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Degarelix

Recommended OncologyRestrictedFirst-line line

Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate.

2
Submissions
1 resub
2010–17
On the record
—
ICER range
Cost-min
Cost basis

Decisions on record

2 decisions
  • Meeting Mar 2017 Recommended Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate
  • Meeting Jul 2010 Recommended Anti-cancer drug

Access path

2 submissions · public record
  1. Jul 2010
    Recommended · restricted

    vs leuprorelin acetate 7.5 mg powder for I.M. injection

  2. Mar 2017
    Recommended · restricted

    Comparator changed: leuprorelin acetate 7.5 mg powder for I.M. injection → leuprorelin

  3. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
6.1 The PBAC recommended amending the PBS listings of degarelix from Authority Required (STREAMLINED) to a Restricted Benefit for the treatment of locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate to be consistent with the PBS listed gonadotrophin releasing hormone (GnRH) agonists (goserelin, leuprorelin and triptorelin), which are also used in this treatment setting.PSD · Mar 2017
6.2 The PBAC noted that degarelix is used in the same clinical setting, and has the same restriction text, as the GnRH agonists. The PBAC also noted that degarelix was listed on a cost-minimisation basis to leuprorelin, and the requested change was not expected to increase utilisation.PSD · Mar 2017

Cost-effectiveness

This was a minor submission requesting a change in restriction level only. Cost-minimisation basis was established at the original July 2010 listing; no new economic evaluation was conducted.

Cost-effectiveness accepted

Decision context

PopulationAdults with locally advanced (stage C) or metastatic (stage D) carcinoma of the prostate.

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Mar 2017 Recommended · restricted leuprorelin — Cost-minimisation · Cost-minimisation
Jul 2010 Recommended · restricted leuprorelin acetate 7.5 mg powder for I.M. injection — RCT · cumulative probabilities of maintaining testosterone ≤0.5 ng/mL from Day 28 to Day 364

Similar precedents

By decision profile
Leuprorelin And Bicalutamide68%Triptorelin68%Abiraterone64%Abiraterone Acetate64%Abiraterone Acetate And Prednisolone64%Docetaxel65%Apalutamide64%Darolutamide63%

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to first-line treatment; TGA label permits any line of therapy.