PBAC's latest decision on Leuprorelin acetate: Not recommended (2022). Considered for Treatment of central precocious puberty (CPP) in girls 10 years or younger or boys 11 years or younger.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2015
Submissions
2
2015 → 2022
Eligible population
Children 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).
Therapy area
Endocrinology
Line of therapy
Any
Evidence base
Single-arm
Primary endpoint
Surrogate
Pivotal trial size
64 patients
Key trials
TOL2581A, Lee 2012, Lee 2014, Study 301
Comparator
leuprorelin acetate 30 mg (Lucrin Paediatric)
Economic model
Cost-minimisation
ICER note
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.
Why PBAC said no
Reasons cited in the latest PSD: 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