[PHP168] Early Market Access for Pharmaceuticals in EU: What is the Impact of EMA’s Accelerated Assessment Procedure?

[PHP168] Early Market Access for Pharmaceuticals in EU: What is the Impact of EMA’s Accelerated Assessment Procedure?

2016 Value in Health

Parviainen, L. | Belgaied, W. | Sediri, Y. | Haijeji, B. | Rémuzat, C. | Toumi, M. | Volume: 19, Issue: 7, Pages: A469,

OBJECTIVE: In 2005, the accelerated assessment procedure (AAP) for medicines of major public health interest was introduced reducing timelines from 210 to 150 days for the Committee for Medicinal Products for Human Use (CHMP) opinion. The objective is to determine market access (MA) status of products accepted for AAP in selected countries: France, Germany and United Kingdom (UK). METHODS: All products accepted for AAP in 2015 were extracted from the European Medicines Agency (EMA) website. Health technology assessments (HTA) of these products were reviewed for France, Germany and UK through HAS, IQWiG/G-BA, NICE and SMC websites. RESULTS: Out of 17 products (8 with an orphan drug designation) accepted for AAP in 2015, 7 had marketing authorisation, and 2 had conditional marketing authorisation on the basis of less than comprehensive clinical evidence (as of June 2016). Remaining 8 products were either rejected, assessment is ongoing, or status is unknown. Thus far, 20 % (2/9) of approved products accepted for AAP were positively assessed by HTA bodies in France, and 10% (1/9) in UK (NICE and SMC) and Germany. Positive recommendations were granted without any restrictions in UK, while in Germany, G-BA recognised additional benefit in some specific subgroups. Timeframe from EMA approval to reimbursement-decision varied between HTA bodies; HAS providing the quickest and NICE the slowest route to MA (TC: 76-187, SMC: 113, G-BA: 182 and NICE: 314 days). In France, quick route to MA was facilitated by Temporary Authorisation for Use (ATU) scheme. CONCLUSIONS: Improved efficiency in EMA review time due to AAP is increasingly used to facilitate effective access to promising new treatments at regulatory level. Further alignment between regulators and HTA bodies is needed to bridge the gap between marketing authorisation and MA across Europe.

https://www.doi.org/10.1016/j.jval.2016.09.710