Научно-практический журнал Медицинские технологии. Оценка и выбор
  • Русский
  • English

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.087-100 meta

Аннотация

Aim: to assess economic consequences of alectinib compared with the recommended therapy schemes for patients with non-small cell lung cancer (NSCLC) with tumor expression of anaplastic lymphoma kinase (ALK+) without previous experience of targeted therapy from the Russian healthcare
system perspective.

Material and methods. Markov model was developed in Microsoft Excel 2010 software for cost calculation. 5-year costs of alectinib, crizotinib and ceritinib were calculated, taking into account the differences in clinical effectiveness and safety of the compared drugs. Data about clinical effectiveness and safety were derived from the network meta-analysis Steenrod A. et al, 2018, where alectinib showed superior effectiveness in the first line of therapy for ALK+ NSCLC vs crizotinib and ceritinib: relative risk (RR) of progression-free survival (PFS) was 0,50 (95% confidence interval 0,36–0,70) and 0,41 (0,25–0,67) respectively. Safety of alectinib in the first line therapy was superior to the safety of ceritinib – RR of severe adverse events (SAE)3–4 grade 0,36 (95% CI 0,17–0,79), – and was comparable with safety of chemotherapy and crizotinib – RR of SAE 3–4 grade 0,81 (95% CI 0,44–1,52) and 0,65 (95% CI 0,51–1,04) respectively. Cost effectiveness analyses and budget impact analysis were conducted from the Russian healthcare system perspective.

Results. Cost of one year course of alectinib was 3 431 970 rubles, which was comparable with crizotinib (3 435 405 rub.) and 55% higher than the one-year cost of ceritinib. Cost-effectiveness ratio was lower for alectinib compared with crizotinib, incremental cost-effectiveness ratio (ICER) for alectinib vs crizotinib was 2 735 900 rub., which was 66% lower than ICER for ceritinib vs crizotinib. Given the number of patients eligible for alectinib, it’s impact on State Guarantees Program of Free Medical Care is not much. Sensitivity analysis showed that the results of budget impact assessment are stable.

Conclusion. Alectinib is a preferred option for patients with ALK+ NSCLC from economic point of view. It doesn’t have a significant impact on the budget within the State Guarantees Program of Free Medical Care, and also has higher effectiveness compared with crizotinib and ceritinib and better safety when compared with ceritinib.

Keywords

ALK-positive non-small cell lung cancer, alectinib, crizotinib, ceritinib, budget impact analysis, cost-effectiveness analysis.

For citation

Nedogoda S.V., Salasyuk A.S., Barykina I.N., Smirnova V.O., Popova E.A. Assessment of clinical and economic effectiveness of Alectinib for patiens with ALK+ non-small cell lung cancer without previous experience of targeted therapy. Medical Technologies Assessment and Choice. 2019;(4):87–100. DOI: 10.31556/2219-0678.2019.38.4.087-100

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.076-086 meta

Abstract

Multiple randomised controlled trials (RCTs) have compared the efficacy of targeted therapies for the treatment of moderate-to-severe plaque psoriasis with placebo. However, the relative effectiveness of these treatments is not studied sufficiently.

The aim of this study was to compare the effectiveness and safety of targeted drugs (netakimab, ixekizumab, guselkumab, secukinumab, ustekinumab, certolizumab, infliximab, adalimumab, etanercept, tofacitinib and apremilast) in adult patients with moderate-to-severe plaque psoriasis using such outcomes as PASI 75/90/100, PGA/IGA, DLQI, AEs, SAEs and withdrawals due to AEs.

Material and methods. We performed a systematic literature review in PubMed database and in the CENTRAL section of Cochrane library (Embase filter) to identify relevant RCTs. The primary outcome was Psoriasis Area and Severity Index (PASI) 75 response at week 12 of treatment. Other analyzed outcomes: PASI 90/100, Physician’s Global Assessment (PGA) /IGA, Dermatology Life Quality Index (DLQI), number of patients suffering from at least one adverse event (AE) / severe AE and number of patient withdrawals from the study due to AE during initial 12 weeks of treatment. For each outcome we conducted network meta-analyses (NMAs) and univariate meta-regression analyses to adjust for baseline risk differences and cross-trial differences.

