Special Authority Quick Guide for SGLT2 inhibitors for type-2 diabetes

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He Ako Hiringa
25 January 2021

This is a quick guide to the Special Authority criteria for the newly funded (1 Feb 2021) SGLT2 inhibitor empagliflozin (Jardiance®) and empagliflozin with metformin (Jardiamet®). Additionally, the GLP1 agonist dulaglutide (Trulicity®), once it gains Medsafe approval for use in New Zealand, will also be funded under these Special Authority criteria.

Special Authority criteria for subsidy of empagliflozin, empagliflozin with metformin, or dulaglutide

Initial application from any relevant practitioner (including GPs, nurse practitioners and pharmacist prescribers). Approvals valid without further renewal unless notified for applications meeting the following criteria1:

All of the following:

1. Patient has type 2 diabetes; and

2. Any of the following:

  • 2.1 Patient is Māori or any Pacific ethnicity; or
  • 2.2 Patient has pre-existing cardiovascular disease or risk equivalent*; or
  • 2.3 Patient has an absolute 5-year cardiovascular disease risk of 15% or greater according to a validated cardiovascular risk assessment calculator; or

  • 2.4 Patient has a high lifetime cardiovascular disease risk due to being diagnosed with type 2 diabetes during childhood or as a young adult; or

  • 2.5 Patient has diabetic kidney disease **; and

3. Target HbA1c (of 53 mmol/mol or less) has not been achieved despite the regular use of at least one blood-glucose lowering agent (eg, metformin, vildagliptin, or insulin) for at least 3 months; and

4. SGLT2 therapy will not be funded if patient is taking a funded GLP1, and vice versa.

Criteria 2.1 – 2.5 describe patients at high risk of cardiovascular or renal complications of diabetes.

* Defined as: prior cardiovascular disease event (ie, angina, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, transient ischaemic attack, ischaemic stroke, peripheral vascular disease), congestive heart failure or familial hypercholesterolaemia.

** 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.

Click here to read the updated New Zealand Society for the Study of Diabetes (NZSSD) guidance on the management of type 2 diabetes, which includes the new medicines.

1. PHARMAC press release 21 December 2020.