Targeted-release budesonide should be an option for treating patients in England with primary immunoglobulin A nephropathy, the National Institute for Health and Care Excellence (NICE) said.
Immunoglobulin A nephropathy (IgAN) – also known as Berger's disease, Henoch-Schönlein Purpura, or IgA vasculitis – is a progressive chronic kidney disease in which IgA protein builds up, causing inflammation and scarring in the kidney.
IgAN is one of the most common causes of chronic kidney disease and kidney failure, and it affects around 1 in 50,000 people in the UK. It has an incidence of around 14,000 people per year in England.
In Western countries, men are more likely to be affected than women, and peak incidence is seen in the second and third decades of life. Over 90% of cases are sporadic and of unknown aetiology, with the remainder having familial IgA nephropathy.
Adding Budesonide "More Effective Than Standard Care Alone"
In final draft guidance, NICE acknowledged that IgAN could substantially affect physical and psychological aspects of quality of life. It highlighted that "in most people, IgAN progresses to kidney failure within 10 to 15 years after diagnosis". Moreover, there was no available cure for IgAN, and limited pharmacological options to delay disease progression.
Standard care for IgAN included lifestyle and dietary changes, and angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs).
Targeted-release budesonide (Kinpeygo, Britannia) works by targeting IgA protein in the kidney and reducing inflammation, which in turn improves kidney function.
Clinical trial evidence suggested that targeted-release budesonide, plus standard care, was "more effective than standard care alone", NICE underlined. The appraisal committee noted that it was the first licensed treatment that specifically treated the condition, increasing the likelihood that people might avoid, or delay, the need for dialysis or a kidney transplant.
The regulator recommended targeted-release budesonide as an option for treating primary IgAN when there was a risk of rapid disease progression in adults with a urine protein-to-creatinine ratio of 1.5 g/g or more.
NICE stipulated that it should be an "add-on to optimised standard care", including the highest tolerated licensed dose of ACE inhibitors or ARBs, unless these were contraindicated.
Patient Discount Scheme
The drug's list price is £6528.54 for a 120-pack of 4 mg modified-release hard capsules. Treatment is one capsule a day for 9 months. NICE said that the likely cost-effectiveness was within the range that it considered an acceptable use of NHS resources. However, its recommendation depended on the manufacturer providing the drug in accordance with a discount patient access scheme.
NICE estimated that almost 2000 patients could benefit from the recommendation.
Fiona Loud, policy director at Kidney Care UK, told Medscape News UK: "Although not a cure, the hope is that the use of targeted-release budesonide may help many people with IgAN who have slow declining kidney function from ever reaching kidney failure. It may also mean that those who have the more aggressive type of IgAN may have a slower journey to kidney failure."