Dulaglutide receives Medsafe approval
Dulaglutide will be funded from 1 September 2021.
What we’re doing
We’re pleased to announce that dulaglutide (Trulicity), a GLP-1 agonist supplied by Eli Lilly, will be funded from 1 September 2021 for patients who meet certain eligibility criteria.
The first of these medicines, empagliflozin with and without metformin (Jardiamet and Jardiance), were funded from 1 February 2021.
At that time, we announced that dulaglutide (Trulicity) would be funded as soon as possible following Medsafe approval.
We are able to confirm that there is stock available and that dulaglutide will be listed in the Pharmaceutical Schedule from 1 September 2021.
What does this decision mean for people?
This means from 1 September 2021, people who are at high risk of heart and kidney complications from type 2 diabetes will have funded access to either empagliflozin or dulaglutide, subject to certain access criteria (called Special Authority criteria).
People will not be able to have funded access to both empagliflozin and dulaglutide at the same time. If someone stops treatment with empagliflozin they can start treatment with dulaglutide, and vice versa. A new Special Authority application will be needed for the alternative agent.
Any relevant practitioner, including Nurse Practitioners and Pharmacist Prescribers, will be able to apply for a Special Authority for these medicines.
Details about this decision
Dulaglutide (Trulicity) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from the 1 September 2021 at the following price and subsidy (ex-manufacturer, excluding GST):
Price and subsidy
Inj 1.5 mg per 0.5 ml prefilled pen
Trulicity will be the sole subsidised brand of a GLP-1 agonist for the treatment of type 2 diabetes until at least 30 June 2024. This date could be extended by mutual consent between Pharmac and Eli Lilly until 30 June 2025 and/or 30 June 2026.
Dulaglutide will be listed in Section B of the Pharmaceutical Schedule subject to the following proposed Special Authority criteria:
Special Authority for Subsidy
Initial application from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:
- Patient has previously received an initial approval for an SGLT-2 inhibitor; or
- All of the following:
- Patient has type 2 diabetes; and
- Any of the following:
- Patient is Māori or any Pacific ethnicity*; or
- Patient has pre-existing cardiovascular disease or risk equivalent (see note a)*; or
- Patient has an absolute 5-year cardiovascular disease risk of 15% or greater according to a validated cardiovascular risk assessment calculator*; or
- Patient has a high lifetime cardiovascular risk due to being diagnosed with type 2 diabetes during childhood or as a young adult*; or
- Patient has diabetic kidney disease (see note b)*; and
- Target HbA1c (of 53 mmol/mol or less) has not been achieved despite the regular use of at least one blood-glucose lowering agent (e.g. metformin, vildagliptin, or insulin) for at least 3 months.
* Criteria intended to describe patients at high risk of cardiovascular or renal complications of diabetes.
- Pre-existing cardiovascular disease or risk equivalent as: prior cardiovascular disease event (i.e. angina, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, transient ischaemic attack, ischaemic stroke, peripheral vascular disease), congestive heart failure or familial hypercholesterolaemia.
- Diabetic kidney disease defined as: persistent albuminuria (albumin:creatinine ratio greater than or equal to 3 mg/mmol, in at least two out of three samples over a 3-6 month period) and/or eGFR less than 60 mL/min/1.73m2 in the presence of diabetes, without alternative cause.
Similar restrictions will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List). Small changes have been made to the empagliflozin Special Authority criteria to align with funding both treatments.
The decision to fund dulaglutide was made at the same time as the funding of empagliflozin. This was subject to a public consultation.
If you have any questions about this decision, you can email us at firstname.lastname@example.org; or call our toll-free number 0800 660 050 (9 am to 5 pm, Monday to Friday).