Pub Date : 2023-11-09DOI: 10.17749/2070-4909/farmakoekonomika.2023.202
N. A. Avxentyev, Yu. V. Makarova
Objective : to perform a cost-effectiveness analysis of using encorafenib and binimetinib combination in the first-line therapy for metastatic or unresectable BRAF V600-mutated melanoma in the Russian Federation. Material and methods. The comparators included “dabrafenib + trametinib” combination and vemurafenib monotherapy, which are listed in the Russian clinical guidelines and the Vital and Essential Drugs List. Since “encorafenib and binimetinib” combination demonstrated superior overall response rate compared to “dabrafenib + trametinib” and vemurafenib monotherapy, the method of cost-effectiveness analysis was used. We developed a disease progression model based on data from the COLUMBUS randomized control trial and published network meta-analysis. The model was used to calculate the direct medical costs associated with the considered alternatives over a 3-year modeling horizon. We compared the incremental cost-effectiveness ratio for “encorafenib + binimetinib” vs. “dabrafenib + trametinib” to the same ratio calculated for “dabrafenib + trametinib” vs. vemurafenib monotherapy. Results. Mean costs of using “encorafenib + binimetinib” combination over a 3-year period, considering the discontinuation of treatment as the disease progresses, was 6,547,693.07 rubles. Meanwhile, it was 5,962,742.52 rubles for “dabrafenib + trametinib” and 2,581,781.45 rubles for vemurafenib monotherapy. The incremental cost-effectiveness ratio of “encorafenib + binimetinib” vs. “dabrafenib + trametinib” was 3,846,818.71 rubles per 1 patient with a response to therapy. This was 85.14% lower than the same ratio estimated for “dabrafenib + trametinib” vs. vemurafenib monotherapy (25,890,022.64 rubles per 1 patient with a response to therapy). Conclusion. The “encorafenib + binimetinib” combination is a cost-effective treatment method for patients with unresectable or metastatic BRAF V600-mutated melanoma in the Russian Federation.
{"title":"Cost-effectiveness analysis of encorafenib and binimetinib combination as first-line treatment for metastatic or unresectable <i>BRAF</i> V600-mutated metastatic melanoma in Russia","authors":"N. A. Avxentyev, Yu. V. Makarova","doi":"10.17749/2070-4909/farmakoekonomika.2023.202","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.202","url":null,"abstract":"Objective : to perform a cost-effectiveness analysis of using encorafenib and binimetinib combination in the first-line therapy for metastatic or unresectable BRAF V600-mutated melanoma in the Russian Federation. Material and methods. The comparators included “dabrafenib + trametinib” combination and vemurafenib monotherapy, which are listed in the Russian clinical guidelines and the Vital and Essential Drugs List. Since “encorafenib and binimetinib” combination demonstrated superior overall response rate compared to “dabrafenib + trametinib” and vemurafenib monotherapy, the method of cost-effectiveness analysis was used. We developed a disease progression model based on data from the COLUMBUS randomized control trial and published network meta-analysis. The model was used to calculate the direct medical costs associated with the considered alternatives over a 3-year modeling horizon. We compared the incremental cost-effectiveness ratio for “encorafenib + binimetinib” vs. “dabrafenib + trametinib” to the same ratio calculated for “dabrafenib + trametinib” vs. vemurafenib monotherapy. Results. Mean costs of using “encorafenib + binimetinib” combination over a 3-year period, considering the discontinuation of treatment as the disease progresses, was 6,547,693.07 rubles. Meanwhile, it was 5,962,742.52 rubles for “dabrafenib + trametinib” and 2,581,781.45 rubles for vemurafenib monotherapy. The incremental cost-effectiveness ratio of “encorafenib + binimetinib” vs. “dabrafenib + trametinib” was 3,846,818.71 rubles per 1 patient with a response to therapy. This was 85.14% lower than the same ratio estimated for “dabrafenib + trametinib” vs. vemurafenib monotherapy (25,890,022.64 rubles per 1 patient with a response to therapy). Conclusion. The “encorafenib + binimetinib” combination is a cost-effective treatment method for patients with unresectable or metastatic BRAF V600-mutated melanoma in the Russian Federation.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":" 10","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135290572","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 : 2023-10-10DOI: 10.17749/2070-4909/farmakoekonomika.2023.207
O. A. Shavlovskaya, V. V. Omelyanovskiy, O. A. Gromova, A. Yu. Kochish, Yu. D. Yukhnovskaya, I. D. Romanov, I. A. Bokova
The review examines pharmacological agents that can have potential disease-modifying osteoarthritis drugs (DMOADs) status. DMOADs prevent the progression and further structural joint damage (structure-modifying effect), leading to a decrease in symptoms severity (symptom-modifying effect), such as pain, and improvement of joint function. Approaches to potential DMOADs selection are discussed: (1) the preferred target (bone, cartilage, synovia); (2) action drug mechanism/anti-cytokine therapy (matrix metalloproteinase inhibitors, inhibitors of pro-inflammatory interleukins, etc.). The main delivery systems of drugs claiming to be of DMOADs status and possible contribution of immunological mechanisms to osteoarthritis pathogenesis are considered. Methods evaluating the effectiveness of DMOADs therapy are of great interest (cytology, microscopy, radiological research methods, blood and synovia biochemical markers). Based on research results analysis, the following substances can be considered as potential DMOADs: chondroitin sulfate, glucosamine sulfate, undenatured type II collagen, vitamin D. Each of them has symptom-modifying and structural-modifying effects.
