GoserelinZoladex 10.8mg Implant
Noted Women's healthRestrictedNot applicable line 💬 consumer voice
Prevention of premature ovarian failure (POF) in pre-menopausal women undergoing treatment with alkylating agents for malignancy or autoimmune disorders.
3
Submissions
3 resub
2016–17
On the record
—
ICER range
Not modelled
Cost basis
Decisions on record
- Meeting Jul 2017 Noted For the prevention of premature ovarian failure
- Meeting Mar 2017 Deferred Breast cancer
- Meeting Nov 2016 Deferred Chemotherapy- induced menopause
- Meeting Nov 2014 Recommended Indication not stated
Access path
- TGA registered · Zoladex 10.8mg Implant
- Nov 2016Deferred
- Mar 2017Deferred
- Jul 2017Recommended · restricted
Evidence: RCT → Other
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended extending the listing of goserelin 3.6 mg as a restricted benefit for the prevention of premature ovarian failure (POF) in pre-menopausal women undergoing treatment with alkylating agents for which there is a risk to fertility.PSD · Jul 2017
6.2 The PBAC recalled its previous advice that the clinical evidence indicated goserelin was effective in reducing the risk of POF in women receiving cyclophosphamide for breast cancer. By extrapolation, it was biologically plausible that goserelin would also be effective in other conditions treated with alkylating agents, such as cyclophosphamide (goserelin, March 2017 PSD).PSD · Jul 2017
Economic analysis
6.9 The minor submission did not present an economic comparison. The PBAC noted that although no evaluation of the cost-effectiveness of fertility preservation was presented, it would be difficult to determine the value of retained fertility or pregnancy and children.PSD · Nov 2016
Consumer comments
The resubmission claimed that the application was for use in breast cancer only because there is limited evidence to support the use of goserelin for all women undergoing menopause-inducing chemotherapy.PSD · Mar 2017
Financial management – risk sharing
5.6 The submission argued against a risk sharing arrangement for goserelin, for the reasons outlined in paragraph 4.2.PSD · Jul 2017
5.7 A further analysis of PBS script data conducted by the Department showed that '''''''''' women aged 18-49 years received PBS-subsidised cyclophosphamide therapy in 2016. At the March 2017 meeting, the PBAC considered use of cyclophosphamide to be a reasonable surrogate for drugs causing POF, but noted that this includes a much broader population than would actually elect to use goserelin to prevent POF.PSD · Jul 2017
Cost-effectiveness
This was a minor submission; no economic evaluation or ICER was conducted.
The PBAC noted that while there was unlikely to be use outside the restriction for prevention of POF due to the undesirable side effects of goserelin, an unrestricted listing may also result in increased use for other indications, such as endometriosis and uterine fibroids. PBAC · 2017
ICER uncertainEconomic model disputed
Decision context
PopulationPre-menopausal women undergoing treatment with alkylating agents (for malignancy or autoimmune disorders) at high risk of premature ovarian failure.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Recommended · restricted | — | — | Other |
| Mar 2017 | Deferred | — | — | RCT · POF prevention |
| Nov 2016 | Deferred | — | — | RCT · Ovarian failure rate, pregnancy rate |
Consumer voice
Breast Cancer Network Australia supported making goserelin available to premenopausal women with hormone receptor negative breast cancer undergoing chemotherapy, emphasizing the importance of fertility preservation to this population.
preservation of fertility is very important to many premenopausal women who may wish to start or grow their family, and may otherwise become infertile as a result of their treatment Consumer comments · PSD
fertility preservationunmet needtreatment accessquality of life