AstraZeneca (AZ) has announced that a wider range of chronic kidney disease (CKD) patients across England and Wales will be able to access Forxiga (dapagliflozin), following updated final draft guidance from the National Institute for Health and Care Excellence (NICE).
The health technology assessment agency has recommended that the drug be used on the NHS to treat CKD in adults if it is an add-on to optimised standard care, including the highest tolerated licensed dose of angiotensin-converting enzyme inhibitors and angiotensin-2 receptor antagonists, unless these are contraindicated.
Eligible patients must either have an estimated glomerular filtration rate (eGFR) of 20 ml/min/1.73m2 to less than 45ml/min/1.73 m2, or an eGFR of 45ml/min/1.73m2 to 90 ml/min/1.73m2 and have a urine albumin-to-creatine ratio of at least 22.6mg/mmol or type 2 diabetes.
An estimated 7.2 million people in the UK are living with CKD, a progressive condition categorised by the gradual loss of kidney function. Uncontrolled diabetes and hypertension are among the most common causes, and the disease is associated with an increased risk of cardiovascular events.
Taken orally once daily and sold as Farxiga in certain markets, AZ’s Forxiga is a selective SGLT2 inhibitor that helps excess glucose pass out of the body in the urine.
The updated guidance expands access to Forxiga outside of the eGFR restrictions outlined in NICE’s final appraisal document in 2022, and comes shortly after the Scottish Medicines Consortium accepted the drug for use in the same expanded patient population.
The agency’s latest decision was based on the submission of several data sets, including real-world evidence supporting the use of Forxiga in CKD and clinical trial results demonstrating its benefit within a wider subset of patients.
Tom Keith-Roach, president of AstraZeneca UK, said: “We are delighted by NICE’s decision to broaden access to [Forxiga] for patients with CKD… We look forward to working in partnership with the health system to ensure eligible patients can benefit from this important therapy as soon as possible.”