Proposal to fund β-hCG low sensitivity urine test kits
What we’re proposing
We’re asking for feedback on a proposal to fund β-hCG low sensitivity urine test kits, brand name CheckToP, supplied by Istar Limited from 1 December 2024.
Further details on this proposal can be found below.
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 boost covers medicines for both cancer and non-cancer health conditions. This proposal is one of many that we’re working on to put our budget increase into action.
Questions and answers on Pharmac's budget increase
Consultation closes at 5 pm Wednesday 30 October, and feedback can be submitted via our online form or by sending us an email: consult@pharmac.govt.nz
What would the effect be?
CheckToP test kits would be funded from 1 December 2024 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 would be available via prescription and on a practitioner supply order (PSO).
We anticipate around 9,300 people would use these test kits, rather than blood tests, in the first year of funding.
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 New Zealand | Te Whatu Ora hospitals.
- Pharmacies and wholesalers.
- Pharmaceutical suppliers.
About β-hCG low sensitivity urine test kits
A medical abortion (also known as a medical termination) is used to end a pregnancy. In a medical abortion, an individual can take two pills, rather than needing a surgical procedure (known as a surgical abortion).
In New Zealand, people receive blood and urine tests, looking for a hormone called β-hCG (human chorionic gonadotropin). An increase in β-hCG levels can indicate the early stages of pregnancy.
After a medical abortion, it is important to check the pregnancy has ended with follow up testing. Blood tests check there has been a decrease in β-hCG levels, which show that the abortion has been successful.
β-hCG low sensitivity urine tests are different to standard pregnancy tests. They both test β-hCG levels in someone’s urine. However, the tests check different levels of β-hCG. This means they are used for different purposes. A standard pregnancy test is used to confirm someone is pregnant. β-hCG low sensitivity urine tests are used following an abortion, to confirm it has been successful.
CheckToP test kits are designed for at home use following an abortion. Funding a β-hCG low sensitivity urine test kits would help people who have limited access to a blood test facilities or other barriers to healthcare after having an abortion. Some people may still require a blood test or further monitoring following a medical abortion. This will depend on an individual’s circumstances. People would need to talk with their healthcare provider to understand what option is best for them.
More information on β-hCG low sensitivity urine test kits can be found on the supplier’s website(external link).
Why we’re proposing this?
We received a funding application for β-hCG low sensitivity urine test kits in November 2021. We received advice on this application from the Reproductive and Sexual Health Advisory Committee in July 2022 [PDF, 147 KB].
The Committee advised us that about half of people having medical abortions aren’t able to complete the follow-up tests that are needed after an abortion. Two blood tests are needed to check β-hCG levels for people who have undergone an early medical abortion. We understand these tests may create additional barriers for people.
This proposal would allow people who have undergone abortion to access telehealth care and confirm the end of the pregnancy at home. This would reduce the mental and administrative burden, costs and privacy concerns that they may experience with an in-person visit.
In addition, we expect the funding of this test kit would reduce overall costs to the New Zealand health sector, for example from a reduction in blood tests.
Details about our proposal
β-hCG low sensitivity urine test kits, brand name CheckToP, would 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 |
Cassette |
CheckToP |
1 test OP |
$16.28 |
This listing would be subject to the following note in Section B and Part III of Section H:
Note: for use in abortion services only.
CheckToP test kits would also be available on Practitioner Supply Order (PSO).
Pharmac has reached a provisional agreement with Istar for the supply of CheckToP tests. This agreement also includes ongoing supply of mifepristone. There would be no changes to the price or distribution of mifepristone as a result of this agreement.
To provide feedback
We welcome your feedback on this proposal. To submit feedback:
Use our online form or send us an email: consult@pharmac.govt.nz by 5pm Wednesday 30 October.
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.
Your feedback may be shared
When you give feedback on a consultation, your feedback becomes official information that Pharmac holds. Pharmac has legal responsibilities for how we manage this official information, under laws such as the Official Information Act and Privacy Act.
Pharmac may receive a request from people for official information, which could include your feedback. Legally, Pharmac must consider whether your feedback should be released.
We will consider your views when assessing whether the feedback has to be released.
If your feedback is proposed for release, then Pharmac will contact you, unless there is a legal reason that we can't.
Note that Pharmac collects and holds your information in line with our Privacy Statement. Tell us if there is anything about your feedback that you would prefer wasn’t released.