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- W2111337384 abstract "To evaluate all medicines that received a conditional regulatory approval in Europe and to compare these decisions with the products current market access status through the evaluation of Health Technology Assessments (HTAs). A manual search of the European Medicines Agencies (EMA) website was carried out to identify all pharmaceuticals that received a conditional approval (January 2007 to May 2013). Of the medicines identified, the statutory funding status was checked by reviewing the websites of the key HTA agencies in the EU 5 countries-: HAS (France), G-BA (Germany), AIFA (Italy), DGFPS (Spain) and AWMSG, NICE, SMC (UK). A total of 15 pharmaceuticals were found that had received an EMA conditional approval. Of these, 10 met the inclusion criteria and were analysed further: etravirine, everolimus, fampridine, lapatinib, ofatumumab, panitumumab, pixantrone, pazopanib, stiripentol and vandetanib. Of the 10 pharmaceuticals, a total of 50 HTA assessments were conducted by the 7 agencies, with 31 (62%) of the HTAs reaching a positive funding decision. Both NICE and AWMSG recommended only 1 of the conditionally approved drugs for funding, G-BA recommended 2, SMC 3, DGFPS 6, AIFA 6 and HAS 8. Of the 10 drugs, everolimus was the most successful and is funded by 6 (of the 7) HTA agencies. The key reasons for the success of everolimus were due to convincing efficacy (prolonging progression-free survival), combined with an economic case that was considered demonstrated despite some uncertainties. Whilst regulatory bodies recognise the need to grant marketing authorisation on the basis of less complete data, this does not necessarily mean a straight forward path through market access. Although the majority of HTA agencies did provide a positive funding decision; sound health economic evidence remains essential for new medicines to increase the chances of market access approval." @default.
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- W2111337384 date "2013-11-01" @default.
- W2111337384 modified "2023-09-28" @default.
- W2111337384 title "Are Conditionally Approved Therapies Successful in Gaining Market Access?" @default.
- W2111337384 doi "https://doi.org/10.1016/j.jval.2013.08.912" @default.
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