OBJECTIVES: Health technology assessment (HTA) bodies underwent policy and guideline rehaul during the recent COVID-19 pandemic with prioritised access being in the foreground. This research aimed to understand the trends in these updates adopted by the EU-5 HTA bodies.

METHODS: A review of recent HTA agency guideline and policy decisions in the EU-5 [namely UK , France, Italy, Spain and Germany] was done using IQVIA™ ’s proprietary platform ‘HTA Accelerator’ from 01/Jan/2020 to 06/Jun/2022. Thorough hand-searching of these updates were made to understand the patterns of HTA guideline changes.

RESULTS: 24 guidelines and policy updates were made during the above timeframe: 11 (France [HAS]); 2 (Spain [AEMPS, AETSA]) ; 2 (Italy [AIFA]); 4 (Germany [G-BA]) and 5 (UK [NICE, SMC]). In France, the guideline updates were mostly around performing economic evaluation, pricing rules and health benefits. While in Germany they were around adopting evaluation methods (assessments service quantity and quality; treatment durations in trial arms; and a concrete definition of clinical relevance). Also, G-BA clarified the procedure for collecting RWE for European medicines agency (EMA) approved orphan products under conditional marketing authorization or exceptional circumstances when the data is insufficient for a benefit assessment. A delayed dossier submission to facilitate "rolling review procedure" was initiated for all COVID-19 therapies. In the UK, a framework for RWE in HTA to encourage use of available data for informing NICE guidance. Also, EMA and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a joint work plan to implement the European HTA Regulation in January 2025. While changes by the Italian and Spanish HTA bodies mainly concerned with creating HTA network, pricing and reimbursement decree.

CONCLUSIONS: Emphasis on dissemination of RWE data remained mainstay for the updates. Pertaining to the pandemic, specialized delayed dossier submission policy for COVID-19 targeted therapies was also noteworthy.