Gonadotrophin, Menopausal Human, Highly Purified
Not recommended Women's healthRestrictedSecond-line line 💬 consumer voice
Anovulatory infertility in women who have failed to ovulate or conceive on clomiphene citrate and/or gonadorelin.
1
Submissions
1 resub
2016–16
On the record
—
ICER range
Cost-min
Cost basis
From the public summary
PBAC outcome
7.1 The PBAC decided not to recommend the PBS listing of HP-hMG for the treatment of anovulatory infertility on the basis that the minor resubmission did not adequately support a claim of non-inferiority to follitropin alfa.PSD · Nov 2016
7.2 The PBAC recalled that in March 2016 it rejected a major submission for HP-hMG on the basis that the evidence presented did not adequately support a claim of non-inferiority to the comparator, follitropin alfa. The PBAC considered that as no new clinical trial data had been provided in the resubmission, there was an insufficient basis on which to change its previous consideration regarding the claim of non-inferiority to follitropin alfa. 8PSD · Nov 2016
Economic analysis
6.9 The equi-effective doses were estimated in the March 2016 submission as 1 IU of HP-hMG and 1 IU of follitropin alfa. In March 2016, the PBAC considered that there was considerable uncertainty regarding the equi-effective doses, noting that the evaluation and the ESC advised different equi-effective dose ratios (1.46:1 and 1.32:1 respectively) to the major submission's proposed 1:1 ratio.PSD · Nov 2016
6.10 The minor resubmission expressed concern about using a dose ratio from the clinical trial as it claimed that imbalances in the baseline characteristics of the study population may have contributed to a higher mean dose of HP-hMG compared to follitropin alfa.PSD · Nov 2016
Clinical claim
6.7 The resubmission claimed non-inferior comparative effectiveness and non-inferior comparative safety of HP-hMG compared with follitropin alfa. In March 2016, the PBAC considered that the claim of non-inferior comparative effectiveness was not adequately supported by the data, and that a claim of non-inferior safety of HP-hMG to follitropin alfa may be reasonable.PSD · Nov 2016
6.8 The PBAC considered that the submission did not provide any new data or information to address the issues raised by the PBAC at the March 2016 meeting; the PBAC’s previous consideration regarding the clinical claim therefore remained unchanged. 6PSD · Nov 2016
Consumer comments
6.2 The PBAC noted and welcomed the input from one health care professional via the Consumer Comments facility on the PBS website. The comment indicated that patients with low levels of LH benefit from the combination of FSH and LH activity through HP-hMG for ovulation induction. The comment also noted the anomaly that patients are able to access subsidised HP-hMG if they proceed to IVF treatment.PSD · Nov 2016
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as this was a cost comparison submission.
Economic model disputed
Decision context
PopulationWomen with WHO Group II anovulatory infertility who have failed to ovulate or conceive on clomiphene citrate and/or gonadorelin, with or without primary amenorrhoea or hypopituitarism.
Why it was knocked back
- Clinical claim of non-inferior comparative effectiveness not adequately supported by data; lower confidence interval for live births and ongoing pregnancy exceeded the previously accepted 10% non-inferiority margin; considerable uncertainty regarding equi-effective doses; no unmet clinical need for anovulatory infertility; no new data provided to address PBAC's March 2016 concerns
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Not recommended | follitropin alfa | — | RCT · Ovulation rate |
Consumer voice
One healthcare professional commented that patients with low LH levels benefit from HP-hMG combination therapy for ovulation induction, and noted an inconsistency in subsidy access between ovulation induction and IVF treatment pathways.
patients with low levels of LH benefit from the combination of FSH and LH activity through HP-hMG for ovulation induction Consumer comments · PSD
unmet needaccess barrierstreatment efficacy