TGA approves extended use of Bayer’s longest-acting contraceptive: What will it take to boost uptake?

Pharma News: Bayer has received regulatory approval from the Therapeutic Goods Administration (TGA) to extend the use of Mirena (52mg levonorgestrel IUD) for contraception from five to eight years. There has been no change to the duration of use for the treatment of heavy menstrual bleeding (5 years) or for endometrial protection (4 years).

Sexual and reproductive health are fundamental human rights that play a crucial role in empowering women and achieving gender equality. Ensuring universal access to sexual and reproductive health services is essential for this goal. Globally, around 40% of pregnancies are unintended, leading to significant negative consequences for women, their families, and society.

Since its introduction in 1990, Mirena has played a key role in shaping women’s healthcare.

Professor Deborah Bateson, Professor of Practice at the Faculty of Medicine and Health, University of Sydney, and former Medical Director at Family Planning NSW, welcomed the approval. She believes it may help increase the relatively low rate of long-acting reversible contraceptive (LARC) use in Australia.

“Mirena is now the longest-acting hormonal contraceptive, providing women up to eight years of contraception, with the option of removal at any time,” said Professor Bateson.

She further added, “Extending the duration for which Mirena can be used for contraception will hopefully accelerate the adoption of LARCs, where Australia lags many other countries. The longer a contraceptive works, the more appealing an option it may become for many women. 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.”

The decision to extend Mirena’s use was based on the phase III Mirena Extension Trial, which evaluated its contraceptive efficacy and safety between five and eight years. The study demonstrated that Mirena’s contraceptive efficacy remains greater than 99% during years six to eight and confirmed that its safety profile was maintained with no new or unexpected findings.

“With contraception, effectiveness is the primary consideration. However, practicality should also factor heavily into decision-making,” explained Professor Bateson. “The challenge is that most women are simply not offered the option of long-acting reversible contraception.”

LARC usage remains relatively low in Australia, at just 10.8%, compared to 46% in the United Kingdom. This discrepancy is largely due to the fact that women in Australia are not typically offered LARC options during contraceptive consultations in primary care.

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) refers to LARC as “highly cost effective” where “increased availability and uptake has the potential to result in enormous cost savings”.

Professor Bateson said “GPs, nurse practitioners, and pharmacists all have a role to play in facilitating informed contraceptive choice. We know that currently, only seven percent of contraceptive consultations in general practice involve discussion of LARCs. 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.”

Professor Bateson supports expanding the scope of practice for nurses to include LARC insertion and removal, along with the Senate Inquiry into Universal Access to Reproductive Healthcare recommendations for greater professional training and increased Medical Benefits Scheme (MBS) funding for LARC procedures.

“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.”

According to RANZCOG, public hospital services for contraception are important to ensure equity of access across Australia. Increasing access to free outpatient contraceptive procedures, especially in rural and remote areas is key to reducing disparities that currently exist with rural women being 1.4 times more likely to have an unintended pregnancy. Such services need to include IUD insertions, ultrasound-guided IUD removal, office hysteroscopy for complex IUD removals, and ultrasound-guided impalpable implant removal.

Manoj Saxena, CEO of Bayer ANZ and Country Division Head for the Pharmaceutical Division, stated “As a leading company in women’s healthcare, Bayer is committed to offering modern innovations as well as advances in the use of trusted products like Mirena, which has been used in Australia for more than 20 years.

“Six decades after the introduction of oral contraception, it is concerning that more than a quarter of pregnancies in Australia are unintended. Experts agree that greater utilisation of long-acting reversible contraceptives is one of the most effective strategies to address this issue.”

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