{"title":"Disease-modifying osteoarthritis drugs (DMOADs): new trends in osteoarthritis therapy","authors":"O. A. Shavlovskaya, V. V. Omelyanovskiy, O. A. Gromova, A. Yu. Kochish, Yu. D. Yukhnovskaya, I. D. Romanov, I. A. Bokova","doi":"10.17749/2070-4909/farmakoekonomika.2023.207","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.207","url":null,"abstract":"The review examines pharmacological agents that can have potential disease-modifying osteoarthritis drugs (DMOADs) status. DMOADs prevent the progression and further structural joint damage (structure-modifying effect), leading to a decrease in symptoms severity (symptom-modifying effect), such as pain, and improvement of joint function. Approaches to potential DMOADs selection are discussed: (1) the preferred target (bone, cartilage, synovia); (2) action drug mechanism/anti-cytokine therapy (matrix metalloproteinase inhibitors, inhibitors of pro-inflammatory interleukins, etc.). The main delivery systems of drugs claiming to be of DMOADs status and possible contribution of immunological mechanisms to osteoarthritis pathogenesis are considered. Methods evaluating the effectiveness of DMOADs therapy are of great interest (cytology, microscopy, radiological research methods, blood and synovia biochemical markers). Based on research results analysis, the following substances can be considered as potential DMOADs: chondroitin sulfate, glucosamine sulfate, undenatured type II collagen, vitamin D. Each of them has symptom-modifying and structural-modifying effects.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136254749","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 : 2023-10-09DOI: 10.17749/2070-4909/farmakoekonomika.2023.193
I. A. Narkevich, E. A. Tsitlionok
Objective: to analyse the consumption pattern of antiviral therapy (AVT) for chronic hepatitis C on the example of an infectious hospital. Material and methods. The study was based on data from 380 discharge summaries of an infectious diseases hospital for 2011–2019. The criterion of sampling was the established diagnosis of chronic hepatitis C. The first line therapy regimens were analyzed and compared; the calculations were based on direct treatment costs of the study sample. The pharmacoeconomic effectiveness of therapy was assessed by calculating the cost-effectiveness ratio (CER). Results. A retrospective analysis of patients’ sampling allowed to establish a general profile: a 40-year-old man with hepatitis C virus genotype 1 and a mild degree of liver fibrosis. A total of 18 international nonproprietary names (17 trade names) were used for AVT. The pattern of drugs prescribed correlated with the clinical guidelines for the studied period and allowed to distinguish the beginning of the transition from interferon-based regimens to direct-acting antivirals (DAAs). The change in the treatment paradigm was associated not only with increased efficacy in achieving a sustained virological response, but also with minimization of side effects. The high frequency of prescribing interferon regimens as AVT was accompanied by low rates of achieving virus elimination (63.69%), high frequency of relapses (12.88%), as well as the lack of response to pharmacological correction (21.32%) and premature discontinuation of therapy due to adverse events (2.11%). A total of 142,450,414.91 rubles was spent on the first line pharmacotherapy in the study cohort during the study period. Costs per 1 patient with the diagnosis “chronic hepatitis C” and F0–F3 fibroses according to METAVIR were 372,847.07 rubles with achieving sustained virologic response without relapse in 66% of cases, costs per patient with F4 liver lesion were 398,464.73 rubles (45,16%, respectively). Conclusion. The findings allow us to note the transition from interferon-, nucleoside- and nucleotide-based drugs to DAAs, which can be associated with an increase in therapy effectiveness and proportion of cases with sustained virologic response achieved along with a decrease in the number of adverse events. The results of the study have practical implications for building a strategy for hepatitis C virus elimination in terms of choosing effective pharmacotherapy while reducing the economic burden.
