Katie Rose (Consultant – Market Access), Maria Dimitrova (Consultant – HTA) and Samantha Gillard (Director – HTA) provide an overview of the EU Joint Clinical Assessment (JCA) and what it means for Pharma and Medical Device manufacturers launching new technologies from 2025.
This article was updated in November 2024, with reflections on the latest information about the EU JCA and how industry is responding.
Jump to:
- What is the EU JCA?
- When will the JCA be a requirement?
- Will the JCA replace local HTA?
- JCA methods and guidelines
- Who conducts and assesses the JCA?
- The JCA scoping process
- Four key considerations for Pharma and Medtech
- How can Mtech Access & Petauri™ provide support?
What is the EU JCA?
In January 2022, the European Parliament enacted a new EU Health Technology Assessment Regulation (HTAR), with the main aims being to:
- Standardise clinical assessment of medicines and high-risk medical devices across the EU
- Avoid duplication of work
- Improve access to innovative health technologies to patients across Europe
- Strengthen the quality of health technology assessments (HTAs)
Currently, Pharma and Medtech manufacturers have to submit evidence individually in each of the 27 EU markets; the intention of the JCA is that at least some of the assessment can be done centrally.
The JCA will provide an assessment report, which acts as a universal information source for relative treatment effects, safety, and other clinical parameters agreed in the scoping process. The report will also cover the clinical area addressed by the technology and its technical characteristics. A summary report will be developed. Both reports will be based on scientific, clinical, patient, industry, and HTA body expertise.
The introduction of the JCA should benefit smaller markets, which may not have the required capacity or expertise to conduct assessments independently.
When will the JCA be a requirement?
The JCA will be rolled out in stages. New cancer medicines and advanced therapy medicinal products (ATMPs) will require a JCA from 12th January 2025. Orphan medicines will require assessment at EU level from 13th January 2028. Finally, all other new medicines launching in the EU will need a JCA from 13th January 2030.
Will the JCA replace local HTA?
The JCA is not a full HTA and is focused only on clinical evidence. It is not an appraisal, and local agencies reserve the right to draw their own conclusions on relative efficacy and safety.
Whilst all member states will be required to give each JCA “due consideration”, each state will be able to request additional information relevant to their market. Cost-effectiveness and reimbursement decisions will be made at national level.
JCA methods and guidelines
The voluntary EU HTA cooperation, EUnetHTA21, a consortium of 12 European HTA bodies, were contracted to develop guidance documents to support the EU HTAR.
EUnetHTA21 developed HTA methodological guidelines, including guidance on scoping, evidence synthesis, endpoints, validity of studies, etc. Whilst these guidelines are written for the assessors and co-assessors, Pharmaceutical and Medtech companies can also learn from the information provided.
JCA guidelines published by EUnetHTA21 include::
- JCA submission dossier guidance and template
- JCA assessment report guidance and template
- JCA procedural guideline for appointing assessors and co-assessors
- Production of JCA on medical products and medical devices
In September 2023, the Member State Coordination Group on Health Technology Assessment (HTACG) was established to oversee future joint EU HTA work. HTACG have published the following two pieces of guidance:
- Guidance on outcomes for joint clinical assessments
- Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments
The guidance on outcomes for JCAs will help member state authorities define the scope of the JCAs and help assessors report all elements that member states need for the national appraisal of the clinical added value of health technology.
The guidance on reporting requirements for multiplicity issues and subgroup, sensitivity, and post hoc analyses in joint clinical assessments describes how assessors should deal in practice with multiplicity issues and complementary analyses in JCA reports.
Who conducts and assesses the JCA?
The JCA process will be conducted by the HTACG. The HTACG comprises four subgroups, with two (Joint Clinical Assessment and Joint Scientific Consultation) directly responsible for the delivery of JCA reports. One subgroup will be responsible for the identification of emerging health technologies, and another will focus on methodology.
The JCA will be conducted by representatives from the designated subgroups who will be responsible for all JCA activities and timelines, as well as collecting input from regulatory agencies, clinicians, and patients.
For each technology requiring assessment, the JCA group will appoint two member states, one leading and one supporting, who will be responsible for assessing the manufacturer’s dossier and producing the JCA report. The appointed member states will liaise with the other member states as required.
The JCA scoping process
To inform development of the assessment scope, the manufacturer will submit elements of their European Medicines Agency (EMA) application, namely the summary of product characteristics and clinical overview. Based on this information, assessors will prepare a proposal for the assessment scope in terms of population, intervention, comparators, outcomes (PICO), which has the aim of specifying the framework for assessment and the evidence requirements the manufacturer will need to satisfy.
Each of the 27 EU member states will be required to fill out a PICO survey, to allow them to identify national needs. Following the survey, the JCA assessor and co-assessor will consolidate all PICOs, which will be validated by EU patients and clinical experts, as well as the Committee for Scientific Consistency and Quality (CSCQ).
The finalised assessment scope will be communicated to Pharmaceutical and Medtech manufacturers, from which point they have 90 days to develop and submit the JCA dossier. Submission of the dossier is required at least 45 days prior to publication of the Committee for Medicinal Products for Human Use (CHMP) opinion.
Four key considerations for Pharma and Medtech
Manufacturers can expect to face various challenges throughout the JCA process, including:
1. Different national requirements
EU member states will be able to request additional information, such as cost-effectiveness evidence, during the JCA process. Yet, additional clinical information will still be required at national level and this is where reimbursement decisions will be made. Additionally, there may be differences in accepted methods for evidence synthesis between the EU member states. Presumably, individual member states will still be able to request the same evidence as at EU level, but analysed differently.
2. Risk of needing to repeat submission following CHMP opinion
The JCA dossier submission needs to be made prior to CHMP opinion (at least 45 days prior to publication of the opinion). Since aspects of PICOs may change following CHMP opinion, there is a risk that the whole JCA process will need to be repeated.
3. Potential for an unmanageable number of PICOs
Even though PICOs at national level will be consolidated, there is no cap on the number of consolidated final PICOs. The definition of standard of care and patient populations are likely to vary across member states and so there is a risk of an unmanageable workload for manufacturers.
4. Limited contact with assessors
Manufacturers will have limited input into the JCA process. As the JCA is not an appraisal, and reimbursement decisions won’t be made, it is understood that the EU assessor and co-assessor’s contact with manufacturers will be limited to requesting clinical evidence if missing from the JCA submission dossier.
Despite the intention to avoid duplication of efforts, the four challenges above are likely to increase the workload for manufacturers.
How can Mtech Access & Petauri™ provide support?
We can help Pharma and Medtech companies with strategic considerations, evidence synthesis, and dossier development for their JCA submissions.
We are HTA experts and our team have collectively completed more than 170 HTA submissions, with a 100% success rate in oncology and rare diseases. We work closely with our clients, becoming an extension of their teams, to ensure the value of their products is appropriately communicated. We provide continuous strategic support throughout to maximise the chances of successful reimbursement, whilst project timelines are closely monitored for timely delivery.
At Mtech Access – Powered by Petauri, we have specialist teams of Systematic Reviewers and Statisticians who consistently deliver evidence synthesis according to the most robust standards, across all disease areas. Several of our Evidence Team were previously members of an Evidence Assessment Group for the National Institute for Health and Care Excellence (NICE) and use this experience to ensure that our systematic reviews adhere to HTA requirements and are of the highest quality. In addition, our large in-house team of specialist Medical Writers are experienced in writing reimbursement and HTA submission dossiers. All of our submissions undergo a thorough proofing process by our Editorial Team, who offer quality assurance.
Please email info@mtechaccess.co.uk to discuss how we can support you with your JCA dossier.
