Access to medicines in the United Kingdom: a document analysis regarding health technology assessment recommendations for innovative medicines (2017-2020)

IntroductionAccess to medicines is a critical aspect of healthcare, and health technology assessment (HTA) agencies play a pivotal role in evaluating innovative medicines.ObjectivesThe objective of this study was to critically review Health Technology Assessment (HTA) recommendations for innovative medicines across the United Kingdom (England, Scotland, Wales and Northern Ireland) following their licensure by the European Medicines Agency (EMA) in 2017. By analysing HTA recommendations, we aimed to understand differences between licensing and reimbursement recommendations and explore variations in access to innovative treatments within the UK.MethodsThe study focused on HTA decisions made between 2017 and 2020 in the UK for innovative medicines that were licensed by the European Medicines Agency (EMA) in 2017. Published documents were used for the analysis. The decisions were categorized as 'recommend without restrictions', 'recommend with restrictions', 'not recommended' or 'not assessed'.ResultsIn 2017, the EMA approved licenses for 56 new innovative medicines. Between 2017 and January 2020, the National Institute for Health and Care Excellence (NICE) in England completed the appraisal of 28 of these medicines. Out of the 28, 11 were 'recommended without restrictions', 15 were 'recommended with restrictions' and 2 were 'not recommended'. The majority of NICE recommendations (21 out of 26, or 81%) were made through managed access agreements. The Scottish Medicines Consortium (SMC) assessed 31 out of the 56 medicines licensed in 2017. Among these 31, 8 were 'recommended without any restriction', 22 were 'recommended with restrictions' and 1 was 'not recommended'. In Wales, the All Wales Medicines Strategy Group (AWMSG) follows NICE guidance and does not review a medicine if NICE is planning to assess it within the next 12 months. In Northern Ireland, HTA guidance from either NICE or SMC is followed, and a decision is adopted shortly after one of them makes its decision. In Northern Ireland, 39 recommendations were adopted from either NICE or SMC, including 10 without restrictions, 21 with restrictions and 8 not recommended decisions.ConclusionsThis study sheds light on the complex landscape of medicine licensing and reimbursement in the UK. While licensing approval ensures safety and efficacy, it does not guarantee access to medicines without reimbursement recommendations. Health technology assessment (HTA) bodies play a crucial role in evaluating clinical effectiveness and cost-effectiveness. Our findings reveal variations in HTA adoption across UK countries, emphasizing the importance of timely recommendations. Notably, 'recommendations with restrictions' prevail, often linked to managed access agreements. As we navigate this complex system, optimizing patient care remains paramount.