‘An excellent change’: Dapagliflozin PBS access expanded

More diabetes patients now have access to dapagliflozin under the Pharmaceutical Benefits Scheme (PBS), with restrictions easing on its use with metformin this month.
 
The change means there is now no specific unmet glycaemic target required for the use of the sodium–glucose cotransporter 2 (SGLT2) inhibitor as an add-on therapy to metformin for patients with type 2 diabetes.
 
The criteria for PBS access to dapagliflozin – which goes under the tradename Forxiga – now includes type 2 diabetes patients at risk of cardiovascular disease (CVD), as well as those with CVD, and Aboriginal and Torres Strait Islander patients.
 
Dr Michael Tam, a New South Wales GP and member of the RACGP Expert Committee – Quality Care, welcomed the expanded PBS listing.
 
‘This is an excellent change that improves access … it follows the evidence,’ he told newsGP.
 
‘It reduces the administrative load of GPs regarding compliance to more arbitrary rules rather than clinical judgement.’
 
The shift, which was approved by the Pharmaceutical Benefits Advisory Committee (PBAC) in July, brings the medication’s availability on the PBS in line with RACGP recommendations and the Australian evidence-based clinical guidelines for diabetes.
 
‘We recommend the addition of an SGLT2 inhibitor to other glucose lowering medication(s) in adults with type 2 diabetes who also have cardiovascular disease, multiple cardiovascular risk factors and/or kidney disease,’ the latter documents states.
 
Dapagliflozin is known to act as an effective glucose lowering agent with manageable risks and is also indicated by the Therapeutic Goods Administration for preventing heart failure hospitalisations in adults with type 2 diabetes.
 
The RACGP diabetes management guidelines emphasise the impact of CVD among the cohort.
 
‘CVD is the leading cause of death in people with diabetes, making the assessment, prevention and management of CVD risk a vital part of diabetes care,’ the guidelines state.
 
Patients with type 2 diabetes defined as having multiple cardiovascular risk factors are men over 55 and women over 60 with one or more traditional risk factors such as hypertension, dyslipidaemia, or smoking.
 
The PBAC says high CVD risk is defined as having an estimated risk of a cardiovascular event of more than 10% over five years.
 
In its notes recording the decision to expand access, the PBAC said it is satisfied that the use of SGLT2 inhibitors gives ‘a significant improvement in efficacy’ compared to the use of sulfonylureas as add-on therapy to metformin.
 
The PBAC has previously deferred a recommendation to expand access due to concerns over cost and cost-effectiveness.
 
It said those concerns would be addressed with a 15% price cut to SGLT2 inhibitors used for type 2 diabetes indications.
 
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