The National Institute for Health and Care Excellence (NICE) has issued an Appraisal Consultation Document (ACD) for AstraZeneca’s Forxiga (dapagliflozin) within its marketing authorisation for the treatment of adults with chronic kidney disease (CKD).
AstraZeneca estimates that approximately 91,000 adults living with CKD in England could be eligible for treatment under the current recommendation.31
NICE recommends dapagliflozin for treating CKD in adults if it is an add-on to optimised standard care including angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated or not tolerated. Additionally, if people have an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m2 to 75 ml/min/1.73 m2 and either a urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more, or a uACR of 3 mg/mmol or more and type 2 diabetes (T2D).4
This decision is based on positive results from the DAPA-CKD Phase III trial, which demonstrated that dapagliflozin, in addition to standard care, was more effective than standard of care alone in adults with or without type 2 diabetes, who had an eGFR of 25 to 75 ml/min/1.73 m2 and a uACR of 22.6–565 mg/mmol.
Professor James Burton, Professor of Renal Medicine and Honorary Consultant Nephrologist at the 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 of AstraZeneca UK: “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 ten people in the UK and has seen very little progress in treatment options for nearly 20 years. 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. There were 127 (5.9%) and 90 (4.2%) patients in the dapagliflozin and placebo arms respectively who reported symptoms of volume depletion.
- NHS England. Chronic Kidney Disease in England: The Human and Financial Cost. Available at: https://www.england.nhs.uk/improvement-hub/wp-content/uploads/sites/44/2017/11/Chronic-Kidney-Disease-in-England-The-Human-and-Financial-Cost.pdf Last accessed November 2021.
- Foreman KJ, Marquez N, Dolgert A, et al. Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: reference and alternative scenarios for 2016-40 for 195 countries and territories. Lancet. 2018; 392:2052–2090.
- AstraZeneca Data on File. REF-130661. November 2021.
- National Institute for Health and Care Excellence. Dapagliflozin for treating chronic kidney disease: Appraisal Consultation Document – Published 5 November 2021.