The questionnaire of the Cochrane Collaboration developed to assess risks of the main bias in randomized controlled trials (RCT) was translated into Russian. It was also adapted and validated. We proposed to consider the risk of the conflict of interests as a mandatory part of the questionnaire. Also we slightly modified the rule to determine the total risk of bias in RCTs. Validation of the questionnaire accomplished by two experts on 20 RCTs demonstrated good agreement: Kappa = 0.785, 95% CI (0.503; 1.000)
We have developed an instrument to assess the methodological quality of network meta-analyzes and indirect comparisons based on International Society for Pharmacoeconomics and Outcomes Research (ISPOR) tool. This instrument includes 15 questions on five aspects (domains): the evidence base, analysis, presentation of results, interpretation, conflict of interests. For each domain the estimate is given informally then the general credibility (methodological quality) of the research is assessed.
The article presents the Russian-language version of the questionnaire to assess the risk of systematic bias in case-control studies and cohort studies. These questionnaires are translations of the Newcastle-Ottawa Scale to assess the methodological quality of non-randomized studies. The risk of systematic bias in the original scale is not stratifi ed, but in practice the Cochrane Collaboration considered trials with 5 or fewer points (of 9) to have a low methodological quality. We propose to assess the methodological quality not only by the assessing risk of systematic errors, but also the risk of incorrectness of statistical analysis.
Effectiveness of health care can be significantly enhanced through the rational use of its resources. One of the tools to achieve this goal is to use the basic principles of corporate management.
Meta-analysis is often considered as the highest level evidence on the effectiveness and safety of drugs and other medical technologies; however, the methodological quality of meta-analyses and systematic reviews varies considerably, which leads to the differences of effect values and the levels of evidence of the results. In 2007, validated tool to assess the methodological quality of systematic reviews AMSTAR has been developed. It is based on the combination of many elements of the previous evaluation systems. We have translated AMSTAR into Russian and made some extra explanation. The current publication presents the Russian-language version of the questionnaire. We believe that the Russian version of AMSTAR questionnaire can be used for a more objective assessment of the evidence of medical technology.
The article presents the Russian-language version of the questionnaire to assess the risk of systematic bias in cross-sectional studies of diagnostic tests. This version is the adapted translation of the international consensus questionnaire QUADAS. The risk of systematic bias in the original scale is not stratified, however, we propose to evaluate the overall risk of systematic bias as low, medium or high, depending on the score sum according to the criteria of the questionnaire. To assess the overall methodological quality not only the risk of systematic bias should be assessed, but also the risk of incorrect statistical analysis.
Multicriteria decision analysis (MCDA) is the mathematical approach that allows to take into account several factors when making diffi cult decisions. The article presents the results of a pilot application of MCDA for rare diseases and orphan drugs. Comparison of two methods (direct weighting and swing weighting) for assessing the importance of the criteria was conducted. The advantage of the second approach was shown.
To evaluate economic efficiency of the use of obinutuzumab and ibrutinib in chronic lymphocytic leukemia (CLL) within the framework of access to high-cost medicines. Methods. A model was created to assess budgetary changes of the program of seven high-cost diseases (7HCD) after the inclusion of new drugs, i. e. obinutuzumab and ibrutinib. The model was based on clinical studies and a registry of patients with CLL, and considered costs of medications offered within the federal program. The number of patients who would gain access to new drugs in various versions of expanded list of medications was calculated, as well as additional costs associated with the use of these drugs in the changed modeled lists. The time horizon of the model was 3 years. Results. The inclusion of new drugs (obinutuzumab and ibrutinib) into 7HCD program would enable to effectively treat 652, 1328 and 2014 patients with CLL in the first, second and third year of the program, respectively. A separate modeling of costs for each of the new drugs showed that the burden of obinutuzumab was 482 million RUB (12,4%) lower for the budget of 7HCD program starting from the second year, and 2407 million RUB (41,5%) lower at the third year, compared with ibrutinib. This in turn will enable to provide effective treatment to a higher number of patients with CLL. Conclusion. If 7HCD program will be expanded with new drugs for patients with CLL, additional costs connected with the use of obinutuzumab will be lower in a long-term perspective compared to costs associated with the use of ibrutinib.
Enzalutamide, abiraterone plus prednisone and cabazitaxel plus prednisone (hereafter referred to as abiraterone and cabazitaxel, respectively) are ap- proved for the post-chemotherapy treatment of metastatic castration-resistant prostate cancer (mCRPC) in Russia. Currently, none of these treatments are included in the Government Drug Reimbursement Program (GDRP).
The aim of this pharmacoeconomic evaluation is to comapre enzalutamide, abiraterone and cabazitaxel used after chemotherapy in patients with mCRPC from the Russian healthcare system perspective.
Materials and methods. Based on data from clinical trials - AFFIRM (enzalutamide), COU-AA-301 (abiraterone) and TROPIC (cabazitaxel) – and indirect comparisons of considered drugs, we proposed an mCRPC Markov chain model and calculated medical costs associated with three options. We used the 5-year time horizon as proposed by the national guidelines for pharmacoeconomic research. Budget impact, cost-effectiveness and cost-utility analyses were conducted.
Results: Use of enzalutamide, abiraterone and cabazitaxel resulted in 1.04, 0.94 and 0.96 quality-adjusted life years, respectively. Monthly medication costs for enzalutamide were 183 550,71 RUB per patient, 15% less than for abiraterone and 49% less than for cabazitaxel. Five-year total medical costs were 3 330 982 RUB, 3 331 998 RUB and 4 434 624 RUB per patient for enzalutamide, abiraterone and cabazitaxel, respectively. The smaller differ- ence in total medical costs resulted from longer progression-free survival on enzalutamide compared to abiraterone or cabazitaxel. If included in GDRP, enzalutamide results in the lowest budget impact: 6 524,6 RUB million, compared to 6 526,6 RUB million for abiraterone and 8 688,4 RUB million for cabazitaxel.
Conclusions: Enzalutamide is more effective compared to abiraterone and cabazitaxel and requires the same or less additional budget expenditure in Russia.