Somapacitan

PBAC's latest decision on Somapacitan: Recommended with restriction (2023). Considered for Treatment of paediatric patients with growth hormone deficiency (GHD), including short stature associated with biochemical GHD (SSABGHD) and short stature slow growth (SSSG).

Eligible population

Paediatric patients with growth hormone deficiency, defined by biochemical criteria (peak serum GH <10 mU/L or ≤3.3 micrograms per litre) and height/growth velocity criteria, without malignancy risk conditions, bone age ≤15.5 years (boys) or ≤13.5 years (girls)

Therapy area

Endocrinology

Line of therapy

First-line

Evidence base

RCT

Primary endpoint

Height velocity

Key trials

REAL-3, REAL-4

Comparator

somatrogon (primary comparator); somatropin (secondary comparator)

Economic model

Cost-minimisation

ICER note

Cost-minimisation analysis; no ICER calculated by design

Submission history

• Mar 2022: Recommended with restriction · Authority Required
• Jul 2023: Recommended with restriction · Authority Required

Similar precedents

• Somatrogon
  similarity 0.78
• Somatropin
  similarity 0.76
• Pegvisomant
  similarity 0.66
• Lanreotide acetate
  similarity 0.64
• Semaglutide
  similarity 0.62
• Pasireotide
  similarity 0.61