PBAC's latest decision on Somatrogon: Recommended with restriction (2022). Considered for Treatment of growth hormone deficiency in paediatric patients, specifically for short stature associated with biochemical growth hormone deficiency (SSABGHD) and short stature and slow growth (SSSG) in patients who do not have a mature skeleton.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2022
Submissions
1
2022 → 2022
Eligible population
Paediatric patients with growth hormone deficiency, specifically those with short stature associated with biochemical growth hormone deficiency or short stature and slow growth, with a bone age less than 13.5 years in females or less than 15.5 years in males, aged 3 years or older.
Therapy area
Endocrinology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Non-inferior effectiveness and safety (annualised height velocity, change in height SDS, IGF-1 and IGFBP-3 levels)
Pivotal trial size
224 patients
Key trials
Study 4006, Study 4004, Study 4009, Study 1002
Comparator
somatropin
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. PBAC assessment based on cost-effectiveness being acceptable if cost-minimised to somatropin.