Decision to fund β-hCG low sensitivity urine test kits

12 November 2024

Medicines Decision

What we’re doing

We're pleased to announce a decision to fund β-hCG low sensitivity urine test kits, brand name CheckToP, supplied by Istar Limited from 1 December 2024.

The Government provided additional funding to Pharmac in June 2024 to fund new medicines and widen access to medicines that are already funded. The funding increase covers medicines for both cancer and non-cancer health conditions. This decision is one of many that we’re working on to put our budget increase into action.

Questions and answers on budget increase

Who we think will be interested

People who have accessed health care services where medical abortions are provided, their whānau, partners, friends and caregivers.
Obstetricians, gynaecologists, general practitioners, clinical nurse specialists, nurse practitioners, midwives, pharmacists, and other healthcare professionals who work in reproductive and sexual health or sexual assault services.
Telehealth services
Groups who support people with their sexual and reproductive health.
Health NZ | Te Whatu Ora hospitals.
Pharmacies and wholesalers.
Pharmaceutical suppliers.

What does this mean for people?

From 1 December 2024 CheckToP test kits will be funded for use both in the community and in Health New Zealand | Te Whatu Ora hospitals. CheckToP test kits are a specific type of urine test kits that can be used following a medical abortion, instead of a blood test. CheckToP test kits will be available via prescription and on a practitioner supply order (PSO).

We anticipate around 9,300 people will use these test kits, rather than blood tests, in the first year of funding.

Any changes to the original proposal?

This decision was subject to a consultation letter released on 15 October 2024. We received feedback from clinicians, medical colleges, suppliers, patient support groups, and consumers.

We’re grateful to those who took the time to respond to our consultation. This is an important part of our decision-making process. It gives us the opportunity to listen to the voices of the community and acknowledge and respond to feedback. The feedback received was supportive of the proposal.

We have not made any changes to the availability of β-hCG low sensitivity urine test kits following consultation. We received some requests for additional resources and training for health care professionals and for people who use the test kit. Based on the feedback received, we will work with sector education providers such as HealthPathways to ensure there is publicly available information to support people using β-hCG low sensitivity urine test kits. Pharmac will also work with the supplier to determine what educational resources are available to Health Care works and users.

We have also provided anonymised feedback to the Ministry of Health’s DECIDE(external link), national telehealth abortion services, who provide advice and resources for people who are seeking an abortion.

A summary of the feedback and our responses to this are detailed below.

Details of this decision

β-hCG low sensitivity urine test kits, brand name CheckToP, will be listed in Section B and Part III of Section H of the Pharmaceutical Schedule from 1 December 2024 as follows:

Presentation	Formulation	Brand	Pack Size	Price and Subsidy
beta-hCG low sensitivity urine test kit	Midstream	CheckToP	1 test OP	$16.28

This listing will be subject to the following note in Section B and Part III of Section H:

Note: for use in abortion services only.

Up to 15 CheckToP test kits will also be available on Practitioner Supply Order (PSO).

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. Responses were largely supportive of the proposal.

Theme	Pharmac Comment
Support for the proposal noting that the funding of this product supports the management of abortion in home and community settings – particularly in rural communities. It would also create greater autonomy, reduce barriers and result in positive outcomes across health and socio-economic spaces. This proposal would save consumers travel costs and time off work, may help to reduce loss to follow up. Low sensitivity tests are currently used in abortion care regularly. Suitable test kits are crucial for safe healthcare provision for an often-vulnerable population. Individuals tend to find the urine tests more suitable than blood tests.	We appreciate this feedback and are pleased to be funding a proposal that benefits New Zealanders. The advice we have received is that funding low sensitivity urine tests will provide a number of benefits to people, their families, and the wider health system. It is encouraging to hear the support for this proposal and ease of use for people requiring this urine test kit.
Respondents considered the price for the test kit to be expensive and considered there may be other suppliers in the market.	This decision means individuals will not have to pay for a urine test themselves. The CheckToP brand will now be publicly funded for use in abortion services. Pharmac is not aware of any other potential suppliers of a low sensitivity urine tests. This item was included in Pharmac’s 2023/24 Annual Invitation to Tender. However, Pharmac did not secure supply of a product through this process. This decision to fund the CheckToP brand does not stop Pharmac from funding alternative low sensitivity urine tests in the future.
Questions about the evidence for device sensitivity, specificity, accuracy or user friendliness.	We understand the CheckToP brand of low sensitivity urine test is widely used in private services in New Zealand and internationally for abortion care. We also received feedback from service providers who provide the kit to individuals. Their feedback supported the use of this test and highlighted data to support the ‘user friendliness’ of the urine test kit. We will work closely with the supplier and relevant regulator if we receive any feedback by users of this product.
Feedback regarding information needed to support healthcare professionals prescribing β-hCG low sensitivity urine test kit: Training on use. How to order. When to use and when not to use the test. What should be involved in follow-up. Contact information for the abortion provider if there are any issues with the tests. Including a link to BPAC article on EMA for reference. Update to Ministry of Health clinical guidelines on abortion care recommendations. Update the Ministry of Health EMA training module.	Pharmac will work with the supplier to determine what resources it is able to provide. We have shared anonymised feedback with the Ministry’s DECIDE national abortion services. In addition, we will collaborate with other sector partners and government agencies including HealthPathways to ensure there is appropriate guidance available for prescribers to support the use of β-hCG low sensitivity urine test kits. We understand that the availability of CheckToP will not reduce the requirement for follow-up with a person who has had an abortion. Instead, it will provide an alternative testing approach, which will improve the likelihood that post-abortion testing is completed.
Feedback regarding information needed to support people using a β-hCG low sensitivity urine test kit: Clear infographic information in an accessible form. Information on how to do the test in various languages. What to do with positive or negative results. A video of how to use the device and an information leaflet on how to use it. Contact information for the EMA provider to contact if there are any issues in taking the test.	Pharmac will work with the supplier to determine what resources it is able to provide and has shared this feedback with the Ministry’s DECIDE national abortion services. In addition, we will work with sector education providers, such as HealthPathways, to ensure there is publicly available information to support people using β-hCG low sensitivity urine test kits.
Feedback about funding and fees. Additional funding should be made available to provide abortion services in primary care. The test should be free and not subject to dispensing fees.	Pharmac is not responsible for funding additional services, such as abortion services in primary care. This is determined by the Ministry of Health. We have shared this feedback to the Ministry. If the test is dispensed via Practitioner’s Supply Order (PSO), there will be no charge for the dispensing to the person. However, if the prescription is dispensed via a community pharmacy, a dispensing fee may apply. This is consistent with the dispensing pathways for medicines used in medical abortion. Pharmac does not determine the dispensing fees for medicines dispensed through community pharmacy. This is determined by the Ministry of Health. We have provided this feedback to the Ministry’s national abortion service DECIDE.
It’s important that tests can be accessed by midwives, GPs, and Nurse Practitioners.	CheckToP will be listed in Section B on the Pharmaceutical Schedule, available via prescription and Practitioner’s Supply Order (PSO). Midwives, GPs and Nurse Practitioners will be able to prescribe and order the tests for use in the community.

