OsimertinibTagrisso
First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to EGFR tyrosine kinase inhibitors, as either osimertinib monotherapy or in combination with platinum-based chemotherapy plus pemetrexed.
Decisions on record
- Meeting Nov 2025 Withdrawn Non-small cell lung cancer – Stage IIIB/IV EGFR mutation-positive, first-line with pemetrexed and platinum no PSD
- Meeting Sep 2025 Recommended Non-small cell lung cancer (stage IIIB/IV, EGFRm-positive) first-line with chemotherapy
- Meeting Jul 2025 Recommended Unresectable locally advanced (Stage III) EGFR mutation positive NSCLC after chemoradiation
- Meeting May 2025 Not recommended First-line EGFRm NSCLC in combination with chemotherapy
- Meeting Nov 2023 Recommended Stage IB-IIIA EGFR mutation positive NSCLC (adjuvant therapy post-resection)
- Meeting Jul 2020 Recommended Non-small cell lung cancer (NSCLC)
- Meeting Jul 2019 Not recommended Non-small cell lung cancer (NSCLC)
- Meeting Nov 2018 Recommended Non-small cell lung cancer (NSCLC)
2 earlier decisions
- Jul 2018 Deferred Locally advanced (Stage IIIB) or metastatic (Stage IV) epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC)
- Nov 2017 Not recommended Locally advanced (Stage III) or metastatic (Stage IV) epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC)
Access path
- TGA registered · Tagrisso
TGA label narrower than the PBS population
- Nov 2017Recommended · restricted
vs platinum-based doublet chemotherapy
- Jul 2018Deferred
Listing: Restricted → Authority Required
- Nov 2018Recommended · restricted
Comparator changed: platinum-based doublet chemotherapy → standard chemotherapy
- Jul 2019Not recommended
Comparator changed: standard chemotherapy → erlotinib and gefitinib
- ↻ resubmittedJul 2020Recommended · restricted
Comparator changed: erlotinib and gefitinib → erlotinib or gefitinib
- Nov 2023Recommended · restricted
Comparator changed: erlotinib or gefitinib → standard of care (watch and wait)
- May 2025Not recommended
Comparator changed: standard of care (watch and wait) → osimertinib monotherapy
- ↻ resubmittedJul 2025Recommended · restricted
Comparator changed: osimertinib monotherapy → placebo (standard of care consisting of…
- Sep 2025Recommended · restricted
Comparator changed: placebo (standard of care consisting of active surveillance) →…
- PBS listing · Restricted
From the public summary
5.1 The PBAC recommended the listing of osimertinib in combination with cisplatin or carboplatin, and pemetrexed for the first-line treatment of patients with locally 2 Calculated as ($ - $ )/$ from Table 8 12 OFFICIALPSD · Sep 2025
OFFICIAL Public Summary Document – September 2025 PBAC Meeting advanced or metastatic non-small cell lung cancer (NSCLC) with evidence in tumour material of an activating epidermal growth factor receptor mutation (EGFRm) known to confer sensitivity to EGFR tyrosine kinase inhibitors (TKIs). The PBAC considered the early re-entry resubmission had addressed the outstanding issues from its May 2025 consideration.PSD · Sep 2025
4.5 The resubmission accepted the parameters of the ESC respecified base case and proposed a price reduction to achieve an incremental cost effectiveness ratio (ICER) of $55,000 to < $75,000 per quality adjusted life year (QALY). The PBAC noted this met the requirements of its previous consideration.PSD · Sep 2025
• Superior in terms of effectiveness compared to placebo (added to standard of care) and • Has an inferior but manageable safety profile. Source: Table 1-1, p14 of the submission.PSD · Jul 2025
CRT=Chemoradiation therapy; DCR=disease control rate; DoR=duration of response; EGFR=Epidermal growth factor receptor; HRQoL= health-related quality of life; NSCLC=non-small cell lung cancer; PFS=Progression-free survival; ORR=objective response rate; OS=overall survivalPSD · Jul 2025
An individual with experience of taking osimertinib in a later stage of disease noted the side effects were minor and their quality of life on the drug enabled them to live a more normal life.PSD · Jul 2025
Two medical organisations (the Thoracic Oncology Group of Australasia [TOGA] and the Medical Oncology Group Australia [MOGA]) indicated their support for the PBS listing of osimertinib to be extended to unresectable Stage III NSCLC patients with an EGFR mutation.PSD · Jul 2025
4.11 There is a current Deed of Agreement for osimertinib which includes use in first-line, second-line and adjuvant treatment of EGFRm positive NSCLC, with % rebate for spend above expenditure caps (Table 8).PSD · Sep 2025
Cost-effectiveness
The PBAC noted this met the requirements of its previous consideration. PBAC · 2025
Decision context
PopulationPatients with locally advanced (Stage IIIB/C) or metastatic (Stage IV) NSCLC with evidence of activating EGFR mutations (exon 19 deletions or exon 21 L858R substitutions) known to confer sensitivity to EGFR tyrosine kinase inhibitors, receiving first-line treatment as either monotherapy or in combination with platinum-based chemotherapy plus pemetrexed.
Risk sharingA revised risk-sharing arrangement for osimertinib indications was proposed, with increased caps to account for additional net expenditure on osimertinib associated with the extended listing (O+C joining the existing risk sharing agreement for osimertinib).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Sep 2025 | Recommended · restricted | osimertinib monotherapy | $55k–75k | RCT · PFS |
| Jul 2025 | Recommended · restricted | placebo (standard of care consisting of active surveillance) | — | RCT · PFS |
| May 2025 | Not recommended | osimertinib monotherapy | — | RCT · PFS |
| Nov 2023 | Recommended · restricted | standard of care (watch and wait) | — | RCT · DFS |
| Jul 2020 | Recommended · restricted | erlotinib or gefitinib | — | RCT · PFS |
| Jul 2019 | Not recommended | erlotinib and gefitinib | — | RCT · PFS |
| Nov 2018 | Recommended · restricted | standard chemotherapy | — | RCT · OS |
| Jul 2018 | Deferred | platinum-based doublet chemotherapy | — | RCT · OS |
| Nov 2017 | Recommended · restricted | platinum-based doublet chemotherapy | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| AURA3 | Ph 3 | 421 | Progression Free Survival (PFS) by Investigator Assessment | completed |
| LAURA | Ph 3 | 216 | Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) | active not recruiting |
| FLAURA2 | Ph 3 | 587 | Adverse Events Graded by Common Terminology Criteria for Adverse Event v5 (Safety Run-In T… | active not recruiting |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| EGFR T790M mutation testing for osimertinib eligibility | EGFR T790M mutation | supported | 2018 |
| EGFR mutation testing in locally advanced or metastatic NSCLC | EGFR mutation | supported | 2020 |
| Small gene panel testing for NSCLC | EGFR, ALK, ROS1, MET exon 14, BRAF, KRAS, RET, NTRK1, NTRK2, NTRK3 | supported | 2022 |
Consumer voice
Consumer input from 4 organisations and an individual supported PBS listing of osimertinib for unresectable Stage III NSCLC. An individual reported minor side effects and improved quality of life; medical and consumer organisations emphasised clinical benefits including extended PFS and CNS protection, while highlighting the significant financial burden and access barriers currently faced by NSCLC
An individual with experience of taking osimertinib in a later stage of disease noted the side effects were minor and their quality of life on the drug enabled them to live a more normal life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to first-line treatment with specified chemotherapy combinations; TGA label permits broader first-line use without chemotherapy requirement.