PNS101 YOU REAP WHAT YOU SOW; EUNETHTA COMING TO FRUITION

Abstract

EUnetHTA was established in 2005 to create an effective and sustainable network for Health Technology Assessment (HTA) across Europe. JA2 (Joint Action 2) the first major assessment program, assessed four drugs between 2012 and 2015. JA3 was established in 2016 with the aim to increase the use, quality and efficiency of joint HTA work at the European level, including expedited timelines for development with final report to coincide with EPAR publication. This research aims to evaluate whether drugs evaluated under EUnetHTA JA3 have received better/faster outcomes by national European HTA bodies. Publicly available information on EUnetHTA JAs for individual drugs were identified along with the associated appraisal by NICE, SMC, IQWIG, TLV, HAS, AIFA, SMC, NCPE, ZIN, Medicinradet, AOTM and NOMA (to 16/01/2019). Statistical tests were carried out using a two-tailed t-test. Seven EUnetHTA JAs were identified, 4/7 were assessed during JA2, 3/7 were assessed during JA3. Overall 5/7 were for oncology indications and 2/7 were orphan drugs. Forty three corresponding national HTA appraisals were identified, 24% being positive recommendations with a mean delay of 289 days post-EC approval. EUnetHTA JA3 appraised products had a significantly higher recommendation rate by national HTAs (70%; 16/23) vs. those appraised under EUnetHTA JA2 (45%; 9/20). In addition, the mean delay from EC-approval to national HTA publication for EUnetHTA JA3 appraisals was significantly lower than that of EUnetHTA JA2 appraisals (218 days and 364 days respectively; p=0.006). To date, drugs appraised under JA3 have received significantly better national outcomes in a shorter time in comparison to those appraised under JA2. This likely reflects an improvement in the JA3 framework, including reducing the time to publication for JAs to prior to the start of national HTA processes. However, this may be confounded by differences in the types of drugs appraised under JA2 vs. JA3.