Pub Date : 2021-07-25DOI: 10.17749/2070-4909/farmakoekonomika.2021.088
D. Ivanov, I. Dyakov, S. Zyryanov
Objective: comparative assessment of the economic effect of oral vinorelbine when used as indicated, taking into consideration the new registered price.Material and methods. A clinical-economic study was performed to compare active platinum-containing chemotherapy regimens of the first line for stage IV non-small-cell lung cancer with oral vinorelbine and pemetrexed as well as first-line chemotherapy regimens for metastatic breast cancer presented with oral vinorelbine and ixabepilone alone. A systematic search for information in medical databases was carried out, the cost estimate was made out in accordance with the recommendations of The Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation. The direct medical costs were estimated, formed on the basis of the dosage, frequency and dosage regimen of the compared drugs, based on the data of the State Register of maximum selling prices, clinical guidelines for the studied nosologies, and instructions for medical use. The comparison of the economic effect of the studied drugs was carried out in pairs using the cost minimization method with a sensitivity analysis. Further, the calculations of the amounts of reimbursement of medical care provided were made using each of the compared drugs. An economic assessment of the economic effect of oral vinorelbine was carried out taking into consideration the change in the price of the drug and a budget impact analysis with a sensitivity analysis.Results. It was determined that the use of oral vinorelbine provides financial savings for a medical organization at the amount of 246,042.34 rubles per 6 cycles of chemotherapy for each patient with stage IV non-small-cell lung cancer compared with the use of pemetrexed, and 558,659.32 rubles per year – for the treatment of each patient with metastatic breast cancer compared with ixabepilone. The results of the budget impact analysis showed that the indication of oral vinorelbine saved 3,287,470.56 rubles for the budget fund considering the change in the cost of 1 mg of the drug for a hypothetical population of patients with stage IV non-small-cell lung cancer in 1000 people. This would create the possibility of therapy for additional 15 patients with this diagnosis. The indication of oral vinorelbine in first-line chemotherapy of metastatic breast cancer for a similar target population would save 18,355,043.96 rubles for the budget fund, which makes it possible to treat 15 more patients with this diagnosis.Conclusion. The use of oral vinorelbine is associated with the saving of financial resources of a medical organization. In addition, the reimbursement for medical care provided from the compulsory medical insurance funds when using regimens with oral vinorelbine is primarily lower than for comparison drugs. Thus, the use of regimens with oral vinorelbine is more beneficial for the payer (the Federal Compulsory Health Insurance Fund) and for the medical organization
{"title":"Pharmacoeconomic aspects of oral vinorelbine application: a budget impact analysis considering the new registered price","authors":"D. Ivanov, I. Dyakov, S. Zyryanov","doi":"10.17749/2070-4909/farmakoekonomika.2021.088","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.088","url":null,"abstract":"Objective: comparative assessment of the economic effect of oral vinorelbine when used as indicated, taking into consideration the new registered price.Material and methods. A clinical-economic study was performed to compare active platinum-containing chemotherapy regimens of the first line for stage IV non-small-cell lung cancer with oral vinorelbine and pemetrexed as well as first-line chemotherapy regimens for metastatic breast cancer presented with oral vinorelbine and ixabepilone alone. A systematic search for information in medical databases was carried out, the cost estimate was made out in accordance with the recommendations of The Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation. The direct medical costs were estimated, formed on the basis of the dosage, frequency and dosage regimen of the compared drugs, based on the data of the State Register of maximum selling prices, clinical guidelines for the studied nosologies, and instructions for medical use. The comparison of the economic effect of the studied drugs was carried out in pairs using the cost minimization method with a sensitivity analysis. Further, the calculations of the amounts of reimbursement of medical care provided were made using each of the compared drugs. An economic assessment of the economic effect of oral vinorelbine was carried out taking into consideration the change in the price of the drug and a budget impact analysis with a sensitivity analysis.Results. It was determined that the use of oral vinorelbine provides financial savings for a medical organization at the amount of 246,042.34 rubles per 6 cycles of chemotherapy for each patient with stage IV non-small-cell lung cancer compared with the use of pemetrexed, and 558,659.32 rubles per year – for the treatment of each patient with metastatic breast cancer compared with ixabepilone. The results of the budget impact analysis showed that the indication of oral vinorelbine saved 3,287,470.56 rubles for the budget fund considering the change in the cost of 1 mg of the drug for a hypothetical population of patients with stage IV non-small-cell lung cancer in 1000 people. This would create the possibility of therapy for additional 15 patients with this diagnosis. The indication of oral vinorelbine in first-line chemotherapy of metastatic breast cancer for a similar target population would save 18,355,043.96 rubles for the budget fund, which makes it possible to treat 15 more patients with this diagnosis.Conclusion. The use of oral vinorelbine is associated with the saving of financial resources of a medical organization. In addition, the reimbursement for medical care provided from the compulsory medical insurance funds when using regimens with oral vinorelbine is primarily lower than for comparison drugs. Thus, the use of regimens with oral vinorelbine is more beneficial for the payer (the Federal Compulsory Health Insurance Fund) and for the medical organization","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128970379","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 : 2021-07-25DOI: 10.17749/2070-4909/farmakoekonomika.2021.082
