Empagliflozin is now available on the PBS to treat chronic kidney disease in patients with or without T2D, following the latest expansion of funding for the therapy.
The 1 April listing means the SGLT2 inhibitor, branded Jardiance, can be prescribed for the treatment of patients with with proteinuric CKD with an estimated glomerular filtration rate (eGFR) of 25–75 mL/min/1.73 m2 and urine albumin-creatinine ratio (UACR) of 200–5000 mg/g.
Eligible patients must have also been stable using an ACE inhibitor or ARB for at least four weeks unless contraindicated and cannot be on another SGLT2i, per the PBS criteria (link here).
The PBS listing comes just weeks after the TGA granted a new indication for the drug, enabling a broader group of patients with CKD than ever before to receive SGLT2i therapy in Australia.
Professor Eugenia Pedagogos, renal physician at Western Health Victoria, welcomed the new PBS listing, noting that CKD was now the number one cause of hospitalisation in Australia.
“We can and must do more when it comes to CKD,” said Dr Pedagogos in a media release for Boehringer Ingelheim and Eli Lilly.
“Since the turn of the century, deaths associated with CKD have doubled and rates of kidney replacement therapy have risen by almost 150%.”
“New first-line treatments like Jardiance are an essential component of CKD care, and the earlier the condition is diagnosed and treated the better.”
“CKD must also be managed holistically. 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.
“Treatment should protect both the kidneys and the heart,” she said.
The listing follows a partial recommendation by the Pharmaceutical Benefits Advisory Committee late last year (link here).
Meeting minutes noted the PBAC did not recommend the listing of empagliflozin for the proposed incremental CKD population based upon the subgroup analysis in the EMPA-KIDNEY trial which showed little or no improvement from empagliflozin in patients categorised as low, moderate and high-risk (KDIGO staging) or in those patients with UACR < 200 mg/g at baseline.
The PBAC also said it did not consider that the EMPA-KIDNEY trial adequately demonstrated a benefit in the broadened indication for CKD.
“The PBAC noted the modelled treatment effects were not representative of the incremental population, and the overall complexity and uncertainty of the cost-effectiveness analysis made it uninformative,” it said.
Ultimately, the more limited recommendation for listing was based on an assessment that the cost-effectiveness of empagliflozin would be acceptable if it were cost-minimised against dapagliflozin.