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- W2541125330 abstract "Access to medicines in Russia has traditionally been highly correlated with the national Essential Drug List (ЖНВЛП) inclusion. Although an explicit methodology of assessing the new drug dossier exists, significant variation in the decision-making process and outcomes is common. This research aims to explore the current spectrum of decision drivers for pharmaceutical product assessment in Russia and the influence of pharmacoeconomics and regional price variability on this process. The video-protocol of the decisions for drug inclusion in the Russian EDL in 2014 and 2015 were analysed (163 drugs) to identify the key drivers for Ministry of Health reimbursement and the role of pharmacoeconomics within it. Two categories of drugs were identified to test the research hypotheses: (1) drugs successfully securing a place on the EDL-2015 following an initial rejection for EDL-2014 (25 drugs), and (2) drugs unsuccessful in securing a place for both EDL-2014 and EDL-2015 (32 drugs). The Russian tender database system (zakupki.gov.ru) was used to analyse the regional price and reimbursement variations. Analysis of key decision-making drivers yielded the growing importance of secondary decision drivers in the face of currently stringent drug budget in Russia at the national and local levels. Such criteria includes some aspect of manufacturing that takes place locally, EDL listing of other therapeutics within the same class , date of approval, and the number of indications. Pharmacoeconomic analysis has not been considered consistently throughout the committee decisions, however remains the key question for high-value therapeutic options. Price variation across regional tenders, which sometimes rise to 20%, were not taken into consideration. To gain EDL-listing, an effort to ration the budget should include a request to delist older,less effective therapies, as well as provide a comprehensive overview of the difference between the therapy’s nominal and real budget impact." @default.
- W2541125330 created "2016-11-04" @default.
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- W2541125330 date "2016-11-01" @default.
- W2541125330 modified "2023-09-28" @default.
- W2541125330 title "The Road to Russian Pharmacoeconomics: Understanding the Drivers for Access to High-Value / Orphan Disease Drugs" @default.
- W2541125330 doi "https://doi.org/10.1016/j.jval.2016.09.713" @default.
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