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HTA dossier

G-BANSCLC

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_M1
    Module 1 — Summary
    required79%
  • AMNOG_M2
    Module 2 — MoA & approved indication
    required84%
  • AMNOG_M3
    Module 3 — ZVT, disease, prevalence, costs
    required82%
  • AMNOG_M4
    Module 4 — Medical benefit vs ZVT (patient-relevant endpoints)
    required49%
  • AMNOG_M5
    Module 5 — Full study reports (confidential)
    required97%

PICO questions (3)

  1. G-BA-PICO-01g-ba_zvt
    P: 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, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)
  2. G-BA-PICO-02g-ba_zvt
    P: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy
    I: Test drug, monotherapy, q3w until progression
    C: atezolizumab; platinum doublet chemotherapy
    O: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)
  3. G-BA-PICO-03g-ba_zvt
    P: 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, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)

Evidence requirements

Missing (9)

  • G-BA-002
    P0blocker
    Comparator therapy
    ZVT operationalisation per Verfahrensordnung §6
    type: CLINICAL_EXPERTclose: 1mo
  • G-BA-003
    P0blocker
    Mortality endpoints
    Overall survival data per ZVT comparator
    type: RCTclose: 14mo
  • G-BA-008
    P1major
    Quality of life
    MID (minimal important difference) justification per IQWiG
    type: PROclose: 3mo
  • G-BA-012
    P1major
    Adverse events
    Discontinuation due to AE (relative + absolute)
    type: RCTclose: 13mo
  • G-BA-014
    P1major
    Subpopulations
    Effect modification analysis (heterogeneity tests)
    type: RCTclose: 8mo
  • G-BA-020
    P2minor
    Therapeutic indication
    Wording aligned to EMA label and approved indication
    type: CLINICAL_EXPERTclose: 2mo
  • G-BA-023
    P1major
    Indirect comparisons
    NMA where direct ZVT comparison unavailable
    type: ITC_NMAclose: 4mo
  • G-BA-026
    P0blocker
    Pivotal study
    Full study report (CSR) appendix for each pivotal trial
    type: RCTclose: 10mo
  • G-BA-027
    P1major
    Pivotal study
    Risk-of-bias appraisal (Cochrane RoB 2)
    type: RCTclose: 9mo

In progress (6)

  • G-BA-001
    P0blocker
    Comparator therapy
    Evidence vs zweckmäßige Vergleichstherapie (ZVT) defined by G-BA
    type: RCTclose: 16mo
  • G-BA-007
    P1major
    Quality of life
    HRQoL data using validated instrument (EORTC QLQ-C30 or similar)
    type: PROclose: 3mo
  • G-BA-013
    P1major
    Subpopulations
    Analyses for each pre-defined G-BA subgroup
    type: RCTclose: 14mo
  • G-BA-015
    P2minor
    Patient numbers
    Eligible patient estimate for Germany
    type: RWEclose: 8mo
  • G-BA-018
    P2minor
    Cost data
    Additional therapy costs (concomitant + AE management)
    type: BIAclose: 2mo
  • G-BA-021
    P2minor
    Therapeutic indication
    Orphan / accelerated-approval status documentation
    type: CLINICAL_EXPERTclose: 2mo

Available (14)

  • G-BA-004
    P0none
    Mortality endpoints
    Time-to-event analysis with appropriate censoring
    type: RCT
  • G-BA-005
    P1none
    Morbidity endpoints
    Patient-relevant morbidity outcomes (validated)
    type: RCT
  • G-BA-006
    P1none
    Morbidity endpoints
    Symptom-relevant outcomes for indication
    type: RCT
  • G-BA-009
    P2none
    Quality of life
    Response-shift / floor-effect assessment
    type: PRO
  • G-BA-010
    P1none
    Adverse events
    AE profile with CTCAE grading by ZVT arm
    type: RCT
  • G-BA-011
    P1none
    Adverse events
    Time-to-AE / -SAE analysis
    type: RCT
  • G-BA-016
    P2none
    Patient numbers
    Annual incidence + prevalence (DESTATIS / RKI)
    type: RWE
  • G-BA-017
    P1none
    Cost data
    Annual treatment cost calculation per indication
    type: BIA
  • G-BA-019
    P2none
    Cost data
    Lauer-Taxe pricing reference
    type: BIA
  • G-BA-022
    P3none
    Comparator products
    List of comparator products with PZN codes
    type: CLINICAL_EXPERT
  • G-BA-024
    P1none
    Indirect comparisons
    ITC quality appraisal (NICE DSU TSD18) for sensitivity
    type: ITC_NMA
  • G-BA-025
    P1none
    Indirect comparisons
    Population-adjusted ITC (MAIC/STC) if cross-trial heterogeneity
    type: ITC_NMA
  • G-BA-028
    P1none
    Anwendungsbegleitende DE
    Anwendungsbegleitende Datenerhebung (AbD) plan if requested
    type: REGISTRY
  • G-BA-029
    P2none
    Versorgungsanteil
    Versorgungsanteil estimate (market share assumption)
    type: BIA

Related storyline events

  • 05-06 11:00
    NICE submission timeline locked. Module B due 6/15.
    Sara Lindqvist · slack
  • 05-13 17:00
    Updated: NICE STA Submission Plan — Veltarix
    Sara Lindqvist · gdocs
  • 05-15 09:00
    T-109 days to NICE STA submission for Veltarix (2026-09-01). 4 blocker gaps remain.
    Sara Lindqvist · slack