The lives of thousands of people with chronic kidney disease
could be changed for the better after NICE today (Friday, 23 May)
recommended a new treatment option for use in the NHS.
Just over 4,200 people could be set to benefit after Sparsentan
(also known as Filspari and made by Vifor Pharma) was recommended
in final draft guidance as an option for treating primary
immunoglobulin A nephropathy (IgAN), also known as Berger's
disease.
It is recommended when there is a risk of rapid disease
progression in adults with a urine protein excretion of 1.0 g/day
or more, or a urine protein-to-creatinine ratio (UPCR) of 0.75
g/g or more.
Immunoglobulin A nephropathy (IgAN) is a progressive chronic
kidney disease, where the IgA protein builds up in and damages
the filtering part of the kidney, making it harder to filter
waste from the blood. The kidneys not working properly can cause
inflammation and damage which can lead to kidney failure.
Sparsentan, which is given as a tablet taken once a day, works by
blocking the receptors for two hormones, endothelin-1 and
angiotensin II, which cause kidney damage. By blocking these
receptors, the medicine reduces the amount of protein leaking
into the urine (proteinuria) and slows down the progression of
kidney damage.
Clinical trial evidence shows that sparsentan reduces UPCR more
than standard treatment and may be better at maintaining kidney
function. Unlike other treatments such as targeted-release
budesonide, which is currently given for a limited duration of
nine months, sparsentan is intended for long-term use.
The treatment 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.
Helen Knight, director of medicines evaluation at NICE, said: “I
am pleased that we have been able to recommend this effective new
treatment, which could make a huge difference to people's lives
by delaying kidney failure.
“Our independent 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.
“Sparsentan offers long-term benefits to patients, and we are
determined to ensure that we continue to get the best care to
patients fast while ensuring value for the taxpayer.”
Fiona Loud, Policy Director at Kidney Care UK, said: “IgAN has
few symptoms at the early stages so is often not diagnosed until
the condition has significantly progressed. 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.
“IgAN generally affects a younger group of patients and is
therefore extremely disruptive to people's lives as they may have
young families or are starting out in their careers. We're
pleased that this new treatment for IgAN will now be an option
for patients who need it.”
IgAN affects just over 18,000 people in England. It is one of the
most common causes of chronic kidney disease and kidney failure,
particularly in people under 40. Men are more likely to be
affected by the disease than women.
The company has a confidential commercial arrangement in place
through a simple patient access scheme, which makes sparsentan
available to the NHS with a discount.
Read the full final draft guidance for sparsentan for treating primary
IgA nephropathy.
ENDS
Notes to editors
- The medicine was not recommended at draft guidance but
following a price reduction and additional analyses being
provided by the company it has now been recommended.
- The guidance states people should stop taking sparsentan
after 36 weeks if their UPCR is 1.76 g/g or more and has not
reduced by 20% or more.
- The treatment would be available on the NHS in England within
three months of NICE's final guidance being published.
