A Call for Standardization: Navigating the Inconsistency in European HTA Pharmacoeconomic Guideline Reporting

OBJECTIVES: Health technology assessment (HTA) processes are applied throughout Europe to evaluate the comparative clinical and economic value of a novel intervention to inform resource allocation decision-making. Various economic evaluation frameworks are employed in European HTA submissions, including - predominantly - cost-effectiveness and cost-utility analyses and this research explores the clarity and standardisation (or lack thereof) of these evaluations in a European context.

METHODS: A pragmatic literature review was performed on all relevant European HTAs which covered the United Kingdom, Scandinavia, Western Europe, Central and Southern Europe. It is clear there is substantial amount of information generated by economic evaluations and systematic literature reviews, checklists such as CHEERs and PRISMA which are available to inform the standards and minimum amount of information for reporting, ensuring consistency and transparency. However, similar consideration is not given to the reporting of pharmacoeconomic guidelines, and between-country variation in the format, content and standard of reporting limits the comparability and transferability between guidelines.

RESULTS: Guidelines for agencies such as the TLV, SUKL and AIFA are also not universally available in additional languages. EU HTA Regulation, published in January 2022, aims to standardise clinical assessment of pharmaceutical interventions to enable a central assessment across the 27 EU markets. Joint Clinical Assessment is reportedly beginning implementation in January 2025, signalling increased cross-country collaboration in HTA. There is an opportunity for further standardisation in evidentiary requirement reporting.

CONCLUSIONS: By providing a standardised, validated template for reporting pharmacoeconomic guideline requirements would aid companies when planning clinical trials, ensuring the necessary patient outcomes are collected. Clearer reporting surrounding preferred methods, evidence sources (e.g. value sets, population norm data) may contribute to higher evidence standards. Consensus across EU HTA agencies may also inform standards for less established agencies, such as AIFA, aiding development of HTA procedures in their respective regions.