JCA process: timeline, scoping, dossier and assessment under EU HTA

A JCA is not a European decision on clinical added value, pricing or reimbursement. The JCA report describes comparative clinical effects and the certainty, strengths and limitations of the available evidence. Member States remain responsible for their national HTA processes and for decisions on clinical added value, pricing and reimbursement.

Regulatory status: September 2026. Procedural requirements, timelines, templates and methodological guidance should be checked against the latest primary sources for each individual JCA.

1. JCA process at a glance
2. What is a Joint Clinical Assessment?
3. Which medicinal products are subject to JCA?
4. Who is involved in the JCA process?
5. How does the JCA process work?
6. How is the JCA assessment scope defined?
7. What role do PICOs play in JCA?
8. How is the JCA dossier submitted?
9. What evidence is assessed in a JCA?
10. How are clinical studies assessed in a JCA?
11. Which outcomes are considered in a JCA?
12. How are the JCA report and summary report produced?
13. What are the key timelines in the JCA process?
14. What happens after publication of the JCA report?
15. What is the difference between EMA authorisation, JCA and national HTA?
16. Why does JCA preparation begin before the formal process?
17. What does the JCA process mean for health technology developers?
18. Frequently asked questions about the JCA process
19. Further information on the JCA process

The JCA process for medicinal products runs in close coordination with the centralised European marketing authorisation procedure. It extends from identification of a medicinal product subject to JCA through scoping and dossier submission to the joint clinical assessment and publication of the final JCA report.

What is a Joint Clinical Assessment?

A Joint Clinical Assessment is the joint scientific assessment of the relative clinical effectiveness and relative safety of a health technology at European level. The assessment follows an assessment scope reflecting Member State requirements in terms of population, intervention, comparator and outcomes.

When does the JCA process for medicinal products begin?

The JCA scoping process for a medicinal product begins following submission of the marketing authorisation application to the European Medicines Agency (EMA). Identification of a medicinal product expected to fall within JCA scope and other preparatory activities start earlier.

What is the output of the JCA process?

The principal outputs of the JCA process are the joint clinical assessment report and its summary report. The JCA report describes relative clinical effects, scientific uncertainty, and the strengths and limitations of the evidence. It does not provide a European conclusion on clinical added value or reimbursement.

A Joint Clinical Assessment evaluates the available clinical evidence for a health technology relative to one or more comparators. The legal basis is Regulation (EU) 2021/2282 on health technology assessment, commonly referred to as the HTA Regulation or HTAR.

One objective of the HTA Regulation is to reduce duplication in the submission and assessment of clinical evidence across Member States. Information, data, analyses and other evidence required for the JCA are submitted at European level.

The JCA focuses on the clinical domains of HTA. These include the description of the health problem, the technical characterisation of the health technology, its relative clinical effectiveness and its relative safety.

What does a Joint Clinical Assessment evaluate?

A JCA evaluates the relative clinical effects of a health technology against the comparators defined in the assessment scope. It also considers the certainty of the results and the strengths and limitations of the underlying evidence.

The clinical research question is defined through PICO:

• Population
• Intervention
• Comparator
• Outcomes

A single medicinal product may therefore be assessed against several PICOs where Member State requirements include different populations or comparators.

What does a Joint Clinical Assessment not evaluate?

A JCA does not determine the price, national reimbursement status or overall clinical added value of a medicinal product. The JCA report must remain scientific and factual and should not provide an overall conclusion on the benefit or clinical added value of the assessed health technology.

Health economic assessment, national healthcare considerations and pricing negotiations also remain outside the core JCA.

This distinction is important for the subsequent use of the JCA. A joint European analysis of clinical evidence does not replace the national appraisal of that evidence within individual healthcare systems.

What role does JCA play in national HTA?

The JCA provides a common clinical evidence base for subsequent national HTA processes. Member States must give due consideration to published JCA reports but remain responsible for their national conclusions and decisions.

National HTA bodies may therefore require complementary clinical analyses. This may apply, for example, where nationally relevant populations, comparators or outcomes are not fully covered by the analyses included in the JCA.

The HTA Regulation introduces JCA for medicinal products through a stepwise approach. Since 2025, the process initially covers certain oncology medicinal products and advanced therapy medicinal products. The scope expands in 2028 and 2030.

Which medicinal products have been subject to JCA since 2025?

Since 13 January 2025, certain new oncology medicinal products and advanced therapy medicinal products (ATMPs) have been subject to JCA. For oncology products, this includes the requirement that the applicant declares in the marketing authorisation application that the medicinal product contains a new active substance for the treatment of cancer and that the other applicable HTAR conditions are fulfilled.

