TriptorelinDecapeptyl
Recommended EndocrinologyRestrictedFirst-line line
Treatment of central precocious puberty (CPP) in children aged 2 years and older with onset before 8 years in girls and 10 years in boys.
2
Submissions
2006–21
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2021 Recommended Central precocious puberty
- Meeting Jul 2010 Recommended Anti-cancer no PSD
Access path
- TGA registered · Decapeptyl
TGA label narrower than the PBS population
- Nov 2006Recommended · restricted
vs goserelin acetate
- Jul 2021Recommended · restricted
Comparator changed: goserelin acetate → leuprorelin acetate depot 30 mg
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
The PBAC recommended the General Schedule, Restricted Benefit listing of triptorelin for the treatment of central precocious puberty (CPP). In making this recommendation, the PBAC considered the evidence presented supported a conclusion that triptorelin is of non-inferior comparative efficacy and safety to leuprorelin for the management of CPP.PSD · Jul 2021
The Committee advised the equi-effective doses were 2 injections of triptorelin (22.5 mg) over one year at 6-monthly intervals = 4 injections of leuprorelin (30 mg) over one year at 3-monthly intervals.PSD · Jul 2021
Economic analysis
Table 5 presents key components and assumptions of the submission’s cost- minimisation analysis. 9PSD · Jul 2021
Triptorelin is non-inferior in safety compared with leuprorelin based on overall and Therapeutic claim: safety system organ class (SOC) AEs.PSD · Jul 2021
Clinical claim
The submission claimed that for children with CPP: Triptorelin is non-inferior compared to leuprorelin in terms of efficacy measured as suppression of LH to pre-pubertal levels. Triptorelin is non-inferior in safety compared with leuprorelin based on overall and system organ class (SOC) AEs.PSD · Jul 2021
Both claims are based on numerical trends in a naïve comparison of single treatment arms of different studies with high risk of bias. Consequently, the evaluation considered the reliability of these claims is not strong. Nevertheless, the included evidence does not indicate any strong efficacy or safety signals which would point to inferiority of triptorelin.PSD · Jul 2021
Consumer comments
The PBAC noted that this item received no consumer comments.PSD · Jul 2021
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The submission did not explicitly state the equi-effective doses. However, based on the presented cost-minimisation analysis, the implied equi-effective dose was based on dosing over one year: 2 injections of triptorelin (22.5 mg) PSD · 2021
Cost-effectiveness accepted
Decision context
PopulationChildren with central precocious puberty aged 11 years or younger (girls) or 12 years or younger (boys), with onset before 8 years (girls) or 10 years (boys).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2021 | Recommended · restricted | leuprorelin acetate depot 30 mg | — | Single-arm · Surrogate |
| Nov 2006 | Recommended · restricted | goserelin acetate | — | RCT, Single-arm · Other |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to CPP with onset before age 8 (girls) or 10 (boys), and treatment age limits; TGA label has no such onset/age restrictions.