Results. We selected 35 RCTs. We conducted several types of NMAs for each outcome to avoid bias in research. In most cases random effects NMAs adjusted to differences in placebo response rate provided the best model fit statistics and were selected for interpretation. Pairwise indirect comparisons from most NMAs suggested IL-17 inhibitors (netakimab and ixekizumab) along with IL-23 inhibitor guselkumab have superior effectiveness and favorable safety profile compared to other targeted therapies used to treat adults with moderate-to-severe plaque psoriasis during initial 12 weeks of therapy based on PASI 75/90/100, PGA/IGA, and DLQI.

Keywords

plaque psoriasis, systematic review, meta-analysis, meta-regression, targeted therapies, biologics.

For citation

Tolkacheva D.G., Sokolova V.D., Mladov V.V. Effectiveness and safety of targeted drugs for the treatment of adults with moderate-to-severe plaque psoriasis in the Russian Federation. Medical Technologies Assessment and Choice. 2019;(4):76–86. DOI: 10.31556/2219-0678.2019.38.4.076-086

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.062-075 meta

Abstract

Application of “novel agents” for treatment of relapsing and/or refractory multiple myeloma (r/r MM) in lenalidomide-based schemes: daratumumab (DRd), carfilzomib (KRd), ixazomib (IRd) or elutuzumab (ERd) can improve treatment outcomes for patients compared with standard therapy with lenalidomide and dexamethasone (Rd). Access to lenalidomide is generally provided for Russian citizens in the framework of the federal high-cost nosologies program. But expenses for “novel agents” for patients with r/r MM are covered by local regional healthcare systems.

The aim of this work was to conduct a clinical and economical study of “novel agents” in lenalidomide-based schemes from the perspective of regional healthcare systems of Russian Federation.

Material and Methods. Based on data from randomized clinical trials of “novel agents” and our own indirect comparison of considered alternatives we proposed a Markov model for progression of r/r MM. In the model, we compared DRd, KRd, IRd, ERd and Rd schemes by calculating average number of life years without progression and direct medical costs from the perspective of regional healthcare systems per 1 patient over 5-year period. Based on the obtained data we conducted cost-effectiveness analysis and estimated cost of an incremental year of life without progression when using “novel agents” vs Rd combination, as well as for DRd scheme vs each of the other “novel agents”.

Results. Cost of an incremental year of life without progression for DRd scheme vs Rd scheme was 10,402,613 rub., which is 11.5-62.2% lower than for other “novel agents” vs Rd. Cost of an incremental life year without progression for DRd scheme vs IRd scheme was 72.4% lower than for IRd vs Rd. The same ratio for DRd vs KRd was 22.4% lower than for KRd vs Rd. Cost of an incremental life year without progression for DRd scheme vs ERd scheme was not identified because DRd scheme was both less costly and more effective than ERd.

Conclusions. Treatment of r/r MM with DRd scheme is more cost-effective compared with IRd and KRd schemes, and less costly and more effective than ERd scheme.

Keywords

multiple myeloma, daratumumab, carfilzomib, ixazomib, elotuzumab, lenalidomide, dexamethasone, pharmacoeconomic analysis, cost-effectiveness analysis.

For citation

Avxentyev N.A., Derkach E.V., Makarov A.S. Clinical and economic study of daratumumab in combination therapy for previously treated patients with multiple myeloma. Medical Technologies. Assessment and Choice. 2019;(4):62–75. DOI: 10.31556/2219-0678.2019.38.4.062-075

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.055-061 meta

Abstract

The sodium-glucose co-transporter type 2 inhibitors (SGLT2i) used in the treatment of type 2 diabetes mellitus (DM) do not only affect the blood glucose level, but also help to reduce body weight and blood pressure. Recently ipragliflozin, the new drug from the SGLT2i group has appeared on the Russian market.

The aim of this study was to analyze the budget impact of including ipragliflozin into the vital and essential drugs (VED) list for treatment of type 2 DM in adults.

Material and methods. Budget impact analysis was performed in a mathematical model. The modeling period was 5 years. The target population included adult patients with type 2 DM eligible for glucose-lowering therapy with SGLT2i. The number of patients during the modeling period was calculated based on the information about SGLT2i public procurement and the data from the Federal Register of DM (FRDM). The cost of ipragliflozin was calculated on the basis of the price planned for state registration if the drugis included into the VED list (2.118 rubles for 30 tablets, 50 mg each); costs of dapagliflozin and empagliflozin were equal to the registered maximum selling prices plus VAT and the weighted average maximum wholesale allowance in the Russian Federation. The sensitivity analysis was performed to the variability of prices and target population size.