D. Shchurov, V. Dombrovskiy
Objective: early assessming the clinical and economic efficacy of the thrombodynamics test in infertile patients undergoing treatment with assisted reproductive technologies (ART), as well as the impact of this test on the health care budget of the Russian Federation.Material and methods. The study was carried out on the basis of statistical data on the number of ART cycles, the proportion of patients with hypercoagulation and normocoagulation of blood, data on the clinical effectiveness of ART programs in Russia, including the dependency on the status of blood coagulation, as well as cost data. The analysis was carried out according to three scenarios: 1) thrombodynamics test with subsequent correction of the revealed hypercoagulability status before in vitro fertilization (IVF); 2) thrombodynamics test with the subsequent refusal to perform IVF in patients with hypercoagulability; 3) thrombodynamics test with subsequent correction of the revealed hypercoagulability status before the start of the frozen-thawed embryo transfer. The criteria for clinical effectiveness were the following indicators: the number of children born and the number of potentially saved life years. Clinical and economic efficacy criteria included: total direct medical costs; incremental cost-effectiveness ratio (ICER); changes in the amount of total direct medical costs; resizing effectively and ineffectively spent funds.Results. The use of the thrombodynamics test will potentially increase the number of children born by 21–33 children and the number of years of life saved, with discounting considered, within the range of 923–1448 years per 1000 ART cycles, depending on the study scenario. The smallest ICER values were observed in Scenario 2, and amounted to 112,120 rubles for 1 child born and 2519 rubles for 1 saved year of life. The highest ICER values were obtained in Scenario 1: 275,576 rubles for 1 child born and 6191 rubles for 1 saved year of life. The use of the thrombodynamics test in women with infertility before ART in Russia will require an increase in direct medical costs from 174 to 425 million rubles (by 1–5% of the initial level of costs) in absolute terms, depending on the chosen scenario with a time horizon of 1 year.Conclusion. Due to the expected significant improvement in treatment outcomes and the small amount of additional costs, the introduction of the thrombodynamics test into the routine practice of assessing blood clotting in infertile patients before the start of the ART cycle is potentially cost-effective, but further clinical studies are required for a more accurate economic assessment.
{"title":"Clinical and economic analysis of using the thrombodynamics test in patients undergoing treatment with assisted reproductive technologies in the Russian Federation","authors":"D. Shchurov, V. Dombrovskiy","doi":"10.17749/2070-4909/farmakoekonomika.2021.082","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.082","url":null,"abstract":"Objective: early assessming the clinical and economic efficacy of the thrombodynamics test in infertile patients undergoing treatment with assisted reproductive technologies (ART), as well as the impact of this test on the health care budget of the Russian Federation.Material and methods. The study was carried out on the basis of statistical data on the number of ART cycles, the proportion of patients with hypercoagulation and normocoagulation of blood, data on the clinical effectiveness of ART programs in Russia, including the dependency on the status of blood coagulation, as well as cost data. The analysis was carried out according to three scenarios: 1) thrombodynamics test with subsequent correction of the revealed hypercoagulability status before in vitro fertilization (IVF); 2) thrombodynamics test with the subsequent refusal to perform IVF in patients with hypercoagulability; 3) thrombodynamics test with subsequent correction of the revealed hypercoagulability status before the start of the frozen-thawed embryo transfer. The criteria for clinical effectiveness were the following indicators: the number of children born and the number of potentially saved life years. Clinical and economic efficacy criteria included: total direct medical costs; incremental cost-effectiveness ratio (ICER); changes in the amount of total direct medical costs; resizing effectively and ineffectively spent funds.Results. The use of the thrombodynamics test will potentially increase the number of children born by 21–33 children and the number of years of life saved, with discounting considered, within the range of 923–1448 years per 1000 ART cycles, depending on the study scenario. The smallest ICER values were observed in Scenario 2, and amounted to 112,120 rubles for 1 child born and 2519 rubles for 1 saved year of life. The highest ICER values were obtained in Scenario 1: 275,576 rubles for 1 child born and 6191 rubles for 1 saved year of life. The use of the thrombodynamics test in women with infertility before ART in Russia will require an increase in direct medical costs from 174 to 425 million rubles (by 1–5% of the initial level of costs) in absolute terms, depending on the chosen scenario with a time horizon of 1 year.Conclusion. Due to the expected significant improvement in treatment outcomes and the small amount of additional costs, the introduction of the thrombodynamics test into the routine practice of assessing blood clotting in infertile patients before the start of the ART cycle is potentially cost-effective, but further clinical studies are required for a more accurate economic assessment.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133412120","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 : 2021-07-25DOI: 10.17749/2070-4909/farmakoekonomika.2021.095
A. Rudakova, D. Tolkacheva, V. Sokolova
