Joint Clinical Assessment

From January 2025, the European Union (EU) Health Technology Assessment regulation (HTAR) is set to go live, which will require Health Technology Developers (HTDs) to submit a Joint Clinical Assessment (JCA) dossier documenting the comparative effectiveness of their assets, relevant for the 27 member states of the European Union. The process will first begin with oncology products and advanced therapy medicinal products (ATMPs), with orphan drugs and all other central authorised medicinal products subject to JCA by 2028 and 2030, respectively.

At Adelphi Values PROVE™, with our expert team of systematic reviewers, statisticians and HTA dossiers writers, we bring all specialisms in one place to support our clients throughout the process in a strategically integrated way:

Strategizing the evidence generation to ensure a timely quality delivery despite the short timeline between consolidated PICOs and submission

Executing evidence generation in a smooth way from PICO planning to updates, with the evidence synthesis integrated upfront.

Writing the submission dossier for success, using our expert knowledge of the policy needs of the member states to increase likelihood of acceptability by the local HTA authorities.

Communicating with authorities before and during the process (Joint Scientific Consultations, PICO explanation meeting).

Using our expertise in stakeholder consultation to ensure the right input is integrated in the file.

View a case study on a previous Joint Clinical Assessment workstream

Planning the PICO and designing the literature reviews for the JCA Evidence synthesis

Applying the lessons learned from EUnetHTA21

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Planning the PICO and designing the literature reviews for the JCA Evidence synthesis

Applying the lessons learned from EUnetHTA21

The challenge

Our client has an asset anticipated to qualify for JCA. They could not benefit from JSC. Given the short timelines between communication of the PICOs by the JCA working group and the submission (100 days), the PICO sets need to be anticipated to plan the evidence generation.

The solution

We simulated the JCA process through landscape analysis, our client internal resources and our stakeholders’ network. We used our previous experience in PICO planning projects to select the most likely and second most likely PICO sets. Stakeholder consultation was used to optimise and justify the choices. We structured the literature reviews to accommodate selection of PICO sets and updates.

Key results

We derived a manageable number of PICO sets reflecting the reimbursement landscape in the therapeutic area across Europe and addressing the likely policy questions of the member states. The sets have been externally validated. The evidence synthesis is structured in such a way to be updating easily and accommodate requirements from authorities.

Value to the client

Our client is well prepared for the upcoming JCA of their asset. The PICO sets have strong expert justification and evidence generation is structured in a flexible way to accommodate JCA requirements.