{"title":"Development of approaches to the evaluation of pharmacotherapy effectiveness for chronic hepatitis C","authors":"I. A. Narkevich, E. A. Tsitlionok","doi":"10.17749/2070-4909/farmakoekonomika.2023.193","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.193","url":null,"abstract":"Objective: to analyse the consumption pattern of antiviral therapy (AVT) for chronic hepatitis C on the example of an infectious hospital. Material and methods. The study was based on data from 380 discharge summaries of an infectious diseases hospital for 2011–2019. The criterion of sampling was the established diagnosis of chronic hepatitis C. The first line therapy regimens were analyzed and compared; the calculations were based on direct treatment costs of the study sample. The pharmacoeconomic effectiveness of therapy was assessed by calculating the cost-effectiveness ratio (CER). Results. A retrospective analysis of patients’ sampling allowed to establish a general profile: a 40-year-old man with hepatitis C virus genotype 1 and a mild degree of liver fibrosis. A total of 18 international nonproprietary names (17 trade names) were used for AVT. The pattern of drugs prescribed correlated with the clinical guidelines for the studied period and allowed to distinguish the beginning of the transition from interferon-based regimens to direct-acting antivirals (DAAs). The change in the treatment paradigm was associated not only with increased efficacy in achieving a sustained virological response, but also with minimization of side effects. The high frequency of prescribing interferon regimens as AVT was accompanied by low rates of achieving virus elimination (63.69%), high frequency of relapses (12.88%), as well as the lack of response to pharmacological correction (21.32%) and premature discontinuation of therapy due to adverse events (2.11%). A total of 142,450,414.91 rubles was spent on the first line pharmacotherapy in the study cohort during the study period. Costs per 1 patient with the diagnosis “chronic hepatitis C” and F0–F3 fibroses according to METAVIR were 372,847.07 rubles with achieving sustained virologic response without relapse in 66% of cases, costs per patient with F4 liver lesion were 398,464.73 rubles (45,16%, respectively). Conclusion. The findings allow us to note the transition from interferon-, nucleoside- and nucleotide-based drugs to DAAs, which can be associated with an increase in therapy effectiveness and proportion of cases with sustained virologic response achieved along with a decrease in the number of adverse events. The results of the study have practical implications for building a strategy for hepatitis C virus elimination in terms of choosing effective pharmacotherapy while reducing the economic burden.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135095536","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 : 2023-09-26DOI: 10.17749/2070-4909/farmakoekonomika.2023.192
I. Yu. Torshin, O. A. Gromova
Objective: comprehensive analysis of the spectrum of antibacterial action of bactriocins. Material and methods. Chemomicrobiome analysis of bacteriocins A/B, C, S, 28b, RS-2020 was performed to assess the minimum inhibitory concentration (MIC) values for 152 strains of pathogenic bacteria and the area under the growth curve (AUC) values for a representative sample of normobiota (38 human commensal bacteria). Results. Compared to other molecules, bacteriocin C was characterized by lower MIC constants for a wide range of pathogenic bacterial strains. Thus, it more effectively inhibited strains of pathogens of bacterial pneumonia ( H. influenzae, S. mutans, S. pneumoniae, S. pyogenes ), nosocomial infections ( K. pneumoniae, P. aeruginosa, S. aureus, S. epidermidis, S. pneumoniae ), skin diseases ( M. audouinii , T. mentagrophytes , etc.), urinary tract infections ( E. cloacae , P. mirabilis and P. vulgaris ), Fusobacterium necrophorum and Candida fungi . At the same time, bacteriocin C to a lesser extent than the reference molecules inhibited the growth of the normophysiological microbiota of the Bacteroides , Enterococcus genera, non-pathogenic Escherichia , yeast S. cerevisiae and others. By stimulating butyrate (butyric anion) producing microorganisms, bacteriocin C can exhibit prebiotic properties. Conclusion. The main structural features of the bacteriocin C molecule associated with the antibacterial effect on pathogenic microbiota were identified and described.
