EU Published Its First Joint Clinical Assessment Report Under the HTA Regulation

Regulation (EU) 2021/2282 establishes a common EU process for joint clinical assessments of health technologies. Since 12 January 2025, medicines with new active substances intended to treat cancer and advanced therapy medicinal products that apply for central marketing authorisation have been within scope. Under the phased timetable reported by secondary sources, orphan medicinal products enter scope on 13 January 2028 and all new centrally authorised medicinal products on 13 January 2030. Commentators note that orphan coverage depends on an EU orphan designation rather than on rare-disease status alone.

A joint clinical assessment is a scientific report on the relative clinical effects of a medicine against the comparators requested by Member States. It is not a decision on pricing or reimbursement. Member States must give due consideration to the report in their national HTA procedures, but each country continues to draw its own conclusions on added benefit and value.

On 9 June 2026 the Commission published the first joint clinical assessment report, which concerns tovorafenib (Ojemda) for paediatric low-grade glioma. According to the Commission and secondary reporting, the Member State Coordination Group on HTA endorsed the report on 30 April 2026, and the Commission concluded its procedural review on 19 May 2026. The European pharmaceutical industry association EFPIA described the report as the result of 14 months of joint work.

The report is limited to clinical evidence. It sets out the available results for the requested comparisons and describes gaps and uncertainties in the evidence, but it does not state whether the medicine offers an added benefit over comparators and makes no recommendation on access. The Commission stated at publication that further joint clinical assessment reports would be completed and published in the coming months. One trade article dated September 2026 refers to further reports having followed; this could not be verified against the Commission’s own pages at the time of checking.

The structure of the first report is relevant beyond the individual product. Because the report records evidence gaps and uncertainties without weighing them, the same document can be used by HTA bodies with different decision frameworks. A body that places weight on randomised comparisons with a specific national comparator may read the same uncertainty differently from a body that accepts indirect evidence more readily. Companies should therefore expect national discussions to focus on how each country interprets the gaps that the joint report describes.

Activity in the first year was lower than some early projections. A consultancy review by ICON reports that the first year of the regulation supported 10 joint clinical assessments and seven joint scientific consultations, compared with an earlier EMA-based estimate of around 17 oncology assessments in the first year. ICON also reports that the Commission’s list of ongoing assessments on 20 January 2026 included 11 products, and that the 2026 work programme anticipates around 50 joint clinical assessments for medicinal products. These figures come from a secondary source and should be checked against Commission and Coordination Group publications before use.

The first national procedures that build on a joint clinical assessment are now under way. In Germany, for example, the Federal Joint Committee (G-BA) said it expected the first benefit assessments following a prior EU assessment to start in spring 2026.

As the 2028 and 2030 phases approach, the number of assessments is expected to rise, which will place greater demands on Member State assessors and on developers preparing dossiers in parallel with regulatory submissions. Developers of orphan medicines in particular should begin preparing now, since their products enter scope in the next phase.

Developers of in-scope products need to plan evidence generation around a scope that may contain several population, intervention, comparator and outcome combinations requested by different Member States. The first report illustrates that uncertainties in the evidence are recorded explicitly, which national bodies may then weigh in their own decisions. Companies should therefore expect national HTA bodies to read the joint report alongside any country-specific submission.

Teams preparing products that will enter scope in 2028 or 2030 can use the first published reports to understand the presentation of results, the treatment of indirect comparisons and the level of detail expected. Pubrica’s summary is for information only and does not replace the regulation, the implementing acts or guidance from the Commission and the Coordination Group.

Internal planning should also allow for the parallel timing of the joint assessment and the marketing authorisation procedure. Scoping, dossier preparation and report drafting take place while the regulatory review is still under way, so changes to the proposed indication or to the evidence package can affect the joint assessment. Cross-functional teams covering regulatory affairs, health economics, biostatistics and medical writing are generally needed to keep the regulatory and HTA submissions consistent.