Objective: to perform cost-effectiveness analysis of the treatment for adult patients with psoriatic arthritis (PsA) with a Russian interleukin- 17А inhibitor netakimab in comparison with other biologic disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) and to evaluate the influence of the inclusion of netakimab in the therapy for PsA on the budget of the Russian healthcare system.Material and methods. The evaluation of cost-effectiveness was performed from the position of the Russian healthcare system for patients with moderate and severe PsA. The evaluation was performed based on the results of the network meta-analysis of the randomized clinical studies. The criterion of clinical effectiveness included the changes in the condition of the joints by the criteria of the American College of Rheumatology (ACR20, ACR50, and ACR70) and changes in skin symptoms by the index of the prevalence and severity of psoriasis (PASI 75 and PASI 90) with a recalculation into quality-adjusted life-year (QALY). The time horizon of the cost-effectiveness analysis was 2 years. The calculation was based on the registered prices and VAT. If there was an original drug and a biosimilar registered on the pharmaceutical market, the calculation was based on the median of the registered prices. The budget impact analysis of the influence of netakimab inclusion in the therapy for patients with PsA was performed considering the structure of the prescription of bDMARDs and tsDMARDs that was determined in the pharmaco-epidemiological study conducted in the Russian Federation in 2020. The analysis was performed for patients that received medication by the scheme of reimbursement. The time horizon of the study was 3 years old.Results. In the base-case analysis, the cost-effectiveness ratio for netakimab was 1.210 mln rub/QALY (by 66.2–88.5% lower than in cases when comparison drugs were used). The budget impact analysis showed that the inclusion of netakimab in the therapy for PsA could reduce the costs by 376.60 mln rub (21.1%). Considering budget saving, the number of additional patients that can be treated will increase by 26.7% within 3 years.Conclusion. Netakimab is characterized by higher cost-effectiveness in comparison with other bDMARDs (adalimumab, golimumab, guselkumab, ixekizumab, infliximab, secukinumab, ustekinumab, certolizumab pegol, etanercept) and tsDMARDs (apremilast, tofacitinib) prescribed in the Russian Federation for patients with PsA. The inclusion of netakimab in the therapy for PsA will reduce the financial burden on the healthcare system.
{"title":"Pharmacoeconomic aspects of the therapy for moderate and severe psoriatic arthritis","authors":"A. Rudakova, D. Tolkacheva, V. Sokolova","doi":"10.17749/2070-4909/farmakoekonomika.2021.095","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.095","url":null,"abstract":"Objective: to perform cost-effectiveness analysis of the treatment for adult patients with psoriatic arthritis (PsA) with a Russian interleukin- 17А inhibitor netakimab in comparison with other biologic disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) and to evaluate the influence of the inclusion of netakimab in the therapy for PsA on the budget of the Russian healthcare system.Material and methods. The evaluation of cost-effectiveness was performed from the position of the Russian healthcare system for patients with moderate and severe PsA. The evaluation was performed based on the results of the network meta-analysis of the randomized clinical studies. The criterion of clinical effectiveness included the changes in the condition of the joints by the criteria of the American College of Rheumatology (ACR20, ACR50, and ACR70) and changes in skin symptoms by the index of the prevalence and severity of psoriasis (PASI 75 and PASI 90) with a recalculation into quality-adjusted life-year (QALY). The time horizon of the cost-effectiveness analysis was 2 years. The calculation was based on the registered prices and VAT. If there was an original drug and a biosimilar registered on the pharmaceutical market, the calculation was based on the median of the registered prices. The budget impact analysis of the influence of netakimab inclusion in the therapy for patients with PsA was performed considering the structure of the prescription of bDMARDs and tsDMARDs that was determined in the pharmaco-epidemiological study conducted in the Russian Federation in 2020. The analysis was performed for patients that received medication by the scheme of reimbursement. The time horizon of the study was 3 years old.Results. In the base-case analysis, the cost-effectiveness ratio for netakimab was 1.210 mln rub/QALY (by 66.2–88.5% lower than in cases when comparison drugs were used). The budget impact analysis showed that the inclusion of netakimab in the therapy for PsA could reduce the costs by 376.60 mln rub (21.1%). Considering budget saving, the number of additional patients that can be treated will increase by 26.7% within 3 years.Conclusion. Netakimab is characterized by higher cost-effectiveness in comparison with other bDMARDs (adalimumab, golimumab, guselkumab, ixekizumab, infliximab, secukinumab, ustekinumab, certolizumab pegol, etanercept) and tsDMARDs (apremilast, tofacitinib) prescribed in the Russian Federation for patients with PsA. The inclusion of netakimab in the therapy for PsA will reduce the financial burden on the healthcare system.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126114814","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 : 2021-07-05DOI: 10.17749/2070-4909/farmakoekonomika.2021.101
А. Kolbin, А. Kurylev, Y. Balykina, М. А. Proskurin, S. Mishinova
Background. Spinal muscular atrophies (SMA) are clinically and genetically heterogenous inherited orphan diseases leading to progressive spinal motoneurons degeneration and loss of function. Risdiplam and nusinersen are both authorized in Russia for pathogenic SMA treatment and included in the list of vital and essential drugs.Objective: health-economic evaluation of risdiplam (Evrysdi®) in patients with SMA.Material and methods. The health-economic analysis was done in accordance with local Russian regulation. Cost-minimization analysis was used. We accounted for direct medical costs of pathogenic treatment of SMA, adverse events correction, and supportive care. Decision tree analysis was used. In budget impact analysis the rise of risdiplam share from 0% to 8.5% during 3 years was modelled. Time horizon was 3 years. Probabilistic sensitivity analysis was done.Results. Total direct medical costs for risdiplam (53,372,153 rubles for one patient in 3 years) were by 21.1% (14,968,427.82 rubles) lower comparing to nusinersen. The most pronounced difference in favor of risdiplam (41,9%) was during first treatment year. The rise of risdiplam share from 0% to 8.5% during 3 years is associated with lower budget costs by 13.9% in 3 years.Conclusion. Risdiplam is economically more effective comparing to nusinersen, because having equal effectiveness, it’s use is associated with lower direct medical costs.
