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- W2766651378 abstract "To improve patient access, the EU has implemented orphan drug policies. Canada, however, has yet to adopt a formal policy. This study aimed to compare health technology assessment (HTA) recommendations between Canada, Germany, and the United Kingdom (UK) for orphan products in oncology. Oncology drugs with an orphan designation approved by the Food and Drug Administration (FDA) between 2012 and 2017 were included. Associated HTA recommendations were retrieved from publicly available sources (Canada: pan-Canadian Oncology Drug Review [pCODR]; UK: National Institute for Health and Care Excellence [NICE] and Scottish Medicines Consortium [SMC]; Germany: Institute for Quality and Efficiency in Healthcare [IQWIG]). Decisions were categorized as either recommended or not recommended. Of the 73 identified indications for orphan drugs, SMC received the most submissions (74%), followed by IQWIG (60%), pCODR (58%) and NICE (36%). For the submissions assessed by pCODR, 69% (n=29) were recommended and 31% (n=13) were not recommended. NICE and SMC had similar recommendation rates (73%, n=19; 63%, n=34 respectively), while IQWIG had the lowest rate of positive recommendations (25%, n=11). Of the positive recommendations at pCODR, 34% (n=10) were conditional on improving cost-effectiveness. The proportion of positive HTA decisions for oncology therapies with an orphan designation are consistent between Canada and the UK, with these countries providing more positive recommendations than Germany. The absence of a Canadian orphan drug policy does not appear to negatively influence the HTA recommendation of therapies for oncologic rare diseases. IQWIG places a high priority on products supported by head-to-head trials, and this possibly affects their decisions on orphan drugs. This study is limited to publicly available data and not representative of all recommendations within the EU. Future studies will include additional EU countries, assess the impact of incremental cost-effectiveness ratios on HTA decisions and formulary access." @default.
- W2766651378 created "2017-11-10" @default.
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- W2766651378 date "2017-10-01" @default.
- W2766651378 modified "2023-09-30" @default.
- W2766651378 title "Does The Presence of An Orphan Drug Polcy Affect HTA Recommendations For Oncologic Orphan Drugs?" @default.
- W2766651378 doi "https://doi.org/10.1016/j.jval.2017.08.974" @default.
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