PBAC's latest decision on Afatinib: Not recommended (2013). Considered for 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.
PBAC outcome
Not recommended
Not applicable
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2013
Submissions
2
2013 → 2013
Eligible population
Adults 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.
Therapy area
Oncology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
585 patients
Key trials
LUX Lung 1, LUX Lung 2, BR.21, ISEL
Comparator
erlotinib, gefitinib
Economic model
Cost-minimisation
ICER note
Cost-minimisation approach used; PBAC rejected the economic analysis as not supported by the clinical claim.
Why PBAC said no
Reasons cited in the latest PSD: 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
Jul 2013: Recommended with restriction · Authority Required