{"title":"Health-economic evaluation of risdiplam (Evrysdi®) in patients with spinal muscular atrophy","authors":"А. Kolbin, А. Kurylev, Y. Balykina, М. А. Proskurin, S. Mishinova","doi":"10.17749/2070-4909/farmakoekonomika.2021.101","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.101","url":null,"abstract":"Background. Spinal muscular atrophies (SMA) are clinically and genetically heterogenous inherited orphan diseases leading to progressive spinal motoneurons degeneration and loss of function. Risdiplam and nusinersen are both authorized in Russia for pathogenic SMA treatment and included in the list of vital and essential drugs.Objective: health-economic evaluation of risdiplam (Evrysdi®) in patients with SMA.Material and methods. The health-economic analysis was done in accordance with local Russian regulation. Cost-minimization analysis was used. We accounted for direct medical costs of pathogenic treatment of SMA, adverse events correction, and supportive care. Decision tree analysis was used. In budget impact analysis the rise of risdiplam share from 0% to 8.5% during 3 years was modelled. Time horizon was 3 years. Probabilistic sensitivity analysis was done.Results. Total direct medical costs for risdiplam (53,372,153 rubles for one patient in 3 years) were by 21.1% (14,968,427.82 rubles) lower comparing to nusinersen. The most pronounced difference in favor of risdiplam (41,9%) was during first treatment year. The rise of risdiplam share from 0% to 8.5% during 3 years is associated with lower budget costs by 13.9% in 3 years.Conclusion. Risdiplam is economically more effective comparing to nusinersen, because having equal effectiveness, it’s use is associated with lower direct medical costs.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131032771","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 : 2021-06-03DOI: 10.17749/2070-4909/farmakoekonomika.2021.089
N. Nikolenko, D. Kudlay, N. Doktorova
Treatment of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) is a current problem worldwide. Currently, special attention is paid to the possibility of using new high-cost chemotherapy regimens in the treatment of MDR/XDR-TB. Numerous studies have shown that, from a clinical point of view, the effectiveness of MDR/XDR-TB therapy increases with the inclusion of bedaquiline, delamanid, linezolid, fluoroquinolones (moxifloxacin, levofloxacin), and pretomanid. At the same time, there is an assumption that the use of new and repurposed anti-tuberculosis drugs (ATDs) may be associated with an increase in overall costs. This paper demonstrates the potential of pharmacoepidemiology and pharmacoeconomics to evaluate the widespread introduction of new anti-tuberculosis drugs (ATDs), taking into account all the typical features of MDR/XDR-TB therapy. The authors analyzed studies of pharmacoeconomic feasibility of using expensive drugs in treatment regimens of pulmonary tuberculosis patients with MDR/XDR pathogen. It was shown that the use of chemotherapy regimens containing new high-cost and highly effective drugs (moxifloxacin, linizolid, and bedaquiline) in rational combinations with other drugs of the basic and reserve series, selected concerning drug resistance of the pathogen, is associated with a significant economic effect. From the applicability of pharmacoeconomic analysis point of view, the introduction of short-term MDR-TB treatment regimens is also a promising direction in phthisiology. The key link to achieve effective MDR/XDR-TB treatment is the use of new drugs. Considering the specificity of pharmacoeconomic analysis in phthisiology and results of existing clinical and economic studies, the authors have formed recommendations aimed at a more complete realization of pharmacoeconomic analysis potential in MDR- and XDR-TB treatment.