{"title":"Comparative chemomicrobiomic analysis of bacteriocins","authors":"I. Yu. Torshin, O. A. Gromova","doi":"10.17749/2070-4909/farmakoekonomika.2023.192","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.192","url":null,"abstract":"Objective: comprehensive analysis of the spectrum of antibacterial action of bactriocins. Material and methods. Chemomicrobiome analysis of bacteriocins A/B, C, S, 28b, RS-2020 was performed to assess the minimum inhibitory concentration (MIC) values for 152 strains of pathogenic bacteria and the area under the growth curve (AUC) values for a representative sample of normobiota (38 human commensal bacteria). Results. Compared to other molecules, bacteriocin C was characterized by lower MIC constants for a wide range of pathogenic bacterial strains. Thus, it more effectively inhibited strains of pathogens of bacterial pneumonia ( H. influenzae, S. mutans, S. pneumoniae, S. pyogenes ), nosocomial infections ( K. pneumoniae, P. aeruginosa, S. aureus, S. epidermidis, S. pneumoniae ), skin diseases ( M. audouinii , T. mentagrophytes , etc.), urinary tract infections ( E. cloacae , P. mirabilis and P. vulgaris ), Fusobacterium necrophorum and Candida fungi . At the same time, bacteriocin C to a lesser extent than the reference molecules inhibited the growth of the normophysiological microbiota of the Bacteroides , Enterococcus genera, non-pathogenic Escherichia , yeast S. cerevisiae and others. By stimulating butyrate (butyric anion) producing microorganisms, bacteriocin C can exhibit prebiotic properties. Conclusion. The main structural features of the bacteriocin C molecule associated with the antibacterial effect on pathogenic microbiota were identified and described.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"61 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134960800","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 : 2023-07-20DOI: 10.17749/2070-4909/farmakoekonomika.2023.188
I. Zheleznyakova, O. Volkova, D. Fedyaev, A. V. Zuev, O. Plakhotnik, G. V. Trifonova, Yu. S. Zueva, I. A. Alexandrov, V. Omelyanovskiy
Background. The implementation of individual methods of high-tech medical care (HTMC) with methods of specialized medical care within the framework of a phased transition to payment methods by diagnostic-related groups (DRGs), on the one hand, significantly expanded the availability of HTMC methods for the population. Still, it created a situation with duplication of individual treatment methods in the list of HTMC types and DRGs. Amendments to the Order of the Ministry of Health of the Russian Federation (MH RF) of August 1, 2017 No. 484n, regulating the revision of HTMC types list in terms of excluding treatment methods and (or) HTMC types in case of their duplication in the context of HTMC groups and/or DRGs, marked the beginning of large-scale work in this area and required methodological ensuring the processes of forming HTMC types list, including in terms of its revision.Objective: development of a methodological approach to the formation of HTMC types list (using the example of the list for 2023). Material and methods. An analysis of legal documents regulating the HTMC availability in the Russian Federation was carried out, including the list of medical services approved by the Order of the MH RF of October 13, 2017 No. 804n, clinical recommendations for certain nosological entities, the International Classification of Diseases (10th revision), methodological recommendations on ways to pay for medical care at the expense of the compulsory health insurance (CHI) and appendices to them (decoders of DRGs for payment of medical care provided in inpatient and daytime hospital conditions), posted on the official website of the Federal CHI Fund. The frequency of the use of certain HTMC methods and DRGs was analyzed on the basis of impersonalized information from the database of registers of bills for specialized medical care, including HTMC for 2021–2022.Results. A methodological approach to the revision of HTMC types list was developed. It included its primary analysis, expert discussion of the obtained results, consideration by the Interdepartmental Council of the MH RF of proposals agreed with experts on each HTMC method submitted for discussion, followed by a decision on the appropriateness of the proposed changes, and recalculation of the standard of financial costs for HTMC and/or basic tariff for DRGs.Conclusion. The proposed methodological approach makes it possible to unify the process of revising the HTMC types list, including the exclusion of duplicate treatment methods and/or HTMC types in the sections of HTMC list types and/or in DRGs, as well as treatment methods missing in clinical recommendations, etc. in order to bring the HTMC types list in accordance with legal documents regulating the provision of medical care in the Russian Federation.
{"title":"Methodological approach to the formation of the list of high-tech medical care types","authors":"I. Zheleznyakova, O. Volkova, D. Fedyaev, A. V. Zuev, O. Plakhotnik, G. V. Trifonova, Yu. S. Zueva, I. A. Alexandrov, V. Omelyanovskiy","doi":"10.17749/2070-4909/farmakoekonomika.2023.188","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.188","url":null,"abstract":"Background. The implementation of individual methods of high-tech medical care (HTMC) with methods of specialized medical care within the framework of a phased transition to payment methods by diagnostic-related groups (DRGs), on the one hand, significantly expanded the availability of HTMC methods for the population. Still, it created a situation with duplication of individual treatment methods in the list of HTMC types and DRGs. Amendments to the Order of the Ministry of Health of the Russian Federation (MH RF) of August 1, 2017 No. 