PBAC's latest decision on Exenatide: Recommended with restriction (2019). Considered for Type 2 diabetes mellitus in patients with inadequate glycaemic control on metformin and/or a sulfonylurea, for use as second- or third-line therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
9
first 2007
Submissions
9
2007 → 2019
Eligible population
Patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin and/or a sulfonylurea, requiring additional therapy as second- or third-line treatment.
Therapy area
Endocrinology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Surrogate
Pivotal trial size
377 patients
Key trials
NEO-1, DURATION-1, DURATION-5
Comparator
exenatide 2 mg once weekly dual chamber pen (exenatide DCP)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated.
ICER (historical)
$15k/QALY–$45k/QALY across 2 submissions (2007–2008) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Jul 2007: Not recommended — ICER $45k/QALY
Mar 2008: Not recommended · Authority Required — ICER $45k/QALY
Nov 2008: Recommended with restriction · Authority Required
Jul 2011: Recommended with restriction · Authority Required
Nov 2013: Recommended with restriction · Authority Required
Mar 2015: Recommended with restriction · Authority Required
Jul 2015: Recommended with restriction · Authority Required
Mar 2016: Recommended with restriction · Authority Required
Mar 2019: Recommended with restriction · Authority Required