Orphan medicinal products may already be subject to JCA before 2028 if they also fall within a category covered since 2025, such as an eligible oncology medicinal product.

Which medicinal products will be added to JCA from 2028?

From 14 January 2028, orphan medicinal products meeting the relevant requirements of the HTA Regulation will additionally be subject to JCA.

This expansion will increase the number of products for which European and national evidence requirements need to be planned in parallel.

Which medicinal products will be subject to JCA from 2030?

From 14 January 2030, JCA will expand to all other medicinal products meeting the relevant conditions under Article 7 of the HTA Regulation.

JCA will therefore develop from a process initially limited to selected product categories into a routine component of European market access.

The JCA process distributes scientific, coordinating and administrative responsibilities across several actors. Key participants include the health technology developer, assessor and co-assessor, the JCA Subgroup, the HTA Coordination Group and the HTA Secretariat.

What is the role of the health technology developer in JCA?

The health technology developer (HTD) submits the evidence requested by the assessment scope in a structured JCA dossier. For medicinal products, the HTD will generally be the pharmaceutical company applying for marketing authorisation.

The HTD receives the final assessment scope and must address the resulting evidence requirements within the applicable submission deadline. During the assessment, further specifications, clarifications, information, data or analyses may be requested.

What are the responsibilities of the JCA assessor and co-assessor?

The assessor and co-assessor lead the scientific and technical work for an individual JCA and jointly prepare the JCA report. They are appointed from different Member States.

Their appointment takes into account HTA expertise as well as the scientific and therapeutic expertise required for the specific assessment. Statistical and information retrieval expertise may also be required to support the JCA.

What is the role of the JCA Subgroup?

The JCA Subgroup conducts and reviews the joint clinical assessment on behalf of the HTA Coordination Group. Its members contribute Member State requirements during scoping and participate in quality assurance of the assessment scope and JCA report.

What is the role of the HTA Coordination Group in JCA?

The Member State Coordination Group on Health Technology Assessment (HTACG) oversees the European joint work and endorses finalised JCA reports.

The HTACG also adopts methodological and procedural guidance for the joint work under the HTA Regulation.

How are patients and clinical experts involved in JCA?

Patients, clinical experts and other relevant experts can contribute at several stages of the JCA process. Their involvement can support both development of the assessment scope and interpretation of the subsequent assessment.

Input can be collected through written formats or defined consultation procedures. Relevant expertise in the disease and therapeutic area is considered when experts are selected.

The JCA process for medicinal products can be divided into seven main steps: initiation, scoping, finalisation of the assessment scope, dossier submission, completeness check, clinical assessment, and finalisation and publication of the JCA report.

These steps are closely coordinated with the centralised EMA marketing authorisation procedure.

Step 1: Identification and initiation of the JCA process

A medicinal product potentially subject to JCA is identified in connection with the planned EMA marketing authorisation application. The HTD provides the relevant information through the regulatory process and notifies the HTA Secretariat accordingly.

An assessor and co-assessor are appointed for the individual JCA. Final confirmation of the start of the JCA is linked to submission of the marketing authorisation application to EMA.

For HTDs, operational preparation needs to start considerably earlier. Potential populations, comparators and evidence gaps need to be understood before formal scoping if the necessary analyses are to be available within the later submission timelines.

Step 2: Assessment scope and PICO scoping in JCA

JCA scoping translates Member State requirements into defined clinical research questions. The assessor and co-assessor first develop an assessment scope proposal. Member States can then provide their national requirements through the PICO survey.

The PICO survey addresses:

• relevant populations,
• the intervention under assessment,
• relevant comparators,
• relevant outcomes,
• additional requirements such as subgroup analyses where applicable.

The assessment scope is intended to be inclusive and reflect the needs of Member States.

Step 3: Finalisation of the JCA assessment scope

The final JCA assessment scope consolidates Member State requirements into the lowest possible number of PICOs while preserving the relevant needs of Member States.

Following finalisation, the HTA Secretariat communicates the assessment scope to the HTD and requests submission of the JCA dossier.

The HTD may request an assessment scope explanation meeting. This meeting is intended to explain the final consolidated assessment scope. It is not designed to renegotiate the PICOs or provide advice on the appropriateness of the methods or analyses the HTD intends to submit.

