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HTA dossier

CADTH — NSCLC

Canada · currency CAD

Reimbursement Review (oncology uses pCODR pathway). Recommendation gates pCPA pricing negotiation.

Submission
2026-09-01
in 93d
Total requirements
29
across all modules
Met
16
55% complete
Gaps
13
in progress + missing
Blocker gaps
4
P0, filing-blocking

Decision state

Status
pending
Body-specific enum: reimburse / reimburse_with_conditions / do_not_reimburse

Dossier modules

  • CADTH_PIRF
    Pre-submission Information Requirements Form (≥120d pre-submission)
    required60%
  • CADTH_CLIN
    Clinical evidence + ITC (per CADTH methods)
    required64%
  • CADTH_ECON
    Pharmacoeconomic model (reference case CUA, public payer, lifetime)
    required61%
  • CADTH_BIA
    3-year budget impact analysis for participating drug plans
    required70%
  • CADTH_INPUT
    Patient + clinician group input
    required47%
  • CADTH_PCPA
    Confidential price submission to pCPA
    required98%

PICO questions (3)

  1. CADTH-PICO-01cadth_review_team
    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. CADTH-PICO-02cadth_review_team
    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
    O: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)
  3. CADTH-PICO-03cadth_review_team
    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 (7)

  • CADTH-003
    P0blocker
    Clinical evidence
    Systematic literature review with PRISMA flow
    type: SLRclose: 4mo
  • CADTH-004
    P1major
    Clinical evidence
    GRADE assessment of certainty of evidence
    type: SLRclose: 2mo
  • CADTH-006
    P0blocker
    Comparator
    Comparator rationale aligned to provincial drug plans
    type: CLINICAL_EXPERTclose: 2mo
  • CADTH-008
    P0blocker
    Cost-effectiveness
    Lifetime horizon with appropriate discounting (1.5% per CADTH)
    type: ECON_MODELclose: 2mo
  • CADTH-010
    P1major
    Cost-effectiveness
    Public payer perspective (provincial drug plans)
    type: ECON_MODELclose: 4mo
  • CADTH-020
    P1major
    Subgroup analyses
    Pre-specified subgroups aligned to Canadian practice
    type: RCTclose: 8mo
  • CADTH-024
    P1major
    Pricing
    Confidential price submission to pCPA
    type: BIAclose: 2mo

In progress (6)

  • CADTH-002
    P1major
    Clinical evidence
    Risk-of-bias assessment (Cochrane RoB 2 or ROBINS-I)
    type: RCTclose: 15mo
  • CADTH-007
    P0blocker
    Cost-effectiveness
    Reference case CUA economic model per CADTH guidelines
    type: ECON_MODELclose: 2mo
  • CADTH-009
    P1major
    Cost-effectiveness
    Probabilistic sensitivity analysis (PSA)
    type: ECON_MODELclose: 3mo
  • CADTH-011
    P1major
    Cost-effectiveness
    Scenario analyses for parameter uncertainty
    type: ECON_MODELclose: 2mo
  • CADTH-022
    P1major
    Indirect comparisons
    NMA per CADTH methods guidance if no direct evidence
    type: ITC_NMAclose: 4mo
  • CADTH-023
    P1major
    Indirect comparisons
    MAIC sensitivity for cross-trial heterogeneity
    type: ITC_NMAclose: 3mo

Available (16)

  • CADTH-001
    P0none
    Clinical evidence
    Pivotal trial data with Health Canada-approved indication alignment
    type: RCT
  • CADTH-005
    P1none
    Comparator
    Evidence vs relevant Canadian standard of care
    type: ITC_NMA
  • CADTH-012
    P2none
    Cost-effectiveness
    Equity-relevant considerations narrative
    type: ECON_MODEL
  • CADTH-013
    P1none
    Budget impact
    3-year BIA for pCPA participating drug plans
    type: BIA
  • CADTH-014
    P1none
    Budget impact
    Provincial-level BIA breakdown
    type: BIA
  • CADTH-015
    P1none
    Budget impact
    Drug acquisition + administration costs
    type: BIA
  • CADTH-016
    P2none
    Patient input
    Patient group submissions via CADTH input process
    type: PATIENT_INPUT
  • CADTH-017
    P2none
    Patient input
    Lived-experience narrative summary
    type: PATIENT_INPUT
  • CADTH-018
    P2none
    Clinician input
    Clinician group input on place in therapy (pCODR for oncology)
    type: CLINICAL_EXPERT
  • CADTH-019
    P2none
    Clinician input
    Drug Advisory Committee perspective (oncology DAC)
    type: CLINICAL_EXPERT
  • CADTH-021
    P1none
    Subgroup analyses
    Biomarker-defined subgroups (if companion diagnostic)
    type: RCT
  • CADTH-025
    P2none
    Pricing
    PMPRB reference for international price comparison
    type: BIA
  • CADTH-026
    P3none
    Implementation
    Considerations for jurisdictional implementation (pCODR / drug plans)
    type: CLINICAL_EXPERT
  • CADTH-027
    P3none
    Implementation
    Indigenous health services consultation evidence
    type: PATIENT_INPUT
  • CADTH-028
    P1none
    Quality of life
    EQ-5D-5L or similar with Canadian value set
    type: PRO
  • CADTH-029
    P1none
    Safety
    AE profile vs comparator + serious AE rates
    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