Proposal to widen access to levonorgestrel intrauterine (LIUS) systems (Mirena and Jaydess)

What would the effect be?

For consumers

From 1 November, people would have a choice of funded LIUS, either the 13.5 mg (for 3 years duration) or 52 mg (for 5 years duration). Both the LIUS 52 mg (Mirena) and LIUS 13.5 mg (Jaydess) would be funded with no restrictions. We estimate that an additional 21,000 people per year would access funded LIUS under this proposal. 

There would be no change to the current funded brand of LIUS 52 mg. People who already have a Mirena inserted would be eligible to access a funded replacement of the same product when their Mirena needs replacing.

Patient’s would need to cover the costs of insertion and removal of the LIUS by their health service provider, unless they are eligible for subsidised insertion or removal.

For prescribers

From 1 November 2019, any prescriber would be able prescribe either presentation of LIUS for any appropriate use. Jaydess is only used for contraception, whereas Mirena is used for contraception as well as other indications such as the management of heavy menstrual bleeding, endometriosis and endometrial hyperplasia without atypia.

There would be no change to the current funded brand of LIUS 52 mg.

The supplier would continue to be responsible for providing comprehensive training (for insertion and removal) for clinicians nationwide for the use of Mirena and Jaydess.

For community pharmacies

From 1 November 2019, people would no longer need a Special Authority approval to access funded LIUS. There would be no change to the current list price of LIUS 52 mg. Mirena and Jaydess would be the only funded brands of LIUS in the community setting.

For hospital pharmacies

From 1 November 2019, there would be no funding restrictions for LIUS in the hospital setting. Mirena and Jaydess would be the only funded brands of LIUS in the hospital setting.

For funders and service providers

From 1 November 2019, there would be no funding restrictions for LIUS, and PHARMAC expects this would increase the number of people accessing funded LIUS in both the community and hospital settings. This proposal relates only to the funding of the two LIUS devices. The proposal does not cover any service costs for insertion or removal of LIUS in the hospital and community settings.

PHARMAC staff are aware of local and national funding arrangements for eligible people to have subsidised insertion or removal of LIUS in the community setting and note that the Ministry of Health has implemented initiatives to improve funding in this area. PHARMAC’s proposal would likely see greater utilisation of these funding arrangements.

PHARMAC’s main clinical advisory committee, the Pharmacology and Therapeutic Advisory Committee (PTAC), noted that widening access to LIUS would increase demand to train inserters. Bayer, which is the supplier of Mirena and Jaydess, would continue to provide comprehensive training for clinicians nationwide to support the increased uptake of Mirena and Jaydess.

Bayer would continue to supply free LIUS replacement directly to clinics in the case of device expulsion.

PHARMAC considers all health sector costs when it undertakes its economic analysis, such as insertion/removal costs for the LIUS device. This proposal remained cost-effective even when considering these costs.