Introduction
The EU Joint Clinical Assessment (JCA) was introduced to reduce duplication and establish a common clinical evidence base across Member States. As the first JCA reports are published, manufacturers still face uncertainty over how well this evidence aligns with national payer requirements. National health technology assessment (HTA) bodies continue to consider country-specific priorities, including the impact on healthcare budgets and how a treatment fits within existing clinical pathways. These questions may not be fully addressed by the JCA evidence, leaving gaps that could affect national pricing and reimbursement decisions.
Manufacturers therefore need to understand where their existing evidence package can support national access ambitions, where gaps remain and which are worth addressing. This article explores how early discussions with payers across markets can help identify and prioritise the evidence gaps most likely to affect pricing and reimbursement, while evidence generation and launch plans can still be shaped.
Local context shapes national value frameworks
To identify which evidence gaps matter most, manufacturers first need to understand the questions national payers are seeking to answer.
These questions are shaped by local treatment pathways, funding constraints and health policy priorities. How does the treatment compare with the local standard of care? Which patients should be reimbursed, and where would it fit within existing treatment pathways? What would its adoption mean for healthcare budgets and resource use?
As a result, the common JCA evidence package may leave gaps in areas such as locally relevant comparators, patient populations, outcomes and healthcare resource use. Understanding which gaps could materially affect pricing and reimbursement is essential to prioritising further evidence generation across markets.
National HTA differences create market-specific evidence needs
Member States are incorporating the JCA into their national assessment processes, but national evidence requirements continue to differ. As Table 1 illustrates, markets vary in how they assess clinical benefit, cost-effectiveness, budget impact and unmet need. For manufacturers, these differences highlight where the common JCA evidence package may leave national questions unanswered and help identify which market-specific evidence needs to explore through targeted payer research
| Assessment component | France | Germany | Spain | Italy | Netherlands | Sweden |
| Use of JCA clinical evidence | Considered [1] | Considered [1,3] | Incorporated [1,4] | Considered [1] | Considered [1] | Considered [1] |
| Distinctive national value assessment | SMR / ASMR [2] | Additional benefit [3] | Added clinical value [4] | Innovativeness assessment* [5] | Package criteria [7] | Severity and cost-effectiveness [8] |
| Cost-effectiveness assessment | Conditional [2] | Not routine [3] | Required when additional clinical value is claimed, subject to guidance [4] | Required for specified applications [6] | Conditional [7] | Core component [8] |
| Budget impact assessment | Conditional [2] | Treatment costs considered [3] | Required for medicines [4] | Required for specified applications [6] | Established component [7] | Considered in reimbursement decisions [8] |
| Perspective for economic evaluation | Healthcare perspective [2] | Not routinely applicable [3] | SNS perspective; broader aspects where relevant [4] | SSN perspective [6] | Societal perspective [7] | Limited societal perspective [8] |
| Unmet need / disease severity | Considered [2] | Considered [3] | Considered [4] | Considered [5] | Considered [7] | Central consideration [8] |
| Price negotiation | CEPS [2] | GKV-SV [3] | CIPM [4] | AIFA [6] | Minister / insurers [7] | TLV / regions [8] |
Which evidence gaps are worth closing?
Differences in national HTA requirements can leave manufacturers with several potential evidence gaps, yet not all will have equal impact on pricing and access outcomes. The challenge is to identify which gaps could materially affect national access outcomes and are therefore worth addressing.
The starting point is to define the access ambition in each market: a target price, time to access, and the breadth of reimbursement for a particular population. Before finalising these ambitions, global and regional teams should align with local affiliates to ensure they reflect national payer expectations and practical constraints.
Manufacturers can then use targeted payer discussions or advisory boards to understand what evidence national decision-makers would need to support their desired access position. Comparing these requirements with the current evidence package helps identify gaps that could affect the achievable price, reimbursed population or adoption in practice.
Testing alternative evidence scenarios with payers can help establish which gaps are most likely to influence access outcomes and whether generating additional evidence would justify the investment. Such priorities will differ across markets. One market archetype may focus on comparative efficacy; another on long-term survival model assumptions, while others may focus more on population comparability, quality of life, or resource use.
Understanding these differences helps manufacturers to prioritise evidence generation where it is likely to have the greatest impact on national access, while also identifying where their commercial ambitions may need to be reconsidered.
Explore the trade-offs before they become global launch constraints
Once the most important evidence gaps have been identified, manufacturers must decide which can realistically be addressed within development budgets and timelines. Additional evidence may support access in one market but offer limited value elsewhere, while evidence relevant across several markets may justify broader investment. These trade-offs need to be considered early to avoid creating additional costs, delays or constraints on global launch plans.
