Levonorgestrel, intrauterine drug delivery system 52 mg (releasing approximately 20 micrograms per 24 hours), Mirena®, March 2007
Public summary document for Levonorgestrel, intrauterine drug delivery system 52 mg (releasing approximately 20 micrograms per 24 hours), Mirena®, March 2007
Page last updated: 29 June 2007
Public Summary Document
Product: Levonorgestrel, intrauterine drug
delivery system 52 mg (releasing approximately 20 micrograms per 24
Sponsor: Schering Pty Ltd
Date of PBAC Consideration: March 2007
1. Purpose of Application
The submission sought extension of the current listing to include
This drug has not previously been considered by the PBAC for this
indication. Mirena was listed for contraception on 1 February
3. Registration Status
Mirena is TGA-approved for contraception, treatment of idiopathic
menorrhagia and prevention of endometrial hyperplasia during
oestrogen replacement therapy.
4. Listing Requested and PBAC’s View
Treatment of idiopathic menorrhagia when oral medical therapies for menorrhagia have been ineffective or are contraindicated.
See Recommendation and Reasons for PBAC’s view
5. Clinical Place for the Proposed Therapy
Mirena would provide an alternative treatment strategy to surgery
in women where oral treatments have been ineffective or are
The submission nominated hysterectomy as the main comparator to
levonorgestrel intrauterine delivery system (LNG-IUS). The
comparator was considered appropriate.
7. Clinical Trials
The submission provided a single head to head randomised trial over
five years comparing LNG-IUS with hysterectomy, in menstruating
women aged 35-49 who had completed their family.
The trial had been published at the time of submission, as follows:
|Protocol title/Publication title
|Hurskainen R et al
|Clinical outcomes and costs with the LNG-IUS-releasing intrauterine system or hysterectomy for treatment of menorrhagia: randomized trial 5-year follow-up.
|Jama 2004, 291: 1456-1463.
|Hurskainen R et al
|Quality of life and cost-effectiveness of LNG-IUS-releasing intrauterine system versus hysterectomy for treatment of menorrhagia: a randomised trial.
|Lancet 2001, 357:273-277
8. Results of Trials
The results showed that five years after insertion of LNG-IUS, 48%
of the women in the LNG-IUS group still had a LNG-IUS in situ, and
42% had undergone hysterectomy. The main reasons for
discontinuation with LNG-IUS were bleeding problems. At the 5-year
follow-up, 94% of the women in the LNG-IUS group and 93% of women
in the hysterectomy group were satisfied with treatment.
9. Clinical Claim
The submission claimed that LNG-IUS is an effective alternative to
initial hysterectomy and in contrast to hysterectomy, LNG-IUS is
10. Economic Analysis
A preliminary economic evaluation was presented using a
cost-minimisation approach. The trial based incremental cost
(LNG-IUS compared to hysterectomy) was estimated to provide savings
to the health care system.
The submission did not present a modelled economic evaluation.
11. Estimated PBS Usage and Financial Implications
The submission estimated the financial cost/year to the PBS to be
< $10 million in Year 2 of listing. The submission estimated the
likely number of patients/year to be < 10,000 in Year 2.
12. Recommendation and Reasons
The PBAC considered that levonorgestrel IUD has a place in the
treatment of menorrhagia and accepted that a number of patients
would progress to have a hysterectomy despite its use.
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.
LEVONORGESTREL, intrauterine drug delivery system 52 mg (releasing approximately 20 micrograms per 24 hours)
Add the following to the restriction:
Idiopathic menorrhagia where oral treatments are ineffective;
Idiopathic menorrhagia where oral treatments are contra-indicated.Maximum Quantity: 1
13. Context for Decision
The PBAC helps decide whether and, if so, how medicines should be
subsidised in Australia. It considers submissions in this context.
A PBAC decision not to recommend listing or not to recommend
changing a listing does not represent a final PBAC view about the
merits of the medicine. A company can resubmit to the PBAC or seek
independent review of the PBAC decision.
The sponsor chose not to make any comments.