Leuprorelin AcetateEligard
Recommended EndocrinologyRestricted
Treatment of central precocious puberty (CPP) in girls 10 years or younger or boys 11 years or younger.
2
Submissions
2015–22
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2022 Recommended Central precocious puberty
- Meeting Mar 2009 Not recommended Anti-cancer drug no PSD
- Meeting Nov 2006 Not recommended Prostate cancer no PSD
Access path
- TGA registered · Eligard
TGA label narrower than the PBS population
- Jul 2015Recommended
- Jul 2022Recommended
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
The PBAC recommended the listing of Eligard 6 month for the treatment of CPP on a cost-minimisation basis to Lucrin Paediatric (leuprorelin 3-month). In making this recommendation, the PBAC considered that Eligard 6 month was non-inferior in effectiveness and safety to Lucrin Paediatric and Diphereline (triptorelin) for the treatment of CPP.PSD · Jul 2022
The PBAC considered that the equi-effective doses over a 1-year period were:PSD · Jul 2022
Economic analysis
The submission presented a cost-minimisation approach. The key assumptions and components of the cost-minimisation approach are summarised in Table 8.PSD · Jul 2022
Table 8: Key components and assumptions of the cost-minimisation analysis Component Claim or assumption Based on evidence presented in the Comparative Effective and Clinical Claim Therapeutic claim: effectiveness sections, effectiveness is assumed to be non-inferior Based on evidence presented in the Comparative Harm and Clinical Claim Therapeutic claim: safety sections, safety is assumed to be non-inferior Naïve treatment comparison of TOL2581A (Eligard …PSD · Jul 2022
Clinical claim
The submission described Eligard 6 month as non-inferior in terms of effectiveness and safety compared with Lucrin Paediatric. The submission also described Eligard 6 month as non-inferior in terms of effectiveness and safety compared with Diphereline. Both claims were based on numerical trends in a naïve comparison of the single treatment arms of different studies with a high risk of bias.PSD · Jul 2022
The PBAC considered that the claim of non-inferior comparative effectiveness and safety was reasonably supported by the data.PSD · Jul 2022
Cost-effectiveness
Cost-minimisation analysis: no ICER calculated by design. Submission requested listing based on cost-minimisation against the least costly PBS medicine for CPP (Diphereline), with proposed price equal to Eligard 6 month prostate cancer indication price.
The PBAC accepted the financial estimates presented and noted that listing the 45 mg intramuscular formulation would result in savings to the PBS. PBAC · 2015
Cost-effectiveness accepted
Decision context
PopulationChildren with central precocious puberty aged 10 years or younger (girls) or 11 years or younger (boys), with onset of CPP before 8 years (girls) or 9 years (boys).
Why it was knocked back
- Inadequate clinical evidence of non-inferiority; naïve indirect comparison with high risk of bias; no empirical evidence provided for claimed unmet clinical need; higher percentage of injection pain adverse events in Eligard 6-month trial compared to Lucrin Paediatric; flexibility in GnRH analogue restrictions already exists for medication shortages
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2022 | Recommended | leuprorelin acetate 30 mg (Lucrin Paediatric) | — | Single-arm · Surrogate |
| Jul 2015 | Recommended | — | — | Single-arm · Surrogate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts by age at assessment (≤10 girls/≤11 boys) and age at CPP onset (before 8 girls/9 boys); TGA label has no such limits.