Decision to widen access to levonorgestrel intrauterine (LIUS) systems (Mirena and Jaydess)
We’re pleased to announce a decision to widen access to levonorgestrel intrauterine systems (LIUS), brand name Mirena, and list a new LIUS, brand name Jaydess.
This will result in the following changes from 1 November 2019:
- the Special Authority and Hospital restrictions for LIUS 52 mg (Mirena) will be removed
- a new LIUS 13.5 mg (Jaydess) will be funded with no restriction
- Bayer (the supplier of Mirena and Jaydess) will be awarded sole supply, meaning that Mirena and 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 will 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, endometriosis (unapproved indication) and endometrial hyperplasia without atypia.
This decision will improve funded access and provide a choice of a 3-year or 5-year long-acting reversible contraceptive.
Patients would need to cover the costs of insertion and removal of the LIUS by their health service provider.
Any changes to the original proposal?
This decision was subject to a consultation letter released on 1 September 2019
We received an enormous amount of supportive feedback regarding the widening of access to LIUS and want to thank everyone who provided their thoughtful feedback to this consultation. There were no changes made to the original proposal.
Who we think will be most 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, and other interested clinician groups
- Family planning, sexual health clinics and student health
- Hospital and community pharmacies, DHBs and wholesalers
- Suppliers of contraceptives
Detail about this decision
Funded access to LIUS will be widened from 1 November 2019:
- Special Authority criteria and hospital medicines restrictions for the LIUS 52 mg presentation will be removed.
- A new LIUS 13.5 mg presentation will be listed.
Mirena and Jaydess will 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 52 mg | Mirena | 1 | $269.50 |
| Levonorgestrel | Intra-uterine device 13.5 mg | Jaydess | 1 | $215.60 |
A confidential rebate applies to Mirena and Jaydess that reduces the net price to the Funder.
From 1 November 2019, Mirena and Jaydess will 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 means that Mirena and Jaydess will be the only funded brands until 31 October 2022.
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.
Bayer will continue to be responsible for providing comprehensive training (for insertion and removal) for clinicians nationwide for the use of Mirena and Jaydess, and will continue to supply free LIUS replacements directly to clinics in the case of device expulsion.
This decision relates only to the funding of the two LIUS devices and does not cover any service costs for insertion or removal of LIUS in the hospital and community settings.
Our response to what you told us
We’re really grateful for the time people took to respond to this consultation.
A summary of the main themes raised in feedback and our response is provided below:
|
Theme |
PHARMAC comment |
|---|---|
|
PHARMAC received over 250 responses to the consultation to widen access to LIUS, all of which were supportive of the proposal. |
PHARMAC thanks everyone for their thoughtful feedback. |
|
Request funding for consultation, insertion and removal costs. |
PHARMAC is responsible for the funding of pharmaceuticals, while service provision costs are covered through DHB and Ministry of Health funding. PHARMAC plans to share this feedback with the Ministry of Health and other stakeholders involved in the subsidised long-acting reversible contraceptives funding programme that subsidises the fees associated with insertion and removal of the device for low-income people. |
|
Training enough clinicians across all of New Zealand will be important for people to have consistent access. |
Bayer and the Ministry of Health are currently working together to establish training programmes and are aware that training requirements will increase as a result of this decision. PHARMAC will ensure updated education materials are available to primary care through its contract with BPACnz. |
|
Request that Mirena and Jaydess be available on a Practitioner’s Supply Order (PSO). |
PHARMAC understands that currently a minimum of two consultations are required for insertion of LIUS (one to discuss contraceptive options and the suitability of LIUS, and another for the insertion procedure itself). Therefore, availability of LIUS on a PSO would not reduce the number of consult visits for patients. PHARMAC acknowledge patients would have to cover the prescription co-pay fee. PHARMAC considers that it will be important to gather prescribing data for LIUS (which would not be possible on a PSO). |
If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.