FILLING AND MANAGING THE JOINT CLINICAL ASSESSMENT (JCA) SUBMISSION PACKAGE: STRUCTURAL, TEMPLATE, AND PLATFORM DIFFICULTIES FROM FIRST-YEAR EXPERIENCE
Author(s)
Asma Jouini, Bioengineer1, Mikolaj Parkitny, MSc2, Piotr Wojciechowski, MSc3, Aleksandra Caban, PharmD2, Elzbieta Olewinska, MSc3, Souha Zarai, BSc4, Mondher Toumi, MSc, PhD, MD5.
1Clever Access, Paris, France, 2Clever Access, Kraków, Poland, 3Clever-Access, Kraków, Poland, 4Clever Access, Tunis, Tunisia, 5Aix-Marseille University, Marseille, France.
1Clever Access, Paris, France, 2Clever Access, Kraków, Poland, 3Clever-Access, Kraków, Poland, 4Clever Access, Tunis, Tunisia, 5Aix-Marseille University, Marseille, France.
OBJECTIVES: The JCA introduced a new dossier template and submission platform. Drawing on first-year submissions, we identify difficulties in filling and managing the JCA package to inform template and platform improvements.
METHODS: We synthesised learnings from supporting first-year health technology developer (HTD) submissions, the JCA dossier template, the table-template collection, the filled-in examples, and the guidance documents. Difficulties during preparation, upload, and file exchange were catalogued into themes.
RESULTS: Three themes emerged. (1) Structural fragmentation: the dossier is organised by content type rather than by PICO, so evidence for one comparison is dispersed across the main dossier and at least eight appendices, safety across three documents, efficacy across three, methods across a chapter and four appendices, preventing continuous PICO-by-PICO reading. (2) Template gaps and inconsistencies: no output template exists for population-level network meta-analysis and unanchored comparisons via MAIC/STC; for adverse events by SOC/PT, the guidance, note, and templates give three conflicting category sets (omitting required "severe", supplying non-required "discontinuation"), and the only SOC/PT templates assume a head-to-head study, with no per-study or indirect format despite indirect templates for aggregate outcomes; no risk-of-bias template is provided, forcing HTDs to build one; and no subgroup-feasibility template exists to document data availability per factor level, outcome and study, generating repeated assessor questions. (3) Package management and platform barriers: the 100-day window forced parallel multi-team editing of oversized shared files; the mandatory tracked-plus-clean resubmission exceeded platform upload limits, requiring package splitting; and the prescribed file-naming convention produced names too long for assessors to extract.
CONCLUSIONS: Difficulties arose from dossier structure, template design, and platform capacity. PICO-centric structuring, output templates for evidence synthesis and subgroup feasibility results, reconciliation of conflicting adverse event requirements, and platform capacity tested against real package sizes and path-length limits would reduce burden and risk for both HTDs and assessors.
METHODS: We synthesised learnings from supporting first-year health technology developer (HTD) submissions, the JCA dossier template, the table-template collection, the filled-in examples, and the guidance documents. Difficulties during preparation, upload, and file exchange were catalogued into themes.
RESULTS: Three themes emerged. (1) Structural fragmentation: the dossier is organised by content type rather than by PICO, so evidence for one comparison is dispersed across the main dossier and at least eight appendices, safety across three documents, efficacy across three, methods across a chapter and four appendices, preventing continuous PICO-by-PICO reading. (2) Template gaps and inconsistencies: no output template exists for population-level network meta-analysis and unanchored comparisons via MAIC/STC; for adverse events by SOC/PT, the guidance, note, and templates give three conflicting category sets (omitting required "severe", supplying non-required "discontinuation"), and the only SOC/PT templates assume a head-to-head study, with no per-study or indirect format despite indirect templates for aggregate outcomes; no risk-of-bias template is provided, forcing HTDs to build one; and no subgroup-feasibility template exists to document data availability per factor level, outcome and study, generating repeated assessor questions. (3) Package management and platform barriers: the 100-day window forced parallel multi-team editing of oversized shared files; the mandatory tracked-plus-clean resubmission exceeded platform upload limits, requiring package splitting; and the prescribed file-naming convention produced names too long for assessors to extract.
CONCLUSIONS: Difficulties arose from dossier structure, template design, and platform capacity. PICO-centric structuring, output templates for evidence synthesis and subgroup feasibility results, reconciliation of conflicting adverse event requirements, and platform capacity tested against real package sizes and path-length limits would reduce burden and risk for both HTDs and assessors.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA122
Topic
Health Technology Assessment, Medical Technologies, Organizational Practices
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas