CeritinibZykadia
Treatment of adult patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on a prior ALK inhibitor (ALKi).
Decision on record
- Meeting Nov 2016 Recommended Non-small cell lung cancer (NSCLC)
Access path
- TGA registered · Zykadia
TGA label narrower than the PBS population
- Nov 2016Recommended · restricted
vs platinum doublet chemotherapy (carboplatin or cisplatin…
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended an Authority Required General Schedule listing of ceritinib for the treatment of ALK-positive NSCLC. The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of ceritinib would be acceptable if it were cost-minimised against platinum chemotherapy followed by pemetrexed maintenance therapy.PSD · Nov 2016
7.2 In making this recommendation, the PBAC noted the relatively small population size (less than 10,000 patients/year) with ALK-positive NSCLC; the high clinical need for effective treatments for patients with this condition; and the likelihood that access to ceritinib would significantly improve quality of life in ALK-positive NSCLC patients 14PSD · Nov 2016
6.26 The submission presented a cost-minimisation analysis of ceritinib compared with the platinum chemotherapy followed by pemetrexed.PSD · Nov 2016
6.27 The equi-effective doses proposed in the submission were assumed on the basis that treatment duration with ceritinib and with platinum chemotherapy followed by pemetrexed would be the same, and the monthly cost of ceritinib was equal to the average monthly cost of chemotherapy followed by pemetrexed.PSD · Nov 2016
6.24 The submission described ceritinib as non-inferior in terms of efficacy and inferior in terms of safety to platinum doublet chemotherapy followed by pemetrexed, based on the subgroup analysis of ceritinib compared with pemetrexed in the ASCEND-5 trial.PSD · Nov 2016
6.25 The PBAC considered that the submission’s claim of at least non-inferiority for 9PSD · Nov 2016
6.3 The comment from Rare Cancers Australia noted that ceritinib would make a big difference in the quality of life of patients who progress on crizotinib. The advice received from the Lung Foundation placed emphasis on ceritinib being an effective option for second-line treatment of patients with ALK positive NSCLC, particularly those with brain metastases.PSD · Nov 2016
6.40 The submission sought a Special Pricing Arrangement for ceritinib.PSD · Nov 2016
Cost-effectiveness
Cost-minimisation analysis submitted; no ICER calculated.
The submission sought listing on the basis of a cost-minimisation analysis of ceritinib compared with platinum doublet chemotherapy followed by pemetrexed maintenance. PSD · 2016
Decision context
PopulationAdult patients with ALK-positive locally advanced or metastatic NSCLC who have progressed on or are intolerant of crizotinib, with WHO performance status ≤2.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Recommended · restricted | platinum doublet chemotherapy (carboplatin or cisplatin with gemcitabine) followed by pemetrexed maintenance | — | RCT · PFS |
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 18 individuals and 3 organisations supported ceritinib as an effective second-line treatment for ALK positive NSCLC, particularly highlighting improved quality of life for patients progressing on crizotinib and benefits for those with brain metastases.
ceritinib would make a big difference in the quality of life of patients who progress on crizotinib Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to prior ALKi progression and WHO PS ≤2; TGA label includes crizotinib-intolerant patients without these constraints.