Afatinib
Second/third-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with progressive disease after prior platinum doublet chemotherapy or in whom further cytotoxic chemotherapy is not tolerated, contraindicated, or not appropriate.
Decision on record
- Meeting Jul 2015 Not recommended Monotherapy for patients with advanced or metastatic non-squamous type non-small cell lung cancer (NSCLC), either as a first line therapy or after failure of cytotoxic chemotherapy.
Access path
- Jul 2013Not recommended
Comparator changed: platinum-based doublet chemotherapy (cisplatin/gemcitabine and…
- Jul 2013Not recommended
requested listing outside proposed TGA indication (requires EGFR mutation status), inclusion of squamous cell NSCLC…
From the public summary
the frequency of EGFR mutations in Australian non-squamous or NOS NSCLC patients the proportion of NSCLC patients diagnosed at Stage IIIb/IV disease, and time to disease progression the treatment effect of TKIs in EGFR M+ Asian versus Caucasian patients the inclusion of maintenance therapy in the comparator arm the number of cycles of comparator treatment the extrapolation of trial PFS and OS data beyond the trial period the fit and …PSD · Jul 2013
The PBAC noted that the submission did not consider the prognostic impact of EGFR mutation status and the economic model assumes 100% specificity and sensitivity. The PBAC also noted that the submission did not explore the quantitative impact of false positives and false negatives in the economic evaluation. It also did not explore any variation in the base case prevalence of 15% for tested patients being EGFR positive.PSD · Jul 2013
Cost-effectiveness
Cost-minimisation approach used; PBAC rejected the economic analysis as not supported by the clinical claim.
The PBAC considered this economic approach was not supported due to the weakness of the clinical claim. PBAC · 2013
Decision context
PopulationAdults with locally advanced or metastatic NSCLC without specified EGFR mutation status, with progressive disease after prior platinum doublet chemotherapy or for whom further cytotoxic chemotherapy is not tolerated, contraindicated, or not appropriate, or who are TKI-experienced.
Why it was knocked back
- requested listing outside proposed TGA indication (requires EGFR mutation status), inclusion of squamous cell NSCLC inconsistent with consensus view, TKI-experienced patient population not justified, inadequate evidence for non-inferiority claim, weak evidence for non-inferior harms, inappropriate use of cost-minimisation approach without adequate clinical evidence
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Not recommended | platinum-based doublet chemotherapy (cisplatin/gemcitabine and cisplatin/pemetrexed) | — | RCT · PFS |
| Jul 2013 | Not recommended | erlotinib, gefitinib | — | RCT · PFS |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| EGFR mutation testing for afatinib eligibility in NSCLC | EGFR activating mutation | supported with conditions | 2013 |
| 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 comments cited improvement in reduced hospital visits for intravenous chemotherapy, decreased toxicity, and superior symptom control as benefits associated with afatinib treatment.
comments cited improvement in less hospital visits for I.V chemotherapy, less toxicity and superior control of symptoms as benefits associated with treatment with afatinib Consumer comments · PSD