Contributed by:
Emma Hawe, MSc
Head, Data Analytics and Design Strategy
RTI Health Solutions
Joint Clinical Assessments
Joint clinical assessments (JCAs) centralise the clinical domains of the health technology assessment (HTA) process on a European-wide level. The 4 clinical domains are: current use (background information on patient population, burden of disease, comparators and their use); technical (description of the technology and its characteristics); safety (safety of asset and how it compares to comparators); and clinical effectiveness. Non-clinical HTA domains, which mainly involve cost, economic evaluation, and ethical aspects remain with the national HTA bodies of the EU's 27 member states. The national decision-makers also retain the final appraisal of a medicine and its recommendation for reimbursement for subsequent pricing negotiations.
The JCA will be an overall document, which should contain relevant clinical information for the HTA bodies of the member state. Then, the individual HTAs will use the JCA dossier and may request or require extra information including that not in the JCA dossier.
Quality, Transparency, and Timeliness
The aim of JCAs is to increase the quality, transparency, and timeliness of clinical HTAs so that access to innovative medicines is accelerated for EU patients in the EU. Whether the new legislation and centralised process will meet these aims remains to be seen.
It is important to understand that the JCA process runs in parallel to the marketing authorisation process of the European Medicines Agency (EMA).
The goal is endorsement of the final JCA report within 30 days of the European Commission’s decision to approve the medicine. This puts considerable time pressure on the entire process. It is fair to say that a good part of this pressure is placed squarely on the shoulders of the manufacturer. The process is kicked off when the regulatory dossier is submitted to the EMA.
HTA Firmly in the Driving Seat
In practice, this means that the HTA bodies are now firmly in the driving seat, and the manufacturers no longer retain control over when to launch the HTA process. This assumes the submission is subject to the EU HTA Regulation (HTAR), which applies to all new oncology drugs and cell and gene therapies beginning January 2025, orphan medicinal products starting January 2028, and lastly, all new drugs from 2030 onward.
It also means that the clinical efficacy and safety evidence submitted as part of the EMA regulatory dossier will effectively be mirrored in the JCA, placing an even greater emphasis on the importance of including payer-relevant endpoints and comparators in pivotal, registration-enabling clinical trials.
Joint Scientific Consultations
Joint scientific consultation is a non-binding scientific advice procedure in parallel consultations with participating HTA bodies and the EMA. They are being introduced together with JCAs and are typically provided before the start of pivotal clinical trials.
The aim of joint scientific consultations is to provide common EMA and HTA recommendations for the design of the planned registration-enabling clinical studies. This includes fundamental criteria such as patient populations, comparator selection, relevant endpoints, study design, and an economic evidence-generation plan.
The ultimate success of JCAs and market access in Europe will increasingly hinge on including key payer-relevant endpoints and comparators in a product’s pivotal clinical trials, with submissions occurring in parallel to the EMA and the JCA.
At RTI Health Solutions, we support clients along the entire scientific advice process, including the preparation of joint scientific consultation briefing books. We analyse and interpret scientific feedback clients receive and develop tailored recommendations for the design of clinical trials that specifically address requirements of the EMA and HTA bodies.
Take a look at our additional articles on the topic of Joint Clinical Assessments
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Navigating EU Joint Clinical Assessments and Joint Scientific Consultations from January 2025 Onward
