PBAC's latest decision on Levonorgestrel, intrauterine drug delivery system: Recommended with restriction (2007). Considered for Treatment of idiopathic menorrhagia when oral medical therapies for menorrhagia have been ineffective or are contraindicated.
PBAC outcome
Recommended with restriction
Restricted benefit
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2007
Submissions
1
2007 → 2007
Eligible population
women where oral treatments have been ineffective or are contraindicated
Therapy area
Women's health
Line of therapy
Not applicable
Evidence base
RCT
Pivotal trial size
1,024 patients
Key trials
Hurskainen R et al Clinical outcomes and costs with the LNG-IUS- JAMA 2004, 291:1456-1463., Hurskainen R et al Quality of life and cost-effectiveness of LNG-IUS- Lancet 2001, 357:273-277
Comparator
hysterectomy
Economic model
Cost-minimisation
Eligible patients/year
10,000
ICER note
Cost-minimisation analysis used; no ICER calculated. PBAC noted overall savings of approximately $5,000 per patient over five years for cases where hysterectomy was not undertaken.