To examine Health Technology Assessment (HTA) decisions for new innovative medicines in the UK (England, Scotland, Wales, Northern Ireland).

Methods

The study examined HTA decisions made between 2017 and 2020 across UK countries for innovative medicines licensed by European Medicines Agency (EMA) in 2017. The analysis was done using published documents. The decisions were classified as “recommend without restrictions,” “recommend with restrictions,” or “not recommended”.

Results

EMA approved licenses for 56 new innovative medicines in 2017. From the date of licensing the medicines in 2017 until January 2020, the National Institute for Health and Care Excellence (NICE) in England had completed the appraisal of 28 out of the 56 medicines. Out of these 28, 12 were “recommended without restrictions” 14 were “recommended with restrictions” and 2 were “not recommended”. Majority of the NICE recommendations (i.e. 21 of 26 or 81%) were done through managed access agreements. The Scottish Medicines Consortium (SMC) has assessed 31 out of the 56 medicines licensed in 2017. Out of these 31, 8 were, “recommended without any restriction”, 22 were “recommended with restriction” and 1 was “not recommended”. AWMSG in Wales follows NICE guidance and does not review a medicine if NICE is considering assessing it in the next 12 months. Northern Ireland follows HTA guidance issued by NICE or SMC and adopts a decision shortly after either has made its decision. In Northern Ireland, 37 recommendations were adopted from either NICE or SMC. These 37 include: 10 without restrictions, 21 with restrictions and 6 not recommended decisions.

Conclusions

Adoption of HTA recommendations is low and it varies across UK countries. The number of HTA assessments resulting in “not recommended” decision was found consistently low across all UK countries. However, the number of “recommendation with restriction” is relatively high compared to the “recommendation without restrictions”.