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JCA Self‑Assessment

Are you JCA ready?

This form will help you to highlight the unique gaps and advice on the next steps to make sure you are ready for what comes next

Step 1/5

Leadership & portfolio

1.
Has an assessment been performed against your R&D portfolio to understand which products will fall in scope and when?
2.
Where products have multiple indications, has the sequence of JCA requirements been clearly outlined?
3.
Where products and indications will be subject to JCA, have estimated report timelines been mapped against other global processes?
4.
Do your Senior Leaders (Department Heads) understand the impact that EU-HTA will have on the ways of working for your team and those that you work with?
5.
Do you have an established Project Charter agreed with Senior Leaders, for the way that teams should interact in the planning, preparation and delivery of JCA?
6.
Do you have an identified lead within the organisation, who is responsible for  implementing the process for planning, preparation and delivery of JCA?
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Step 2/5

Project Management

7.
Do you have a clearly defined governance process for JCA?
8.
Is it clear who will review and agree to strategic decisions and when?
9.
Do you have a clearly defined process for escalating areas of disagreement?
10.
Is It clear which team budget for and conduct SLRs for the JCA process? (e.g. global, regional, local)
11.
Have you evaluated your pipeline assets to identify the optimal timing of a joint scientific consultation (JSC) for those that meet the criteria?
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Step 3/5

Team Structure and Alignment

12.
Have you agreed where the necessary budgets for JCA design, preparation and delivery will be planned and tracked?
13.
Have you identified where you have organisational gaps in the necessary expertise and is there a plan to recruit, upskill or partner with vendors?
14.
Have you identified where the necessary expertise for JCA design, preparation and delivery will be located and managed?
15.
Have you conducted an RFI to review potential vendors who can support your JCA preparedness?
16.
Has the anticipated workload associated with a JCA process been appropriately factored into your capacity planning and cross-functional team design?
17.
Have you designed working processes for delivering JCAs that will be able to work in parallel with your existing processes up to 2030?
18.
Have you agreed on how affiliate teams will provide input for and support the JCA process?
19.
Are affiliate teams clear on how the JCA process will run and do they understand the role they will play?
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Step 4/5

PICO

20.
Have you planned out the timings for the SLRs to align EU PICOs and ensure updates within prescribed window?
21.
Have you established ways of working, including how and when to run PICO prediction exercises relevant to individual EU member states through development?
22.
Have you created a cross-functional project team for PICO prediction within each relevant program team?
23.
Have you conducted a PICO prediction exercise for every phase 3 asset which is either an ATMP or Oncology Medicine?
24.
Have you conducted a PICO prediction exercise for every phase 2/3 asset in Rare Disease which will launch in 2028+?
25.
Do you have an established mechanism for engaging affiliate teams in PICO prediction?
26.
Do you have an agreed cadence for updating PICO predictions through development and policy environments change?
27.
Have you developed an internal process to evidence gap analysis based on PICO predictions?
28.
Have you developed a mechanism for sharing evidence gap analysis based on PICO prediction with the core project team?
29.
Have you developed internal processes for conducting indirect comparisons and evidence synthesis based on PICO prediction gap analysis?
30.
Is it clear where evidence gaps linked to PICO prediction should be budgeted and have contingencies been considered in program team planning?
31.
Have adequate resourcing been identified and provisionally held to address additional biostats needs as a result of PICO requirements?
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Step 5/5

Cross Functional Impact

32.
Have you shared the timings and project requirements cross-functionally to ensure that all contributing departments know what to expect?
33.
Have you agreed roles and responsibilities for each step in a JCA process across the different functions involved?
34.
Do you have a working group set up for JCA between Regulatory Leadership and Access Leadership?
35.
Do you have a regular forum set up to engage effectively with Regulatory Affairs at a strategic level through individual program development?
36.
Have you worked with your regulatory teams to review the requirements for JSC and to establish work teams to prepare and implement effectively?
37.
Have you worked with your R&D teams to explore the relative importance of EU input for pivotal trial design and to agree ways of working for inputting to global development plans?
38.
Do you have a dedicated section in the Global development plans which explores the Joint Consultation strategies for HTA around the globe?
39.
Do the relevant brand teams have a clear understanding of how the JCA process will affect brand strategy across Europe?
40.
Given that the JCA dossier will be made public at EMA approval and will include many sub analyses has the impact of this on publication planning been assessed?
41.
Given that the JCA dossier will be made public at EMA approval has the impact on regulatory filings and HTA beyond Europe been assessed and considered?
42.
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