PBAC's latest decision on Somatropin: Recommended with restriction (2023). Considered for Treatment of severe late onset growth hormone deficiency (GHD) in adults. The drug is indicated for replacement therapy in adults with pronounced GHD as diagnosed in dynamic tests.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
11
first 2006
Submissions
11
2006 → 2023
Eligible population
Adults with severe late onset growth hormone deficiency, diagnosed by dynamic tests with peak GH concentrations less than 2.5 nanogram/mL, who have either childhood-onset GHD (requiring retesting and confirmation) or adult-onset GHD (requiring GHD from hypothalamic or pituitary disease with at least one other hormone deficiency and adequate replacement therapy).
Therapy area
Endocrinology
Line of therapy
Any
Evidence base
Cost-minimisation
Primary endpoint
Cost-minimisation
Comparator
other somatropin products PBS-listed for severe late onset GHD (Genotropin GoQuick, Norditropin FlexPro, NutropinAq)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated as Saizen is not expected to provide substantial and clinically relevant improvement in efficacy or reduction of toxicity over other PBS-listed somatropin products for this indication.
ICER (historical)
$15k/QALY–$45k/QALY across 2 submissions (2008–2016) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Nov 2006: Not recommended
Mar 2008: Recommended with restriction · Restricted — ICER $75k/QALY
Jul 2011: Noted
Mar 2016: Recommended · Restricted
Nov 2016: Not recommended · Restricted — ICER $45k/QALY
Nov 2016: Recommended · Authority Required
Jul 2017: Deferred · Authority Required
Jul 2018: Recommended · Restricted
Mar 2019: Recommended with restriction · Authority Required
Aug 2019: Noted · Authority Required
Sep 2023: Recommended with restriction · Authority Required