PBAC's latest decision on Levonorgestrel: Recommended with restriction (2019). Considered for Contraception for up to 5 years. Kyleena® is a long-acting reversible hormone-releasing contraceptive intrauterine system (LARC-IUS) indicated for women requesting contraception.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2013
Submissions
3
2013 → 2019
Eligible population
Women requesting contraception, including nulliparous and parous women aged 16-49 years
Therapy area
Women's health
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
ORR
Pivotal trial size
2,885 patients
Key trials
LCS Phase II, LCS Pearl Index, Andersson 1994, Luukkainen 1986, Sivin 1990
Comparator
levonorgestrel 52 mg intrauterine system (Mirena®)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design
Submission history
Jul 2013: Deferred · Restricted
Mar 2014: Deferred · Restricted
Mar 2019: Recommended with restriction · Restricted