JCA REALITY CHECK: DIVERGING PAYER READINESS FOR MEDICINES VS. MEDICAL DEVICES IN THE EU

Author(s)

Dimitrios Tzaras, MSc1, Richard Macaulay, BA, PhD2.
1Senior Engagement Manager, Precision AQ, London, United Kingdom, 2Precision AQ, London, United Kingdom.
OBJECTIVES: Joint Clinical Assessments (JCAs) were introduced in the EU to support more consistent clinical evaluation across Member States. While JCAs for oncology medicines and ATMPs have been in place since early 2025, their extension to high-risk medical devices is still at an early stage and has received limited attention. This study explores payer perspectives across key EU markets, focusing on awareness, expected impact on reimbursement, and anticipated challenges for device JCAs compared with medicines.
METHODS: Payer experts in Germany, France, Italy, and Spain (N=1 per market) completed an online survey in June 2026 covering their views on JCAs for both medicines and medical devices. Responses were collated and reviewed qualitatively.
RESULTS: Awareness is higher for JCAs in medicines than for medical devices, with 75% versus 50% of respondents reporting high awareness. A similar pattern is seen for preparedness (50% vs. 25% “well prepared”). JCAs for medicines are also seen as more influential in decision-making, with 75% rating them as decisive or highly influential compared with 50% for devices. Across both areas, uncertainty around how JCA outputs will be integrated into national processes is a key concern. However, views diverge on evidence applicability: this is a leading issue for devices, but less prominent for medicines.
CONCLUSIONS: JCAs for medicines are starting to feed into national decision-making, but those for medical devices remain at an earlier stage. Lower awareness, limited preparedness, and greater uncertainty point to a clear gap in implementation. Concerns around how well EU-level evidence applies to national settings are particularly acute for devices. Greater clarity on methods, closer alignment with national requirements, and more active engagement with stakeholders will be important to support consistent uptake across both areas.

Conference/Value in Health Info

2026-11, ISPOR Europe 2026, Vienna, Austria

Value in Health, Volume 29, Issue 12S

Code

HTA236

Topic

Health Policy & Regulatory, Health Technology Assessment, Medical Technologies

Topic Subcategory

Systems & Structure

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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