What is the role of antineoplastic drug safety in reimbursement decision making?
Rationale. From 2014 to 2017, the portion of antineoplastic drugs dossiers submitted to reimbursement in Russia has grown from 15% to 28%. This group of drugs is characterized by severe adverse events (Aes). The question whether drug safety is taken into consideration by decision makers is still ope...
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| Format: | Article |
| Language: | Russian |
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IRBIS LLC
2018-11-01
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| Series: | Фармакоэкономика |
| Subjects: | |
| Online Access: | https://www.pharmacoeconomics.ru/jour/article/view/260 |
| _version_ | 1797878882518433792 |
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| author | A. S. Kolbin A. A. Kurylev |
| author_facet | A. S. Kolbin A. A. Kurylev |
| author_sort | A. S. Kolbin |
| collection | DOAJ |
| description | Rationale. From 2014 to 2017, the portion of antineoplastic drugs dossiers submitted to reimbursement in Russia has grown from 15% to 28%. This group of drugs is characterized by severe adverse events (Aes). The question whether drug safety is taken into consideration by decision makers is still open.Aim: To evaluate the role of drug safety in making the decision on reimbursement.Materials and methods. The data were taken from the reports of expert committees concerning the dossiers submitted between 2014 and 2016. The year of submission, the international drug name, the total safety score and the final decision of the committee were entered into our database. Parametric and non-parametric statistics were used to calculate the difference between the mean safety scores plotted by years and by inclusion/noninclusion into VeD lists.Results. The mean safety score for all drugs of this group was -4,67 (95% CI from -5,04 to -4,29); for the drugs included into VeD lists it was -4,05 (95% CI from -4,68 to -3,42), that was significantly higher (p = 0,01) compared to the non-included medications (-5,03; 95% CI from -5,49 to -4,58). The mean safety scores year-by-year for the non-included drugs were lower than those for the VeD-included drugs, but the difference reached significance only in 2015 (p = 0,01). The safety scores were mainly based on Aes of type A.Conclusion. our analysis shows that the drug safety data play a role in the decision making on reimbursement and inclusion/noninclusion into VeD lists. Yet the total safety score contributes much less than other criteria in the decision making process. The safety analysis is usually based on Aes of type A, whereas the data on Aes of types C and D are insufficient. |
| first_indexed | 2024-04-10T02:40:05Z |
| format | Article |
| id | doaj.art-776c98da4f854dba95463eb9d4f403c3 |
| institution | Directory Open Access Journal |
| issn | 2070-4909 2070-4933 |
| language | Russian |
| last_indexed | 2024-04-10T02:40:05Z |
| publishDate | 2018-11-01 |
| publisher | IRBIS LLC |
| record_format | Article |
| series | Фармакоэкономика |
| spelling | doaj.art-776c98da4f854dba95463eb9d4f403c32023-03-13T07:48:16ZrusIRBIS LLCФармакоэкономика2070-49092070-49332018-11-01113384210.17749/2070-4909.2018.11.3-038-042238What is the role of antineoplastic drug safety in reimbursement decision making?A. S. Kolbin0A. A. Kurylev1Pavlov First Saint Petersburg State Medical University ; Saint-Petersburg State University.Pavlov First Saint Petersburg State Medical University.Rationale. From 2014 to 2017, the portion of antineoplastic drugs dossiers submitted to reimbursement in Russia has grown from 15% to 28%. This group of drugs is characterized by severe adverse events (Aes). The question whether drug safety is taken into consideration by decision makers is still open.Aim: To evaluate the role of drug safety in making the decision on reimbursement.Materials and methods. The data were taken from the reports of expert committees concerning the dossiers submitted between 2014 and 2016. The year of submission, the international drug name, the total safety score and the final decision of the committee were entered into our database. Parametric and non-parametric statistics were used to calculate the difference between the mean safety scores plotted by years and by inclusion/noninclusion into VeD lists.Results. The mean safety score for all drugs of this group was -4,67 (95% CI from -5,04 to -4,29); for the drugs included into VeD lists it was -4,05 (95% CI from -4,68 to -3,42), that was significantly higher (p = 0,01) compared to the non-included medications (-5,03; 95% CI from -5,49 to -4,58). The mean safety scores year-by-year for the non-included drugs were lower than those for the VeD-included drugs, but the difference reached significance only in 2015 (p = 0,01). The safety scores were mainly based on Aes of type A.Conclusion. our analysis shows that the drug safety data play a role in the decision making on reimbursement and inclusion/noninclusion into VeD lists. Yet the total safety score contributes much less than other criteria in the decision making process. The safety analysis is usually based on Aes of type A, whereas the data on Aes of types C and D are insufficient.https://www.pharmacoeconomics.ru/jour/article/view/260drug safetyreimbursementpharmacovigilance |
| spellingShingle | A. S. Kolbin A. A. Kurylev What is the role of antineoplastic drug safety in reimbursement decision making? Фармакоэкономика drug safety reimbursement pharmacovigilance |
| title | What is the role of antineoplastic drug safety in reimbursement decision making? |
| title_full | What is the role of antineoplastic drug safety in reimbursement decision making? |
| title_fullStr | What is the role of antineoplastic drug safety in reimbursement decision making? |
| title_full_unstemmed | What is the role of antineoplastic drug safety in reimbursement decision making? |
| title_short | What is the role of antineoplastic drug safety in reimbursement decision making? |
| title_sort | what is the role of antineoplastic drug safety in reimbursement decision making |
| topic | drug safety reimbursement pharmacovigilance |
| url | https://www.pharmacoeconomics.ru/jour/article/view/260 |
| work_keys_str_mv | AT askolbin whatistheroleofantineoplasticdrugsafetyinreimbursementdecisionmaking AT aakurylev whatistheroleofantineoplasticdrugsafetyinreimbursementdecisionmaking |