Leuprorelin And BicalutamideBI Eligard CP
Recommended OncologyRestrictedNot applicable line
Treatment of metastatic (Stage D) carcinoma of the prostate. Patients must require a combination of an antiandrogen and a GnRH (LH-RH) agonist.
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Submissions
2016–16
On the record
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ICER range
Cost-min
Cost basis
Access path
- TGA registered · BI Eligard CP
TGA label narrower than the PBS population
- Jul 2016Recommended
vs co-prescribed leuprorelin and bicalutamide (primary)…
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the listing of the combination drug leuprorelin and bicalutamide on a cost minimisation basis compared with the individual components.PSD · Jul 2016
7.2 The PBAC accepted the nominated comparators of co-prescribed leuprorelin and bicalutamide (primary comparator) and goserelin and bicalutamide combination pack (secondary comparator). The PBAC noted that the components of the proposed product and comparator combination pack are TGA registered and PBS listed for metastatic prostate cancer.PSD · Jul 2016
Economic analysis
6.4 The sponsor requested listing on the basis of the sum of the prices of the individual components at the ex-manufacturer level. A summary of the comparative prices from the submission is shown below. 5PSD · Jul 2016
Cost-effectiveness
Cost-minimisation analysis. No ICER calculated; submission based on price comparison of combination pack versus individual components.
The PBAC recommended the listing of the combination drug leuprorelin and bicalutamide on a cost minimisation basis compared with the individual components. PBAC · 2016
Cost-effectiveness accepted
Decision context
PopulationAdults with metastatic (Stage D) carcinoma of the prostate requiring combination antiandrogen and GnRH agonist therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2016 | Recommended | co-prescribed leuprorelin and bicalutamide (primary); goserelin and bicalutamide combination pack (secondary) | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to metastatic (Stage D) disease requiring combination antiandrogen plus GnRH agonist therapy; TGA label covers all advanced prostate cancer.