484n, regulating the revision of HTMC types list in terms of excluding treatment methods and (or) HTMC types in case of their duplication in the context of HTMC groups and/or DRGs, marked the beginning of large-scale work in this area and required methodological ensuring the processes of forming HTMC types list, including in terms of its revision.Objective: development of a methodological approach to the formation of HTMC types list (using the example of the list for 2023). Material and methods. An analysis of legal documents regulating the HTMC availability in the Russian Federation was carried out, including the list of medical services approved by the Order of the MH RF of October 13, 2017 No. 804n, clinical recommendations for certain nosological entities, the International Classification of Diseases (10th revision), methodological recommendations on ways to pay for medical care at the expense of the compulsory health insurance (CHI) and appendices to them (decoders of DRGs for payment of medical care provided in inpatient and daytime hospital conditions), posted on the official website of the Federal CHI Fund. The frequency of the use of certain HTMC methods and DRGs was analyzed on the basis of impersonalized information from the database of registers of bills for specialized medical care, including HTMC for 2021–2022.Results. A methodological approach to the revision of HTMC types list was developed. It included its primary analysis, expert discussion of the obtained results, consideration by the Interdepartmental Council of the MH RF of proposals agreed with experts on each HTMC method submitted for discussion, followed by a decision on the appropriateness of the proposed changes, and recalculation of the standard of financial costs for HTMC and/or basic tariff for DRGs.Conclusion. The proposed methodological approach makes it possible to unify the process of revising the HTMC types list, including the exclusion of duplicate treatment methods and/or HTMC types in the sections of HTMC list types and/or in DRGs, as well as treatment methods missing in clinical recommendations, etc. in order to bring the HTMC types list in accordance with legal documents regulating the provision of medical care in the Russian Federation.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"49 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90319873","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 : 2023-07-20DOI: 10.17749/2070-4909/farmakoekonomika.2023.166
A. Zhuravlev, O. Knysh
Objective: to summarize scientific information about the basic principles of modern drug therapy for patients with chronic myeloid leukemia (CML) considering their individual characteristics.Material and methods. The basis of the study included modern scientific articles and clinical guidelines on CML diagnosis and treatment (2021), State Register of Medicines (SRM) of the Russian Federation, instructions for the use of medicines. The following methods were used: structural analysis, analytical method, content analysis, retrospective analysis, systematic approach, situational-logical and graphical methods of analysis.Results. The analysis made it possible to summarize scientific information about the basic principles of drug therapy for patients suffering from CML. It was revealed that the problem of CML therapy today is relevant, since every year there is an increase in the incidence of this nosology. Currently, the most significant is the prescription of tyrosine kinase inhibitors (TKIs), since they have pronounced effects and are well tolerated by patients. Therapy for CML in TKIs prescription consists of several lines. Imatinib is the first line therapy because it has better safety profile. There are combinations with imatinib; for example, it is used together with interferon alfa, which allows, in some cases, to increase the response to treatment. The following drugs are used in the second line: nilotinib, dasatinib, bosutinib, ponatinib. If TKI therapy is ineffective, it is possible to prescribe standard chemotherapy, interferon therapy, or bone marrow transplantation in the absence of contraindications. Studies are underway on the possibility of using and including in clinical guidelines such drugs as arsenic trioxide, decitabine, omacetaxime, inhibitors of farnesyl transferases, granulocyte-macrophage factors, antitumor vaccines. The analysis of SRM identified 27 trade names for TKIs, the share of domestic drugs was 60%. There were no Russian analogues for bosutinib and ponatinib in SRM, which are recommended for use in case of ineffective TKI therapy of previous lines.Conclusion. The study of drug provision for CML patients is an urgent task for pharmaceutical practice and for the healthcare system as a whole. Currently, the acute issues are the individual approach to the treatment of each CML patient considering concomitant diseases, and the search for new, more effective drugs that can increase the life expectancy and quality of life of patients suffering from this disease.
