SomapacitanSogroya
Treatment of paediatric patients with growth hormone deficiency (GHD), including short stature associated with biochemical GHD (SSABGHD) and short stature slow growth (SSSG).
Decisions on record
- Meeting Jul 2025 Noted Paediatric growth hormone deficiency no PSD
- Meeting Jul 2025 Noted Adult-onset growth hormone deficiency no PSD
- Meeting Jul 2023 Recommended Paediatric growth hormone deficiency (GHD)
- Meeting Mar 2022 Recommended Adult growth hormone deficiency
Access path
- TGA registered · Sogroya
TGA label narrower than the PBS population
- Mar 2022Recommended · restricted
vs somatropin
- Jul 2023Recommended · restricted
Comparator changed: somatropin → somatrogon (primary comparator); somatropin (secondary…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Section 100 Growth Hormone Program listing of somapacitan for the treatment of paediatric patients with growth hormone deficiency (GHD). The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of somapacitan would be acceptable if it were cost-minimised to the lowest priced comparator of somatropin or somatrogon, for the same indication.PSD · Jul 2023
The PBAC advised that the equi-effective doses are: 1 mg of somatrogon is equivalent to 0.240 mg of somapacitan 1 mg of somatropin is equivalent to 0.665 mg of somapacitan.PSD · Jul 2023
The submission presented a CMA comparing somapacitan once-weekly with somatrogon once-weekly (base case) and somatropin once daily (sensitivity analysis).PSD · Jul 2023
The key components and assumptions of the CMA are presented in Table 6. 19PSD · Jul 2023
The submission described somapacitan as non-inferior in terms of effectiveness compared to somatropin and somatrogon. The evaluation considered this claim was adequately supported for the comparison with somatropin based on direct evidence from REAL-3 and REAL-4.PSD · Jul 2023
The evaluation considered a claim of non-inferior effectiveness for somapacitan compared to somatrogon to be less clearly supported. Based on the ITC between somapacitan and somatrogon (with somatropin as the common comparator), non- inferiority between somapacitan and somatrogon could be concluded when results 18PSD · Jul 2023
The PBAC noted and welcomed the input from individuals (4) via the Consumer Comments facility on the PBS website. The comments described the potential benefit that once weekly, compared to daily, injections can have on quality of life.PSD · Jul 2023
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design
Decision context
PopulationPaediatric 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)
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2023 | Recommended · restricted | somatrogon (primary comparator); somatropin (secondary comparator) | — | RCT · Height velocity |
| Mar 2022 | Recommended · restricted | somatropin | — | RCT · Change in truncal fat percentage (REAL-1); safety and adverse events (REAL-2, REAL-Japan) |
Consumer voice
Four individuals provided consumer input highlighting the quality of life benefits of once-weekly injections compared to daily injections.
The comments described the potential benefit that once weekly, compared to daily, injections can have on quality of life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC adds biochemical thresholds (peak GH <10 mU/L), growth velocity criteria, bone age limits, and malignancy risk exclusion; TGA label does not specify these.