Triptorelin AcetateDecapeptyl
Recommended Women's healthAuthority RequiredNot applicable line
Down-regulation and prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) as part of an Assisted Reproductive Technology (ART) treatment program.
1
Submissions
2016–16
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Mar 2016 Recommended Assisted reproduction
Access path
- TGA registered · Decapeptyl
TGA label equal than the PBS population
- Mar 2016Recommended · restricted
vs nafarelin
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the Authority Required (STREAMLINED) listing of triptorelin (as acetate) for assisted reproductive technology (ART) under Section 100 (IVF Program) on a cost-minimisation basis with nafarelin, where the equi-effective doses are triptorelin 100 micrograms (as acetate) daily and nafarelin 800 micrograms (base) daily over an ART treatment cycle.PSD · Mar 2016
7.2 The PBAC considered that the submission’s nominated main comparator, nafarelin, was appropriate.PSD · Mar 2016
Economic analysis
6.23 The equi-effective doses are estimated as triptorelin acetate 100 microgram daily and nafarelin 800 microgram daily over an ART treatment cycle. The equi-effective doses are based on the fixed doses used in the trials presented. These doses are the same as recommended in the Product Information documents.PSD · Mar 2016
6.24 The submission assumed the duration of treatment with triptorelin acetate is the same as with nafarelin. This appears reasonable based on the trial data (median of 26 days with triptorelin acetate and mean of 27 days with nafarelin) however; limited data were available to enable a robust comparison of the treatment durations.PSD · Mar 2016
Clinical claim
6.17 The submission described triptorelin as non-inferior in terms of comparative effectiveness and non-inferior in terms of comparative safety over the primaryPSD · Mar 2016
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
Decision context
PopulationWomen undergoing controlled ovarian hyperstimulation as part of an Assisted Reproductive Technology (ART) treatment program requiring prevention of premature luteinisation and ovulation.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2016 | Recommended · restricted | nafarelin | — | RCT · Ongoing pregnancy rate |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both describe identical indication: down-regulation and prevention of premature LH surges in women undergoing COH as part of ART treatment.