A427 resource allocation. The objective of this study is to compare the company-predicted budget impact with the actual budget impact of high-cost drugs reimbursed in Ireland. Methods: All drugs submitted to the health service executive (HSE, health care payer in Ireland) for reimbursement under the high-tech drug scheme (a scheme used to administer high cost drugs) from 2009 to 2012 were included in the review. Company estimates of the likely budget impact of the drug in 2013 were extracted from submissions and compared with actual expenditure in 2013 from the health service executive-primary care reimbursement service (HSE-PCRS). Only drugs for which budget impact estimates were available and which were reimbursed by the HSE in 2013 were included in the analysis. Results: Ten drugs were included in the analysis, including six cancer drugs, two immunomodulators for multiple sclerosis and rheumatoid arthritis, and two orphan drugs for cystic fibrosis and idiopathic thrombocytopenic purpura. The cumulative expenditure on these drugs in 2013 was € 55.8 million compared with a predicted gross budget impact of € 53.4 million, representing a € 2.4 million underestimate in company submissions. The most significant underestimate related to the drug for multiple sclerosis (€ 3.4 million) while the biggest overestimate related to the orphan drug for cystic fibrosis (€ 2.9 million). ConClusions: Company submissions have been shown to both under-and over-estimate budget impact predictions. It is important that budget impact estimates are as realistic as possible in order to effectively inform decisions on resource allocation or reimbursement.objeCtives: The dynamic of the reimbursement politics shows a very different pattern in different countries. The REDEL study examined the elapsed time from marketing authorization to the starting date of reimbursement of the original medicines in Central and Eastern
average time from FDA approval to US launch was 8 weeks (oncology 5 weeks; orphan drugs 4 weeks). Across the EU5, Germany was the fastest to market (16 weeks) with the most drugs launched (219) in the six year period. Italy appeared to be the slowest to market (67 weeks); however HTA assessments by NICE in the UK often mean significant delays, with access times for some drugs, especially oncology agents being several months/years. Lowest number of drugs were launched in France between 2009 and 2015 (117) with time to P&R completion over one year (55 weeks). Few orphan drugs launched in Spain; only 13 compared to 48 in Germany with average time to launch being 79 weeks. ConClusions: Substantial differences exist in number of products approved by the EMA that are eventually launched in the EU5 countries. Huge disparity in time to P&R completion underlines market realities and has access implications for all drugs, in particular specialty oncology and orphan therapies. Further analysis of shifts in the launch timing during this period is warranted.
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