LevonorgestrelKyleena
Recommended Women's healthRestricted 💬 consumer voice
Contraception for up to 5 years in women requesting contraception.
4
Submissions
1 resub
2007–19
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2019 Recommended Contraception
- Meeting Mar 2014 Recommended Jaydess® Bayer Australia Limited Contraception Resubmission to request the PBS listing of levonorgestrel as an ultralow dose contraceptive system.
- Meeting Jul 2013 Deferred Contraception
Access path
- TGA registered · Kyleena
TGA label equal than the PBS population
- Mar 2007Recommended · restricted
vs hysterectomy
- Jul 2013Recommended
Comparator changed: hysterectomy → Mirena
- Mar 2014Recommended · restricted
Comparator changed: Mirena → Mirena (levonorgestrel intrauterine system) and Implanon…
- Mar 2019Recommended · restricted
Comparator changed: Mirena (levonorgestrel intrauterine system) and Implanon…
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the listing of a new form of the currently listed drug levonorgestrel, intrauterine drug delivery system 19.5 mg (Kyleena®) for contraception on the General Schedule as a restricted benefit.PSD · Mar 2019
7.2 The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of Kyleena® would be acceptable on the basis that it is cost-minimised to Mirena® based on the current indication-specific approved ex-manufacturer price (AEMP) for contraception, factoring in any statutory price reductions. 14PSD · Mar 2019
Economic analysis
6.27 Based on the non-inferiority claim, the submission presented a cost-minimisation analysis with the equi-effectiveness dose being 9 μg/day over 5 years (Kyleena®) = 14 μg/day over 5 years (Mirena®). This is based on the mean daily in vivo levonorgestrel release rate from product information. The ESC considered that this is reasonable.PSD · Mar 2019
6.28 The proposed DPMQ for Kyleena® was $'''''''''''''', which was incorrectly calculated by the submission because incorrect prices and indication-based weighting for Mirena® were used. The submission stated that the current weighted AEMP of Mirena® was $182.67 (post 1 June 2018 SPR), derived from the AEMP for contraception ($'''''''''''''' weighted at '''''''''%) and idiopathic menorrhagia ($'''''''''''''' weighted at ''''''''%).PSD · Mar 2019
Clinical claim
6.23 The submission claimed Kyleena® was non-inferior in terms of effectiveness in contraception and safety compared with Mirena® over 5 years.PSD · Mar 2019
6.24 The claim that Kyleena® was non-inferior in terms of contraception efficacy over 5 years to Mirena® was uncertain as: despite an overall low pregnancy rate, the results showed more unintended pregnancies in the Kyleena® group in comparison to Mirena® from both the direct 10PSD · Mar 2019
Consumer comments
6.2 The PBAC noted and welcomed the input from health care professionals and organisations via the Consumer Comments facility on the PBS website. The comments described a range of benefits associated with the use of Kyleena® including its smaller size and lower dose compared to Mirena®.PSD · Mar 2019
Financial management – risk sharing
6.41 The submission requested that Kyleena® be considered under the pricing arrangements outlined in Clause 5.7 of the Strategic Agreement between Medicines Australia and the Commonwealth of Australia (the Strategic Agreement), specifically that Kyleena® not be subject to statutory price reductions that have been applied to the comparator, Mirena®.PSD · Mar 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Requested listing based on cost-minimisation compared with Mirena®.
The PBAC recommended listing as a restricted benefit on a cost-minimisation basis compared to hysterectomy and on the basis that over a five year period, overall savings in the order of <$5,000 per patient on average would result for cases where hysterectomy had not been undertaken during that time period. PBAC · 2007
Economic model disputed ×2
Decision context
PopulationWomen aged 16-49 years requesting contraception; the submission focused on women aged 18-40 years in the included clinical trials.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2019 | Recommended · restricted | levonorgestrel 52 mg (Mirena®) | — | RCT · Pearl Index |
| Mar 2014 | Recommended · restricted | Mirena (levonorgestrel intrauterine system) and Implanon (etonogestrel sub-dermal implant) | — | RCT · Number of pregnancies |
| Jul 2013 | Recommended | Mirena | — | RCT · Other |
| Mar 2007 | Recommended · restricted | hysterectomy | — | RCT |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| LCS12 Phase 2 study | Ph 3 | 304 | Number of adverse events reported by study subjects | completed |
| Phase 3 Study (Protocol 310442-91665) | Ph 3 | 105 | Number of Participants With Successful Treatment of Heavy Menstrual Bleeding | completed |
Consumer voice
Healthcare professionals and organisations highlighted benefits of Kyleena® including its smaller size, lower hormone dose compared to Mirena®, suitability for younger and nulliparous women, and reduced insertion complication risks. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists noted likely clinical uptake and potential public health savings from prevention of un
The comments described a range of benefits associated with the use of Kyleena® including its smaller size and lower dose compared to Mirena®. Consumer comments · PSD
treatment burdenside effectsunmet needaccess barriersquality of life
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify contraception for up to 5 years in women aged 16–49 years, including nulliparous and parous women.