Pharma Commercial Mock
HTA dossier

NICENSCLC

United Kingdom · currency GBP

Single Technology Appraisal (STA) per PMG24. Recommendation drives NHS coverage. ICER threshold £20-50k/QALY.

Submission
2026-09-01
in 93d
Total requirements
32
across all modules
Met
18
56% complete
Gaps
14
in progress + missing
Blocker gaps
2
P0, filing-blocking

Decision state

Status
pending
Body-specific enum: recommended / optimised / cdf / only_in_research / not_recommended

Dossier modules

  • NICE_A
    Module A — Decision problem & technology
    required92%
  • NICE_B
    Module B — Clinical effectiveness (SLR + RCTs)
    required67%
  • NICE_C
    Module C — Cost effectiveness model (CEM, ICER, £/QALY)
    required66%
  • NICE_D
    Module D — Budget impact analysis (BIA)
    required68%
  • NICE_PAS
    Patient Access Scheme (PAS)
    90%
  • NICE_EAG
    External Assessment Group report
    required46%

PICO questions (3)

  1. NICE-PICO-01nice_scope
    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. NICE-PICO-02nice_scope
    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. NICE-PICO-03nice_scope
    P: 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, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)

Evidence requirements

Missing (4)

  • NICE-003
    P1major
    Clinical evidence
    Indirect treatment comparison vs current standard of care
    type: ITC_NMAclose: 2mo
  • NICE-005
    P0blocker
    Clinical evidence
    Pivotal Phase 3 published results (peer-reviewed)
    type: RCTclose: 10mo
  • NICE-021
    P2minor
    Patient input
    Lay summary of patient experience for committee
    type: PATIENT_INPUTclose: 1mo
  • NICE-022
    P2minor
    Clinical expert input
    EAG-nominated clinical lead statement
    type: CLINICAL_EXPERTclose: 1mo

In progress (10)

  • NICE-004
    P0blocker
    Clinical evidence
    Systematic literature review per PMG24 methods
    type: SLRclose: 4mo
  • NICE-010
    P1major
    Cost-effectiveness
    Severity modifier (1.0 / 1.2 / 1.7) justification
    type: ECON_MODELclose: 4mo
  • NICE-014
    P2minor
    Patient-reported outcomes
    Mapped utilities from disease-specific instruments
    type: PROclose: 4mo
  • NICE-015
    P1major
    Long-term extrapolation
    Survival extrapolation beyond trial follow-up
    type: ECON_MODELclose: 4mo
  • NICE-020
    P2minor
    Patient input
    Patient organisation submission
    type: PATIENT_INPUTclose: 3mo
  • NICE-027
    P1major
    Subgroup analysis
    Biomarker-defined subgroup outcomes
    type: RCTclose: 10mo
  • NICE-028
    P2minor
    Safety
    Long-term safety follow-up commitment
    type: RCTclose: 8mo
  • NICE-030
    P2minor
    Resource use
    Healthcare resource use estimates from trial / RWE
    type: RWEclose: 12mo
  • NICE-031
    P1major
    PAS
    Confidential commercial access scheme (PAS) proposal
    type: BIAclose: 1mo
  • NICE-032
    P3none
    Equality
    Equality impact assessment / EHRC compliance
    type: PATIENT_INPUTclose: 1mo

Available (18)

  • NICE-001
    P0none
    Decision problem
    Final scope aligned with NICE STA matrix
    type: SLR
  • NICE-002
    P0none
    Clinical evidence
    RCT data versus NICE-agreed comparator
    type: RCT
  • NICE-006
    P0none
    Cost-effectiveness
    Partitioned-survival cost-effectiveness model (CEM)
    type: ECON_MODEL
  • NICE-007
    P0none
    Cost-effectiveness
    ICER deterministic + PSA at £20k-£50k/QALY thresholds
    type: ECON_MODEL
  • NICE-008
    P1none
    Cost-effectiveness
    Model validation (face, internal, cross, external)
    type: ECON_MODEL
  • NICE-009
    P2none
    Cost-effectiveness
    Discounting at 3.5% per Treasury Green Book
    type: ECON_MODEL
  • NICE-011
    P2none
    Cost-effectiveness
    End-of-life criteria evidence (if applicable)
    type: ECON_MODEL
  • NICE-012
    P2none
    Cost-effectiveness
    Equity weighting analysis (if QALY shortfall claimed)
    type: ECON_MODEL
  • NICE-013
    P1none
    Patient-reported outcomes
    EQ-5D-5L utility data from pivotal trial
    type: PRO
  • NICE-016
    P1none
    Long-term extrapolation
    Parametric model fit (Weibull/log-normal/gen. gamma) justification
    type: ECON_MODEL
  • NICE-017
    P1none
    Long-term extrapolation
    Cure modelling assumptions if claimed
    type: ECON_MODEL
  • NICE-018
    P1none
    Budget impact
    5-year BIA for NHS England
    type: BIA
  • NICE-019
    P1none
    Budget impact
    Eligible patient flow diagram + treatment pathway
    type: BIA
  • NICE-023
    P2none
    Clinical expert input
    Specialist society endorsement (e.g. UKONS, BSH)
    type: CLINICAL_EXPERT
  • NICE-024
    P2none
    Real-world evidence
    Registry data on current treatment pathway
    type: RWE
  • NICE-025
    P2none
    Real-world evidence
    RWE on subsequent therapies (post-progression)
    type: RWE
  • NICE-026
    P1none
    Subgroup analysis
    Pre-specified subgroups for severity modifier
    type: RCT
  • NICE-029
    P1none
    Safety
    AE rates with CTCAE grading by treatment arm
    type: RCT

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