered biological response modifi ers (GEBRM) are a class of drugs that allow the aforementioned results to be attained in patients who have not obtained the required clinical response from other therapeutic approaches. One of the modern GEBRM that have performed well in clinical trials is tocilizumab, which is available in both subcutaneous and intravenous formulation. Currently, not only clinical efficacy and safety, but also pharmacoeconomic expediency of a treatment regimen must be evaluated, which is the goal of current investigation. Aim. To assess the respective pharmacoeconomic performances of subcutaneous and intravenous forms of tocilizumab in Russian patients suff ering from RA. Methodology. A decision-tree model was constructed for this pharmacoeconomic analysis based on Russian healthcare standards and clinical practice. Each modelled group contained 1000 patients. The analysis was performed from the point of view of Russian healthcare system within context of Mandatory Medical Insurance system. Randomized controlled clinical trials investigating safety and effi cacy of analyzed drugs were used as source of efficacy and safety data. Time horizon of pharmacoeconomic analysis was set at 1 year. Clinical response per American college of rheumatology criteria and proportion of patients achieving remission or low activity of RA per DAS28 score were used as efficacy criteria. Safety criteria used were adverse event (AE) frequency and frequency of discontinuation due to AEs. Existing Russian RA treatment standard was used to calculate the healthcare resources utilization parameters. Modelling results were used to carry out Cost Minimization Analysis (CMA) and Budget Impact Analysis (BIA). Single-factor sensitivity analysis (SA) was used to ensure the results are robust to changes in market situation. Result. CMA factor has been determined to be -68 347 289 rubles in favor of subcutaneous tocilizumab, which indicates significant reduction of costs when using this drug form. Furthermore, BIA, when performed for 100 000 of Russian population indicates a 5.4% reduction of budgetary burden (which equals 17 155 170 rubles per 100 000 of population or 68 347 per patient). SA has proven that results are robust to price fl uctuations of up to 5%, which is a good result for a high-cost pharmaceutical. Conclusion. Use of subcutaneous form of tocilizumab results in cost reduction of 68 347 289 rubles, decreases the budgetary burden by 5,4% (17 155 170 rubles per 100 000 of Russian population). This indicates that use of subcutaneous tocilizumab for therapy of RA in Russian Federation is pharmacoeconomically justified.

Aim of the study: Determine the validity of alogliptin choice in comparison with other DPP-4 inhibitors, available in Russia (saxagliptin, linagliptin, vildagliptin, sitagliptin) for add-on treatment in patients with inadequate glycemic control on metformin monotherapy, basing on pharmacoeconomic analysis Methodology. Retrospective modeling was performed according to standard pharmacoeconomic methods: cost-minimization analysis, cost-effectiveness analysis (CEA), cost-utility analysis (CUA) and sensitivity analyzes. To predict the long-term impact of the compared therapies on CUA results, a Markov model with 10-year simulation horizon has been used. Results. CEA results showed that lowering HbA1C level by 1% using alogliptin was less expensive than using other agents of the group (sitagliptin, vildagliptin, saxagliptin, linagliptin). The calculated cost per QALY gained for alogliptin therapy was 27 150 rubles, which made the use of alogliptin cost-effective. Conclusions. Alogliptin is a cost-effective alternative in comparison with any other DPP-4 inhibitors (sitagliptin, vildagliptin, saxagliptin, linagliptin) for adding to unsuccessful metformin monotherapy.

Usage of glucagon like peptide-1 receptors’ agonists (aGLP-1) is a new step in the treatment of Diabetes Mellitus Type 2 (DM 2). General attractive effects are positive effect on bodyweight, lower risk of hypoglycemia, compliance and possibility of combination with insulin or it’s analogues etc. Clinical-economic analysis of Lixisenatide in combination with insulin glargine has been performed for evaluation of reasons for state or insurance budgeting. Methods: Model of DM 2 has been used for comparison of Direct Costs (DC) of glargine+lixisenatid and basal bolus glargine+glulisine, detemir+aspart, glargine+aspart, glargine+lispro, detemir+lispro, detemir+glulisis as well as with combnations of metformin with exenatide or liraglutide. Efficacy criteria were amount of patient-years without complications during one-year period and amount of patient-years with targeted HbA1c level. Calculation cost has included: expenditures on pharmacotherapy of DM2 and complications, costs of out-patients aid, emergency and hospital treatment. Cost-efficacy ratio and incremental cost-efficacy rate as well Budget Impact have been performed. Results: Highest DC based on 2-year horizon of modelling were calculated for detemir+aspart -277 356 RUR, DC for glargine+lixisenatide was less on 5,6%. Costs of aGLP-1 and insulins were different, and expenditures on hypoglycemia too. Thus detemir+aspart were most expensive 77 763 RUR. Also in this group treatment of hypoglycemia was very costly. CERs (cost- effectiveness ratios) were 2 456 RUR, 3 752 RUR and 3 980 RUR. for glargine+glulisine, glargine+lixisenatide and detemir+aspart accordingly. Highest level of DC has been done for detemir+glulisine 281 628 RUR and detemir+lispro 278 744 RUR. Lixisenatide has led to insulin (glargine) dose reduction in compare with other combinations that reflected in less cost (54 186 RUR for glargine vs 81 289 RUR for detemir+glulisine during 2 years). Amount of patient-years with targeted level of HbA1c was the same in different treatment options but scheme glargine+lixisenatide was less costly DC among schemes with another aGLP-1 was less in glargine+lixisenatide on 65% in compare with metformin+liraglutide (741 531 RUR with 2-years of modelling horizon). Conclusion: Scheme glargine+lixisenatide more cost-saving regimen in compare with metformin+exenatide, metformin+liraglutide, detemir+short acting insulin analogues Scheme glargine+lixisenatide has not benefits in compare with glargine+glulisin but has less hypoglycemia level. Glargine+lixisenatide is an economic appropriate scheme for state (insurance) budgeting.

Breast cancer is one of the most wide spread oncological disease and metastatic breast cancer is very severe, because of its high resistance. One of the recent drugs aimed for this group of patients is еribulin, which is microtubules dynamics inhibitor, leading to non-functional tubuline complex formation. Statistically relevant and clinically signifi cant еribulin action according to total survival was approved among HER2-negative and triple negative breast cancer. Eribulin is the only cytostatic approved as a monotherapy that leads to relevant and significant life prolongation among metastatic breast cancer patients, who had several regimens of therapy before.

Aim. To determine budget impact and life years saved aft er adding Halaven® (еribulin) to the offi cial lists for metastatic breast cancer treatment.

Methodology. Th is PHe was conducted according to standart implemented in the RF. All the breast cancer patients according to the state statics were included. The modelling horizon was 5 years. Drugs comparison are docetaxel, paclitaxel, kapezitabine, gemzitabine, vinorelbine, eribulin. Randomized controlled clinical trials investigating safety and effi cacy of these drugs, as well as performing head-to-head comparisons of some of them, were used as data source on safety and efficacy. A «decision tree» model was then constructed in order to estimate healthcare costs and patients outcomes. Two parameters were chosen as criteria for eff ectiveness assessment — overall survival and survival without progression. The results were used to perform Budget Impact Analysis (BIA) and evaluation of phramacoeconomic expediency and health impact.

Results. Eribulin instead of standart therapy prolongs the patients’ life for 76 days. Budget impact analysis was performed to the terms of the treatment and adverse events correction. The profit of the eribulin treatment for every patient was 462858 rubles for 5 years or 5.59% of the budget impact. Sensitivity analysis confirms result stability, however, when price increase reaches 25%, the profit is 321356 rubles or 3.85% of the budget impact.

Conclusion. It has been determined that eribulin is the most clinically and economically effective drug for metastatic breast cancer after 2nd line chemotherapy with the lowest budgetary burden.