Modifying funded access to mifepristone and misoprostol

Source: Pharmac

• List mifepristone in Section B of the Pharmaceutical Schedule, enabling it to be supplied on a Practitioners’ Supply Order (PSO).
• Amend the listing of misoprostol in Section B of the Pharmaceutical Schedule, enabling it to be supplied on a Practitioners’ Supply Order (PSO).

The above listings will be subject to temporary restrictions, with supply on a PSO limited to Family Planning New Zealand Clinics and abortion service providers with a DHB contract.

These changes will be effective from 1 August 2020.

These medicines will be funded and on-hand for qualified health practitioners who provide medical abortion services in Family Planning New Zealand Clinics or in DHB contracted clinics. People using these services will not have to take a prescription to a pharmacy to get these medicines dispensed.

Any changes to the original proposal? 

The decision was subject of a consultation letter dated 20 April 2020.

Following consultation feedback and advice from suppliers and clinicians, we have made some changes to the proposed listings that were consulted on.

Both mifepristone and misoprostol supply on PSO will be subject to the following criteria:

“Subsidised on a PSO only if from a Family Planning New Zealand Clinic or an abortion service provider with a DHB contract and the PSO is endorsed with the name of the institution for which the PSO is required.”

The endorsement requirements for PSO are intended to be a temporary arrangement to support a smooth transition to community provision of early medical abortions – allowing time for clinical guidelines and standards to be implemented, and to afford the supply chain time to respond to changes in demand. We expect to remove these endorsement requirements within 4 to 6 months. This would widen funding to all eligible prescribers.

Who we think will be most interested

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

Detail about this decision

The following changes will occur in Section B of the Pharmaceutical Schedule.

Mifepristone tablets (Mifegyne) will be listed in Section B of the Pharmaceutical Schedule from 1 August 2020 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Price and subsidy
Mifepristone	200 mg tablet	Mifegyne	3	$180.00

The following subsidy restrictions will apply to mifepristone tab 200 mg in Section B of the Pharmaceutical Schedule from 1 August 2020:

a) Up to 15 tab available on a PSO

b) Only on a PSO

Subsidised on a PSO only if from a Family Planning New Zealand Clinic or an abortion service provider with a DHB contract and the PSO is endorsed with the name of the institution for which the PSO is required.

The listing of misoprostol tab 200 mcg in Section B of the Pharmaceutical Schedule will be amended from 1 August 2020 as follows:

Up to 120 tab available on a PSO

Subsidised on a PSO only if from a Family Planning New Zealand Clinic or an abortion service provider with a DHB contract and the PSO is endorsed with the name of the institution for which the PSO is required.

Note that we expect to remove these endorsement requirements within 4 to 6 months.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. All consultation responses received were considered in their entirety in making the decision to modify funded access to mifepristone and misoprostol.

Responses were generally supportive of the proposal. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you are set out below. 

Theme	PHARMAC Comment
Fully support the proposal
Responders noted that this proposal would result in improved privacy and convenience, with better access for people in remote areas and fewer surgical interventions. They considered that the proposed approach would help mitigate social and cultural obstacles to accessing abortion services. Responders considered that the proposal would help to reduce inequities and would be particularly beneficial to individuals with low incomes.	We note that the decision will result in an increase in the number of locations that can provide access to medical abortion services, resulting in more consistent access around the country.
Guidelines and clinical standards
Some responders stated that guidelines and clinical standards would need to be developed to support safe and proper use of these medicines for early medical abortion in primary care and community settings.	We are aware that guidelines and clinical standards to support early medical abortion in the primary/community setting are under development by relevant colleges. In light of this consultation feedback, we have made some changes to the proposed funding arrangements that were consulted on. There will be a temporary endorsement requirement for 4 to 6 months before funding is widened to all eligible prescribers, allowing time for clinical guidelines and standards to be implemented.
Availability on prescription
Some responders considered that medicines used in early medical abortion should be available on prescription, as well as on PSO, to provide further access options for people. Other responders stated that these medicines should not be available on prescription to protect patient privacy and to avoid barriers, extra steps and cost for those accessing abortion services.	The majority of responders supported these products only being available on PSO. However, there are some outstanding issues relating to telemedicine in particular that we will need consider for these (and other) products in the future.
Prescribing legislation
Responders were concerned that non-medical practitioners will be excluded from using misoprostol under s29 of Medicines Act 1981.	Misoprostol is a registered (approved) medicine (i.e. it is not a s29 medicine), although is unapproved for obstetric indications. Please refer to Medsafe for information on the unapproved use of approved medicines under the Medicines Act 1981.(external link)
Funding in primary care
Some responders suggested that funding should be provided to cover extra GP appointments for abortion services.	These matters fall outside PHARMAC’s scope of responsibility. We will forward these comments to the Ministry of Health.
Do not support the proposal
Some responders did not support widening access to abortion services for a range of reasons, including concerns about mental health and safety.	Most responders consider use of mifepristone and misoprostol in early medical abortion to be safe and in line with international best practice.

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 660 050.

MIL OSI