AlectinibAlecensa
Adjuvant therapy for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) after tumour resection in patients with tumours ≥4 cm or node-positive disease.
Decisions on record
- Meeting Mar 2026 Advice provided Non-small cell lung cancer (NSCLC), anaplastic lymphoma kinase (ALK)-positive NSCLC
- Meeting May 2025 Recommended Adjuvant treatment of ALK-positive NSCLC following tumour resection
- Meeting Nov 2019 Noted Non-small cell lung cancer (NSCLC)
- Meeting Mar 2019 Not recommended Non-small cell lung cancer (NSCLC)
- Meeting Jul 2017 Recommended Non-small cell lung cancer (NSCLC)
Access path
- TGA registered · Alecensa
TGA label narrower than the PBS population
- Jul 2017Recommended · restricted
vs ceritinib
- Mar 2019Not recommended
insufficient long-term utilisation data (alectinib recently listed 1 January 2018), risk of inappropriately extending…
- ↻ resubmittedMay 2025Recommended · restricted
Evidence: Other → RCT
- Mar 2026Recommended · restricted
Comparator changed: platinum-based chemotherapy → observation (standard adjuvant care)
- PBS listing · Authority Required
From the public summary
5.1 The PBAC reaffirmed its recommendation that alectinib be made available for the treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumours ≥4 cm or node positive) as adjuvant therapy after tumour resection.PSD · Mar 2026
Based on the additional input received from consumer and clinical groups, the PBAC provided additional advice that: (1) reaffirmed that re-treatment with alectinib in the locally advanced/metastatic setting would not be permitted following treatment with alectinib as adjuvant therapy after tumour resection; however (2) adjuvant alectinib may be followed by use of another ALK TKI in the locally advanced/metastatic setting.PSD · Mar 2026
6.38 The submission presented a cost-utility analysis. A summary of the model structure, key inputs and rationale is given in Table 7. 21 OFFICIALPSD · May 2025
OFFICIAL Public Summary Document – May 2025 PBAC Meeting Table 7: Summary of model structure, key inputs and rationale Component Summary Adjuvant: alectinib vs platinum-based chemotherapy, cisplatin with pemetrexed.PSD · May 2025
6.34 The submission described alectinib as superior in terms of effectiveness compared to platinum-based chemotherapy. This claim was adequately supported. The key issues were the moderate risk of bias in the key trial and that the overall survival results were immature. The ESC considered some of the issues contributing to the risk of bias were unavoidable and that the uncertainty may bias results in both directions.PSD · May 2025
6.35 The submission described alectinib as similar in terms of safety compared to platinum- based chemotherapy. This claim was adequately supported. The ESC noted toxicities were well known and mild for both the intervention and comparator.PSD · May 2025
6.2 The PBAC noted and welcomed input from individuals (9), a health care professional (1) and organisations (4) [the Medical Oncology Group of Australia (MOGA), Rare Cancers Australia, Lung Foundation Australia, and ALK Positive Australia Inc.] via the Consumer Comments facility on the PBS website.PSD · May 2025
The input described alectinib as less burdensome to administer being a daily oral tablet and as more tolerable than currently available treatment and that it would increase the ability to lead a normal life with less stress and worry.PSD · May 2025
Cost-effectiveness
The PBAC considered alectinib would be cost effective in the adjuvant treatment setting with a price reduction to maintain an ICER in the order of $25,000 to < $35,000 per QALY gained, using the revised model from the pre-PBAC response with appropriate DPMQs rather than AEMPs. PBAC · 2026
Decision context
PopulationAdults with resected ALK-positive NSCLC (tumours ≥4 cm or node-positive) with ALK gene rearrangement (≥15% positive cells by FISH or positive NGS), WHO performance status ≤1, requiring adjuvant therapy within 26 weeks of surgery.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | observation (standard adjuvant care) | $25k–35k | RCT · DFS |
| May 2025 | Recommended · restricted | platinum-based chemotherapy | — | RCT · DFS |
| Mar 2019 | Not recommended | — | — | Other |
| Jul 2017 | Recommended · restricted | ceritinib | — | Single-arm · ORR |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| FISH test for ALK rearrangement in NSCLC | ALK gene rearrangement | supported | 2019 |
| 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 9 individuals, 1 healthcare professional, and 4 organisations described alectinib as a proactive treatment reducing metastasis risk, extending survival, and improving quality of life through reduced treatment burden and better tolerability compared to current therapies. Input highlighted severe side effects of current treatments and advocated for early access to alectinib to ad
The individual comments described how alectinib was perceived as a proactive treatment that would reduce the risk of metastases or disease recurrence, extend survival and time with family and friends. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO performance status ≤1 and explicitly specifies first-line treatment, narrowing the TGA label.
Listed in law
PBS listings commencing 1 Jul 2026 were made by these 3 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 70 of 2026 | 11 Jun 2026 | In force | PDF ↗ |
| PB 73 of 2026 | 30 Jun 2026 | In force | PDF ↗ |
| PB 74 of 2026 | 30 Jun 2026 | In force | PDF ↗ |