{"title":"Key principles of drug therapy in patients with chronic myeloid leukemia","authors":"A. Zhuravlev, O. Knysh","doi":"10.17749/2070-4909/farmakoekonomika.2023.166","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.166","url":null,"abstract":"Objective: to summarize scientific information about the basic principles of modern drug therapy for patients with chronic myeloid leukemia (CML) considering their individual characteristics.Material and methods. The basis of the study included modern scientific articles and clinical guidelines on CML diagnosis and treatment (2021), State Register of Medicines (SRM) of the Russian Federation, instructions for the use of medicines. The following methods were used: structural analysis, analytical method, content analysis, retrospective analysis, systematic approach, situational-logical and graphical methods of analysis.Results. The analysis made it possible to summarize scientific information about the basic principles of drug therapy for patients suffering from CML. It was revealed that the problem of CML therapy today is relevant, since every year there is an increase in the incidence of this nosology. Currently, the most significant is the prescription of tyrosine kinase inhibitors (TKIs), since they have pronounced effects and are well tolerated by patients. Therapy for CML in TKIs prescription consists of several lines. Imatinib is the first line therapy because it has better safety profile. There are combinations with imatinib; for example, it is used together with interferon alfa, which allows, in some cases, to increase the response to treatment. The following drugs are used in the second line: nilotinib, dasatinib, bosutinib, ponatinib. If TKI therapy is ineffective, it is possible to prescribe standard chemotherapy, interferon therapy, or bone marrow transplantation in the absence of contraindications. Studies are underway on the possibility of using and including in clinical guidelines such drugs as arsenic trioxide, decitabine, omacetaxime, inhibitors of farnesyl transferases, granulocyte-macrophage factors, antitumor vaccines. The analysis of SRM identified 27 trade names for TKIs, the share of domestic drugs was 60%. There were no Russian analogues for bosutinib and ponatinib in SRM, which are recommended for use in case of ineffective TKI therapy of previous lines.Conclusion. The study of drug provision for CML patients is an urgent task for pharmaceutical practice and for the healthcare system as a whole. Currently, the acute issues are the individual approach to the treatment of each CML patient considering concomitant diseases, and the search for new, more effective drugs that can increase the life expectancy and quality of life of patients suffering from this disease.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"9 4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75695785","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 : 2023-07-20DOI: 10.17749/2070-4909/farmakoekonomika.2023.191
M. Zhuravleva, V. Chulanov, Yu. V. Gagarina, E. A. Shabalina
Objective: to evaluate the pharmacoeconomic feasibility of using monoclonal antibodies or their combinations vs standard therapy in patients with mild and moderate-severe COVID-19 in order to prevent the severe course of the disease.Material and methods. The decision tree and Markov models for calculation of costs and outcomes were used for patients with COVID-19 and post-COVID-19 syndrome, respectively. The cost-effectiveness of tixagevimab and cilgavimab was evaluated in persons ≥18 years old not vaccinated against COVID-19 with a high risk of progression to severe COVID-19. Effectiveness and safety of tixagevimab and cilgavimab combination was assessed based on TACKLE phase III study results. The quantities of life years gained (LYG) and quality-adjusted life years (QALY) were calculated. Results were compared with the wiliness-to-pay threshold measured as tripled gross domestic product per capita according the World Health Organization recommendations.Results. Treatment of COVID-19 with tixagevimab and cilgavimab results in additional 0.2657 LIGs or 0.2255 QALYs. The cost of 1 LIG was 213,4 thousand rubles, the cost of 1 QALY was 251,5 thousand rubles. Both costs of LIG and QALY appeared to be significantly less compared to the wiliness-to-pay threshold equal to 3.09 million rubles in 2022.Conclusion. Treatment of mild and moderate-severe COVID-19 is economically feasible and may be recommended for wide use in the Russian healthcare system.
目的:评价单克隆抗体或其联合治疗与标准治疗在轻、中重度COVID-19患者中预防病程加重的药物经济学可行性。材料和方法。对COVID-19患者和COVID-19后综合征患者分别使用决策树和马尔可夫模型计算成本和结果。在≥18岁未接种COVID-19疫苗且进展为严重COVID-19的高风险人群中，评估了替沙吉韦单抗和西加维单抗的成本效益。根据TACKLE III期研究结果评估替沙吉维单抗和西gavimab联合用药的有效性和安全性。计算获得生命年(LYG)和质量调整生命年(QALY)。研究结果与世界卫生组织(World Health Organization)建议的人均国内生产总值(gdp)的三倍衡量的支付意愿阈值进行了比较。使用替沙吉维单抗和西伽维单抗治疗COVID-19可获得额外的0.2657 LIGs或0.2255 qaly。1个LIG的成本是213.4万卢布，1个QALY的成本是25.5万卢布。与2022年达到的309万卢布的支付意愿阈值相比，LIG和QALY的成本似乎都要低得多。治疗轻重度COVID-19在经济上是可行的，可能建议在俄罗斯卫生保健系统中广泛使用。
{"title":"Pharmacoeconomic analysis of tixagevimab and cilgavimab combination for COVID-19 therapy","authors":"M. Zhuravleva, V. Chulanov, Yu. V. Gagarina, E. A. Shabalina","doi":"10.17749/2070-4909/farmakoekonomika.2023.191","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.191","url":null,"abstract":"Objective: to evaluate the pharmacoeconomic feasibility of using monoclonal antibodies or their combinations vs standard therapy in patients with mild and moderate-severe COVID-19 in order to prevent the severe course of the disease.Material and methods. The decision tree and Markov models for calculation of costs and outcomes were used for patients with COVID-19 and post-COVID-19 syndrome, respectively. The cost-effectiveness of tixagevimab and cilgavimab was evaluated in persons ≥18 years old not vaccinated against COVID-19 with a high risk of progression to severe COVID-19. Effectiveness and safety of tixagevimab and cilgavimab combination was assessed based on TACKLE phase III study results. The quantities of life years gained (LYG) and quality-adjusted life years (QALY) were calculated. Results were compared with the wiliness-to-pay threshold measured as tripled gross domestic product per capita according the World Health Organization recommendations.Results. Treatment of COVID-19 with tixagevimab and cilgavimab results in additional 0.2657 LIGs or 0.2255 QALYs. The cost of 1 LIG was 213,4 thousand rubles, the cost of 1 QALY was 251,5 thousand rubles. Both costs of LIG and QALY appeared to be significantly less compared to the wiliness-to-pay threshold equal to 3.09 million rubles in 2022.Conclusion. Treatment of mild and moderate-severe COVID-19 is economically feasible and may be recommended for wide use in the Russian healthcare system.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88243303","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 : 2023-07-20DOI: 10.17749/2070-4909/farmakoekonomika.2023.139