Step 4: Preparation and submission of the JCA dossier

The standard deadline for submission of the JCA dossier is 100 days from notification of the first request. For a medicinal product assessed under the accelerated EMA procedure, the deadline is generally 60 days.

The JCA dossier must address the research questions defined in the assessment scope using the available clinical data and analyses. This includes identification of relevant studies, presentation of relative clinical effectiveness and safety, and the methods used for evidence synthesis.

The short submission window limits the extent to which fundamental evidence questions can first be addressed after receipt of the final assessment scope. Potential analyses and comparative scenarios may therefore need to be prepared in advance.

Step 5: Completeness check of the JCA dossier

After submission, the European Commission checks within defined timelines whether the JCA dossier meets the applicable submission requirements. The completeness check takes 15 working days under the standard procedure and 10 working days under the accelerated procedure.

Where required information, data, analyses or other evidence are missing, a second request may be issued.

The HTD generally has 15 days to provide the missing information. This is reduced to 10 days under the accelerated procedure. Where only minor information is missing, the deadline may be 7 days.

If the dossier remains insufficient or is not submitted within the required timelines following the second request, the JCA may be discontinued.

Step 6: Scientific assessment of the JCA dossier

The assessor and co-assessor assess the submitted evidence against the PICOs defined in the assessment scope. The assessment focuses on relative clinical effects and the certainty of the underlying evidence.

During preparation of the JCA report, further specifications, clarifications, information, data or analyses may be requested. Depending on the nature of the request, the response deadline can range from a minimum of 7 days to a maximum of 30 days.

New clinical data submitted to EMA during the JCA may also become relevant to the joint clinical assessment.

Step 7: Factual accuracy check and publication of the JCA report

Before final publication, the HTD can identify purely technical or factual inaccuracies in the revised draft JCA report. The factual accuracy check is not a second scientific consultation on the assessment.

The standard deadline is 7 days. In specified circumstances, including the accelerated procedure, the deadline is 5 days.

Following further finalisation, the JCA Subgroup validates the report. The HTA Coordination Group subsequently endorses it. For medicinal products, endorsement should take place no later than 30 days following the European Commission decision granting marketing authorisation.

The JCA assessment scope defines the clinical research questions that the joint assessment must address. It is developed from Member State requirements and determines which populations, interventions, comparators and outcomes the HTD needs to address in the JCA dossier.

The assessment scope is therefore one of the defining elements of the JCA. It does not merely structure the final report. It specifies the European requirements for clinical evidence and analysis.

How is the JCA assessment scope developed?

The JCA assessment scope is developed through an assessment scope proposal, a PICO survey and subsequent PICO consolidation.

The assessor and co-assessor first prepare a proposal. Information from the regulatory procedure, relevant European clinical guidelines, and input from patients and clinical experts can contribute to its development.

Member States then review the proposal and provide their national requirements through the PICO survey. The assessor and co-assessor subsequently consolidate those responses.

What requirements do Member States provide during JCA scoping?

Member States can specify requirements for the population, intervention, comparator and outcomes relevant to their national decision-making. They are asked to limit requests to what is necessary for their national needs.

This is particularly relevant because treatment standards can differ across European healthcare systems. Comparator requirements and relevant subpopulations may therefore differ between Member States.

How are different Member State PICO requirements consolidated?

PICO consolidation aims to represent Member State requirements using the lowest possible number of PICOs.

The JCA scoping guidance describes four principal steps:

1. List the requirements of each Member State.
2. Compare Member State requirements for each population.
3. Select the required comparator treatments for each population and assign PICOs.
4. Create the consolidated PICO structure and add the required outcomes.

Consolidation should not remove a requirement that a Member State needs for its relevant clinical policy question.

Can a JCA include multiple PICOs?

A JCA can include multiple PICOs when Member State requirements cannot be addressed through a single clinical research question.

Multiple PICOs can arise, for example, where separate subpopulations or comparators need to be assessed.

For HTDs, this can substantially increase the analytical requirements. A single pivotal study does not automatically provide evidence for every research question included in the European assessment scope.

PICOs define the individual clinical research questions addressed by the Joint Clinical Assessment. PICO stands for population, intervention, comparator and outcomes.

The assessment scope can contain one or multiple PICOs. For each PICO, the HTD needs to determine which available evidence can answer the defined research question.

How is the population defined in a JCA PICO?

The population in a JCA PICO describes the patients for whom relative clinical effectiveness and safety are to be assessed.

The claimed therapeutic indication provides the starting point. Member States can also identify relevant subpopulations where these are required to address their national policy questions.

