LeuprorelinEligard
Locally advanced (stage C) or metastatic (stage D) carcinoma of the prostate, and central precocious puberty.
Decisions on record
- Meeting Nov 2024 Recommended Central precocious puberty; locally advanced or metastatic prostate carcinoma
- Meeting Jul 2019 Not recommended Prostate cancer
- Meeting Mar 2016 Recommended Locally advanced (stage C) or metastatic (stage D) carcinoma of the prostate; Central precocious puberty
- Meeting Jul 2015 Recommended Prostate cancer
- Meeting Jul 2015 Recommended Central precocious puberty (CPP)
- Meeting Nov 2014 Recommended 30 mg injection: modified release [1 x 30 mg syringe] (&) inert substance diluent [1 x 2 mL syringe], 1 pack Lucrin Depot PDS® AbbVie Pty Ltd Change to listing (Major submission) Central precocious puberty Extend the current Authority Required (STREAMLINED) listing to include the treatment of centra
Access path
- TGA registered · Eligard
TGA label narrower than the PBS population
- Nov 2014Recommended
vs no active treatment / off-label gonadotropin releasing…
- Jul 2015Recommended
Evidence: RCT → Other
- Mar 2016Recommended · restricted
Listing: Authority Required → Restricted
- Jul 2019Recommended · restricted
Evidence: Other → RCT
- Nov 2024Recommended
Comparator changed: leuprorelin acetate 7.5 mg IM depot (Lucrin Depot PDS) for one-month…
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended Eligard with an updated injection device be included in the existing PBS listings for leuprorelin (Eligard), alongside Eligard with the current injection device, in the following forms:PSD · Nov 2024
• Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 7.5 mg, injection set 6PSD · Nov 2024
6.29 The submission presented a cost-minimisation analysis over one year between LERIN and Lucrin. The recommended doses were assumed to be equi-effective: LERIN 3.6 mg (one-month) SC implant and Lucrin 7.5 mg (one-month) IM depot; and LERIN 5 mg (three-month) SC implant and Lucrin 22.5 mg (three-month) IM depot. Lucrin and Eligard are listed at the same price on the PBS.PSD · Jul 2019
6.30 The cost-minimisation analysis included the direct medicine costs only (no other costs or cost-offsets) and the Sponsor offered a ''''''% discount for LERIN SC implant (based on the AEMP), summarised in the table below.PSD · Jul 2019
5.3 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of Eligard with the updated injection device compared with Eligard with the current injection device. The submission also claimed the updated device will reduce potential handling errors.PSD · Nov 2024
5.4 The clinical claim was supported by the TGA’s approval to vary the PI for EligardPSD · Nov 2024
4.2 The PBAC noted and welcomed the advice received from an organisation, the Australian Advanced Prostate Cancer Support Group, via the Consumer Comments facility on the PBS website. The correspondence advocated for a Restricted Benefit listing for leuprorelin to mirror that of goserelin, describing how the mechanism of action was the same for the two drugs, and outlining that they are both used to treat locally advanced and metastatic prostate cancer.PSD · Mar 2016
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as drugs are equi-effective at same cost.
The PBAC noted the listing of Eligard with the updated injection device is expected to have no net cost to the PBS. PBAC · 2024
Decision context
PopulationAdults with locally advanced (stage C) or metastatic (stage D) prostate carcinoma, and children with central precocious puberty (females prior to 10th birthday with onset prior to 8th birthday; males prior to 11th birthday with onset prior to 9th birthday).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended | Eligard with current injection device | — | Cost-minimisation · Cost-minimisation |
| Jul 2019 | Recommended · restricted | leuprorelin acetate 7.5 mg IM depot (Lucrin Depot PDS) for one-month formulation; leuprorelin acetate 22.5 mg IM depot ( | — | RCT · Surrogate |
| Mar 2016 | Recommended · restricted | — | — | Other |
| Jul 2015 | Recommended | — | — | Other |
| Nov 2014 | Recommended | no active treatment / off-label gonadotropin releasing hormone analogues | — | RCT · Surrogate |
Consumer voice
The Australian Advanced Prostate Cancer Support Group advocated for a Restricted Benefit listing for leuprorelin to mirror that of goserelin, noting their identical mechanisms of action and shared use in treating locally advanced and metastatic prostate cancer.
The correspondence advocated for a Restricted Benefit listing for leuprorelin to mirror that of goserelin, describing how the mechanism of action was the same for the two drugs, and outlining that they are both used to treat locally advanced and metastatic prostate cancer. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted subsidy to locally advanced (stage C) or metastatic (stage D) prostate cancer; TGA label scope not specified in text.