Sodium-glucose co-transporter 2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists have been recommended
for the treatment of type 2 diabetes for some time, but until now have not been funded in New Zealand. As of 1 February,
2021, empagliflozin, a SGLT-2 inhibitor, is available fully funded for the treatment of people with type 2 diabetes who
are at high risk of cardiovascular disease or renal complications; dulaglutide, a GLP-1 receptor agonist, will be available
once it has Medsafe approval later this year.
To initiate funded empagliflozin or dulaglutide treatment, patients must have type 2 diabetes and meet all of
the following criteria:
- Have at least one of the following characteristics:
- Māori or any Pacific ethnicity; or
- Pre-existing cardiovascular disease (CVD) or risk equivalent*; or
- An absolute five-year CVD risk of ≥ 15% according to a validated cardiovascular risk assessment calculator; or
- A high lifetime cardiovascular risk due to being diagnosed with type 2 diabetes during childhood or as a young adult;
- Diabetic kidney disease†; and
- HbA1c level > 53 mmol/mol despite the regular use of at least one blood-glucose lowering medicine
(e.g. metformin, vildagliptin or insulin) for at least three months; and
- Treatment will not be used in combination with a funded GLP-1 receptor agonist/SGLT-2 inhibitor (as appropriate)
*Defined 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
†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
Patients who are likely to benefit from treatment, but are not eligible for funding
While the Special Authority criteria for empagliflozin and dulaglutide ensure access for those at high risk of cardiovascular
and renal disease, there are patients who are likely to benefit from these medicines who are not eligible for funded treatment,
cardiovascular or renal disease or heart failure with an HbA1c < 53 mmol/mol or eGFR 60 – 90 mL/min without
cardiovascular or renal disease or heart failure who are already taking funded empagliflozin or dulaglutide (i.e.
dual treatment with these medicines is recommended if HbA1c levels remain above target, but only one can be
funded at a time)
are overweight or obese and have HbA1clevels above target despite regular use of or inability to tolerate
metformin, but who do not have cardiovascular or renal disease and are not of Māori or Pacific ethnicity
an HbA1c above target despite regular use of or inability to tolerate metformin and vildagliptin, but who do
not have cardiovascular or renal disease and are not of Māori or Pacific ethnicity
an HbA1c within the target range but where an SGLT-2 inhibitor is preferred to reduce adverse effects, e.g.
weight gain or hypoglycaemia with a thiazolidinedione or sulfonylurea, respectively.
Discuss the recommendation with patients and the option to self-fund treatment, unless there are contraindications or
significant cautions. This may be a challenging conversation to negotiate as there will be patients who are unable to meet
the financial burden of self-funding treatment and may find this distressing.
Choosing between empagliflozin and dulaglutide
The decision to initiate a SGLT-2 inhibitor versus a GLP-1 receptor agonist is based primarily on the predominant co-morbidity,
i.e. CVD, heart failure or diabetic kidney disease, and patient preference, particularly regarding the route of administration
(i.e. oral versus once-weekly injection). If heart failure or diabetic kidney disease predominates, a SGLT-2 inhibitor (i.e.
empagliflozin) is preferred. If they do not, either a SGLT-2 inhibitor or a GLP-1 receptor agonist is recommended; a GLP-1
receptor agonist treatment will likely lead to greater improvements in glycaemic control and weight loss than SGLT-2 inhibitor
treatment. Dual treatment with empagliflozin and dulaglutide is the preferred next step for patients who have an HbA1c level
above target taking one of these medicines alone, however, this is not funded.
For further information on empagliflozin and dulaglutide, see: Best Practice e-Journal - Issue 2
This audit identifies people with type 2 diabetes who are eligible for funded SGLT-2 inhibitor or GLP-1 receptor agonist treatment to ensure
that they are switched to a regimen that includes empagliflozin or dulaglutide.*
* Availability pending Medsafe approval
N.B. While not the focus of this audit, patients who are likely to benefit from empagliflozin or dulaglutide treatment, but are not
eligible for funding, may also be identified. Consider flagging these patients for a discussion about treatment options, including the possibility of self-funding.
Recommended audit standards
Ideally, all patients with type 2 diabetes who are at high risk of cardiovascular or renal complications will be taking empagliflozin or dulaglutide as part of
their diabetes management regimen. However, empaglifozin has only been funded since 1 February, 2021 and dulaglutide is still awaiting Medsafe approval. Therefore,
the first cycle of this audit will help to identify patients who are eligible for funded empagliflozin or dulaglutide treatment and flag them for review; after the
second cycle ideally all eligible patients will be receiving funded treatment.