Importantly, the implications of JCA and subsequent national HTA assessments may extend beyond Europe. Emerging evidence suggests that US health plans may consider ex-US HTA assessments when informing their coverage policies [9], raising the possibility that restrictive or conditional European outcomes could influence access discussions in other markets.
Early discussions with payers across markets can help manufacturers identify which evidence gaps could materially affect national pricing and reimbursement, and where additional evidence is worth the investment. Using these insights to inform a coordinated global evidence strategy can help balance national payer needs with broader launch objectives, minimise duplication and reduce downstream access risks.
Does your JCA evidence strategy support your national access ambitions?
Remap Consulting supports pharmaceutical and biotechnology companies in navigating pricing and market access, from early pricing and evidence strategy through to HTA submissions and commercialisation. If you are looking to discuss how evolving JCA and national access requirements could affect your launch and pricing strategy,
Frequently asked questions:
Does the JCA replace national HTA and reimbursement assessments?
No. National authorities must consider the JCA report, but they remain responsible for pricing, reimbursement, economic evaluation and other country-specific decisions. Requirements may still differ by market, including the relevant comparator, target population, outcomes, budget impact, cost-effectiveness and the technology’s place in the local treatment pathway.
Can the same JCA evidence lead to different national access outcomes?
Each market applies the common clinical evidence within its own healthcare context. Differences in treatment pathways, comparators, unmet need, funding priorities, economic thresholds and implementation requirements can change how value is judged. As a result, one evidence package may support different prices, reimbursed populations, restrictions or evidence commitments across countries.
When should manufacturers plan for national evidence requirements?
Manufacturers should map national requirements while the JCA evidence package and launch strategy can still be influenced. Early planning helps identify likely differences in populations, comparators and outcomes, align clinical and HEOR evidence generation, and avoid discovering important national gaps only after the JCA report has been finalised.
How can manufacturers prioritise evidence gaps for national access?
Start with the desired access outcome in each priority market, such as a target price, reimbursed population or treatment-pathway position. Compare the evidence required to support that ambition with the available package, then prioritise gaps that could materially alter access. Cross-market payer research can help distinguish critical uncertainties from lower-impact gaps.
Bibliography:
- European Commission. Joint Clinical Assessment: factsheet [Internet]. Brussels: European Commission; 2026 [cited 2026 Oct 14]. Available from: https://health.ec.europa.eu/document/download/ced91156-ffe1-472d-85eb-aa6a91dd707e_it?filename=hta_htar_factsheet-jca_en.pdf
- Haute Autorité de Santé. L’évaluation par la HAS en vue du remboursement et de la fixation du prix [Internet]. Saint-Denis: HAS; 2019 [cited 2026 Oct 14]. Available from: https://www.has-sante.fr/upload/docs/application/pdf/2019-03/le_parcours_du_medicaments_en_france.pdf
- Gemeinsamer Bundesausschuss. Benefit assessment of medicinal products [Internet]. Berlin: G-BA; [cited 2026 Oct 14]. Available from: https://www.g-ba.de/english/benefitassessment/
- Ministerio de Sanidad. Real Decreto 415/2026, de 27 de mayo, por el que se regula la evaluación de tecnologías sanitarias. Boletín Oficial del Estado [Internet]. 2026 May 29 [cited 2026 Oct 14]. Available from: https://www.boe.es/eli/es/rd/2026/05/27/415
- Agenzia Italiana del Farmaco. Farmaci innovativi [Internet]. Rome: AIFA; [cited 2026 Oct 14]. Available from: https://www.aifa.gov.it/farmaci-innovativi
- Agenzia Italiana del Farmaco. Domanda di rimborsabilità e prezzo [Internet]. Rome: AIFA; [cited 2026 Oct 14]. Available from: https://www.aifa.gov.it/domanda-rimborsabilita-e-prezzo
- Zorginstituut Nederland. Guideline for economic evaluations in healthcare. 2024 version [Internet]. Diemen: Zorginstituut Nederland; 2024 Jan 16 [cited 2026 Oct 14]. Available from: https://english.zorginstituutnederland.nl/documents/2024/01/16/guideline-for-economic-evaluations-in-healthcare
- Tandvårds- och läkemedelsförmånsverket. Frågor och svar om riktlinjerna [Internet]. Stockholm: TLV; 2026 [cited 2026 Oct 14]. Available from: https://www.tlv.se/om-tlv/regelverk/allmanna-riktlinjer/fragor-och-svar-om-riktlinjerna.html
- Ramagopalan SV, Pannelay AJ. Access in all areas? A round up of developments in market access and health technology assessment: part 7. J Comp Eff Res. 2025 Jun;14(6):e250043. doi: 10.57264/cer-2025-0043. Epub 2025 Apr 14. PMID: 40223528; PMCID: PMC12142397.