O. Zhukova, D. Fokina, O. V. Ruina, M. Khazov
Objective: to perform pharmacoepidemiological and drug interaction analysis of pharmacotherapy for liver/kidney transplantation.Material and methods. The study was conducted on the basis of multidisciplinary hospital in Nizhny Novgorod, which provides both therapeutic and high-tech surgical care. The object of the study was medical records of 34 patients who had undergone pharmacotherapy for liver/kidney transplantation. We evaluated the particularly dangerous moderate interactions that pose the greatest risk to patient health using Drugs.com electronic resource. Pharmacoepidemiologic assessment was performed using the ATC/DDD methodology (anatomical therapeutic chemical (ATC) classification system – defined daily dose (DDD)) recommended by the World Health Organization. The “average bed occupancy per year” was calculated using DDD per 100 bed-days. ABC analysis was used to estimate the costs of drug groups in therapy for liver/kidney transplantation. Results. In most cases, the third generation cephalosporins were used in the therapy of liver/kidney transplant patients (55.56% of all prescriptions). Antimicrobial drugs were mostly prescribed as monotherapy (61.9%). There were 111 potential major (14.41%) and moderate (72.07%) interactions detected. The largest number of moderate type risks was associated with changes in blood pressure levels (in 23.75% of cases – possible decrease, in 10% – increase), 7.5% of cases were accompanied by headaches, 6.25% – by reduction of drug effectiveness. In antimicrobial therapy, two main interactions were found: moxifloxacin – tacrolimus (arrhythmia), and metipred – moxifloxacin (tendon dystrophy), which is 12.5% of all main interactions for 21 case histories. In the ABC analysis, immunosuppressants were in group A (cost share 85.8%). Tacrolimus accounted for the largest amount of consumption: number of defined daily doses (NDDD) per year was 532.27 mg, NDDD per 100 bed days reached 432.18 (the highest among all drugs).Conclusion. Pharmacoepidemiologic analysis allows us to systematize data on medication use. The choice of drugs in order to ensure safe and effective use of the registered drug interactions is facilitated by electronic databases.
{"title":"Pharmacoepidemiological and drug interaction analysis in the treatment of chronic renal and hepatic failure","authors":"O. Zhukova, D. Fokina, O. V. Ruina, M. Khazov","doi":"10.17749/2070-4909/farmakoekonomika.2023.139","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.139","url":null,"abstract":"Objective: to perform pharmacoepidemiological and drug interaction analysis of pharmacotherapy for liver/kidney transplantation.Material and methods. The study was conducted on the basis of multidisciplinary hospital in Nizhny Novgorod, which provides both therapeutic and high-tech surgical care. The object of the study was medical records of 34 patients who had undergone pharmacotherapy for liver/kidney transplantation. We evaluated the particularly dangerous moderate interactions that pose the greatest risk to patient health using Drugs.com electronic resource. Pharmacoepidemiologic assessment was performed using the ATC/DDD methodology (anatomical therapeutic chemical (ATC) classification system – defined daily dose (DDD)) recommended by the World Health Organization. The “average bed occupancy per year” was calculated using DDD per 100 bed-days. ABC analysis was used to estimate the costs of drug groups in therapy for liver/kidney transplantation. Results. In most cases, the third generation cephalosporins were used in the therapy of liver/kidney transplant patients (55.56% of all prescriptions). Antimicrobial drugs were mostly prescribed as monotherapy (61.9%). There were 111 potential major (14.41%) and moderate (72.07%) interactions detected. The largest number of moderate type risks was associated with changes in blood pressure levels (in 23.75% of cases – possible decrease, in 10% – increase), 7.5% of cases were accompanied by headaches, 6.25% – by reduction of drug effectiveness. In antimicrobial therapy, two main interactions were found: moxifloxacin – tacrolimus (arrhythmia), and metipred – moxifloxacin (tendon dystrophy), which is 12.5% of all main interactions for 21 case histories. In the ABC analysis, immunosuppressants were in group A (cost share 85.8%). Tacrolimus accounted for the largest amount of consumption: number of defined daily doses (NDDD) per year was 532.27 mg, NDDD per 100 bed days reached 432.18 (the highest among all drugs).Conclusion. Pharmacoepidemiologic analysis allows us to systematize data on medication use. The choice of drugs in order to ensure safe and effective use of the registered drug interactions is facilitated by electronic databases.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80994119","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 : 2023-07-20DOI: 10.17749/2070-4909/farmakoekonomika.2023.176
M. S. Soboleva
{"title":"Providing pharmaceutical consultation to visitors of pharmacy organizations in routine pharmaceutical practice","authors":"M. S. Soboleva","doi":"10.17749/2070-4909/farmakoekonomika.2023.176","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.176","url":null,"abstract":"","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"478 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86777697","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 : 2023-07-19DOI: 10.17749/2070-4909/farmakoekonomika.2023.184
