HTA dossier
G-BA — NSCLC
Germany · currency EUR
AMNOG §35a SGB V benefit assessment. Six-month resolution after launch. ZVT comparator prescribed by G-BA — wrong comparator = dossier failure.
Submission
2026-09-01
in 93d
Total requirements
29
across all modules
Met
14
48% complete
Gaps
15
in progress + missing
Blocker gaps
4
P0, filing-blocking
Decision state
Status
minor
Body-specific enum: major / considerable / minor / non_quantifiable / none / less
Dossier modules
AMNOG_M1Module 1 — Summaryrequired79%AMNOG_M2Module 2 — MoA & approved indicationrequired84%AMNOG_M3Module 3 — ZVT, disease, prevalence, costsrequired82%AMNOG_M4Module 4 — Medical benefit vs ZVT (patient-relevant endpoints)required49%AMNOG_M5Module 5 — Full study reports (confidential)required97%
PICO questions (3)
G-BA-PICO-01g-ba_zvtP: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapyI: Test drug, monotherapy, q3w until progressionC: pembrolizumab monotherapy; platinum doublet chemotherapy; atezolizumabO: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)G-BA-PICO-02g-ba_zvtP: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapyI: Test drug, monotherapy, q3w until progressionC: atezolizumab; platinum doublet chemotherapyO: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)G-BA-PICO-03g-ba_zvtP: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapyI: Test drug, monotherapy, q3w until progressionC: pembrolizumab monotherapy; platinum doublet chemotherapy; atezolizumabO: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)
Evidence requirements
Missing (9)
- G-BA-002P0blockerComparator therapyZVT operationalisation per Verfahrensordnung §6type: CLINICAL_EXPERTclose: 1mo
- G-BA-003P0blockerMortality endpointsOverall survival data per ZVT comparatortype: RCTclose: 14mo
- G-BA-008P1majorQuality of lifeMID (minimal important difference) justification per IQWiGtype: PROclose: 3mo
- G-BA-012P1majorAdverse eventsDiscontinuation due to AE (relative + absolute)type: RCTclose: 13mo
- G-BA-014P1majorSubpopulationsEffect modification analysis (heterogeneity tests)type: RCTclose: 8mo
- G-BA-020P2minorTherapeutic indicationWording aligned to EMA label and approved indicationtype: CLINICAL_EXPERTclose: 2mo
- G-BA-023P1majorIndirect comparisonsNMA where direct ZVT comparison unavailabletype: ITC_NMAclose: 4mo
- G-BA-026P0blockerPivotal studyFull study report (CSR) appendix for each pivotal trialtype: RCTclose: 10mo
- G-BA-027P1majorPivotal studyRisk-of-bias appraisal (Cochrane RoB 2)type: RCTclose: 9mo
In progress (6)
- G-BA-001P0blockerComparator therapyEvidence vs zweckmäßige Vergleichstherapie (ZVT) defined by G-BAtype: RCTclose: 16mo
- G-BA-007P1majorQuality of lifeHRQoL data using validated instrument (EORTC QLQ-C30 or similar)type: PROclose: 3mo
- G-BA-013P1majorSubpopulationsAnalyses for each pre-defined G-BA subgrouptype: RCTclose: 14mo
- G-BA-015P2minorPatient numbersEligible patient estimate for Germanytype: RWEclose: 8mo
- G-BA-018P2minorCost dataAdditional therapy costs (concomitant + AE management)type: BIAclose: 2mo
- G-BA-021P2minorTherapeutic indicationOrphan / accelerated-approval status documentationtype: CLINICAL_EXPERTclose: 2mo
Available (14)
- G-BA-004P0noneMortality endpointsTime-to-event analysis with appropriate censoringtype: RCT
- G-BA-005P1noneMorbidity endpointsPatient-relevant morbidity outcomes (validated)type: RCT
- G-BA-006P1noneMorbidity endpointsSymptom-relevant outcomes for indicationtype: RCT
- G-BA-009P2noneQuality of lifeResponse-shift / floor-effect assessmenttype: PRO
- G-BA-010P1noneAdverse eventsAE profile with CTCAE grading by ZVT armtype: RCT
- G-BA-011P1noneAdverse eventsTime-to-AE / -SAE analysistype: RCT
- G-BA-016P2nonePatient numbersAnnual incidence + prevalence (DESTATIS / RKI)type: RWE
- G-BA-017P1noneCost dataAnnual treatment cost calculation per indicationtype: BIA
- G-BA-019P2noneCost dataLauer-Taxe pricing referencetype: BIA
- G-BA-022P3noneComparator productsList of comparator products with PZN codestype: CLINICAL_EXPERT
- G-BA-024P1noneIndirect comparisonsITC quality appraisal (NICE DSU TSD18) for sensitivitytype: ITC_NMA
- G-BA-025P1noneIndirect comparisonsPopulation-adjusted ITC (MAIC/STC) if cross-trial heterogeneitytype: ITC_NMA
- G-BA-028P1noneAnwendungsbegleitende DEAnwendungsbegleitende Datenerhebung (AbD) plan if requestedtype: REGISTRY
- G-BA-029P2noneVersorgungsanteilVersorgungsanteil estimate (market share assumption)type: BIA
Related storyline events
- 05-06 11:00NICE submission timeline locked. Module B due 6/15.Sara Lindqvist · slack
- 05-13 17:00Updated: NICE STA Submission Plan — VeltarixSara Lindqvist · gdocs
- 05-15 09:00T-109 days to NICE STA submission for Veltarix (2026-09-01). 4 blocker gaps remain.Sara Lindqvist · slack