Criteria for evaluation of clinical efficacy make it possible to assess the risk-benefit ratio of anticancer medicines that patients receive, in particular, for the treatment of solid malignant tumors. A medicine’s efficacy is assessed using special criteria called the endpoints of clinical efficacy, allowing most objective assessment of study results. It was demonstrated that nowadays clinical efficacy of anticancer drugs is assessed using «patient-centered» (overall survival and quality of life) and «tumor-centered» (response to therapy, progression-free survival, disease-free survival) endpoints. «Patient-centered» endpoints make it possible to evaluate the direct clinical benefit of chemotherapy in patients, while «tumor-centered» endpoints allow for evaluation of efficacy at earlier stages, without directly reflecting the clinical benefit. The analysis of the most suitable endpoints with the aim of making them interchangeable with the primary outcome measure – overall survival – is becoming more and more relevant in oncology. The choice of criteria of efficacy should be made taking into account the specific features of a particular oncological disease, study population and duration of therapy. The authors of the study analysed Russian and foreign literary sources containing information on criteria of efficacy of anticancer medicines and highlighted the advantages and disadvantages of these criteria. The study showed that clinical endpoints should be clinically significant, sensitive to therapy, easy to measure and interpret. It was demonstrated that comprehensive evaluation of outcome measures makes it possible to adequately assess the risk-benefit ratio of anticancer medicines.

Новые вызовы, с которыми столкнулся мир в 2020 г., определенные пандемией (карантин, ограничения мобильности, тревога заражения, ухудшения общего благополучия и др.), сказались на ухудшении демографической обстановки, социально-экономическом развитии как на уровне страны, так и на уровне ее регионов. Город Москва не стал исключением. В целях выработки и актуализации рекомендаций по конкретным жизненно важным вопросам в соответствии с сформулированными государственными приоритетами стратегического развития страны необходим анализ реальных демографических потерь от распространения COVID-19 на региональном уровне.Ключевые слова: избыточная смертность, статистика распространения коронавируса, сокращение рождаемости, вторая волна депопуляции Для цитирования: Золотарева О. А., Тихомирова А. В. Смертность и рождаемость в Москве: оценка в контексте потерь от пандемии // Развитие территорий. 2021. № 4. С. 73-78.

OBJECTIVES:To assess cost-effectiveness of rituximab (RTX) 1st line maintenance treatment compared to observation (O) in patients with follicular lymphoma (FL) from the Polish public payer perspective. METHODS: Efficacy and safety of rituximab 1st line maintenance therapy was assessed based on the results of systematic review and the PRIMA clinical trial. Direct medical costs were assessed based on the data regarding clinical practice of FL treatment and medical resources use gathered in 5 oncology centers. The following costs were calculated and included: drugs, drug administration, treatment-related adverse events, lymphoma relapse treatment, patient health monitoring. A life-time horizon (25 years) and public payer perspective were assumed. Costs were discounted at 5% and effects at 3.5%. A four health state Markov model (progression-free 1st line, progression-free subsequent line, progression and death) was used. Sensitivity analysis was performed testing the influence of various critical parameters such as utilities values, different costs categories, length of time horizon and patient's body surface. RESULTS: Introduction of 1st line maintenance therapy with RTX resulted in gain of 1.4 life years and 1.3 quality adjusted life years compared to observation. The total incremental costs were 60,707 PLN (1 EUROϭ3.96 PLN) which corresponded to an incremental cost-effectiveness ratio (ICER) of 43,348 PLN and an incremental cost-utility ratio (ICUR) of 47,357 PLN. Both values were below 110 000 PLN cost-effectiveness threshold assumed by the Polish public payer. The results were sensitive to discount rates, utilities values applied to the specific health states, length of time horizon. None of the tested scenarios resulted in values of ICUR and ICER exceeding the 110,000PLN threshold, providing evidence that rituximab treatment is costeffective from public payer perspective. CONCLUSIONS: Rituximab in 1st line maintenance treatment of FL is an effective, safe and cost -effective therapeutic option.

The most rational use of limited resources and cost containment within the framework of state regulation refers to modern trends in the health care of the Russian Federation. There is a need to develop targets aimed at all subjects of the pharmaceutical market, to increase the availability of innovative drugs for melanoma of the skin treatment. This strategy should be based on evidence and assessments of the efficacy, safety and economic viability of anticancer drugs.

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