E. V. Kuznetsova, M. Zhuravleva, I. Mikhailov, T. Kurnosova
Objective: development of approaches to predict the likelihood of adverse reactions (ARs) when using drugs based on a comprehensive assessment of risk factors.Material and methods. We used a database containing 1,450 drug-related ARs reports from January through December 2021. A list of antibacterial drugs by international nonproprietary name (INN) with 4 or more ARs reports was selected as a reference group to perform various types of statistical analysis. A cumulative multivariate regression analysis was carried out on a database of 187 ARs notifications for 13 INN of antibacterial drugs. The study was performed in two stages. In the first stage, a statistical method was used (classical multiple regression, linear discriminant analysis, factor analysis, principal component regression, partial least squares regression, estimation of variance accuracy); at the second stage a modeling method was used. As part of the modeling stage, the integral score of the risk of ARs was presented as a sum of values for individual risk factors. Two groups of risks were proposed to be assessed: 1) intrinsic risk value for each factor (attribute), which was equal to the sum of risks of all factors (conditions) in which the drug had been used; 2) intrinsic risk value for antibacterial drugs by each INN. The total risk value was defined as the sum of the risk of the drug and all factors (conditions) in which this drug had been used.Results. The results were visualized in the form of a two-level risk-based model matrix, with a “heat map” of the risk level overlaid on it. The maximum total risk of ARs was obtained for ceftriaxone – 404.96 points, depending on patient’s gender. The minimum total risk was calculated for azithromycin and cefotaxime depending on the International Classification of Diseases (10th revision) code – 88.46 points. The proposed methodological approach also allows combining all possible combinations of drugs and conditions of their use. For example, for the use of vancomycin in hospital conditions by intravenous administration: intrinsic risk of use – 42.93 points; risk of use in hospital conditions – 183.68 points; risk when administered intravenously – 209.95 points; the total risk value in the designated situation – 436.56 points.Conclusion. The proposed approach can allow medical organizations to reduce significantly the number of ARs when using drugs by categorizing and preventing risks before they occur. It also has significant prospects of application at the federal level, given its modification on a large volume of data.
{"title":"Development of methodological approaches to the formation of a risk-based model to minimize the prevalence of adverse reactions in drug application in medical organizations of Moscow","authors":"E. V. Kuznetsova, M. Zhuravleva, I. Mikhailov, T. Kurnosova","doi":"10.17749/2070-4909/farmakoekonomika.2023.184","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.184","url":null,"abstract":"Objective: development of approaches to predict the likelihood of adverse reactions (ARs) when using drugs based on a comprehensive assessment of risk factors.Material and methods. We used a database containing 1,450 drug-related ARs reports from January through December 2021. A list of antibacterial drugs by international nonproprietary name (INN) with 4 or more ARs reports was selected as a reference group to perform various types of statistical analysis. A cumulative multivariate regression analysis was carried out on a database of 187 ARs notifications for 13 INN of antibacterial drugs. The study was performed in two stages. In the first stage, a statistical method was used (classical multiple regression, linear discriminant analysis, factor analysis, principal component regression, partial least squares regression, estimation of variance accuracy); at the second stage a modeling method was used. As part of the modeling stage, the integral score of the risk of ARs was presented as a sum of values for individual risk factors. Two groups of risks were proposed to be assessed: 1) intrinsic risk value for each factor (attribute), which was equal to the sum of risks of all factors (conditions) in which the drug had been used; 2) intrinsic risk value for antibacterial drugs by each INN. The total risk value was defined as the sum of the risk of the drug and all factors (conditions) in which this drug had been used.Results. The results were visualized in the form of a two-level risk-based model matrix, with a “heat map” of the risk level overlaid on it. The maximum total risk of ARs was obtained for ceftriaxone – 404.96 points, depending on patient’s gender. The minimum total risk was calculated for azithromycin and cefotaxime depending on the International Classification of Diseases (10th revision) code – 88.46 points. The proposed methodological approach also allows combining all possible combinations of drugs and conditions of their use. For example, for the use of vancomycin in hospital conditions by intravenous administration: intrinsic risk of use – 42.93 points; risk of use in hospital conditions – 183.68 points; risk when administered intravenously – 209.95 points; the total risk value in the designated situation – 436.56 points.Conclusion. The proposed approach can allow medical organizations to reduce significantly the number of ARs when using drugs by categorizing and preventing risks before they occur. It also has significant prospects of application at the federal level, given its modification on a large volume of data.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85259260","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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