New diabetes medicines: Your questions answered
Empagliflozin (with and without metformin) and dulaglutide are funded for type 2 diabetes. Funding requires a special authority application.
Who can prescribe empagliflozin (with and without metformin) and dulaglutide?
Any prescriber can prescribe these medicines for people, as long as it's within their scope of practice. Scope of practice is the responsibility of the appropriate Council.
PHARMAC does not have a prescriber restriction on these medicines.
Who can apply for Special Authorities for these medicines?
We've made the prescriber types for these Special Authorities as permissive as possible. Anyone who can apply for Special Authorities can apply for these medicines. This includes:
- general practitioners
- diabetes specialists
- nurse practitioners
- pharmacist prescribers.
Diabetes nurse prescribers cannot apply for any Special Authorities at the moment. This a technical issue caused by the IT system the Ministry of Health manages. PHARMAC and the Ministry of Health are discussing this matter. We support nurse prescribers to be able to apply for Special Authorities.
Resources for health care professionals
He Ako Hiringa is developing resources to support prescribers and healthcare professionals. Information for prescribers to understand the medicines and their place in treatment.
The Ministry of Health and the New Zealand Society for the Study of Diabetes (NZSSD) recently updated their guide on managing type 2 diabetes.
What risks do prescribers need to be aware of when prescribing empagliflozin
All medicines come with a level of risk and benefit. For SGLT-2i, including empagliflozin with or without metformin, there is a risk of diabetic ketoacidosis (DKA), including in perioperative use. Medsafe has issued Prescriber Updates about this.
Monitoring and reporting on the use of empagliflozin (with and without metformin) and dulaglutide
We will monitor uptake of these medicines as we usually do. We will also look at the ethnicity of people being prescribed these medicines. We use the Ministry of Health’s data on:
- Special Authority applications
- medicine dispensing.
We hope to publish data on our website so everyone can see how these medicines are prescribed.
When will dulaglutide (Trulicity) be funded?
Dulaglutide will be funded as soon as possible following Medsafe approval. You can check the status of the application on Medsafe's website.
A patient has been self-funding an SGLT-2 inhibitor or a GLP-1 agonist, can they have funded access?
If a patient met the Special Authority criteria before starting the self-funded treatment, they may be eligible for funded treatment. You will need to apply for a Special Authority waiver.
How long is the Special Authority approval valid? Are renewals required?
Special Authority approvals for these medicines are valid without further renewal.
Which cardiovascular (CV) risk calculator should I use?
The Special Authority requires the use of a validated CV risk calculator. We are aware that in some clinical settings different calculators may be used. Examples of validated CV risk calculators include:
- the NZ PREDICT Primary Prevention Equations
- the NZSSD CV risk assessment calculator.
How is childhood/young adult defined?
This criterion is to help identify people who are at exceptionally high risk of cardiovascular and renal complications due to their young age at onset of type 2 diabetes.
We have been unable to identify an internationally accepted definition of young-onset type 2 diabetes. In general, we consider that a person with onset of disease under the age of 25 could be defined as meeting this criterion. However, we know you will use your clinical judgement.
How does PHARMAC define Māori or Pacific Island ethnicity?
Patients define their ethnicity themselves. Ethnicity is recorded as part of everyone’s National Health Index (NHI) and should be in people’s general practice records.
If someone has identified Māori as an ethnicity, that is a defining ethnicity.
Anyone who defines their ethnicity as Samoan, Cook Island Māori, Tongan, Niuean, Tokelauan, Fijian or other Pacific Island would be considered someone with Pacific ethnicity.
Does the prior treatment need to be metformin?
No. Prior treatment could be any other blood glucose-lowering medicine (this could include insulin) appropriate to treat type 2 diabetes. While metformin is generally the first-line pharmacological treatment for people for type 2 diabetes, it may not be suitable for everyone.
Can a patient have funded access to both medicines at the same time?
The Special Authority criteria do not allow for concomitant use of a SGLT-2 inhibitor and GLP-1 agonist.
We would welcome a funding application for the combined use of these medicines, so that we can assess the combination use.
If a patient stops treatment with a SGLT-2 inhibitor, they would be permitted to start treatment with a GLP-1 agonist, and vice versa. You would need to make a new Special Authority application for the alternative agent.
Can patients switch between the two different treatments?
Yes. If a patient stops treatment with one of these medicines, they can be treated with the other medicine. The prescriber will need to submit a new Special Authority application.
How do I know if I can get funded access to these medicines?
Talk to the person who usually prescribes medicines for you, such as your GP, nurse or diabetes specialist. They can advise whether you meet the criteria for funding.
Getting a prescription and filling it
The person who usually prescribes any medicines for you should be able to prescribe these medicines. This could be your diabetes specialist, doctor, nurse practitioner or pharmacist prescriber. You'll need to ask them if they can prescribe these medicines for you. You may have a cost to have a consultation with your prescriber to have the medicine started.
You will need to get a new prescription every 3 months
You may need tests to renew your prescription. Your prescriber will talk to you about the tests you will need. Tests can be a good way to monitor your diabetes and see whether the medicines you are taking are working for you.
Getting to the pharmacy
Your pharmacy will be able to give you 3 months' supply of the medicine with each prescription. This is called all-at-once or 'stat' dispensing. You will need to pay to collect your prescription, this is usually $5.
What is a Special Authority and what does it mean for me?
A Special Authority tells your prescriber who can get funded access to a particular medicine. For very expensive medicines, PHARMAC restricts funded access to only those who are most likely to benefit. We list these criteria in a 'Special Authority'.
Your doctor fills out the Special Authority and sends it to the Ministry of Health.
Do I have to get my Special Authority approval renewed?
No. Once you have a Special Authority approval for these medicines, you do not need a renewal.
More information about empagliflozin (with and without metformin) and dulaglutide
Medsafe is the agency responsible fo ensuring medicines meet standards of safety, quality and efficacy. Medsafe is part of the Ministry of Health. They have 'data sheets' for every approved medicine.
The dulaglutide data sheet won't be available until Medsafe approves the medicine.
Who to contact
Talk to your health professional if you have questions about empagliflozin (with and without metformin) and dulaglutide. They know you and your clinical circumstances and are in the best place to give you advice.