Relugolix With Estradiol And Norethisterone AcetateRYEQO
Treatment of moderate to severe pain associated with endometriosis in women who have failed to gain adequate pain relief from hormonal treatments and analgesics.
Decisions on record
- Meeting Nov 2024 Noted Endometriosis pain
- Meeting Mar 2024 Recommended Endometriosis
Access path
- TGA registered · RYEQO
TGA label narrower than the PBS population
- Mar 2024Recommended · restricted
vs goserelin 3.6 mg implant plus add-back therapy; best…
- Nov 2024Recommended · restricted
Comparator changed: goserelin 3.6 mg implant plus add-back therapy; best supportive care…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC did not revise its March 2024 advice in relation to the utilisation estimates of relugolix with estradiol and with norethisterone. The PBAC considered that the submission did not provide sufficient justification to support the proposed financial estimates and RSA.PSD · Nov 2024
7.2 The PBAC noted that the submission estimated the net cost to the PBS/RPBS to be $500 million to < $600 million over 6 years, which was a substantial increase from the March 2024 PBAC recommendation of $90 million to < $100 million over 6 years. The increase of 4-8% in overall eligibility of prevalent patients contributed to the increased estimates, but the difference in financial estimates was largely due to the increased uptake rates applied.PSD · Nov 2024
The submission presented two modelled economic evaluations comparing Ryeqo versus: (i) GnRH agonists (assuming sequential use of goserelin and nafarelin) over a one- year time horizon), and (ii) BSC (assuming only contraceptive therapies) over a five-year time horizon.PSD · Mar 2024
The Commentary noted that neither comparison was wholly informative for PBAC decision making given they do not compare Ryeqo to a GnRH analogue plus add-back therapy. The evaluation considered a more informative comparison would be to estimate the costs and benefits associated with the current treatment algorithm on the PBS (GnRH plus add-back treatment for up to 12 months followed by BSC thereafter) versus the proposed treatment algorithm on the PBS with …PSD · Mar 2024
- Ryeqo is superior to goserelin monotherapy in terms of safety;PSD · Mar 2024
- Ryeqo is superior to BSC in terms of efficacy and non-inferior in terms of safety. Source: Table 1.1.1, pp. 4-5 of the submission.PSD · Mar 2024
6.3 The comments described a range of benefits of treatment with relugolix with estradiol (as hemihydrate) and with norethisterone acetate including the delay of surgery and shrinking of fibroids to enable lower risk surgery.PSD · Nov 2024
6.4 The RANZCOG wrote in support of the timely listing wherever possible of appropriate medications for women's health, including this treatment and to consider patient cost barriers more heavily. This issue of cost as a barrier to access and equity issues for those with endometriosis was raised by multiple contributors including the Women's Health and Research Institute of Australia.PSD · Nov 2024
Cost-effectiveness
This is a Category 2 resubmission requesting reconsideration of utilisation and financial estimates. The current submission did not present an economic model (paragraph 6.5); the original March 2024 submission demonstrated cost-effectiveness on a cost-minimisation basis (12-month Ryeqo cost lower than comparator including BMD monitoring and implantation costs).
Decision context
PopulationPre-menopausal women aged 18 years or older with moderate to severe pain associated with endometriosis who have visually confirmed endometriosis and received inadequate response to or are intolerant to previous first-line therapies including hormonal contraceptives or analgesics, without osteoporosis or other metabolic bone disease risk, treated by a specialist medical practitioner.
Risk sharingRisk sharing arrangement (RSA) with percentage rebate caps recommended by PBAC to manage uncertainties in financial estimates. The current submission proposed revised rebate percentages for expenditure over the caps, informed by a new clinician survey.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | goserelin plus add-back therapy | — | Other |
| Mar 2024 | Recommended · restricted | goserelin 3.6 mg implant plus add-back therapy; best supportive care (contraceptive therapies) | — | RCT · Dysmenorrhea; non-menstrual pelvic pain |
Consumer voice
Consumer input from 9 individuals, 7 healthcare professionals, and 2 medical organisations described benefits of relugolix treatment including fibroid shrinkage and delayed surgery, while raising concerns about cost as a barrier to access and equity issues for those with endometriosis.
This issue of cost as a barrier to access and equity issues for those with endometriosis was raised by multiple contributors including the Women's Health and Research Institute of Australia. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to moderate-to-severe pain, prior treatment failure, visual confirmation, and second-line use; TGA label has no such restrictions.