Identifying eligible patients
All patients aged over 18 years with type 2 diabetes are eligible for inclusion in this audit. Many practitioners will
be able to do this by running a “query” through their PMS. Review the clinical notes (or some practitioners may be able
to include this in their query) to determine whether the patient meets the eligibility criteria for funded treatment based
on their glycaemic control and risk of cardiovascular disease or renal complications, i.e.:
- HbA1c level > 53 mmol/mol despite regular use of at least one blood-glucose lowering medicine (e.g. metformin,
vildagliptin or insulin) for at least three months; AND
- Established CVD or high CVD risk,* diabetic kidney disease or heart failure; OR
- Māori or Pacific ethnicity
*Defined as five-year CVD risk of ≥ 15% or a high lifetime CVD risk due to being diagnosed with
type 2 diabetes during childhood or as a young adult
The number of eligible patients will vary according to your practice demographic. If a large number of results are returned,
a sample size of 30 patients is sufficient for this audit. However, all eligible patients will need to be reviewed subsequently.
Criteria for a positive outcome
A positive result is any eligible patient with type 2 diabetes who is prescribed empagliflozin or dulaglutide.
As empagliflozin has only been funded since February, 2021 and dulaglutide is not yet available (as of March, 2021), it
is likely that only a small number of patients will meet the criteria for a positive result in Cycle 1 of the audit if this
is completed in early to mid-2021. Aim for a higher number of positive results in Cycle 2. Alternatively, you may wish to
set the criteria for a positive result in Cycle 1 as “any patient eligible for funded treatment who is flagged for review”.
Use the sheet provided to record your data.
A positive result is any eligible patient with type 2 diabetes who is prescribed
empagliflozin or dulaglutide. The percentage achievement can be calculated by dividing the number of patients with a positive
result (i.e. ‘YES’ in column G) by the number of patients eligible for treatment (i.e. ‘YES’ in column F).
N.B. if you have been able to build a query in your PMS that only identifies patients eligible for funded treatment, then
you can proceed with the audit using columns G and H only.
The first step to improving medical practice is to identify the criteria where gaps exist between expected and actual performance and then to decide how to change practice.
Once a set of priorities for change have been decided on, an action plan should be developed to implement any changes.
It may be useful to consider the following points when developing a plan for action (RNZCGP 2002).
Problem solving process
- What is the problem or underlying problem(s)?
- Change it to an aim
- What are the solutions or options?
- What are the barriers?
- How can you overcome them?
Overcoming barriers to promote change
- Identifying barriers can provide a basis for change
- What is achievable – find out what the external pressures on the practice are and discuss ways of wdealing with them
in the practice setting
- Identify the barriers
- Develop a priority list
- Choose one or two achievable goals
- No single strategy or intervention is more effective than another, and sometimes a variety of methods are needed to
bring about lasting change
- Interventions should be directed at existing barriers or problems, knowledge, skills and attitudes, as well as performance
Monitoring change and progress
It is important to review the action plan developed previously at regular intervals. It may be helpful to review
the following questions:
- Is the process working?
- Are the goals for improvement being achieved?
- Are the goals still appropriate?
- Do you need to develop new tools to achieve the goals you have set?
Following the completion of the first cycle, it is recommended that practitioners complete the first part of the
activity summary sheet (Appendix 1).
Undertaking a second cycle
In addition to regular reviews of progress with the practice team, a second audit cycle should be completed in order to quantify progress on
closing the gaps in performance.
It is recommended that the second cycle be completed within 12 months of completing the first cycle. The second cycle
should begin at the data collection stage.
Following the completion of the second cycle it is recommended that practices complete the remainder of the
Audit of Medical Practice summary sheet.
Claiming credits for Te Whanake CPD programme requirements
Practice or clinical audits are useful tools for improving clinical practice and credits can be claimed towards the Patient Outcomes (Improving Patient Care and Health Outcomes) learning category of the Te Whanake CPD programme, on a credit per learning hour basis. A minimum of 12 credits is required in the Patient Outcomes category over a triennium (three years).
Any data driven activity that assesses the outcomes and quality of general practice work can be used to gain credits in the Patient Outcomes learning category. Under the refreshed Te Whanake CPD programme, audits are not compulsory and the RNZCGP also no longer requires that clinical audits are approved prior to use. The college recommends the PDSA format for developing and checking the relevance of a clinical audit.
To claim points go to the RNZCGP website: www.rnzcgp.org.nz
If a clinical audit is completed as part of Te Whanake requirements, the RNZCGP continues to encourage that evidence of participation in the audit be attached to your recorded activity. Evidence can include:
- A summary of the data collected
- An Audit of Medical Practice (CQI) Activity summary sheet (Appendix 1 in this audit or available on the
N.B. Audits can also be completed by other health professionals working in primary care (particularly prescribers), if relevant. Check with your accrediting authority as to documentation requirements.