Pub Date : 2020-01-01DOI: 10.17116/medtech20204002143
N. Kislov, P. Nesterov, S.B. Belonogov
{"title":"Practical aspects of clinical guidelines in oncology","authors":"N. Kislov, P. Nesterov, S.B. Belonogov","doi":"10.17116/medtech20204002143","DOIUrl":"https://doi.org/10.17116/medtech20204002143","url":null,"abstract":"","PeriodicalId":18386,"journal":{"name":"Medical Technologies. Assessment and Choice (Медицинские технологии. Оценка и выбор)","volume":"122 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75684532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-12-01DOI: 10.31556/2219-0678.2019.38.4.049-054
V. S. Skripov, N. Semenova, L. V. Kochorova, A. Shvedova, V. Sazhin, I. Chekhonadsky
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.
{"title":"Telemedicine Technologies in Psychiatry and Narcology: Specialists’ Point of View","authors":"V. S. Skripov, N. Semenova, L. V. Kochorova, A. Shvedova, V. Sazhin, I. Chekhonadsky","doi":"10.31556/2219-0678.2019.38.4.049-054","DOIUrl":"https://doi.org/10.31556/2219-0678.2019.38.4.049-054","url":null,"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).\u0000\u0000Material 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.\u0000\u0000Results. 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.\u0000\u0000Conclusion. Organizational and methodological work with telemedicine specialists is necessary, resolving the issue of equipping regional hospitals with equipment and medicines.","PeriodicalId":18386,"journal":{"name":"Medical Technologies. Assessment and Choice (Медицинские технологии. Оценка и выбор)","volume":"47 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90173466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-12-01DOI: 10.31556/2219-0678.2019.38.4.035-039
I. A. Doroshev, I. Stilidi, Zhanna Aleksandrovna Zavolskaia, D. A. Riabchikov, V. M. Kulushev, Ekaterina Aleksandrovna Kobiakova, A. Kazakov, E. S. Volkova, S. A. Artemev, S. Ilin
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.
{"title":"Optimization of the Research and Advisory Department of the Oncological Center","authors":"I. A. Doroshev, I. Stilidi, Zhanna Aleksandrovna Zavolskaia, D. A. Riabchikov, V. M. Kulushev, Ekaterina Aleksandrovna Kobiakova, A. Kazakov, E. S. Volkova, S. A. Artemev, S. Ilin","doi":"10.31556/2219-0678.2019.38.4.035-039","DOIUrl":"https://doi.org/10.31556/2219-0678.2019.38.4.035-039","url":null,"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.","PeriodicalId":18386,"journal":{"name":"Medical Technologies. Assessment and Choice (Медицинские технологии. Оценка и выбор)","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90310331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-12-01DOI: 10.31556/2219-0678.2019.38.4.062-075
N. Avxentyev, E. Derkach, A. Makarov
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.
{"title":"Clinical and Economic Study of Daratumumab in Combination Therapy for Previously Treated Patients with Multiple Myeloma","authors":"N. Avxentyev, E. Derkach, A. Makarov","doi":"10.31556/2219-0678.2019.38.4.062-075","DOIUrl":"https://doi.org/10.31556/2219-0678.2019.38.4.062-075","url":null,"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.\u0000\u0000The 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.\u0000\u0000Material 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”.\u0000\u0000Results. 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.\u0000\u0000Conclusions. 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.","PeriodicalId":18386,"journal":{"name":"Medical Technologies. Assessment and Choice (Медицинские технологии. Оценка и выбор)","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78334356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-12-01DOI: 10.31556/2219-0678.2019.38.4.040-048
T. A. Goldina, N. Suvorov, Anastasiya Vadimovna Remizova, D. S. Zhigunova, O. N. Moryleva, V. A. Krechikov, I. Murashko
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.
{"title":"Legal Aspects of Non-Interventional Studies Conduction","authors":"T. A. Goldina, N. Suvorov, Anastasiya Vadimovna Remizova, D. S. Zhigunova, O. N. Moryleva, V. A. Krechikov, I. Murashko","doi":"10.31556/2219-0678.2019.38.4.040-048","DOIUrl":"https://doi.org/10.31556/2219-0678.2019.38.4.040-048","url":null,"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.","PeriodicalId":18386,"journal":{"name":"Medical Technologies. Assessment and Choice (Медицинские технологии. Оценка и выбор)","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84326946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-12-01DOI: 10.31556/2219-0678.2019.38.4.087-100
S. Nedogoda, A. Salasyuk, I. Barykina, V. O. Smirnova, E. Popova
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.
