Mirena lifespan extended to eight years

An update to the product information of long-acting acting reversible contraception (LARC) levonorgestrel 52 mg (sold as Mirena) has made it the longest-acting hormonal contraceptive in Australia.
 
The TGA-approved updated label for Mirena extends the contraceptive lifespan of the hormonal intrauterine device (IUD) from five to eight years, with the duration of use for other indications remaining unchanged.
 
RACGP Specific Interests Sexual Health Medicine Chair, Dr Sara Whitburn, told newsGP the development is ‘very exciting news’ and should help increase uptake of the LARC where Australia still lags compared to many other countries.
 
‘We can now add this to our contraceptive counselling shared decision making with patients so they have the option of eight years of contraception and menstrual control, which may be a factor in someone choosing a LARC who may not have before,’ she said.
 
‘The extension [also] means increasing the cost efficacy of a highly effective contraception which significantly reduces period bleeding and pain.
 
‘The upfront cost of the device and insertion is now spread over eight years for patients and they do not need to return for replacement as quickly.’
 
With an average efficacy rate of 99%, Mirena is considered one of the most effective methods of contraception that does not require further interventions such as daily dosing or monthly administration, with the option of removal at any time.
 
While uptake of LARC has been steadily increasing in Australia, overall use remains relatively low.
 
From July 2023 to April 2024, 74,111 services were processed for Medicare item 35503 – the procedure to insert an IUD – compared to 92,789 from July 2022 to June 2023.
 
PBS prescribing data indicates that from 2008–12, use of the Mirena and other IUDs for contraception was between 3.2–6.1% of women. Another survey estimated that just 10.8% of women aged 15–44 years were using a LARC in 2018.
 
University of Sydney Professor Deborah Bateson, who is former Medical Director at Family Planning NSW, said these low rates are mostly due to women not typically being offered LARC options during contraceptive consultations – but GPs are key to facilitating informed contraceptive choice.
 
‘We know that currently, only 7% of contraceptive consultations in general practice involve discussion of LARCs,’ Professor Bateson said.
 
‘It is essential that women of reproductive age are informed of the pros and cons of the full range of contraceptive options; not just the various forms of the pill.’
 
The recent ACCORD study found that a combination of increased training for GPs on contraceptive effectiveness counselling and ‘rapid access’ to LARC insertion services resulted in greater uptake. The authors said that better remuneration and training for IUD insertion would help promote contraceptive options other than the pill, which is seen as the ‘default’.
 
A shortage of healthcare professionals adequately trained to insert LARCs is a barrier to optimal contraceptive use, according to Professor Bateson, who backs the Senate Inquiry into Universal Access to Reproductive Healthcare recommendations for greater healthcare professional training and increased MBS funding for LARC insertion and removal.
 
‘In order to reduce the number of unintended pregnancies in Australia, the number of healthcare professionals trained and prepared to insert LARCs needs to increase,’ she said.
 
‘That will only happen with greater government support for enhanced training through medical peak bodies and MBS funding, including increasing remuneration for insertion and introducing a new item number for removal procedures.’
 
Dr Whitburn agrees.
 
‘Only 9.5% of people using contraception in Australia chose a LARC,’ she said.
 
‘There are multiple reasons for this, but access – including the need to increase the number of clinics and professionals who can insert LARCs – the cost to users and the cost of providing and setting up LARC services, are all barriers.
 
‘Increasing funding for training and supervising training in LARC as well as rebates for insertion and removal would assist by decreasing costs to users and to offsetting costs of providing LARCs.’
 
Bayer’s decision to extend Mirena’s duration of use is based on the Phase III MIRENA Extension Trial, which evaluated the contraceptive efficacy and safety of the IUD between five and eight years.
 
The study showed efficacy remains at more than 99% during years six to eight of use, while its safety profile remained the same, with no new or unexpected safety findings.
 
Professor Bateson hopes the extended contraceptive lifespan will accelerate adoption of LARCs in Australia.
 
‘The longer a contraceptive works, the more appealing an option it may become for many women,’ she said.
 
‘An extra three years of protection with Mirena means not only peace of mind for longer, but it also further increases the convenience and affordability of this highly effective contraceptive.’
 
Dr Whitburn reminds GPs that for their patients currently using Mirena as contraception, it remains effective for eight years, but there are some things to note for those using it for other reasons.
 
‘The Mirena can be used for managing heavy periods for up to eight years, provided it effectively controls bleeding, but if bleeding returns the Mirena can be changed earlier,’ she said.
 
‘It is important to note that if Mirena is used as endometrial protection/progesterone component of menopausal hormone therapy the Mirena still needs to be changed every five years.’
 
The RACGP has a suite of IUD resources to provide guidance and support for GPs offering IUD insertion and associated consultations.
 
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IUD LARC levonorgestrel long-acting reversible contraception Mirena women’s health