PBAC's latest decision on Pegvisomant: Recommended with restriction (2019). Considered for Second-line treatment for acromegaly in patients who have failed to achieve biochemical control with maximum indicated doses of somatostatin analogues (octreotide LAR or lanreotide ATG).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2016
Submissions
2
2016 → 2019
Eligible population
Patients with acromegaly who have not achieved biochemical control (defined as IGF-1 greater than age- and sex-adjusted upper limit of normal, or growth hormone greater than 1 mcg/L) despite maximum indicated doses of octreotide LAR 30 mg or lanreotide ATG 120 mg every 28 days for 24 weeks.
Therapy area
Endocrinology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
IGF-1 normalisation
Pivotal trial size
91 patients
Key trials
Trial 3614 (Trainer 2000)
Comparator
pasireotide
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated as this was a minor submission with no new economic evaluation.
Submission history
Nov 2016: Recommended with restriction · Authority Required
Mar 2019: Recommended with restriction · Authority Required