目的:从俄罗斯医疗保健系统的角度，比较阿勒替尼与推荐的治疗方案对无靶向治疗经验的肿瘤表达间变性淋巴瘤激酶(ALK+)的非小细胞肺癌(NSCLC)的经济后果。材料和方法。在Microsoft Excel 2010软件中建立马尔可夫模型进行成本计算。考虑到比较药物的临床有效性和安全性差异，计算阿勒替尼、克里唑替尼和西瑞替尼的5年成本。关于临床有效性和安全性的数据来自Steenrod A. et al .， 2018年的网络荟萃分析，其中阿勒替尼在一线治疗ALK+ NSCLC的有效性优于克里唑替尼和塞瑞替尼:无进展生存期(PFS)的相对风险(RR)分别为0.50(95%置信区间为0.36 - 0.70)和0.41(95%置信区间为0.25 - 0.67)。阿勒替尼在一线治疗中的安全性优于塞瑞替尼的安全性-严重不良事件(SAE) 3-4级的RR为0.36 (95% CI 0.17 - 0.79)， -与化疗和克里唑替尼的安全性- SAE 3-4级的RR分别为0.81 (95% CI 0.44 - 1,52)和0.65 (95% CI 0.51 - 1,04)相当。从俄罗斯医疗保健系统的角度进行成本效益分析和预算影响分析。阿勒替尼1年疗程费用为3 431 970卢布，与克唑替尼(3 435 405卢布)相当，比塞瑞替尼1年疗程费用高55%。与克唑替尼相比，阿勒替尼的成本-效果比较低，阿勒替尼与克唑替尼的增量成本-效果比(ICER)为2 735 900例。，比塞瑞替尼与克唑替尼的ICER低66%。考虑到有资格使用alectinib的患者数量，它对国家免费医疗保障计划的影响并不大。敏感性分析表明，预算影响评价结果是稳定的。从经济角度来看，Alectinib是ALK+ NSCLC患者的首选。它对国家免费医疗保障计划内的预算没有显著影响，而且与克里唑替尼和塞瑞替尼相比，它的有效性更高，与塞瑞替尼相比，它的安全性更好。
{"title":"Assessment of Clinical and Economic Effectiveness of Alectinib for Patients with ALK+ Non-Small Cell Lung Cancer without Previous Experience of Targeted Therapy","authors":"S. Nedogoda, A. Salasyuk, I. Barykina, V. O. Smirnova, E. Popova","doi":"10.31556/2219-0678.2019.38.4.087-100","DOIUrl":"https://doi.org/10.31556/2219-0678.2019.38.4.087-100","url":null,"abstract":"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\u0000system perspective.\u0000\u0000Material 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.\u0000\u0000Results. 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.\u0000\u0000Conclusion. 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.","PeriodicalId":18386,"journal":{"name":"Medical Technologies. Assessment and Choice (Медицинские технологии. Оценка и выбор)","volume":"66 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81381468","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-12-01DOI: 10.31556/2219-0678.2019.38.4.008-017
Maria Yuryevna Kovaleva, V. Fediaeva
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.
{"title":"The Assessment of Potential Benefit and Risk Balance in the Process of Clinical Practice Guidelines Development and Grading the Evidence","authors":"Maria Yuryevna Kovaleva, V. Fediaeva","doi":"10.31556/2219-0678.2019.38.4.008-017","DOIUrl":"https://doi.org/10.31556/2219-0678.2019.38.4.008-017","url":null,"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.\u0000\u0000Material 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”.\u0000\u0000Results. 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.\u0000\u0000Conclusion. 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.","PeriodicalId":18386,"journal":{"name":"Medical Technologies. Assessment and Choice (Медицинские технологии. Оценка и выбор)","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79383314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-12-01DOI: 10.31556/2219-0678.2019.38.4.027-034
V. Lutsenko, K. V. Vyalova, Pavel Vasilyevich Bulbenko, I. Zheleznyakova
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.
{"title":"Improving the Access to Radionuclide Therapy for Prostate Cancer within Compulsory Health Insurance System at the Regional Level: Experience of the Kemerovo Region","authors":"V. Lutsenko, K. V. Vyalova, Pavel Vasilyevich Bulbenko, I. Zheleznyakova","doi":"10.31556/2219-0678.2019.38.4.027-034","DOIUrl":"https://doi.org/10.31556/2219-0678.2019.38.4.027-034","url":null,"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.","PeriodicalId":18386,"journal":{"name":"Medical Technologies. Assessment and Choice (Медицинские технологии. Оценка и выбор)","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86997334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-12-01DOI: 10.31556/2219-0678.2019.38.4.055-061
T. Boyarskaya, E. Derkach
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.
{"title":"Inclusion of Ipragliflozin into the Vital and Essential Drugs List: Budget Impact Analysis","authors":"T. Boyarskaya, E. Derkach","doi":"10.31556/2219-0678.2019.38.4.055-061","DOIUrl":"https://doi.org/10.31556/2219-0678.2019.38.4.055-061","url":null,"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.\u0000\u0000The 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.\u0000\u0000Material 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.\u0000\u0000Results. 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%.\u0000\u0000Conclusion. 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.","PeriodicalId":18386,"journal":{"name":"Medical Technologies. Assessment and Choice (Медицинские технологии. Оценка и выбор)","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75732514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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