Given the overlap in Joint Clinical Assessment (JCA) and national-level HTA timelines, manufacturers face increasing pressure to coordinate and plan early for HTA activities across multiple markets. Manufacturers need a clear governance framework that defines who provides input and how unresolved risks are escalated to support both the JCA process and national HTA submissions. Under the European Union HTA Regulation, the JCA is discontinued if a dossier is submitted late or fails to meet specified requirements1. Poor governance can also cause delays that affect the case for national pricing and reimbursement.
It is essential that global, regional, and affiliate teams can share responsibilities and efficiently integrate inputs, such as country-specific requirements and evidence analyses, into an integrated evidence generation plan (IEGP) aimed at facilitating cross-functional and cross-market communication and alignment.
This article will explore the following challenges:
- How can manufacturers optimise internal governance frameworks to prepare for the JCA and national-level HTAs?
- How can insights and learnings from affiliate market access teams be efficiently incorporated into the global IEGP?
How governance frameworks clarify roles and responsibilities across teams
Clarifying responsibilities across global, regional, and affiliate teams is essential for allocating internal resources effectively and avoiding delays or inefficiencies in JCA and national HTA preparation. A governance framework can help clarify ownership of defined tasks and set clear expectations for how teams should contribute to evidence-generation activities (see Table 1).
Over the past two years, we have seen manufacturers undergoing restructuring in response to the introduction of the JCA, including the creation of internal task forces to support JCA preparations2. These findings illustrate that cross-functional planning has become critical and that coordination of roles and responsibilities across workstreams has become a key success driver.
Table 1: Illustrative division of responsibilities across global, regional, and affiliate teams
| Team | Roles and responsibilities |
|---|---|
| Global | Own the IEGP and decisions on development studies and analyses, informed by regional and affiliate input |
| Regional | Coordinate the JCA workstream, consolidate affiliate input and identify overlapping priorities between JCA and national HTA activities |
| Affiliate | Share early payer insights with regional and global; identify and validate country treatment pathways, relevant comparators, populations and outcomes; and plan the national HTA activities required alongside the JC |
How governance frameworks ensure affiliate insights are captured
Integrating country-specific requirements (e.g., at national and regional levels) into the IEGP can facilitate a smooth transition from the JCA to national HTAs. Manufacturers should therefore identify which activities support the shared clinical assessment and which address additional national needs, such as economic evaluation1.
A standardised process for collating local requirements can ensure a consistent approach to sharing evidence needs (e.g., population, intervention, comparator and outcomes (PICO) requirements) and to identifying country differences (e.g., nuances in treatment pathways). This can be defined within a governance framework by mandating the use of a common template for example. Thereby improving internal efficiency and leading to more targeted discussions on the availability of evidence, the feasibility of additional analyses, and the resource implications, supporting both JCA and national HTA submissions.
How governance frameworks support trade-offs
Importantly, manufacturers should establish escalation processes for decisions that could jeopardise a critical milestone, allowing related risks to be assessed against feasibility, budget, and timelines. For example, if an affiliate identifies a locally relevant comparator not included in the pivotal trial, the issue should be escalated so that teams can properly assess the comparative evidence before agreeing on a course of action (e.g., an indirect treatment comparison). Governance frameworks can support these processes by establishing measures to manage such trade-offs and inform decision-making. This may involve a named decision-maker documenting the decision and organising a meeting or providing feedback to the affiliate. Thereby helping to prevent unresolved evidence gaps and ensure the completion of critical milestones.
In conclusion, governance frameworks can help teams coordinate and establish clear processes to support both JCA and national HTA submissions. Traditional siloed approaches are no longer effective. Through effective governance, manufacturers can clarify ownership of workstreams, standardise how evidence requirements are captured, and establish an escalation process for trade-offs. This can lead to greater alignment across teams and prevent key priorities from being omitted from IEGP.
Remap Consulting helps manufacturers prepare for JCA and national HTA activities, including the development of governance frameworks. For more information, please contact us here.
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Bibliography
- European Union. Regulation (EU) 2021/2282 of the European parliament and of the council. Accessed 09/11/2026, Regulation – 2021/2282 – EN – EUR-Lex
- Wang T, McAuslane N. Ensuring the Efficiency and Effectiveness of Joint Clinical Assessment in National HTA Decision-Making: Insights from the 2024 CIRS Multi-Stakeholder Workshop. J Mark Access Health Policy. 2025 Mar 3;13(1):9