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Drug expanded on PBS for CKD treatment
GPs can now prescribe empagliflozin for eligible patients with chronic kidney disease, but should be aware of specific eligibility criteria.
CKD is under-diagnosed for the estimated 1.7 million Australian adults with biomedical signs of the disease, as symptoms become more apparent in advanced stages.
Treatment for a disease responsible for more than two million hospitalisations in Australia each year is now available on the PBS.
Under the new listing, proteinuric chronic kidney disease (CKD) can be treated with empagliflozin 10 mg (sold as Jardiance) for patients with or without type 2 diabetes, who have an eGFR 25–75 mL/min/1.73 m2 and urine albumin to creatinine ratio (ACR) of 22.6–565 mg/mmol (200–5000 mg/g), and who have been stable using an ACE inhibitor or ARB, unless contraindicated, for at least four weeks.
The medicine is the only sodium-glucose co-transporter 2 (SGLT2) inhibitor demonstrating a reduction in the combined risk of kidney disease progression or cardiovascular death in a range of patients with CKD.
The PBS listing follows the Therapeutic Goods Administration (TGA) granting a new indication to expand eligibility for patients with CKD to receive SGLT2 inhibitor therapy in February.
Jardiance is now TGA-indicated to reduce the risk of kidney disease progression in adults with CKD Stages 2 and 3A with urine ACR ≥30 mg/g, or CKD stages 3B, 4 and 5 irrespective of urine ACR. It is not recommended to initiate treatment in patients with an eGFR 20mL/min/1.73 m.
It is also indicated for improved glycaemic control and prevention of cardiovascular disease in people with type 2 diabetes, as well as for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard-of-care therapy.
Renal physician at Western Health Victoria, Professor Eugenia Pedagogos, said the new PBS listing will help GPs expand prescribing options for CKD.
‘GPs are familiar with Jardiance and should feel confident when initiating first-line therapy for CKD, just as they do for type 2 diabetes and heart failure,’ she said.
‘The first step is to diagnose. Patients with diabetes, hypertension and cardiovascular disease should all be regularly screened for signs of kidney damage.
‘New first-line treatments like Jardiance are an essential component of CKD care, and the earlier the condition is diagnosed and treated the better.’
The RACGP-endorsed CKD management in primary care guidelines highlights the benefits of early detection and treatment approaches to slow the progression of kidney disease and reduce risk of cardiovascular disease, including the use of SGLT2 inhibitors.
Professor Pedagogos said it is important CKD is managed holistically, with treatment ideally safeguarding both the kidneys and heart.
‘Not only are we aiming to prevent declining kidney function and eventual kidney failure, but also the cardiovascular complications that go hand-in-hand with kidney disease,’ she said.
The most recently available CKD data shows an estimated 11% (1.7 million) of Australian adults had biomedical signs of the disease in 2011–12.
Furthermore, despite CKD being mostly diagnosed at more advanced stages when symptoms become increasingly apparent, only 6.1% of people showing symptoms in this dataset self-reported having the disease, indicating that CKD is a largely under-diagnosed condition.
In 2020–21, CKD was recorded as the ‘principal or additional diagnosis’ of around two million (17%) hospitalisations in Australia, with dialysis the most common reason, accounting for 14% of all hospitalisations, and 80% of CKD hospitalisations.
As a CKD treatment option, empagliflozin works by blocking the SGLT2 protein in the kidneys, slowing the decline in kidney function and preventing or delaying the requirement for dialysis in people with CKD.
In a large SGLT2 inhibitor CKD randomised trial to assess both kidney and cardiovascular outcomes, the drug’s efficacy and tolerability was shown by reducing the combined risk of progression of kidney disease or death from cardiovascular causes by 28%, compared to placebo, alongside standard of care, with ‘no major safety concerns’.
The study demonstrated that treatment with empagliflozin was effective regardless of diabetes status and in patients with a broad range of eGFRs, with the risk of hospitalisation for any cause 14% lower in the empagliflozin group than in the placebo group.
Among a ‘wide range’ of patients with CKD at risk of disease progression, empagliflozin therapy led to ‘a lower risk of progression of kidney disease or death from cardiovascular causes than placebo’.
For the expanded PBS listing, Australian GPs prescribing empagliflozin should be aware it remains available on private prescription for CKD patients who do not meet the PBS eligibility criteria.
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