A subpopulation defined during scoping results in a separate PICO. This differs from a subgroup analysis within an existing PICO, for example according to age, sex or another potential effect modifier.

How are comparators selected in a JCA PICO?

JCA comparators reflect the treatment alternatives required by Member States for their respective clinical questions.

A PICO may contain a single comparator. Where several treatments are relevant, different scenarios are possible: an effect estimate against each individual treatment may be required, several treatments may form alternative comparators, or an individualised treatment comparator may be used.

The European comparator structure can therefore be broader than the comparator relevant to any single Member State.

What is an individualised treatment comparator in JCA?

An individualised treatment comparator comprises multiple treatment options where the treatment selected for an individual patient depends on patient-specific characteristics.

This can be relevant for heterogeneous populations where no single standard treatment is appropriate for all patients. Previous treatment, disease severity, contraindications, biomarkers or other clinical characteristics may determine the treatment selected for an individual patient.

How are outcomes defined in a JCA PICO?

Outcomes in a JCA PICO represent the clinical results Member States require for their assessments.

Potential outcomes include mortality, morbidity, symptoms, functioning, health-related quality of life and safety. The JCA assessment scope should not rank outcomes according to their perceived importance.

Why can one medicinal product have multiple JCA PICOs?

Multiple JCA PICOs arise where different national requirements cannot be meaningfully consolidated into a single research question.

Differences in populations and comparators are particularly important. One Member State may require a specific treatment as comparator while another Member State uses a different treatment standard.

Evidence planning therefore needs to consider more than whether clinical evidence exists. The relevant question is which European PICOs can be answered by direct evidence and where methodologically appropriate indirect evidence may be needed.

The JCA dossier is submitted digitally after the assessment scope has been finalised. The submission must address the clinical research questions defined in the assessment scope using the available evidence.

The dossier follows a defined structure and documents the assessment scope, methods, identified evidence and results on relative clinical effectiveness and safety.

How long does the HTD have to submit the JCA dossier?

The standard deadline for submission of the JCA dossier is 100 days following the first request. For an accelerated procedure, the deadline is generally 60 days.

An extension may be possible in justified circumstances. However, the parallel regulatory timetable limits the available flexibility.

How is the JCA dossier checked for completeness?

The completeness check determines whether the JCA dossier contains the information, data, analyses and other evidence required under the applicable rules.

This first determines whether the submission is complete. It is distinct from the subsequent scientific assessment of the evidence.

What happens if information is missing from the JCA dossier?

If the JCA dossier is incomplete, the HTD may receive a second request for the missing information, data, analyses or other evidence.

If the submission remains incomplete or the required information is not provided within the applicable deadline, the JCA may be discontinued.

Can additional evidence be requested during a JCA?

The assessor and co-assessor can request further specifications, clarifications, information, data, analyses or other evidence during preparation of the JCA report.

This creates a need for rapid responses during the assessment phase. Evidence, statistical analyses and supporting documentation should therefore be prepared so that additional questions can be addressed within short timelines.

A JCA assesses the clinical evidence relevant to the PICOs defined in the assessment scope. The focus is on comparing the health technology under assessment with the relevant comparators.

The evidence requirement is therefore not determined solely by the regulatory development programme. The available studies and analyses need to answer the European assessment questions.

What role do randomised controlled trials play in JCA?

Randomised controlled trials are the preferred study design for estimating causal relative treatment effects.

The HTA Regulation gives preference to directly comparative clinical studies that are randomised, blinded and include a control group, where their methodology conforms to international standards of evidence-based medicine.

An RCT is nevertheless not automatically suitable for every JCA PICO. Its population, comparator and outcomes must correspond sufficiently to the relevant assessment question.

Can non-randomised studies be considered in JCA?

Non-randomised and observational studies can be considered where they provide evidence relevant to the JCA assessment question.

Their results may, however, be more susceptible to confounding and other sources of bias. These limitations need to be considered when the certainty of the evidence is described.

Uncontrolled single-arm studies have limited value for directly estimating relative effectiveness because they do not contain an internal comparator.

What role do indirect comparisons play in JCA?

Indirect comparisons may become necessary when direct comparative evidence is unavailable for a relevant JCA PICO.

The suitability of an indirect comparison depends on the available evidence network and the methodological approach. Where several European PICOs are plausible, HTDs can therefore assess before final scoping which potential comparators are covered by direct evidence and where additional evidence synthesis may be required.

What role can real-world data play in JCA?

