PBAC's latest decision on Ulipristal acetate: Noted (2017). Considered for Acute management of moderate to severe symptomatic uterine fibroids prior to planned surgery in patients eligible for and planning surgery.
PBAC outcome
Noted
Authority Required
ICER (AUD/QALY)
$15k/QALY
Base-case
Submissions
2
first 2016
Submissions
2
2016 → 2017
Eligible population
Adult women of reproductive age eligible for and planning surgery for uterine fibroids with moderate to severe symptoms, including at least 1 fibroid ≥3 cm in diameter or multiple fibroids confirmed by ultrasound, and significant menstrual bleeding negatively affecting quality of life or confirmed anaemia (haemoglobin ≤120 g/L).
Therapy area
Women's health
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
244 patients
Key trials
PEARL I, PEARL II, PREMYA
Comparator
placebo (no treatment prior to planned surgery)
Economic model
CUA
ICER note
ICER stated as 'less than $15,000 per QALY' in the resubmission cost-utility analysis.
Risk sharing
Risk-sharing arrangement in place — A Risk Share Arrangement was proposed to account for residual uncertainty surrounding cost to the government.
Submission history
Jul 2016: Recommended with restriction · Authority Required
Mar 2017: Noted · Authority Required — ICER $15k/QALY