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European Commission
Public health
Joint Clinical Assessment — Veltarix
Regulation (EU) 2021/2282From 12 January 2025 — oncology & ATMPsJCA-2026-NSCLC-014
Joint Clinical Assessments are coordinated at EU level for new medicines and certain medical devices. For Veltarix in advanced NSCLC, the Health Technology Coordination Group (HTACG) has consolidated 7 PICO questions from EU member states during the scoping phase.
JCA process
- Scoping (130 days) — member states submit PICOs; HTACG consolidates the scope. ✓ Complete
- Health Technology Developer submission (100 days) — company submits dossier per the consolidated PICOs. In progress · 93 days remaining
- Assessment (~200 days) — JCA assessors produce the clinical assessment report.
- JCA report published — national HTA bodies (G-BA, HAS, NICE, others) must give "due consideration" but continue national appraisals.
PICO scope (7 questions, from member states)
JCA-PICO-01jca_scope:FRP: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy...
I: Test drug, monotherapy, q3w until progression
C: pembrolizumab monotherapy; platinum doublet chemotherapy; atezolizumab
O: overall survival, PFS, ORR…
JCA-PICO-02jca_scope:PLP: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy...
I: Test drug, monotherapy, q3w until progression
C: platinum doublet chemotherapy; atezolizumab
O: overall survival, PFS, ORR…
JCA-PICO-03jca_scope:DKP: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy...
I: Test drug, monotherapy, q3w until progression
C: platinum doublet chemotherapy; atezolizumab; pembrolizumab monotherapy
O: overall survival, PFS, ORR…
JCA-PICO-04jca_scope:PTP: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy...
I: Test drug, monotherapy, q3w until progression
C: atezolizumab; pembrolizumab monotherapy
O: overall survival, PFS, ORR…
JCA-PICO-05jca_scope:PLP: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy...
I: Test drug, monotherapy, q3w until progression
C: atezolizumab; platinum doublet chemotherapy; pembrolizumab monotherapy
O: overall survival, PFS, ORR…
JCA-PICO-06jca_scope:PTP: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy...
I: Test drug, monotherapy, q3w until progression
C: pembrolizumab monotherapy; platinum doublet chemotherapy
O: overall survival, PFS, ORR…
JCA-PICO-07jca_scope:ITP: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy...
I: Test drug, monotherapy, q3w until progression
C: platinum doublet chemotherapy; pembrolizumab monotherapy; atezolizumab
O: overall survival, PFS, ORR…
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