Results. The estimated number of patients treated with SGLT2i was 14.052 in the 1-st year and 47.392 in the 5-th year. The calculated difference in the cost of SGLT2i over 5 years between the current and the expected practice (if ipragliflozin is included into the VED list) was –3.02 million rubles (cost reduction by 0.06%). For the first year, costs decreased by 0.1 million rubles, or 0.02%.

Conclusion. The inclusion of ipragliflozin into the VED list leads to a reduction in costs within the budget of the State guarantee program for free provision of medical care to citizens.

Keywords

diabetes mellitus type 2, ipragliflozin, dapagliflozin, empagliflozin, budget impact analysis.

For citation

Boyarskaya T.V., Derkach E.V. Budget impact analysis of the inclusion of ipragliflozin in vital and essential drugs list. Medical Technologies. Assessment and Choice. 2019;(4):55–61. DOI: 10.31556/2219-0678.2019.38.4.055-061

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.049-054 meta

Abstract

Objective: To identify the main problems in the system of medical care provided with the help of telemedicine technologies based on the specialists’ survey (psychiatrists, narcologists, psychotherapists and medical psychologists).

Material and methods. The survey was conducted with the questionnaire developed by employees of Bekhterev Psychoneurological Research Institute. The questionnaire contained general questions (gender, age, length of service, specialization, federal district in which the specialist works) and questions about the prospects, opportunities, and challenges of using telemedicine counseling in psychiatry and narcology. The doctors’ willingness to conduct such consultations and refer patients to them was also evaluated. 235 respondents took part in the survey, 55.3% were psychiatrists, narcologists accounted for 31.9%, and the remainder consisted of psychotherapists, medical psychologists and doctors who indicated several specialties.

Results. Statistically significant differences were found in the evaluation of the usefulness of telemedicine consultations in psychiatry and narcology. Doctors who referred patients before to such consultations rated their usefulness at 3.95 points (on a five-point scale), while doctors without such experience rated their usefulness at 3.0 points. Interviewees also noted the greater effectiveness of video conferences if compared with the flow of medical documents, 3.5 points versus 2.9 points. Number of problems where identified, including the lack of doctors’ awareness about the possibilities of telemedicine, lack of necessary equipment and insufficient drug provision in the regions, which does not allow to implement the recommendations of the consultant in full.

Conclusion. Organizational and methodological work with telemedicine specialists is necessary, resolving the issue of equipping regional hospitals with equipment and medicines.

Keywords

telemedicine, specialized care, psychiatry, narcology, information and communication technologies in medicine, telecommunication technologies, remote consultations, telemedicine center.

For citation

Skripov V.S., Semenova N.V., Kochorova L.V., Shvedova A.A., Sazhin V.L., Chekhonadsky I.I. Telemedicine technologies in psychiatry and narcology: specialists’ point of view. Medical Technologies. Assessment and Choice. 2019;(4):49–54. DOI: 10.31556/2219-0678.2019.38.4.049-054

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.040-048 meta

Abstract

Even though in Russia there has been a growing interest in conducting non-interventional studies (NIS) in recent years, the existence of gaps in their legal regulation leads to the fact that many medical institutions and healthcare professionals refuse to participate in this type of activities. This paper analyzes such refusals and discusses several legal aspects, such as the contracting with medical organizations and investigators, issues of personal data protection, as well as a brief comparative analysis of the requirements for non-intervention trials in the EEU countries. To overcome the organizational barriers of NIS, it is necessary to develop common criteria/concepts at both pharmaceutical companies and professional medical communities levels, with the subsequent training of healthcare professionals and organizers on various aspects of NIS. This article will be helpful for all healthcare professionals, especially physicians, researchers and decision-makers, who decide to conduct NIS at medical institutions.

Keywords

non-interventional studies, legislation, contracts.

For citation

Goldina T.A., Suvorov N.I., Remizova A.V., Zhigunova D.S., Moryleva O.N., Krechikov V.A., Murashko I.S. Legal aspects of non-interventional studies conduction. Medical Technologies Assessment and Choice. 2019;(4):40–48. DOI: 10.31556/2219-0678.2019.38.4.040-048

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.035-039 meta

Abstract

The article provides an example of a successful optimization of the work in a research and advisory department of N.N. Blokhin National Medical Research Center of Oncology Ministry of Health of Russia. All stages of this process are described in detail – from creating a project office and identifying problems to implementing methods for solving them and evaluating results. This work resulted in improving of the quality of medical care provided to the population, which is the most important task of any medical institution. In addition, this optimization experience may be useful for the implementation of similar activities in other health facilities in Russia.

Keywords

optimization, research advisory department, thrifty technologies.

For citation

Doroshev I.A., Stilidi I.S., Zavolskaia Z.A., Riabchikov D.A., Volkova E.S., Kulushev V.M., Kobiakova E.A., Kazakov A.M., Artemev S.A., Ilin S.N. Optimization of the research and advisory department of the oncological center. Medical technologies. Assessment and Choice. 2019;(4):35–39.
DOI: 10.31556/2219-0678.2019.38.4.035-039

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.027-034 meta

Abstract

The article discusses issues of antineoplastic radiation, particularly radionuclide, therapy payment through compulsory health insurance system. Healthcare organization faces several problems in this field when introducing new treatment methods. Regulatory and infrastructural aspects of the radionuclide therapy provision are brought up. The article discusses the problem raised by the average payment for the diagnostic-related groups (DRG) at the federal level, which makes it difficult to use selected medical services with the cost above the average DRG tariff. As an example, the article describes the experience of Kemerovo region on tariff correction using subgroup split-off method for DRG that includes systemic radionuclide therapy with radium-223. Splitting the federal DRG for sub-groups gave the possibility of providing therapy to patients with prostate cancer in the region. Besides, the authors discuss the relevance and practical aspects of interregional payments in the compulsory healthcare insurance system with respect to the radionuclide therapy in order to improve the quality of medical care for patients with cancer, regardless of infrastructural restrictions and the patients’ residence.

Keywords

prostate cancer, diagnostic-related group, systemic alpha-radiotherapy, subgroup split-off mechanism, interregional payments.

For citation

Lutsenko VA, Vyalova KV, Bulbenko PV, Zheleznyakova IA. Improving the access to radionuclide therapy for prostate cancer within compulsory health insurance system at the regional level: experience of the Kemerovo Region. Medical Technologies Assessment and Choice. 2019;(4):27–34. DOI: 10.31556/2219-0678.2019.38.4.027-034

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.018-026 meta

Abstract

The article describes the results of comparative analysis of two classifiers – the nomenclature of medical services, approved by the order of the Ministry of Health of Russia from October 13 2017 № 804(n), and International Classification of Health Interventions (ICHI), developed by World Health Organization. Similarities and differences are identified in classification of medical interventions in ICHI and medical services in nomenclature. Results of this work are expected to serve as a base for nomenclature’s improvement.

Keywords

health intervention, medical service, classification, coding, nomenclature of medical services, international classification of health interventions (ICHI).

For citation

Tyurina I.V., Avxentyeva M.V. Comparative analysis of nomenclature of medical services and international classification of health interventions
of the World Health Organization. Medical Technologies Assessment and Choice. 2019;(4):18–26. DOI: 10.31556/2219-0678.2019.38.4.018-026

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.008-017 meta

Abstract

Aim of the study. A review of international practice of “benefit-risk” ratio assessment in the process of clinical practice guidelines (CPG) development; assessment of its acceptability for Russian Federation.

Material and methods. We analyzed official methodological guides of the GRADE working group and information from the websites of the professional associations, indicated on the official GRADE website. Additionally, the review of methods of quantitative assessment of risk-benefit ratio was conducted. The search was performed in Pubmed and Embase in April 2019, according to the queries “benefit-risk guidelines”, “balance of benefits and harm”, “risk-benefit guidelines”.

Results. The “benefit-risk” ratio assessment is an important component in the development of CPG, however, there were no universal transparent methods for it: in foreign CPG, the “benefit-risk” ratio for medical interventions is determined by the expert group consensus. There were also identified quantitative methods for assessing this ratio, currently not used in the process of the CPG development.

Conclusion. We have not identified universal transparent validated quantitative methods for assessing the “benefit-risk” ratio for medical interventions in CPG. Still many quantitative, semi-quantitative and qualitative methods for analyzing this ratio were found in the literature. Thus it seems appropriate to analyze international experience further, to evaluate the advantages and disadvantages of all assessment systems and to test their acceptability for the development of CPG in the Russian Federation.

Keywords

clinical practice guidelines, evidence-based medicine, health technology assessment, «benefit-risk» ratio.

For citation

Kovalyova MY, Fedyaeva VK. The Assessment of potential benefit and risk balance in the process of clinical practice guidelines development and grading the evidence. Medical Technologies Assessment and Choice. 2019;(4):8–17. DOI: 10.31556/2219-0678.2019.38.4.008-017