PBAC's latest decision on Linzagolix: Not recommended (2024). Considered for Treatment of symptomatic uterine fibroids in adult premenopausal women with moderate to severe heavy menstrual bleeding who are unsuitable for, or have had an inadequate response to prior hormonal therapies.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
1
first 2024
Submissions
1
2024 → 2024
Eligible population
Adult premenopausal women (at least 18 years of age) with moderate to severe symptomatic uterine fibroids (at least one fibroid ≥2 cm diameter or multiple fibroids confirmed by ultrasound) experiencing significant heavy menstrual bleeding that negatively affects quality of life, who are unsuitable for or have had inadequate response to prior hormonal therapies (progestins or progestin and estrogen combinations).
Therapy area
Women's health
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
ORR
Key trials
PRIMROSE 1, PRIMROSE 2
Comparator
best supportive care
Economic model
CUA
ICER note
ICER value not stated in the public summary document provided. The document discusses the economic evaluation but does not include the specific numeric ICER figure in the publicly available text.
Why PBAC said no
Reasons cited in the latest PSD: Significant safety concerns regarding bone mineral density (BMD) loss with long-term GnRH therapy use; insufficient evidence for second-line setting (PRIMROSE trials primarily first-line); lack of comparison against most likely comparator in Australian second-line clinical practice; unclear treatment criteria and population definitions; trial evidence limited to maximum one year duration; no requirement for BMD monitoring in requested restrictions; high placebo response rates in trials; restrictions did not align with trial inclusion/exclusion criteria.