Theme

Pharmac Comment

Support for the proposal noting that the funding of this product supports the management of abortion in home and community settings – particularly in rural communities.

It would also create greater autonomy, reduce barriers and result in positive outcomes across health and socio-economic spaces.

This proposal would save consumers travel costs and time off work, may help to reduce loss to follow up.

Low sensitivity tests are currently used in abortion care regularly.

Suitable test kits are crucial for safe healthcare provision for an often-vulnerable population.

Individuals tend to find the urine tests more suitable than blood tests.

We appreciate this feedback and are pleased to be funding a proposal that benefits New Zealanders. The advice we have received is that funding low sensitivity urine tests will provide a number of benefits to people, their families, and the wider health system. It is encouraging to hear the support for this proposal and ease of use for people requiring this urine test kit.

Respondents considered the price for the test kit to be expensive and considered there may be other suppliers in the market.

This decision means individuals will not have to pay for a urine test themselves. The CheckToP brand will now be publicly funded for use in abortion services.

Pharmac is not aware of any other potential suppliers of a low sensitivity urine tests. This item was included in Pharmac’s 2023/24 Annual Invitation to Tender. However, Pharmac did not secure supply of a product through this process.

This decision to fund the CheckToP brand does not stop Pharmac from funding alternative low sensitivity urine tests in the future.

Questions about the evidence for device sensitivity, specificity, accuracy or user friendliness.

We understand the CheckToP brand of low sensitivity urine test is widely used in private services in New Zealand and internationally for abortion care.

We also received feedback from service providers who provide the kit to individuals. Their feedback supported the use of this test and highlighted data to support the ‘user friendliness’ of the urine test kit.

We will work closely with the supplier and relevant regulator if we receive any feedback by users of this product.

Feedback regarding information needed to support healthcare professionals prescribing β-hCG low sensitivity urine test kit:

Training on use.
How to order.
When to use and when not to use the test.
What should be involved in follow-up.
Contact information for the abortion provider if there are any issues with the tests.
Including a link to BPAC article on EMA for reference.
Update to Ministry of Health clinical guidelines on abortion care recommendations.
Update the Ministry of Health EMA training module.

Pharmac will work with the supplier to determine what resources it is able to provide. We have shared anonymised feedback with the Ministry’s DECIDE national abortion services.

In addition, we will collaborate with other sector partners and government agencies including HealthPathways to ensure there is appropriate guidance available for prescribers to support the use of β-hCG low sensitivity urine test kits.

We understand that the availability of CheckToP will not reduce the requirement for follow-up with a person who has had an abortion. Instead, it will provide an alternative testing approach, which will improve the likelihood that post-abortion testing is completed.

Feedback regarding information needed to support people using a β-hCG low sensitivity urine test kit:

Clear infographic information in an accessible form.
Information on how to do the test in various languages.
What to do with positive or negative results.
A video of how to use the device and an information leaflet on how to use it.
Contact information for the EMA provider to contact if there are any issues in taking the test.

Pharmac will work with the supplier to determine what resources it is able to provide and has shared this feedback with the Ministry’s DECIDE national abortion services.

In addition, we will work with sector education providers, such as HealthPathways, to ensure there is publicly available information to support people using β-hCG low sensitivity urine test kits.

Feedback about funding and fees.

Additional funding should be made available to provide abortion services in primary care.
The test should be free and not subject to dispensing fees.

Pharmac is not responsible for funding additional services, such as abortion services in primary care. This is determined by the Ministry of Health. We have shared this feedback to the Ministry. If the test is dispensed via Practitioner’s Supply Order (PSO), there will be no charge for the dispensing to the person. However, if the prescription is dispensed via a community pharmacy, a dispensing fee may apply. This is consistent with the dispensing pathways for medicines used in medical abortion.

Pharmac does not determine the dispensing fees for medicines dispensed through community pharmacy. This is determined by the Ministry of Health. We have provided this feedback to the Ministry’s national abortion service DECIDE.

It’s important that tests can be accessed by midwives, GPs, and Nurse Practitioners.

CheckToP will be listed in Section B on the Pharmaceutical Schedule, available via prescription and Practitioner’s Supply Order (PSO). Midwives, GPs and Nurse Practitioners will be able to prescribe and order the tests for use in the community.

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.