NICE issues draft recommendation for Forxiga to treat kidney disease

NICE issues draft recommendation for Forxiga to treat kidney disease

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).

This decision follows the recent licence extension granted for dapagliflozin in August by the Medicines and Healthcare products Regulatory Agency (MHRA)[1], and is based on positive results from the DAPA-CKD Phase III trial.

NICE propose to recommend, dapagliflozin as an option for treating CKD in adults, only 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, and
  • people have an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m2 to 75 ml/min/1.73 m2 and:
    • 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).[2]

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 patients 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.[3] AstraZeneca is continuing to engage with NICE to discuss enabling access for all patients within dapagliflozin’s licenced indication who could clinically benefit and the implications to patient access if the recommendation remains limited to subgroups based on uACR levels.

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.”

Tom Keith-Roach, President, 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 10 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.”

References

[1] Electronic Medicines Compendium. Forxiga 10 mg film-coated tablets. Last updated August 2021. Available at: https://www.medicines.org.uk/emc/product/7607/smpc#gref Last accessed November 2021.

[2] National Institute for Health and Care Excellence. Dapagliflozin for treating chronic kidney disease: Appraisal Consultation Document – Published 5 November 2021.

[3] Healthcare Quality Improvement Partnership. National Chronic Kidney Disease Audit: National Report (Part 1). Available at: https://www.hqip.org.uk/wp-content/uploads/2018/02/HtoEm0.pdf Last accessed November 2021.