NICE issues draft recommendation for Forxiga to treat adults with chronic kidney disease

By Editor
5th November 2021
Chronic Kidney Disease, Pharmaceutical Type 2 diabetes

AstraZeneca have announced that the National Institute for Health and Care Excellence (NICE) has issued an Appraisal Consultation Document for Forxiga (dapagliflozin) for the treatment of adults with chronic kidney disease (CKD).

Approximately 91,000 adults are living with CKD in England and could be eligible for treatment under the current recommendation, AstraZeneca say.

The guidelines suggest that dapagliflozin should only be an option for treating CKD if it is an add-on to optimised standard care.

Additionally, dapagliflozin should only be administered to people with type 2 diabetes who have an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 mto 75 ml/min/1.73 m, a urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more or a uACR of 3 mg/mmol or more.

This decision follows the recent licence extension granted for dapagliflozin in August by the Medicines and Healthcare products Regulatory Agency (MHRA).

It is also based on positive results from the DAPA-CKD phase three trial, which demonstrated that dapagliflozin, in addition to standard care, was more effective than standard of care alone.

People living with CKD have had few treatment innovations in the last 20 years and this recommendation marks a significant advancement in the management of the condition.

However, in order for people to access dapagliflozin under this recommendation, they must have a uACR diagnostic test.

The NICE appraisal committee recognise that uACR testing is not implemented consistently across the NHS.

Professor James Burton, Professor of Renal Medicine and Honorary Consultant Nephrologist, University of Leicester, said: “This is welcome news for people living with chronic kidney disease, providing them with access to a new and long-awaited treatment option for a disease that affects millions.

“This announcement represents an important milestone that could make a difference to the lives of many people living with the condition, and even delay their need for dialysis.”

CKD is a long-term condition where the kidneys do not work as well as they should and are unable to remove waste products from the body.

Currently, an estimated 2.8 million people in England have CKD and it is estimated up to one million of these people are living with the condition undiagnosed.

This is particularly relevant in Black, Asian and minority ethnic communities, as they are five times more likely to develop CKD that other groups.

CKD also represents a significant burden on the UK healthcare system, accounting for 2% of NHS spending overall.

Tom Keith-Roach, President, AstraZeneca UK, said: “Today’s draft recommendation from NICE is a step in the right direction but we have more work to do to ensure broad and equitable access to dapagliflozin, particularly for CKD patients without diabetes.

“CKD affects around one in 10 people in the UK and has seen very little progress in treatment options for nearly 20 years.

He added: “We are working with NICE through the appraisal process towards a final appraisal determination that enables access for all CKD patients who would be clinically appropriate and may benefit.”

The safety and tolerability of dapagliflozin in patients with CKD was consistent with the well-established safety profile of the medicine.

The rates of adverse events of special interest including: renal AEs (7.2% vs. 8.7%); definite or probable diabetic ketoacidosis (0% vs <0.1%); major hypoglycaemic events (0.7% vs. 1.3%); amputations (1.6% vs. 1.8%) and fractures (4.0% vs 3.2%) were generally low and balanced across the dapagliflozin and placebo arm respectively.

Photo by Towfiqu barbhuiya on Unsplash

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