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

Medicines

Consultation Closed

We are proposing to widen access to levonorgestrel intrauterine systems (LIUS), brand name Mirena, and list a new LIUS, brand name Jaydess.

If the proposal is approved, the following would occur from 1 November 2019:

  • the Special Authority and Hospital restrictions for LIUS 52 mg (Mirena) would be removed
  • a new LIUS 13.5 mg (Jaydess) would be funded with no restriction
  • Bayer (the supplier of Mirena and Jaydess) would be awarded sole supply, meaning that Mirena Jaydess would be the only funded brands of LIUS from 1 November 2019 until 31 October 2022
  • the overall net price of LIUS per person would reduce.

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, endometrosis* (*unapproved indication) and endometrial hyperplasia without atypia.

This proposal results from a request for proposals (RFP) issued in May 2019 for the supply of funded LIUS. It would improve funded access and provide a choice of a 3-year or 5-year option for a long-acting reversible contraceptive.

Feedback to this consultation will help us decide if this proposal should be approved. 

Consultation closes at 5 pm on Monday, 16 September 2019 and feedback can be emailed to consult@pharmac.govt.nz.

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.

Who we think will be interested

  • People needing contraception or treatment for heavy menstrual bleeding, endometriosis or endometrial hyperplasia
  • Whānau of people needing an LIUS
  • General practitioners, other primary care prescribers, nurses, midwives, obstetricians and gynaecologists, sexual health physicians, interested clinician groups
  • Family planning, sexual health clinics and student health
  • Hospital and community pharmacies, DHBs and wholesalers
  • Suppliers of contraceptives

About levonorgestrel intrauterine systems

LIUS is a hormone-releasing intrauterine device that consists of a T-shaped plastic frame that is inserted into the uterus and releases levonorgestrel.

There are different strengths of LIUS available. LIUS 52 mg (Mirena) has been listed on the Pharmaceutical Schedule since 2002 with funding restricted to heavy menstrual bleeding. It is also currently available in the hospital setting for treatment of endometriosis. There are currently no other strengths funded.

Product information

Presentation

Brand

Device details

Uses

LIUS 52 mg

Mirena(external link)

Device contains 52 mg

Delivers 20 mcg per day

Use for 5 years

contraception

heavy menstrual bleeding

prevention of endometrial hyperplasia during oestrogen replacement therapy

endometriosis*

LIUS 13.5 mg

Jaydess(external link)

Device contains 13.5 mg

Delivers 6 mcg per day

Use for 3 years

contraception

*unapproved indication


The device is inserted and removed by a trained health professional. People currently access this service through their GP, Family Planning clinic or specialist service, and costs for insertion and removal may vary.

Why we’re proposing this

PHARMAC released a Request for Proposal (RFP) for the supply of levonorgestrel intrauterine systems (LIUS) in the community and DHB hospitals on 6 May 2019.  

We sought proposals to secure supply of LIUS and to determine if widened funded access to LIUS would be possible.

Funding applications to widen access to LIUS were considered by the Pharmacology and Therapeutics Advisory Committee (PTAC) in February 2018, and by the Reproductive and Sexual Health Subcommittee of PTAC in April 2017. PTAC and the Subcommittee recommended that LIUS for contraception, heavy menstrual bleeding, endometrial hyperplasia without atypia, and endometriosis be funded with high priority.

PTAC and the Subcommittee also considered that it would be appropriate to fund either a three-year or a five-year LIUS for any or all of these indications, taking into account the relevant Medsafe approved indications.

More information, including links to the PTAC and Subcommittee minutes can be found in the Application Tracker records for levonorgestrel intrauterine system(external link).

As a result of the RFP, PHARMAC has entered into a provisional agreement with Bayer New Zealand Limited for the sole supply of LIUS (Mirena and Jaydess).

This proposal would:

  • secure supply and cost of LIUS;
  • improve funded access for people for all uses; and,
  • provide a choice of a 3-year or 5-year option for reversible contraception.

Feedback to this consultation will help us decide if this agreement should be confirmed.

Details about our proposal

Funded access to LIUS would be widened from 1 November 2019:

  • Special Authority criteria and hospital medicines restrictions for the LIUS 52 mg presentation would be removed.
  • A new LIUS 13.5 mg presentation would be listed.

Mirena and Jaydess would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 November 2019 at the following prices (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Proposed price and subsidy

Levonorgestrel

Intra-uterine device system 52 mg

Mirena

1

$269.50

Levonorgestrel

Intra-uterine device system 13.5 mg

Jaydess

1

$215.60

A confidential rebate would apply to Mirena and Jaydess that would reduce the net price to the Funder.

From 1 November 2019, Mirena and Jaydess would be awarded Sole Subsidised Supply status in the community and Hospital Supply Status in the hospital (subject to a 1% DV limit) until 31 October 2022. This would mean that Mirena and Jaydess would be the only funded brands until 31 October 2022.

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

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5 pm on Monday, 16 September 2019.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.