{"title":"Pharmacoepidemiology and pharmacoeconomics of multidrug- and extensively drug-resistant tuberculosis","authors":"N. Nikolenko, D. Kudlay, N. Doktorova","doi":"10.17749/2070-4909/farmakoekonomika.2021.089","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.089","url":null,"abstract":"Treatment of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) is a current problem worldwide. Currently, special attention is paid to the possibility of using new high-cost chemotherapy regimens in the treatment of MDR/XDR-TB. Numerous studies have shown that, from a clinical point of view, the effectiveness of MDR/XDR-TB therapy increases with the inclusion of bedaquiline, delamanid, linezolid, fluoroquinolones (moxifloxacin, levofloxacin), and pretomanid. At the same time, there is an assumption that the use of new and repurposed anti-tuberculosis drugs (ATDs) may be associated with an increase in overall costs. This paper demonstrates the potential of pharmacoepidemiology and pharmacoeconomics to evaluate the widespread introduction of new anti-tuberculosis drugs (ATDs), taking into account all the typical features of MDR/XDR-TB therapy. The authors analyzed studies of pharmacoeconomic feasibility of using expensive drugs in treatment regimens of pulmonary tuberculosis patients with MDR/XDR pathogen. It was shown that the use of chemotherapy regimens containing new high-cost and highly effective drugs (moxifloxacin, linizolid, and bedaquiline) in rational combinations with other drugs of the basic and reserve series, selected concerning drug resistance of the pathogen, is associated with a significant economic effect. From the applicability of pharmacoeconomic analysis point of view, the introduction of short-term MDR-TB treatment regimens is also a promising direction in phthisiology. The key link to achieve effective MDR/XDR-TB treatment is the use of new drugs. Considering the specificity of pharmacoeconomic analysis in phthisiology and results of existing clinical and economic studies, the authors have formed recommendations aimed at a more complete realization of pharmacoeconomic analysis potential in MDR- and XDR-TB treatment.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"63 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114622328","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 : 2021-04-29DOI: 10.17749/2070-4909/FARMAKOEKONOMIKA.2021.083
O. Gromova, I. Torshin, B. T. Zaychik, E. V. Shikh, A. O. Ruzhitskiy, A. Galustyan, I. S. Sardaryan, I. Sarvilina
Objective: a comparative analysis of 6 different chondroprotectors for injection, containing chondroitin sulfate (CS) based on natural extracts.Material and methods. Five samples were studied for each CS extract. The preparations were compared on the basis of profiles of trace element composition, sulfur content, chromatographic analysis and test for total protein. In each sample, the concentration of 72 elements was determined, then averaging was performed and the variances of the content of each element were calculated. To assess the content of the protein fraction, a modified Lowry method with bicincholic acid was used. Chromatographic profiles of the studied CS extracts were measured to estimate the molecular weight distribution.Results. The studied samples differ significantly from each other in the total and individual content of sulfur, toxic and conditionally toxic microelements. According to the analysis of sulfur and trace elements, a cluster of more standardized CS extracts was identified. It was shown that the assessments of the pharmaceutical quality of the studied extracts made by the elemental profile, correspond to the assessments of the quality by the degree of proteins elimination and by the molecular weight characteristics of CS extracts. In particular, the highest total content of toxic elements was found for CS-6 (14.87±1.81 μg/l) and CS-2 (9.20±1.12 μg/l), and the lowest – for CS-4 (1.46±0.23 μg/l), CS-3 (1.92±0.33 μg/l) and CS-1 (2.98±0.25 μg/l). The highest content of protein impurities was also found in CS-6 (9.62 mg/ml) and CS-2 (6.64 mg/ml), and the lowest – in CS-1 (2.87 mg/ml). At the same time, the highest amount of sulfur was found CS-1 (6400 mg/kg) and much less – for CS-2 (370 mg/kg) and CS-6 (100 mg/kg). Significant amounts of the high-molecular fraction of CS (1–40 kDa) were found only in CS-1, and only trace amounts of high-molecular CS forms were present in CS-2 and CS-6.Conclusion. The highest content of cholesterol and sulfur and, at the same time, the lowest content of toxic microelements and proteins were distinguished by the extract obtained from the trachea of a bovine.
{"title":"Differences in the standardization of medicinal products based on extracts of chondroitin sulfate","authors":"O. Gromova, I. Torshin, B. T. Zaychik, E. V. Shikh, A. O. Ruzhitskiy, A. Galustyan, I. S. Sardaryan, I. Sarvilina","doi":"10.17749/2070-4909/FARMAKOEKONOMIKA.2021.083","DOIUrl":"https://doi.org/10.17749/2070-4909/FARMAKOEKONOMIKA.2021.083","url":null,"abstract":"Objective: a comparative analysis of 6 different chondroprotectors for injection, containing chondroitin sulfate (CS) based on natural extracts.Material and methods. Five samples were studied for each CS extract. The preparations were compared on the basis of profiles of trace element composition, sulfur content, chromatographic analysis and test for total protein. In each sample, the concentration of 72 elements was determined, then averaging was performed and the variances of the content of each element were calculated. To assess the content of the protein fraction, a modified Lowry method with bicincholic acid was used. Chromatographic profiles of the studied CS extracts were measured to estimate the molecular weight distribution.Results. The studied samples differ significantly from each other in the total and individual content of sulfur, toxic and conditionally toxic microelements. According to the analysis of sulfur and trace elements, a cluster of more standardized CS extracts was