The first treatment for an inherited immune system disorder first identified in 2013 will be made available to patients in England, it has been announced.
Leniolisib will be available for patients over the age of 12 with activated phosphoinositide 3-kinase delta syndrome (APDS).
The National Institute for Health and Care Excellence (NICE) says the decision will help up to 50 people. The drug blocks the phosphoinositide 3-kinase delta protein that is overactive in the disease. This should reduce the size of lymph nodes and increase the number of B cells.
The list price of the drug is 拢352,000 a year, but NICE said the developers have agreed a discount for the NHS.
Professor James Palmer, NHS medical director for specialised commissioning, said: 鈥淚鈥檓 delighted that the NHS in England will provide a first-ever targeted treatment for adolescents and adults with this rare, genetic condition which weakens an individual鈥檚 immune system and can lead to serious issues and hospitalisation.
鈥淭he NHS is the first health system in Europe to offer this NICE approved treatment, for a condition identified just over a decade ago.鈥�
NICE director of medicines evaluation Helen Knight said: 鈥淭his is a significant milestone for people with this debilitating genetic condition who will now be able to access this first of its kind treatment routinely on the NHS.
鈥淚t is estimated that between 40 and 50 people have APDS and today鈥檚 decision means leniolisib will help give some of them and their families real hope of a better quality of life. We鈥檙e therefore pleased the company was able to work constructively with us to address the areas where more evidence was needed for NICE to be able to recommend this promising new treatment.鈥�
Source: NICE
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