Mobocertinib
Adults with locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor exon 20 insertion (EGFR ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy (PBC).
Decisions on record
- Meeting Jul 2025 Noted Non-small cell lung cancer no PSD
- Meeting Jul 2023 Recommended Locally advanced or metastatic non-small cell lung cancer (NSCLC)
- Meeting Nov 2022 Not recommended EGFR exon 20 insertion positive non-small cell lung cancer
Access path
- Nov 2022Not recommended
vs standard of care (SOC) comprising standard EGFR tyrosine…
- ↻ resubmittedJul 2023Recommended · restricted
Comparator changed: standard of care (SOC) comprising standard EGFR tyrosine kinase…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the General Schedule Authority Required listing of mobocertinib for the treatment of adults with locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor exon 20 insertion (EGFR ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy (PBC).PSD · Jul 2023
The PBAC’s recommendation for listing was based on, among other matters, its assessment, that the cost-effectiveness of mobocertinib would be acceptable at the price proposed in the submission.PSD · Jul 2023
The resubmission presented a stepped economic evaluation comparing mobocertinib versus SOC for the treatment of patients with locally advanced or metastatic (Stage IIIB-IV) NSCLC with EGFR ex20ins mutations who have previously received PBC based on an indirect comparison of retrospective cohort studies.PSD · Jul 2023
• Application of only chemotherapy costs for comparator and subsequent treatments • Revised proposed price of mobocertinib (reduced by %). 22PSD · Jul 2023
following prior treatment with PBC. Mobocertinib is expected to have a different safety profile compared to chemotherapy or immunotherapy; its safety profile is acceptable and similar to that of other TKIs.PSD · Jul 2023
Source: Table ES.1, p1, Executive Summary of the resubmission.PSD · Jul 2023
The comments from individuals who have used this medicine for their own health condition described a range of benefits of treatment with mobocertinib including efficacy for their condition, the ability to return to work and largely manageable side effects. The comments from health care professionals indicated that mobocertinib was better tolerated than chemotherapy and that patients often responded better.PSD · Jul 2023
Rare Cancers Australia stated that patients with NSCLC EGFR ex20ins mutations are faced with an extremely poor prognosis, and commented better treatment options that provide significant improvements in survival were required. The organisation stated that the fear of progression, which this advanced stage population lives with, has severe mental-health and functioning impacts.PSD · Jul 2023
Cost-effectiveness
ICER value is redacted (shown as '$' in the document). The resubmission proposed a price reduction to achieve an ICER within the range of $45,000–$75,000 per QALY, but the exact ICER is not disclosed in the public summary.
Decision context
PopulationAdults with locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC with EGFR ex20ins mutations who have progressed on or after platinum-based chemotherapy, with WHO performance status ≤ 2.
Risk sharingSpecial Pricing Arrangement applies; exact details are not disclosed in the public summary.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2023 | Recommended · restricted | chemotherapy | — | RCT · PFS |
| Nov 2022 | Not recommended | standard of care (SOC) comprising standard EGFR tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), | — | Single-arm · ORR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT04129502 | Ph 3 | 354 | Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) … | active not recruiting |
Consumer voice
Consumer input from 2 individuals, 2 health care professionals, and 3 organisations (Rare Cancers Australia, Lung Foundation Australia, and MOGA) supported mobocertinib, highlighting its efficacy, improved tolerability compared to chemotherapy, and significance as the first oral therapy targeting EGFR ex20ins mutations for patients with limited treatment options.
The comments from individuals who have used this medicine for their own health condition described a range of benefits of treatment with mobocertinib including efficacy for their condition, the ability to return to work and largely manageable side effects. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line setting and WHO performance status ≤2, whereas TGA label includes all post-platinum patients regardless of line or performance status.