Relugolix with estradiol and norethisterone acetate
Brand: Ryeqo
PBAC's latest decision on Relugolix with estradiol and norethisterone acetate: Recommended with restriction (2024). Considered for Treatment of moderate to severe pain associated with endometriosis in women who have failed to gain adequate pain relief from hormonal treatments and analgesics.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2024
Submissions
2
2024 → 2024
Eligible population
Pre-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.
Therapy area
Women's health
Line of therapy
Second-line
Evidence base
Other
Comparator
goserelin plus add-back therapy
Economic model
Cost-minimisation
ICER note
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).
Risk sharing
Risk-sharing arrangement in place — Risk 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
Mar 2024: Recommended with restriction · Authority Required
Nov 2024: Recommended with restriction · Authority Required