Modifying funded access to mifepristone and misoprostol

Medicines

Decision

We are seeking feedback on a proposal to change funded access arrangements to two medicines currently listed on the Pharmaceutical Schedule that are used for medical abortion.

We are seeking feedback on a proposal to change funded access arrangements to two medicines currently listed on the Pharmaceutical Schedule that are used for medical abortion – mifepristone and misoprostol, noting that misoprostol is unregistered for this indication.

Facilitating funded access in the community to these medicines would support the changes enacted by Parliament in the Abortion Legislation Act 2020.

This consultation process seeks feedback relating to PHARMAC’s proposal to make mifepristone available in a community setting and make an amendment to the listing of misoprostol.  Submitters should note that the consultation does not cover the changes to the Abortion legislation, or where and how procedures can take place; these matters fall outside PHARMAC’s scope of responsibility.

Consultation closes at 5 pm on Friday, 29 May and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

Modifying funded access to mifepristone and misoprostol means that these pharmaceuticals would be available for use by qualified health practitioners who may provide medical abortion services in community or primary care settings.

Health practitioners authorised to provide abortion services could order mifepristone and misoprostol on a Practitioner’s Supply Order (PSO), meaning that they would have these pharmaceuticals on hand. This means that patients would not have to take a prescription to a pharmacy to get the medicines dispensed.

Who we think will be interested

  • Heath Practitioners authorised to provide medical abortion services (includes doctors, midwives, nurse practitioners)
  • Pharmaceutical suppliers
  • District Health Boards
  • Pharmacists

About this proposal

On 24 March 2020 the Abortion Legislation Act 2020 came into force. This amends the law to better align the regulation of abortion services with other health services.

The previous legislative framework that applied to abortion in New Zealand was set out in the Crimes Act 1961 and the Contraception, Sterilisation, and Abortion Act 1977.

The previous legislative framework allowed an abortion to be performed under certain conditions by specified types of medical practitioners in institutions licensed for this purpose.The Abortion Legislation Act 2020 allows qualified health practitioners to provide abortion services in places other than hospitals and licensed clinics, such as in community and primary care settings.

PHARMAC already funds the two medicines that are currently used for medical abortion – misoprostol and mifepristone – through the Pharmaceutical Schedule as follows:

  • Misoprostol is listed in Section B (community) and Section H (hospital) of the Pharmaceutical Schedule, and it has no funding restrictions. Misoprostol is a registered prescription medicine, and its registered indications are set out in the Medsafe datasheet(external link)
  • Mifepristone is only listed in Section H (hospital) of the Pharmaceutical Schedule and therefore only currently funded when used in DHB hospitals. Mifepristone is a registered prescription medicine, and its registered indications are set out in the Medsafe datasheet(external link)

Why we’re proposing this

The Abortion Legislation Act 2020 permits abortion services to be provided in a range of community settings. However, the relevant pharmaceuticals are not currently funded in such a way as to enable this to occur on a publicly funded basis.

In order to support these legislative changes, and to ensure consistent access to these pharmaceuticals across the country, an amendment to the Pharmaceutical Schedule is proposed.

Details about our proposal

The listing of misoprostol in Section B of the Pharmaceutical Schedule would be amended by enabling it to be supplied on a Practitioners’ Supply Order (PSO), to a limit of one pack (120 tablets) at a time.

Mifepristone would be listed in Section B of the Pharmaceutical Schedule from 1 July 2020 as follows (price and subsidy are ex-manufacturer, and exclusive of GST):

Chemical

Formulation

Brand

Pack size

Price and subsidy

Mifepristone

Tab 200 mg

Mifegyne

3

$180

Mifepristone would be subject to the following subsidy restrictions:

  • Up to 15 available on a PSO
  • Only on a PSO

PSOs are a mechanism for provision of funded community pharmaceuticals to ensure they are available for emergency use, teaching and demonstration purposes and for provision to certain patient groups where an individual prescription is not practicable. PSOs are most commonly used for this purpose in general practice.

Provision of misoprostol and mifepristone on PSO would mean that patients would not need to present a prescription to a pharmacy and would instead be given these treatments directly by the abortion services provider.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5 pm on Friday, 29 May 2020.

All feedback received before the closing date will be considered by PHARMAC prior to making a decision on this proposal.

This consultation process is limited to feedback relating to PHARMAC’s proposal to make mifepristone available in a community setting and amendment to the listing of misoprostol.  Submitters should note that the consultation does not cover the changes to the Abortion legislation, or where and how procedures can take place; these fall outside PHARMAC’s scope of responsibility.

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.