The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost Nosologies
Objective: to assess the compliance of the actual practice of conducting clinical and economic research with the requirements applicable in the Russian Federation (RF) when including drugs in the Federal Program of High-Cost Nosologies (HCN).Material and methods. In the CyberLeninka and eLibrary dat...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | Russian |
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IRBIS LLC
2022-04-01
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| Series: | Фармакоэкономика |
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| Online Access: | https://www.pharmacoeconomics.ru/jour/article/view/661 |
| _version_ | 1797878869002289152 |
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| author | A. S. Kolbin Yu. M. Gomon A. R. Kasimova A. A. Kurylev A. E. Bem |
| author_facet | A. S. Kolbin Yu. M. Gomon A. R. Kasimova A. A. Kurylev A. E. Bem |
| author_sort | A. S. Kolbin |
| collection | DOAJ |
| description | Objective: to assess the compliance of the actual practice of conducting clinical and economic research with the requirements applicable in the Russian Federation (RF) when including drugs in the Federal Program of High-Cost Nosologies (HCN).Material and methods. In the CyberLeninka and eLibrary databases, a search was made for clinical and economic studies of medicines included in the HCN list published in the RF in the period from 2011 to June 2021.Results. Information was obtained on 23 published clinical and economic studies of the effectiveness of drugs, which is less than 30% of all drugs included in the HCN program during the specified period. More than half of the studies of chronic disabling diseases had a modeling horizon of 1 year. The sensitivity analysis of the results in over 1/3 of cases considered only the deviation of the price of the strategies under consideration, and in a quarter of cases it was not carried out at all. Only 4 studies evaluated the increase in quality-adjusted life year, although, for chronic disabling diseases, quality of life is one of the key performance indicators.Conclusion. In the RF, less than 30% of the results of pharmacoeconomical studies of drugs included in the HCN Program are published, which does not allow to make adequate evaluation of pharmacoeconomical approaches to its formation. To analyze the effectiveness of the tools used in assessing the economic efficiency of expensive medical technologies, a further retrospective research of the studies conducted in the RF is required. |
| first_indexed | 2024-04-10T02:39:52Z |
| format | Article |
| id | doaj.art-411137fa18374be49b88cd7009aea2a7 |
| institution | Directory Open Access Journal |
| issn | 2070-4909 2070-4933 |
| language | Russian |
| last_indexed | 2024-04-10T02:39:52Z |
| publishDate | 2022-04-01 |
| publisher | IRBIS LLC |
| record_format | Article |
| series | Фармакоэкономика |
| spelling | doaj.art-411137fa18374be49b88cd7009aea2a72023-03-13T07:48:17ZrusIRBIS LLCФармакоэкономика2070-49092070-49332022-04-011518710510.17749/2070-4909/farmakoekonomika.2022.107383The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost NosologiesA. S. Kolbin0Yu. M. Gomon1A. R. Kasimova2A. A. Kurylev3A. E. Bem4Pavlov University; Saint Petersburg State UniversityPavlov University; St. George the Martyr City HospitalPavlov University; Vreden National Medical Research Center of Traumatology and OrthopedicsPavlov UniversityPavlov UniversityObjective: to assess the compliance of the actual practice of conducting clinical and economic research with the requirements applicable in the Russian Federation (RF) when including drugs in the Federal Program of High-Cost Nosologies (HCN).Material and methods. In the CyberLeninka and eLibrary databases, a search was made for clinical and economic studies of medicines included in the HCN list published in the RF in the period from 2011 to June 2021.Results. Information was obtained on 23 published clinical and economic studies of the effectiveness of drugs, which is less than 30% of all drugs included in the HCN program during the specified period. More than half of the studies of chronic disabling diseases had a modeling horizon of 1 year. The sensitivity analysis of the results in over 1/3 of cases considered only the deviation of the price of the strategies under consideration, and in a quarter of cases it was not carried out at all. Only 4 studies evaluated the increase in quality-adjusted life year, although, for chronic disabling diseases, quality of life is one of the key performance indicators.Conclusion. In the RF, less than 30% of the results of pharmacoeconomical studies of drugs included in the HCN Program are published, which does not allow to make adequate evaluation of pharmacoeconomical approaches to its formation. To analyze the effectiveness of the tools used in assessing the economic efficiency of expensive medical technologies, a further retrospective research of the studies conducted in the RF is required.https://www.pharmacoeconomics.ru/jour/article/view/661high-cost nosologiesinnovative medicinesbiomedical cell products |
| spellingShingle | A. S. Kolbin Yu. M. Gomon A. R. Kasimova A. A. Kurylev A. E. Bem The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost Nosologies Фармакоэкономика high-cost nosologies innovative medicines biomedical cell products |
| title | The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost Nosologies |
| title_full | The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost Nosologies |
| title_fullStr | The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost Nosologies |
| title_full_unstemmed | The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost Nosologies |
| title_short | The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost Nosologies |
| title_sort | real practice of clinical and economic research of drugs included in the federal program of high cost nosologies |
| topic | high-cost nosologies innovative medicines biomedical cell products |
| url | https://www.pharmacoeconomics.ru/jour/article/view/661 |
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