HTA dossier
NICE — NSCLC
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_AModule A — Decision problem & technologyrequired92%NICE_BModule B — Clinical effectiveness (SLR + RCTs)required67%NICE_CModule C — Cost effectiveness model (CEM, ICER, £/QALY)required66%NICE_DModule D — Budget impact analysis (BIA)required68%NICE_PASPatient Access Scheme (PAS)90%NICE_EAGExternal Assessment Group reportrequired46%
PICO questions (3)
NICE-PICO-01nice_scopeP: 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)NICE-PICO-02nice_scopeP: 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)NICE-PICO-03nice_scopeP: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapyI: Test drug, monotherapy, q3w until progressionC: platinum doublet chemotherapy; atezolizumab; pembrolizumab monotherapyO: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)
Evidence requirements
Missing (4)
- NICE-003P1majorClinical evidenceIndirect treatment comparison vs current standard of caretype: ITC_NMAclose: 2mo
- NICE-005P0blockerClinical evidencePivotal Phase 3 published results (peer-reviewed)type: RCTclose: 10mo
- NICE-021P2minorPatient inputLay summary of patient experience for committeetype: PATIENT_INPUTclose: 1mo
- NICE-022P2minorClinical expert inputEAG-nominated clinical lead statementtype: CLINICAL_EXPERTclose: 1mo
In progress (10)
- NICE-004P0blockerClinical evidenceSystematic literature review per PMG24 methodstype: SLRclose: 4mo
- NICE-010P1majorCost-effectivenessSeverity modifier (1.0 / 1.2 / 1.7) justificationtype: ECON_MODELclose: 4mo
- NICE-014P2minorPatient-reported outcomesMapped utilities from disease-specific instrumentstype: PROclose: 4mo
- NICE-015P1majorLong-term extrapolationSurvival extrapolation beyond trial follow-uptype: ECON_MODELclose: 4mo
- NICE-020P2minorPatient inputPatient organisation submissiontype: PATIENT_INPUTclose: 3mo
- NICE-027P1majorSubgroup analysisBiomarker-defined subgroup outcomestype: RCTclose: 10mo
- NICE-028P2minorSafetyLong-term safety follow-up commitmenttype: RCTclose: 8mo
- NICE-030P2minorResource useHealthcare resource use estimates from trial / RWEtype: RWEclose: 12mo
- NICE-031P1majorPASConfidential commercial access scheme (PAS) proposaltype: BIAclose: 1mo
- NICE-032P3noneEqualityEquality impact assessment / EHRC compliancetype: PATIENT_INPUTclose: 1mo
Available (18)
- NICE-001P0noneDecision problemFinal scope aligned with NICE STA matrixtype: SLR
- NICE-002P0noneClinical evidenceRCT data versus NICE-agreed comparatortype: RCT
- NICE-006P0noneCost-effectivenessPartitioned-survival cost-effectiveness model (CEM)type: ECON_MODEL
- NICE-007P0noneCost-effectivenessICER deterministic + PSA at £20k-£50k/QALY thresholdstype: ECON_MODEL
- NICE-008P1noneCost-effectivenessModel validation (face, internal, cross, external)type: ECON_MODEL
- NICE-009P2noneCost-effectivenessDiscounting at 3.5% per Treasury Green Booktype: ECON_MODEL
- NICE-011P2noneCost-effectivenessEnd-of-life criteria evidence (if applicable)type: ECON_MODEL
- NICE-012P2noneCost-effectivenessEquity weighting analysis (if QALY shortfall claimed)type: ECON_MODEL
- NICE-013P1nonePatient-reported outcomesEQ-5D-5L utility data from pivotal trialtype: PRO
- NICE-016P1noneLong-term extrapolationParametric model fit (Weibull/log-normal/gen. gamma) justificationtype: ECON_MODEL
- NICE-017P1noneLong-term extrapolationCure modelling assumptions if claimedtype: ECON_MODEL
- NICE-018P1noneBudget impact5-year BIA for NHS Englandtype: BIA
- NICE-019P1noneBudget impactEligible patient flow diagram + treatment pathwaytype: BIA
- NICE-023P2noneClinical expert inputSpecialist society endorsement (e.g. UKONS, BSH)type: CLINICAL_EXPERT
- NICE-024P2noneReal-world evidenceRegistry data on current treatment pathwaytype: RWE
- NICE-025P2noneReal-world evidenceRWE on subsequent therapies (post-progression)type: RWE
- NICE-026P1noneSubgroup analysisPre-specified subgroups for severity modifiertype: RCT
- NICE-029P1noneSafetyAE rates with CTCAE grading by treatment armtype: RCT
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