Joint Clinical Assessments
A Joint Clinical Assessment (JCA) is the main product of this new European collaboration on health technologies. It examines how effective and safe a new medicine, medical device or diagnostic test is compared to other available options.
A Joint Clinical Assessment is a scientific assessment of the relative clinical effectiveness and safety of a health technology (medicine or medical device) compared with available alternatives. It evaluates the benefits, risks and quality of the available clinical evidence.
A JCA focuses only on clinical evidence. It does not include value judgements or reimbursement decisions. These remain the responsibility of each Member State.
The final JCA report provides a single, shared scientific assessment that supports national decision-making across the EU, as well as Norway, Iceland and Liechtenstein.
As stipulated in the EU HTA Regulation, patients, carers and clinical experts are required to be involved in a JCA, specifically in two phases: the Scoping Phase and the Assessment Phase.
Main phases of a JCA
A JCA has two main phases:
- Phase 1
Scoping phase
The research questions are defined using the PICO framework and agreed with Member States, with input from patients, carers and clinical experts.
- Phase 2
Assessment phase
The submitted clinical evidence is assessed against those research questions, reviewed, revised and finalised as the JCA report.
Phase 1: Scoping phase
- Assessors prepare an assessment scope proposal, which defines the research questions the JCA will answer.
- The assessment scope proposal is structured using the PICO framework (Population, Intervention, Comparators and Outcomes).
- Example: For women with advanced breast cancer, is treatment X more effective than standard therapy in improving survival and quality of life?
- The assessment scope proposal is shared with the JCA Subgroup, composed of representatives from Member State HTA bodies, for comments.
- The JCA Subgroup reviews the proposal and provides their national needs.
- The assessors consolidate this input into a feasible assessment scope.
- Patients, carers and clinical experts review the consolidated assessment scope proposal and provide comments.
- The final assessment scope is shared with the health technology developer.
Phase 2: Assessment phase
- The health technology developer submits a dossier containing the relevant clinical and safety evidence.
- Assessors prepare a draft JCA report and summary based on the submitted evidence.
- The report evaluates results from studies (such as clinical trials) that address the PICO research questions agreed during the Scoping phase.
- The draft JCA report is shared with the JCA Subgroup for review and comments.
- Assessors revise the draft report, taking the comments into account.
- Patients, carers and clinical experts review the revised draft report and provide comments.
- Assessors prepare the final JCA report and summary, which are validated by the JCA Subgroup.
- The final JCA report is endorsed by the HTA Coordination Group (HTACG) and published.
The PICO framework
A JCA uses the PICO framework, the research question(s) that guide the assessment.
Population
The specific patients included in the assessment (e.g. disease type, stage, severity, prior treatments, subgroups).
Intervention
The new technology being assessed.
Comparator
The relevant alternative(s): standard of care or other active treatments.
Outcomes
The clinical endpoints to be assessed (e.g. survival, disease progression, symptoms, safety, patient-reported outcomes).
In other words, the PICO tells everyone exactly which patients, which treatment, which alternative, and which results will be looked at. The JCA report aims at answering all the questions participating European countries have on the technology being assessed. Since different countries may have different questions, these are combined and streamlined wherever possible into the lowest number of PICOs needed to still cover all Member States' needs, rather than keeping a separate question for each participating country.
The final JCA report includes evidence from studies, such as clinical trials, that address the research questions defined by the PICO(s). Once finalised, the JCA report is shared with all EU countries as well as Norway, Iceland and Liechtenstein. Each country then uses it, along with other national criteria, to decide how to use the technology in its own health system.