Expenditure trends of orphan drugs in Serbia: 8-year analysis of orphan drug market in Serbia A
نویسندگان
چکیده
Background/Objective: Orphan drugs are medicinal products which treat life-threatening or chronically debilitating diseases which aff ect small patient populations. So far there is a substantial knowledge gap on actual expenditure on orphan drugs in Serbia. Therefore, the aim of this study was to provide insight into the expenditure trends of orphan drugs in Serbia. Material and methods: Annual reports on turnover and the consumption of pharmaceuticals in Serbia published by Medicines and Medical Devices Agency of Serbia (ALIMS) for the period 2006-2013 were used to extract data on expenditure on orphan drugs. Drugs were eligible for inclusion in the analysis if they had active European orphan designation and European marketing authorization during the period covered by the study (2006-2013). Data were analysed across time series. Simple descriptive analysis and observation of chronological trends were applied. Results: Data for annual expenditure on 12 diff erent orphan drugs were available in the analysed reports. Orphan drug expenditure and share of orphan drug expenditure in total drug expenditure increased constantly from 2006 to 2010. Both began to slightly decrease over the next two years (2011-2012), and then suddenly declined nearly threefold in 2013. Share of orphan drug expenditure didn’t exceed 1% of total drug expenditure over a period of eight years. The highest share of expenditure on orphan drugs was attributed to imatinib (87.36%-97.13%), so abrupt decline in 2013 could be explained by its withdrawal from European Community Register of Orphan Medicinal Products in 2012. Conclusions: Expenditure on orphan drugs in Serbia from 2006 to 2013 was considerably low compared to total expenditure on drugs. In the last available year we noted substantial decline of orphan drug expenditure, mainly because of imatinib losing its orphan designation. A broader time horizon would be needed to investigate long term trends.
منابع مشابه
Estimating the budget impact of orphan medicines in Europe: 2010 - 2020
BACKGROUND Orphan drugs are a growing issue of importance to European healthcare policy makers. The success of orphan drug legislation in Europe has resulted in an increasing number of licensed medicines for rare diseases, and many more yet unlicensed products have received orphan drug designation. Increasingly the concerns amongst policy makers relate to issues of patient access and affordabil...
متن کاملPharmaceutical expenditure on drugs for rare diseases in Canada: a historical (2007–13) and prospective (2014–18) MIDAS sales data analysis
BACKGROUND Health Canada has defined rare diseases as life-threatening, seriously debilitating, or serious chronic conditions affecting a very small number of patients (~1 in 2,000 persons). An estimated 9 % of Canadians suffer from a rare disease. Drugs treating rare diseases (DRDs) are also known as orphan drugs. While Canada is currently developing an orphan drug framework, in the United Sta...
متن کاملTop 20 Orphan Drugs Availability, Pricing and Reimbursement In Slovakia: 2005-2012 Review.
RESULT S We considered orphan drugs list defined by Cote and Keating (2012) that globally exceeded 1 billion $ sales in 2008 and compared same molecules’ availability in Slovakia. Several orphan drugs are among best selling 20 orphan drugs in Slovakia, with highest sale of 95 million EUR (Bevacizumab, 2005-2012) compared to lowest sale of 19 million EUR (Tacrolimus, 2005-2012). It took from one...
متن کاملIncentives for orphan drug research and development in the United States
BACKGROUND The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007. METHODS Pr...
متن کاملMarket access of orphan drugs and the role of multi-criteria decision making
Background A number of factors play a role in market access of orphan drugs, such as the extent to which an orphan drug meets a medical need; existence of alternative health technologies; disease prevalence; number of orphan drug indications; and added clinical benefit of the orphan drug. How can these factors be taken into account in market access decisions given that there is uncertainty over...
متن کامل