THE ACCELERATED CLOCK: IS LESS TIME FAIR WHEN THE WORK IS THE SAME?
Author(s)
Asma Jouini, Biology engineer1, Malgorzata Wojtal, MSc2, Lylia Chachoua, PharmD, PhD1, Mondher Toumi, MSc, PhD, MD3.
1Clever Access, Paris, France, 2Analyst, Clever Access, Kraków, Poland, 3Aix-Marseille University, Marseille, France.
1Clever Access, Paris, France, 2Analyst, Clever Access, Kraków, Poland, 3Aix-Marseille University, Marseille, France.
OBJECTIVES: Some Joint Clinical Assessments must be prepared in roughly 60 days rather than 100, depending on the medicine's regulatory track. This study examined whether that shorter window is justified by the assessment work involved, and what running the JCA in parallel with regulatory review implies for developers.
METHODS: A procedural and comparative analysis used Regulation (EU) 2021/2282, Commission Implementing Regulation (EU) 2024/1381 (the differential dossier-preparation windows), and European Medicines Agency procedures, including accelerated assessment and indication-extension pathways. The analytical workload of the JCA was compared across standard and accelerated triggers.
RESULTS: The analysis found that the shorter window is pegged to a regulatory-side characteristic — an accelerated marketing-authorisation or variation pathway — that does not reduce the JCA's own workload. The relative-effectiveness task (PICO scope, comparators, indirect comparisons, subgroup and statistical work) is essentially identical regardless of the regulatory track. As a result, two developers submitting comparable dossiers for comparable products can receive materially different preparation periods for reasons unrelated to the assessment itself. The parallel-track design compounds this: scoping begins while the product's regulatory characterisation — including its likely indication — has not yet stabilised, so the dossier is built on a moving foundation. The framework also lacks a stop-the-clock mechanism of the kind available in regulatory review.
CONCLUSIONS: Equal work deserves equal time. Calibrating the preparation window to the JCA's actual workload — and adding a stop-the-clock for unstable scope — would remove an avoidable fairness gap without delaying access.
METHODS: A procedural and comparative analysis used Regulation (EU) 2021/2282, Commission Implementing Regulation (EU) 2024/1381 (the differential dossier-preparation windows), and European Medicines Agency procedures, including accelerated assessment and indication-extension pathways. The analytical workload of the JCA was compared across standard and accelerated triggers.
RESULTS: The analysis found that the shorter window is pegged to a regulatory-side characteristic — an accelerated marketing-authorisation or variation pathway — that does not reduce the JCA's own workload. The relative-effectiveness task (PICO scope, comparators, indirect comparisons, subgroup and statistical work) is essentially identical regardless of the regulatory track. As a result, two developers submitting comparable dossiers for comparable products can receive materially different preparation periods for reasons unrelated to the assessment itself. The parallel-track design compounds this: scoping begins while the product's regulatory characterisation — including its likely indication — has not yet stabilised, so the dossier is built on a moving foundation. The framework also lacks a stop-the-clock mechanism of the kind available in regulatory review.
CONCLUSIONS: Equal work deserves equal time. Calibrating the preparation window to the JCA's actual workload — and adding a stop-the-clock for unstable scope — would remove an avoidable fairness gap without delaying access.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA398
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment
Topic Subcategory
Systems & Structure, Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas