How Are National HTA Bodies Preparing for the Implementation of the EU HTA Regulation?

OBJECTIVES: While the first European Union (EU) joint clinical assessments (JCA) are imminent, uncertainties remain, including national readiness to integrate EU HTA (Health Technology Assessment) regulation (HTAR). This research explores how member states (MS) are preparing for EU HTAR.

METHODS: Literature review using publicly available resources (01/2023–09/2024) including the European Commission website, PubMed, and grey literature.

RESULTS: Discussions of national implementation strategies were identified for 25 MS and Iceland/Norway part of the European Economic Area. Most MS show willingness to adapt processes, despite organizational, resource, and timeline challenges. Poland is a significant outlier, resisting adaptation. Organizational challenges for EU HTAR implementation include a need to reinforce expertise, e.g. indirect treatment comparisons in Spain and Italy, and to initiate processes for involvement of clinician/patient representatives (e.g. Spain, Italy, Bulgaria, Lithuania). Incorporation of JCA into national economic assessments was identified as a challenge (e.g. Sweden, Poland). A notable controversy surrounds adaptation of the PICO framework, with Italy and Bulgaria planning to involve industry in national-level PICO discussions to align expectations and improve subsequent negotiations. Some countries (e.g. Italy, Portugal, Romania), plan to adapt national submission processes to optimally use JCA, while Greece and Bulgaria are considering changing their national criteria which require prior reimbursement of products in other countries. For countries without fully established HTA processes, e.g. Cyprus and Luxembourg, EU HTAR may provide development opportunities. Cross-border collaborations, e.g. BeNeLuxA, are leveraging existing expertise to maintain joint HTA procedures post-JCA.

CONCLUSIONS: Most MS are preparing their national systems for the EU HTA transition. Countries with less developed HTA systems are taking this opportunity to improve their frameworks and may participate as observers in initial assessments. This process could also benefit more mature markets by enhancing expertise, stakeholder engagement, and transparency. Observing how different markets will engage industry in the PICO scoping process will be crucial.