Evidence Dossier Index — Global Master (Veltarix / Zenvara)
Maintained by Global Value & Access. Updated on every evidence asset change. Distribution: HTA leads (UK, DACH, France, Canada, EU JCA), HEOR Director, Clinical Development, Regulatory Affairs.
Overview
The master index catalogs all evidence assets developed for Veltarix (Zenvara) global HTA and reimbursement submissions. Current count: 47 distinct evidence assets across clinical, economic, patient-reported outcome, real-world evidence, and budget impact categories. The index maps each asset to the HTA body submission requirement(s) it supports, the current asset status, and the responsible team.
Counts by HTA body
NICE (UK): 12 evidence assets required, 10 complete, 2 in progress. Submission deadline 2026-09-01.
G-BA (Germany): 11 evidence assets required (per AMNOG Module 1-5 structure), 8 complete, 3 in progress. Submission required at launch.
HAS (France): 9 evidence assets required, 7 complete, 2 in progress. Submission to Commission de la Transparence in Q1 2027.
CADTH/CDA-AMC (Canada): 8 evidence assets required, 6 complete, 2 in progress. Pre-submission Information Requirements Form due 120 days before complete submission.
EU JCA (Joint Clinical Assessment): 7 evidence assets required, 3 complete, 4 in progress. JCA scoping in progress; 9 member states have submitted PICOs so far.
Clinical evidence assets (12 total)
CL-001 ZENITH-1 Phase 3 primary publication (NEJM, March 2025). Status: published. Supports NICE Module B, G-BA Module 4, HAS clinical, CADTH clinical, JCA clinical.
CL-002 ZENITH-1 long-term follow-up data (24-month update, ESMO 2025). Status: published. Same uses as CL-001.
CL-003 ZENITH-1 4-year OS update (manuscript in preparation, target submission ASCO 2026 abstract). Status: complete, abstract under embargo until June 2.
CL-004 ZENITH-1 subgroup analysis — PD-L1 TPS 50-79% vs 80%+. Status: complete. Supports NICE subgroup gap (gap 3 in NICE plan).
CL-005 ZENITH-1 subgroup analysis — age, sex, race, ECOG performance status. Status: complete.
CL-006 ZENITH-1 safety extension data — 48 months. Status: complete.
CL-007 ITC vs platinum doublet (NMA report v3). Status: complete. Supports NICE comparator gap (gap 2 in NICE plan).
CL-008 ITC vs atezolizumab (NMA report v2). Status: complete. Used in JCA submission.
CL-009 ITC vs cemiplimab (NMA report v2). Status: complete. Used in JCA submission.
CL-010 Real-world effectiveness — ZEN-RWD registry interim analysis. Status: in progress, target Q3 2026. Critical for closing NICE gap 1 (long-term durability) and G-BA evidence requirement on real-world data.
CL-011 Cross-trial outcomes synthesis (Veltarix vs all comparators, Bucher and Bayesian NMA). Status: complete.
CL-012 Indication expansion preparation — IMpact-2 (2L NSCLC, PD-L1 1-49%). Status: enrolling. Readout targeted Q4 2026.
Economic evidence assets (11 total)
EC-001 Cost-effectiveness model v6 (master). Partitioned-survival model with 4 states (PF, PD, AE, dead). Status: complete. Supports NICE Module C, G-BA Module 3, HAS, CADTH.
EC-002 UK-specific cost-effectiveness model (NHS perspective, PSSRU 2025 unit costs). Status: complete.
EC-003 Germany-specific cost-effectiveness model (GKV perspective, EBM 2025 unit costs). Status: complete.
EC-004 France-specific cost-effectiveness model (Assurance Maladie perspective, ATIH 2025 unit costs). Status: in progress.
EC-005 Canada-specific cost-effectiveness model (provincial drug plan perspective). Status: in progress.
EC-006 5-year budget impact analysis — UK NHS England. Status: complete.
EC-007 5-year budget impact analysis — Germany. Status: complete.
EC-008 5-year budget impact analysis — France. Status: in progress.
EC-009 5-year budget impact analysis — Canada (national + provincial). Status: complete.
EC-010 US Cost-effectiveness modeling for AMCP dossier. Status: complete.
EC-011 US Budget impact modeling for AMCP dossier (BIM v4). Status: complete.
Patient-reported outcomes (7 total)
PRO-001 ZENITH-1 EQ-5D-5L data — pivotal trial. Status: complete.
PRO-002 ZENITH-1 EORTC QLQ-C30 data — pivotal trial. Status: complete.
PRO-003 ZENITH-1 EORTC QLQ-LC13 data (NSCLC-specific) — pivotal trial. Status: complete.
PRO-004 ZENITH-1 Functional Assessment of Cancer Therapy-Lung (FACT-L) data. Status: complete.
PRO-005 Real-world PRO data from ZEN-RWD registry. Status: in progress.
PRO-006 Utility valuation set — UK general population. Status: complete.
PRO-007 Patient organization submissions (NICE). Status: pending, due 2026-08-15.
Real-world evidence (5 total)
RWE-001 ZEN-RWD registry baseline analysis. Status: complete.
RWE-002 ZEN-RWD registry interim analysis (real-world OS, PFS, treatment patterns). Status: in progress.
RWE-003 Optum claims cohort analysis (n=12,400) — published JMCP March 2026.
RWE-004 Flatiron/IBM MarketScan cohort analysis (Phase 1, n=4,800). Status: complete.
RWE-005 European RWE — Italian SIO registry, French AMIROS network, German DGHO registry. Status: in progress.
Safety and pharmacovigilance (5 total)
PV-001 Risk Management Plan (EMA-format). Status: complete.
PV-002 Periodic Safety Update Report — first PBRER (post-marketing). Status: in preparation.
PV-003 Phase 4 PMR safety surveillance protocol. Status: complete.
PV-004 Drug-drug interaction studies summary. Status: complete.
PV-005 Special populations safety data (renal, hepatic, geriatric). Status: complete.
Other supporting assets (7 total)
OTH-001 Patient advocacy engagement materials. Status: complete.
OTH-002 Clinician advisory board synthesis (KOL views). Status: complete.
OTH-003 Health-economic systematic literature review (UK perspective). Status: complete.
OTH-004 NICE scoping document (final scope). Status: complete.
OTH-005 G-BA Module 3 disease description and prevalence estimates. Status: complete.
OTH-006 HAS therapeutic strategy positioning. Status: in progress.
OTH-007 CADTH patient input templates. Status: in progress.
Version control
Master model is held in the global value & access SharePoint at /Veltarix/Evidence/v6/. Each model version (EC-001 through EC-005) is versioned by date and lead analyst initials. Major version increments (v6 → v7) require sign-off from HEOR Director.
Submission packages are assembled per body in /Veltarix/Submissions/<body>/ at submission time. Each submission package includes the dossier, the supporting evidence assets, the model files, and the responses to body-specific questions.
Cross-references
NICE STA Submission Plan (1H3…), HTA Evidence Gap Report Q2 2026 (1J4…), 2024 G-BA Dossier Lessons Learned (1K7…), HEOR cost-effectiveness model v6.