The National Institute for Health and Care Excellence (NICE) has recommended a new treatment option for people with chronic kidney disease (CKD).
In final draft guidance, an appraisal committee said empagliflozin (Jardiance, Boehringer Ingelheim and Lilly) should be available for routine NHS use in England.
The sodium-glucose cotransporter-2 (SGLT2) inhibitor reduces renal reabsorption of sodium and glucose, helping to increase their excretion.
It's estimated that around 1.7 million people in England have stage III-V—moderate to severe—CKD. NICE estimated that just over 226,000 people would be eligible to receive the new treatment option, which is taken as a one-a-day tablet.
Clinical Evidence Found Empagliflozin Could Help Slow Disease Progression
Clinical trial evidence suggested that treatment with empagliflozin, plus standard care, was more effective than standard care alone in slowing disease progression. SGLT2 inhibitors could also reduce the risk of cardiovascular problems, of which people with kidney disease have a greater risk.
Fiona Loud, policy director at Kidney Care UK, told Medscape News UK that "slowing down kidney disease can be life-changing, particularly if it reduces the chances of someone needing dialysis or a kidney transplant".
NICE recommended empagliflozin as an option for treating CKD in adults as an add-on to optimised standard care, including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these were contraindicated. Additionally, the drug would be suitable for patients who had an estimated glomerular filtration rate of 20 mL/minute/1.73 m2 to less than 45 mL/minute/1.73 m2, or 45-90 mL/minute/1.73 m2, and either a urine albumin-to-creatinine ratio of 22.6 mg/mmol or more, or type 2 diabetes.
Empagliflozin would be used in a similar way to dapagliflozin, which the healthcare regulator recommended for CKD last year. It said that although no clinical trials had directly compared empagliflozin with dapagliflozin in people with CKD, results of an indirect comparison suggested that empagliflozin had a similar effectiveness to dapagliflozin, and probably had a similar safety profile.
Acceptable Use of NHS Resources
The list price for empagliflozin is £36.59 for 28 tablets (10 and 25 mg). However, the manufacturer had offered a discount under the terms of a confidential agreement. The cost-effectiveness estimates for empagliflozin compared with standard care were within the range normally considered an acceptable use of NHS resources, according to NICE. Moreover, a cost comparison suggested that empagliflozin had similar costs to dapagliflozin, it said.
If empagliflozin was one of a range of suitable treatments, the least expensive option of these should be used, NICE emphasised.
The regulator reassured those already receiving the drug through the NHS that their treatment would not be affected by the new guideline, and that they could continue until they and their NHS clinician considered it appropriate to stop.
Ms Loud commented: "The availability of this treatment provides even more incentive for monitoring people most at risk of CKD, as it enables diagnosis and appropriate treatment as early as possible," she underlined.
Earlier this week, NICE recommended targeted-release budesonide as an option for treating primary immunoglobulin A nephropathy.
Dr Aisling McMahon, executive director of research and policy at Kidney Research UK, said the charity was pleased that the range of treatments for chronic kidney disease was "broadening" and described the recommendation of empagliflozin as an "important step in the right direction".
NICE explained it had applied a "light-touch, streamlined" process to the assessment of empagliflozin, which it said meant that the final draft guidance was available around 4 weeks faster than under its standard appraisal process.
Final guidance on empagliflozin is expected to be published by NICE next month after an appeal period for the appraisal closes on 1 December.