Background
Health-economic modeling analysis of amivantamab access delay in Brazil's Unified Health System (SUS) for EGFR exon 20 insertion-mutated advanced NSCLC. Reference efficacy: median OS 22.8 mo (amivantamab) vs 8.3 mo (docetaxel, SUS standard).
Interventions and follow up
Treatment: Health-economic modeling estimating preventable deaths attributable to delayed amivantamab incorporation into Brazil's SUS for EGFR exon 20 insertion-mutated NSCLC
Primary endpoint: Estimated annual and 10-year preventable deaths and life-years lost
mFollow up: 10-year projection horizon
Primary endpoint: Estimated annual and 10-year preventable deaths and life-years lost
mFollow up: 10-year projection horizon
Results
Annual preventable deaths: 112 patients (base case: 186 × 0.636 × 95%)
10-year projection: 1,120 preventable deaths, 1,353 life-years saved
Assumption: 10-year delay in SUS incorporation post-regulatory approval
10-year projection: 1,120 preventable deaths, 1,353 life-years saved
Assumption: 10-year delay in SUS incorporation post-regulatory approval
Adverse events
Note: Not a primary focus of this modeling study
Amivantamab: safety acceptable per CHRYSALIS (rash, infusion reactions, diarrhea)
Docetaxel: standard chemotherapy toxicity profile assumed
Amivantamab: safety acceptable per CHRYSALIS (rash, infusion reactions, diarrhea)
Docetaxel: standard chemotherapy toxicity profile assumed
Conclusions
Delayed SUS incorporation of amivantamab may result in over 1,000 preventable deaths among EGFR exon 20-mutated NSCLC patients in Brazil; urgent real-world evidence and cost-effectiveness reviews are needed to accelerate access.
Key Limitations
Modeling study reliant on assumptions (population estimates, efficacy transfer from trial to real world, fixed delay duration). Cross-trial OS comparison rather than randomized data. Brazil-specific health-system parameters limit generalizability. No direct patient-level outcomes; projections sensitive to base-case inputs.
Clinical Context
EGFR exon 20 insertions are historically TKI-resistant. FDA and EMA approved amivantamab for platinum-pretreated EGFR exon 20 insertion NSCLC; ANVISA (Brazil) approval preceded SUS incorporation. This analysis underscores access and reimbursement delays in public health systems as a driver of avoidable mortality, relevant to global oncology equity per ASCO and ESMO value frameworks.