Time to HTA Assessment Completion By HTA Agency Archetype: Five-Year Review for 20 European Countries

OBJECTIVES: Countries using health technology assessment (HTA) as part of their pricing and reimbursement review process differ in the way their HTA agency is organized. HTA agencies can be broadly split into four groups: advisory arm-length, advisory integrated, regulatory (i.e., issuing binding decisions) arms-length and regulatory integrated. We examine the length of HTA review by agency archetype to examine if there is a correlation between HTA agency archetype and the length of time between marketing authorization and the publication of an HTA assessment.

METHODS: Twenty national-level European HTA agencies were categorized under the four archetypes. All final HTA decisions in the 20 European countries issued between 1 January 2018 and 31 December 2022, based on POLI data, were examined and the average time, in days, between marketing authorization and first HTA decision, as well as between marketing authorization and first positive HTA decision were calculated for each of the four agency archetypes.

RESULTS: The longest time by far between marketing authorization and first HTA decision was for the regulatory integrated archetype (1,238 days), followed by advisory integrated agencies (782.5 days), while countries with advisory arms-length and regulatory arms-length agencies had a similar time to first HTA of 675.8 days and 674.8 days, respectively. The ranking was maintained if the time to first positive HTA decision is examines instead, with 1,244 days for regulatory integrated agencies, 813 days for advisory arms-length, 748.9 days for regulatory arms-length and 737.7 days for advisory arms-length agencies.

CONCLUSIONS: Countries with arms-length agencies of both archetypes were found to produce HTA reviews faster, and were also more likely to issue the first positive HTA decision faster compared to integrated agencies. The long review time for the regulatory integrated archetype should be treated with caution as there was a single national-level HTA agency in this group.