NICE relents and backs drug for IgAN from CSL Vifor
Thousands of people living with a rare form of chronic kidney disease (CKD) in the UK will soon be able to access a new oral treatment – CSL Vifor's Filspari – that can help slow down the decline in their kidney function.
Final draft guidance from NICE has backed NHS use of Filspari (sparsentan) for primary immunoglobulin A nephropathy (IgAN), also known as Berger's disease, just a few weeks after it was turned down by the health technology assessment (HTA) agency.
NICE estimates that around 4,200 people could be eligible for treatment with the drug, which is recommended for use in adults with a urine protein excretion of 1.0g/day or more, or a urine protein-to-creatinine ratio of at least 0.75g/g.
IgAN occurs when antibodies accumulate in the kidneys, causing inflammation and scarring, and can develop into serious CKD and kidney failure. Filspari, an endothelin-1 and angiotensin II inhibitor, has been shown in clinical trials to reduce levels of protein in the urine (proteinuria), a biomarker for disease activity, and slow down the progression of kidney damage.
In March – ahead of Filspari's approval in the UK the following month – NICE recommended against approval, saying that while the data on proteinuria was clear, it was less certain whether Filspari maintained kidney function better than current treatment, which includes generic angiotensin-2 receptor blockers such as irbesartan.
Its change of heart follows a public consultation period in which NICE's appraisal committee "heard about the devastating impact this disease can have on people's ability to work, travel, and maintain relationships and the limited treatment options available," according to the agency's director of medicines evaluation, Helen Knight.
The drug will help to reduce pressure on the NHS by preventing or delaying the number of people progressing to end-stage renal kidney disease, which could require dialysis or a kidney transplant, according to NICE.
The list price for Filspari is around £3,400 plus VAT for a 30-day supply of tablets, but CSL Vifor is supplying the drug to the NHS at a confidential discount. Now that the final draft guidance is published, it will be funded in England within 90 days of the final version, which is expected to be published on 27th June.
CSL Vifor said it expects to launch sparsentan in the UK in the second half of the year, with commercial stock available from July.
"IgAN has few symptoms at the early stages so is often not diagnosed until the condition has significantly progressed," commented Fiona Loud, policy director at Kidney Care UK.
"This guidance adds a further treatment that can slow the progression of the disease and so is a welcome announcement, which will benefit many of the people with the condition in the UK."
Photo by Sasun Bughdaryan on Unsplash