identified. It was shown that the assessments of the pharmaceutical quality of the studied extracts made by the elemental profile, correspond to the assessments of the quality by the degree of proteins elimination and by the molecular weight characteristics of CS extracts. In particular, the highest total content of toxic elements was found for CS-6 (14.87±1.81 μg/l) and CS-2 (9.20±1.12 μg/l), and the lowest – for CS-4 (1.46±0.23 μg/l), CS-3 (1.92±0.33 μg/l) and CS-1 (2.98±0.25 μg/l). The highest content of protein impurities was also found in CS-6 (9.62 mg/ml) and CS-2 (6.64 mg/ml), and the lowest – in CS-1 (2.87 mg/ml). At the same time, the highest amount of sulfur was found CS-1 (6400 mg/kg) and much less – for CS-2 (370 mg/kg) and CS-6 (100 mg/kg). Significant amounts of the high-molecular fraction of CS (1–40 kDa) were found only in CS-1, and only trace amounts of high-molecular CS forms were present in CS-2 and CS-6.Conclusion. The highest content of cholesterol and sulfur and, at the same time, the lowest content of toxic microelements and proteins were distinguished by the extract obtained from the trachea of a bovine.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"36 12","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133390915","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 : 2021-02-07DOI: 10.17749/2070-4909/FARMAKOEKONOMIKA.2020.066
I. Torshin, A. Lila, A. Naumov, A. Kochish, L. Alekseeva, E. Taskina, I. Sarvilina, A. Galustyan, A. N. Gromov, A. K. Khadzhidis, L. Vasilieva, E. F. Yevstratova, M. I. Udovika, O. Gromova
Aim . A meta-analysis of 8 controlled studies (n=771, age 53.6±6.2 years) of tie use of tie Chondroguard (100 mg i.m. first 3 injections, from tie 4th injection - 200 mg i.m., EOD, course 20-30 injections) in the complex therapy of osteoarthritis (OA). Materials and Methods . Tie meta-analysis according to tie fixed-effects model included all published clinical studies on tie efficacy and safety of the CG drug in OA). The effectiveness of therapy was assessed using the VAS, Lequesne, WOMAC scales/indices. For each study, information was collected on 23 features. Data analysis was carried out using the MEDSTUDY and "R" software packages. Results . Meta-analysis confirmed significant associations between the use of Chondroguard (CG. and pain reduction assessed by the visual analog scale (V)S. - CG: a decrease in pain intensity by -28.3 points, control: -11.6; p=0.042. There was a significant reduction in pain according to VAS at night (CG: -20.1; control: -9.9; p=0.05018., while sitting or lying down (CG: -15.5; control: -7.6; p=0.01656., when walking (CG: -28.2; control: -17.0; p=0.04957). The use of CG led to a significant decrease in the scores of the Lequesne index (CG: -4.3; control: -1.4; p=0.0349., and of the WOMAC index (CG: -338.4; control: -219.8; p=0.004., including WOMAC "function" (CG: -247.8; control: -96; p=0.0027., and WOMAC "stiffness" (CG: -25.4; control: -11.2; p=0.0462.. The incidence of side effects did not differ significantly from the control. Conclusion . Chondroguard is an effective treatment for osteoarthritis and has a good safety profile.
{"title":"Meta-analysis of clinical trials of osteoarthritis treatment effectiveness with Chondroguard","authors":"I. Torshin, A. Lila, A. Naumov, A. Kochish, L. Alekseeva, E. Taskina, I. Sarvilina, A. Galustyan, A. N. Gromov, A. K. Khadzhidis, L. Vasilieva, E. F. Yevstratova, M. I. Udovika, O. Gromova","doi":"10.17749/2070-4909/FARMAKOEKONOMIKA.2020.066","DOIUrl":"https://doi.org/10.17749/2070-4909/FARMAKOEKONOMIKA.2020.066","url":null,"abstract":"Aim . A meta-analysis of 8 controlled studies (n=771, age 53.6±6.2 years) of tie use of tie Chondroguard (100 mg i.m. first 3 injections, from tie 4th injection - 200 mg i.m., EOD, course 20-30 injections) in the complex therapy of osteoarthritis (OA). Materials and Methods . Tie meta-analysis according to tie fixed-effects model included all published clinical studies on tie efficacy and safety of the CG drug in OA). The effectiveness of therapy was assessed using the VAS, Lequesne, WOMAC scales/indices. For each study, information was collected on 23 features. Data analysis was carried out using the MEDSTUDY and \"R\" software packages. Results . Meta-analysis confirmed significant associations between the use of Chondroguard (CG. and pain reduction assessed by the visual analog scale (V)S. - CG: a decrease in pain intensity by -28.3 points, control: -11.6; p=0.042. There was a significant reduction in pain according to VAS at night (CG: -20.1; control: -9.9; p=0.05018., while sitting or lying down (CG: -15.5; control: -7.6; p=0.01656., when walking (CG: -28.2; control: -17.0; p=0.04957). The use of CG led to a significant decrease in the scores of the Lequesne index (CG: -4.3; control: -1.4; p=0.0349., and of the WOMAC index (CG: -338.4; control: -219.8; p=0.004., including WOMAC \"function\" (CG: -247.8; control: -96; p=0.0027., and WOMAC \"stiffness\" (CG: -25.4; control: -11.2; p=0.0462.. The incidence of side effects did not differ significantly from the control. Conclusion . Chondroguard is an effective treatment for osteoarthritis and has a good safety profile.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122266925","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 : 2021-02-07DOI: 10.17749/2070-4909/FARMAKOEKONOMIKA.2020.067
O. Gromova, I. Torshin, A. Naumov, L. Vasilyeva, Ye. F. Yevstratova, А. N. Gromov
The article focuses on the review of a pharmacotherapeutic approach to the therapy of hand osteoarthritis (HO). Apart from non-steroid antiinflammatory drugs (NSAID), promising therapeutic means of HO therapy include steroid drugs, chondroitin sulfate (CS), glucosamine sulfate (GS), and vitamin D. Transdermal application of NSAID and steroid drugs reduces the side effects without a decrease in the effectiveness of the therapy. Reconstructive therapy of cartilaginous and connective tissue of hands includes a long-term application of CS/GS, and in the acute period, injections of CS/GS.