Real-world data and real-world evidence are not excluded from JCA.

Their suitability depends on the research question, data quality, study design and analytical methods. Observational evidence does not automatically replace an appropriate direct comparison, but it can contribute to specific evidence questions.

The certainty of clinical study results in JCA is described through three key dimensions: internal validity, external validity and statistical precision.

These dimensions address different sources of uncertainty. Greater statistical precision, for example, cannot compensate for substantial systematic bias in a study.

How is internal validity assessed in JCA?

Internal validity describes the extent to which a clinical study result may be affected by systematic bias.

For randomised controlled trials, the JCA methodological guidance recommends structured risk-of-bias assessment. Comparative non-randomised studies and cohort studies require appropriate design-specific assessment tools.

Risk of bias can also differ between outcomes within the same study.

How is external validity assessed in JCA?

External validity describes how well the clinical evidence corresponds to the population, intervention, comparator and outcomes of the relevant JCA question.

A potential limitation can arise where the study population differs from the population specified in the PICO or where the study comparator does not adequately represent the requested comparator.

The JCA describes such limitations. The final judgement on applicability within a particular national healthcare system remains with the individual Member State.

How is statistical precision considered in JCA?

Effect estimates in JCA should be presented together with appropriate measures of statistical precision, generally confidence intervals.

Statistical significance alone does not determine the clinical added value of a health technology. The JCA describes the results and their uncertainty, while national authorities remain responsible for interpreting clinical relevance in their respective contexts.

JCA outcomes capture clinical results related to the effectiveness and safety of a health technology. They can include mortality, morbidity, symptoms, functioning, health-related quality of life and adverse events.

Outcome requirements are defined during scoping on the basis of Member State needs.

What is an outcome in JCA?

An outcome is a clinical concept used to estimate the effectiveness or safety of a health technology.

The outcome itself should be distinguished from the way it is measured. Mortality, for example, can be measured through overall survival or as the proportion of patients who have died at a specified time point.

Which patient-centred outcomes are relevant to JCA?

Patient-centred outcomes directly capture mortality, morbidity and effects on how patients feel or function.

The relevant outcomes depend on the disease and research question. Long-term or final patient-centred outcomes are generally preferred where feasible.

What role do patient-reported outcomes play in JCA?

Patient-reported outcomes (PROs) provide information about a patient's health status directly from the patient without interpretation by a clinician or another person.

PROs can assess symptoms, functioning and health-related quality of life. The measurement instruments used need sufficient validity, reliability and interpretability to support meaningful assessment.

How are surrogate outcomes considered in JCA?

Surrogate outcomes can be considered in JCA, but their ability to predict patient-centred outcomes needs to be described transparently.

The methodological guidance distinguishes different levels of evidence supporting surrogate validity. Particularly informative evidence demonstrates an association between treatment effects on the surrogate and treatment effects on the relevant patient-centred outcome.

Remaining uncertainty regarding surrogate validity should be described in the JCA report.

The assessor and co-assessor prepare the JCA report based on the assessment scope and the evidence submitted by the HTD. The report is reviewed within the JCA Subgroup and subsequently endorsed by the HTA Coordination Group.

What results are included in the JCA report?

The JCA report describes the relative clinical effects of the health technology and the certainty of the available evidence.

This includes numerical results, information on statistical uncertainty, and descriptions of the strengths and limitations of the evidence.

The report is intended to provide Member States with a common scientific basis for subsequent national processes.

What conclusions must the JCA report not contain?

The JCA report must not contain an overall conclusion on clinical added value, a ranking of health outcomes or a recommendation on the position of the health technology within a treatment strategy.

This is a central principle of the HTA Regulation. The European JCA describes and assesses the clinical evidence. National appraisal and subsequent decisions remain the responsibility of Member States.

What is the factual accuracy check in JCA?

The factual accuracy check allows the HTD to identify purely technical or factual inaccuracies in the revised draft report and to flag information considered commercially confidential.

It is not intended to reopen the scientific assessment. Comments outside the defined scope of a factual accuracy check do not have to be considered.

The JCA process contains several short and binding timelines coordinated with the EMA marketing authorisation procedure. Particularly important deadlines concern dossier submission, the completeness check, responses to requests for missing information and the factual accuracy check.

The exact timeline of an individual JCA should always be checked against the procedural documents applicable to that assessment.

After publication, the JCA report becomes part of the evidence considered in national HTA processes. Member States must give due consideration to the report but retain responsibility for their own conclusions and decisions.

Can Member States perform complementary clinical analyses after JCA?

