BEHIND THE JOINT CLINICAL ASSESSMENT (JCA) FIRST YEAR: TIMELINES, ASSESSOR INTERACTION, AND THE COMPLETENESS FAILURES
Author(s)
Asma Jouini, Bioengineer1, Aleksandra Caban, PharmD2, Malgorzata Wojtal, MSc2, Mondher Toumi, MSc, PhD, MD3.
1Clever Access, Paris, France, 2Clever Access, Kraków, Poland, 3Aix-Marseille University, Marseille, France.
1Clever Access, Paris, France, 2Clever Access, Kraków, Poland, 3Aix-Marseille University, Marseille, France.
OBJECTIVES: After submission, the JCA generates substantial, poorly documented assessor information requests, and two early assessments have already been discontinued. We summarize first year learnings on timelines and assessor interaction, and on the completeness failures that must be avoided.
METHODS: We combined two sources: operational experience supporting first year JCA submissions (correspondence, requests, timelines), informing timeline and interaction learnings; and analysis of two publicly discontinued JCAs and their completeness reviews (JCA-MP-2024-03; JCA-MP-2025-02), revealing the critical mistakes behind discontinuation.
RESULTS: From supporting submissions: the preparation window (~100 days) was generally met, but the phase after submission was longer and less predictable, dominated by sequential information requests under short windows counted in calendar days while work proceeds in working days; extensions were discretionary and heterogeneous by request type and assessment team (days to three to four weeks). Assessors were responding fast to questions from submitters on JCA requests (two to three working days), with meetings with assessors possible to request for major hurdles. From the discontinuations: both failed not on clinical data but on inadequately prepared dossiers that left assessors unable to verify conclusions. Recurring gaps were missing or unexplained PICOs; incomplete or opaque evidence identification; insufficiently justified methods, where "no comparison possible" no longer suffices and ITC feasibility must be documented, not merely asserted; incomplete or non-comparative results (missing relative effects, Kaplan Meier curves, uncertainty); weak reproducibility and underlying documentation (code, CSR/SAP, RoB); and no traceability from evidence source to conclusion.
CONCLUSIONS: The post-submission phase is as demanding as submission itself, and the assessment team can be engaged to navigate it, while the discontinuations show completeness, transparency, and reproducibility, not clinical quality, determine survival. Following JCA guidelines and templates and preparing early, with a readiness check confirming every conclusion is independently verifiable, is essential to avoid these critical gaps.
METHODS: We combined two sources: operational experience supporting first year JCA submissions (correspondence, requests, timelines), informing timeline and interaction learnings; and analysis of two publicly discontinued JCAs and their completeness reviews (JCA-MP-2024-03; JCA-MP-2025-02), revealing the critical mistakes behind discontinuation.
RESULTS: From supporting submissions: the preparation window (~100 days) was generally met, but the phase after submission was longer and less predictable, dominated by sequential information requests under short windows counted in calendar days while work proceeds in working days; extensions were discretionary and heterogeneous by request type and assessment team (days to three to four weeks). Assessors were responding fast to questions from submitters on JCA requests (two to three working days), with meetings with assessors possible to request for major hurdles. From the discontinuations: both failed not on clinical data but on inadequately prepared dossiers that left assessors unable to verify conclusions. Recurring gaps were missing or unexplained PICOs; incomplete or opaque evidence identification; insufficiently justified methods, where "no comparison possible" no longer suffices and ITC feasibility must be documented, not merely asserted; incomplete or non-comparative results (missing relative effects, Kaplan Meier curves, uncertainty); weak reproducibility and underlying documentation (code, CSR/SAP, RoB); and no traceability from evidence source to conclusion.
CONCLUSIONS: The post-submission phase is as demanding as submission itself, and the assessment team can be engaged to navigate it, while the discontinuations show completeness, transparency, and reproducibility, not clinical quality, determine survival. Following JCA guidelines and templates and preparing early, with a readiness check confirming every conclusion is independently verifiable, is essential to avoid these critical gaps.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA40
Topic
Health Policy & Regulatory, Health Technology Assessment, Medical Technologies
Disease
No Additional Disease & Conditions/Specialized Treatment Areas