{"title":"Acute issues in the pharmacotherapy of hand osteoarthritis","authors":"O. Gromova, I. Torshin, A. Naumov, L. Vasilyeva, Ye. F. Yevstratova, А. N. Gromov","doi":"10.17749/2070-4909/FARMAKOEKONOMIKA.2020.067","DOIUrl":"https://doi.org/10.17749/2070-4909/FARMAKOEKONOMIKA.2020.067","url":null,"abstract":"The article focuses on the review of a pharmacotherapeutic approach to the therapy of hand osteoarthritis (HO). Apart from non-steroid antiinflammatory drugs (NSAID), promising therapeutic means of HO therapy include steroid drugs, chondroitin sulfate (CS), glucosamine sulfate (GS), and vitamin D. Transdermal application of NSAID and steroid drugs reduces the side effects without a decrease in the effectiveness of the therapy. Reconstructive therapy of cartilaginous and connective tissue of hands includes a long-term application of CS/GS, and in the acute period, injections of CS/GS.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115499089","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 : 2021-02-06DOI: 10.17749/2070-4909/FARMAKOEKONOMIKA.2020.073
I. Dyakov, S. R. Varfolomeеva
Aim. The study aimed to evaluate the pharmacoeconomic feasibility of propranolol application in the dosage form of the oral solution in the treatment of proliferating infantile hemangioma requiring systemic therapy.Materials and methods. The study design was a retrospective analysis of the published data. The methods of pharmacoeconomic analysis included a clinical-economic analysis (cost-effectiveness analysis) with a sensitivity analysis; and a "budget impact" analysis with a sensitivity analysis. The authors compared the pharmacoeconomic effectiveness of pharmacotherapy for infant hemangiomas with propranolol and surgical methods of treatment.Results. The efficacy of propranolol therapy was 39% higher than surgical methods of treatment. The relative increase in the efficacy of propranolol therapy compared to surgical treatments was 68.4%. At the same time, the cost of propranolol therapy was lower than the cost of surgical treatments by 31.7% or 56,486,07 RUR per patient per year. The application of propranolol in the treatment for proliferating infantile hemangioma allowed reducing the burden on the budget of the state guarantee program in comparison with surgical methods of treatment for 3 years by 1,562.0 million RUR with a proportion of 12% of patients with infant hemangiomas requiring systemic therapy (9,694 patients per year). The sensitivity analysis of the cost and effectiveness of the compared medical technologies showed that the obtained results are resistant to the fluctuations in these parameters in the range from − 20% to + 20%.Conclusion. The application of propranolol preparation in a dosage form of oral solution for the treatment of patients with proliferating infantile hemangioma will significantly increase the efficiency of therapy and reduce costs associated with the application of surgical methods of treatment.
{"title":"Pharmacoeconomic feasibility of using the drug Hemangiol (propranolol, oral solution) in the treatment of proliferating infantile hemangioma requiring systemic therapy","authors":"I. Dyakov, S. R. Varfolomeеva","doi":"10.17749/2070-4909/FARMAKOEKONOMIKA.2020.073","DOIUrl":"https://doi.org/10.17749/2070-4909/FARMAKOEKONOMIKA.2020.073","url":null,"abstract":"Aim. The study aimed to evaluate the pharmacoeconomic feasibility of propranolol application in the dosage form of the oral solution in the treatment of proliferating infantile hemangioma requiring systemic therapy.Materials and methods. The study design was a retrospective analysis of the published data. The methods of pharmacoeconomic analysis included a clinical-economic analysis (cost-effectiveness analysis) with a sensitivity analysis; and a \"budget impact\" analysis with a sensitivity analysis. The authors compared the pharmacoeconomic effectiveness of pharmacotherapy for infant hemangiomas with propranolol and surgical methods of treatment.Results. The efficacy of propranolol therapy was 39% higher than surgical methods of treatment. The relative increase in the efficacy of propranolol therapy compared to surgical treatments was 68.4%. At the same time, the cost of propranolol therapy was lower than the cost of surgical treatments by 31.7% or 56,486,07 RUR per patient per year. The application of propranolol in the treatment for proliferating infantile hemangioma allowed reducing the burden on the budget of the state guarantee program in comparison with surgical methods of treatment for 3 years by 1,562.0 million RUR with a proportion of 12% of patients with infant hemangiomas requiring systemic therapy (9,694 patients per year). The sensitivity analysis of the cost and effectiveness of the compared medical technologies showed that the obtained results are resistant to the fluctuations in these parameters in the range from − 20% to + 20%.Conclusion. The application of propranolol preparation in a dosage form of oral solution for the treatment of patients with proliferating infantile hemangioma will significantly increase the efficiency of therapy and reduce costs associated with the application of surgical methods of treatment.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"8 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132331042","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 : 2021-02-06DOI: 10.17749/2070-4909/FARMAKOEKONOMIKA.2020.068
A. Kolbin, D. Vlodavets, A. Kurylev, Y. Balykina, M. Proskurin, S. Mishinova, O. Germanenko, N. Y. Kolbina
Introduction . Spinal muscular atrophies (SMA) are clinically and genetically heterogeneous congenital orphan diseases that lead to progressive spinal motoneurons degeneration and loss of their function. There are 4 types of SMA with type I being the most severe. SMA patients need lots of services (medical, social etc.) throughout their life and the cost of the care has never been calculated in Russia before. Aim . The study aims to calculate the socio-economic burden of SMA in the Russian Federation for direct medical procedures and indirect costs before the introduction of pathogenetic therapy and after its implementation. The assessment of the impact of pathogenetic therapy on the dynamics of the socio-economic burden of SMA in the Russian Federation was performed. Materials and methods . The data from patient-reported SMA registry, insurance medical companies, epidemiological, and rehabilitation care data were compiled into the model. The authors accounted for direct medical (diagnostics, drugs, surgery, orthopedics, rehabilitation, and family) and nonmedical expenditures including indirect (loss of GDP) costs. Characteristics of the patient population have been taken from the national SMA register. The sources of costs data included governmental healthcare and insurance companies’ tariffs, price lists of commercial companies, clinics, and laboratory services. The modeling time horizon was 5 years. The two following calculation scenarios were evaluated: 1) none of the patients with SMA receive pathogenic therapy 2) the share of pathogenic therapy is stable during the time horizon at the current level. Results . National SMA register contains the information about 998 patients; 21% of them have SMA I type. In the first scenario, the total social-economic burden of SMA in Russia was 2.37 billion RUR/year (2.38 million RUR/patient/year); the share of in-patient care and rehabilitation were 30.8% and 32.3%, respectively. SMA type I burden was 1.6 billion RUR/year (1.5 million RUR/patient/year). In the second scenario, the total SMA burden was 5.4 billion RUR/year, the highest share of pathogenetic therapy was 43%. Conclusion . The SMA economic burden in Russia is significant and growing along with the increase in the share of pathogenic therapy, but this growth should be compensated by lowering other direct and indirect costs.
{"title":"The social-economic burden of spinal muscular atrophy in Russia","authors":"A. Kolbin, D. Vlodavets, A. Kurylev, Y. Balykina, M. Proskurin, S. Mishinova, O. Germanenko, N. Y. Kolbina","doi":"10.17749/2070-4909/FARMAKOEKONOMIKA.2020.068","DOIUrl":"https://doi.org/10.17749/2070-4909/FARMAKOEKONOMIKA.2020.068","url":null,"abstract":"Introduction . Spinal muscular atrophies (SMA) are clinically and genetically heterogeneous congenital orphan diseases that lead to progressive spinal motoneurons degeneration and loss of their function. There are 4 types of SMA with type I being the most severe. SMA patients need lots of services (medical, social etc.) throughout their life and the cost of the care has never been calculated in Russia before. Aim . The study aims to calculate the socio-economic burden of SMA in the Russian Federation for direct medical procedures and indirect costs before the introduction of pathogenetic therapy and after its implementation. The assessment of the impact of pathogenetic therapy on the dynamics of the socio-economic burden of SMA in the Russian Federation was performed. Materials and methods . The data from patient-reported SMA registry, insurance medical companies, epidemiological, and rehabilitation care data were compiled into the model. The authors accounted for direct medical (diagnostics, drugs, surgery, orthopedics, rehabilitation, and family) and nonmedical expenditures including indirect (loss of GDP) costs. Characteristics of the patient population have been taken from the national SMA register. The sources of costs data included governmental healthcare and insurance companies’ tariffs, price lists of commercial companies, clinics, and laboratory services. The modeling time horizon was 5 years. The two following calculation scenarios were evaluated: 1) none of the patients with SMA receive pathogenic therapy 2) the share of pathogenic therapy is stable during the time horizon at the current level. Results . National SMA register contains the information about 998 patients; 21% of them have SMA I type. In the first scenario, the total social-economic burden of SMA in Russia was 2.37 billion RUR/year (2.38 million RUR/patient/year); the share of in-patient care and rehabilitation were 30.8% and 32.3%, respectively. SMA type I burden was 1.6 billion RUR/year (1.5 million RUR/patient/year). In the second scenario, the total SMA burden was 5.4 billion RUR/year, the highest share of pathogenetic therapy was 43%. Conclusion . The SMA economic burden in Russia is significant and growing along with the increase in the share of pathogenic therapy, but this growth should be compensated by lowering other direct and indirect costs.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127896285","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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