Member States can perform complementary clinical analyses where these are necessary for their national HTA processes.

These analyses may concern populations, comparators or outcomes not sufficiently covered by the JCA report. Different national methodological requirements may also create a need for additional analyses.

Can additional national evidence be required after JCA?

National HTA processes may require information and evidence that were not part of the European JCA.

This can include newly available clinical evidence or country-specific information. Non-clinical HTA domains such as epidemiology, costs, healthcare context and economic evidence also largely remain national responsibilities.

Does JCA replace national HTA?

The Joint Clinical Assessment does not replace national HTA, pricing or reimbursement processes.

JCA reduces duplication in the joint assessment of clinical evidence. The conclusion on the value or clinical added value of a health technology within a specific healthcare system remains a national responsibility.

The main difference between EMA authorisation, JCA and national HTA is the decision question each process addresses. EMA assesses whether a medicinal product meets the requirements for marketing authorisation, JCA assesses comparative clinical evidence, and national HTA processes evaluate that evidence within the relevant healthcare system.

A successful EMA marketing authorisation therefore does not automatically answer the questions defined for JCA. Similarly, the JCA report does not predetermine a national conclusion on clinical added value or reimbursement.

JCA preparation begins before the final assessment scope because fundamental evidence gaps are difficult to resolve within the short submission window.

Potential populations, comparators, outcomes and indirect comparisons should therefore be considered from a European HTA perspective during clinical development.

Why should HTDs simulate potential JCA PICOs early?

Early PICO simulation can identify which potential European assessment questions are directly addressed by the clinical development programme and where evidence gaps may arise.

Differences between national treatment standards are particularly relevant. A comparator required by one Member State may not have been included in the pivotal clinical trial.

Early simulations can therefore identify where comparative effectiveness analyses, indirect comparisons or additional evidence sources may need to be prepared.

Why does JCA require cross-functional preparation?

JCA links the regulatory timeline with European HTA evidence requirements and therefore requires early coordination across Clinical, Regulatory, HEOR and Market Access.

The final indication influences the JCA population. The clinical development programme determines the available evidence. Scoping defines the European comparative questions. National HTA processes then require further interpretation and adaptation of that evidence.

Preparing these elements in isolation increases the risk that evidence is sufficient for regulatory purposes but does not adequately address an important HTA question.

The JCA process moves a substantial part of market access preparation to a much earlier stage of development. HTDs need to consider potential European PICOs, comparators, outcomes and evidence gaps before the formal dossier submission period begins.

Five questions are particularly relevant:

1. Which populations could be included in the European assessment scope?
2. Which comparators are likely to be relevant across key Member States?
3. Which potential PICOs are addressed by direct comparative evidence?
4. Where might indirect comparisons or additional analyses be required?
5. Which European results can subsequently support national HTA submissions, and where will additional national evidence still be needed?

HTDs should anticipate potential JCA PICOs early

The final number and definition of PICOs become known only after European scoping. HTDs can nevertheless assess early which clinical questions may arise from the expected indication and treatment standards across relevant Member States.

This preparation does not replace formal scoping. It provides additional time to prepare analyses that would be difficult to develop from scratch within the later submission window.

HTDs should plan direct and indirect evidence together

A clinical development programme may directly address one central comparator while other JCA PICOs include different comparators.

HTDs should therefore assess which evidence networks are available, which indirect comparison methods may be appropriate and whether the necessary study information can be obtained in time.

HTDs should prepare JCA and national HTA in parallel

The JCA creates a common European clinical evidence base but does not remove national evidence requirements.

For Germany, for example, the subsequent questions include which European PICO corresponds to the German benefit assessment, whether the JCA comparator aligns with the German appropriate comparator therapy and which additional analyses remain necessary for the AMNOG process.

Preparation should therefore not end with the JCA report. The next question is which parts of the European evidence can actually support the relevant national assessment.

The Joint Clinical Assessment creates a common European assessment of relative clinical evidence without replacing national HTA decisions. The assessment scope, its PICOs and the short dossier submission timeline make early evidence planning a central part of JCA preparation.

For HTDs, the critical work therefore begins before the JCA dossier itself. The clinical development programme needs to meet regulatory requirements while providing sufficiently robust evidence for potentially different European comparative questions.

After publication of the JCA report, another assessment begins at national level: which parts of the European evidence are applicable to the national decision question and which complementary analyses are still required? This interface between JCA and national HTA determines how far the common European evidence can ultimately be used across Member States.