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HTA dossier

HAS — NSCLC

France · currency EUR

Commission de la Transparence dossier. Dual ratings: SMR (yes/no + reimbursement level) and ASMR I-V (price negotiation).

Submission
2026-09-01
in 93d
Total requirements
27
across all modules
Met
17
63% complete
Gaps
10
in progress + missing
Blocker gaps
4
P0, filing-blocking

Decision state

SMR
pending
Service Médical Rendu — drives reimbursement level (15/30/65/100%)
ASMR
I
Amélioration du SMR (I major → V none) — drives CEPS price

Dossier modules

  • HAS_CT
    Commission de la Transparence dossier
    required53%
  • HAS_SMR
    Service Médical Rendu evidence package
    required74%
  • HAS_ASMR
    ASMR (improvement) rating justification
    required79%
  • HAS_CEESP
    CEESP medico-economic dossier (ASMR I-III, revenue >€20M)
    45%
  • HAS_CEPS
    CEPS pricing submission (post-CT)
    required98%

PICO question (1)

  1. HAS-PICO-01company
    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 (4)

  • HAS-004
    P0blocker
    ASMR evidence
    ASMR rating I-V justification vs French SoC
    type: RCTclose: 9mo
  • HAS-007
    P0blocker
    Comparator
    Head-to-head data vs French standard of care
    type: RCTclose: 12mo
  • HAS-014
    P1major
    Place in therapy
    Position statement vs existing therapeutic strategies
    type: CLINICAL_EXPERTclose: 2mo
  • HAS-025
    P1major
    Quality of life
    PRO data with French translation / cultural validation
    type: PROclose: 6mo

In progress (6)

  • HAS-001
    P0blocker
    SMR evidence
    Service Médical Rendu evidence package (clinical benefit + therapeutic strategy)
    type: RCTclose: 10mo
  • HAS-006
    P1major
    ASMR evidence
    Evidence quality grading (high/moderate/low/very low)
    type: SLRclose: 2mo
  • HAS-013
    P1major
    Medico-economic
    Efficiency frontier + ICER analysis
    type: ECON_MODELclose: 4mo
  • HAS-022
    P2minor
    CEPS pricing
    MEA (managed-entry agreement) terms if proposed
    type: BIAclose: 2mo
  • HAS-026
    P1major
    Safety
    Adverse events vs SoC (relative + absolute)
    type: RCTclose: 18mo
  • HAS-027
    P0blocker
    Administrative
    AMM (Autorisation de Mise sur le Marché) reference + supporting docs
    type: CLINICAL_EXPERTclose: 2mo

Available (17)

  • HAS-002
    P1none
    SMR evidence
    Disease severity + public-health interest justification
    type: RWE
  • HAS-003
    P1none
    SMR evidence
    Place dans la stratégie thérapeutique narrative
    type: CLINICAL_EXPERT
  • HAS-005
    P1none
    ASMR evidence
    Magnitude of benefit per CT methodology
    type: RCT
  • HAS-008
    P0none
    Comparator
    Comparator selection rationale (CT scoping)
    type: CLINICAL_EXPERT
  • HAS-009
    P1none
    Target population
    Population cible estimate for France
    type: RWE
  • HAS-010
    P1none
    Target population
    Annual incidence + prevalence per HAS scope
    type: RWE
  • HAS-011
    P1none
    Medico-economic
    Cost-effectiveness analysis (required for ASMR I-III)
    type: ECON_MODEL
  • HAS-012
    P1none
    Medico-economic
    CEESP dossier if revenue > €20M / year
    type: ECON_MODEL
  • HAS-015
    P2none
    Place in therapy
    Practitioner usability assessment
    type: CLINICAL_EXPERT
  • HAS-016
    P2none
    Post-inscription study
    Post-inscription study commitment if requested by HAS
    type: RWE
  • HAS-017
    P2none
    Post-inscription study
    PASS (post-authorisation safety study) cross-walk to EMA
    type: REGISTRY
  • HAS-018
    P2none
    Patient association
    Engagement evidence with French patient associations
    type: PATIENT_INPUT
  • HAS-019
    P2none
    Patient association
    Patient testimony / questionnaire data
    type: PATIENT_INPUT
  • HAS-020
    P1none
    CEPS pricing
    CEPS budget impact for French healthcare
    type: BIA
  • HAS-021
    P1none
    CEPS pricing
    Price proposal vs European comparator prices
    type: BIA
  • HAS-023
    P1none
    Indirect comparison
    ITC/NMA if no direct comparator data available
    type: ITC_NMA
  • HAS-024
    P1none
    Indirect comparison
    MAIC/STC sensitivity if cross-trial heterogeneity
    type: ITC_NMA

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