Benlysta failed to get NICE backing after its clinical benefits compared with standard options and cost effectiveness to the NHS were both questioned by the regulator – weeks after the SMC came to the same decision.
Simon Jose, General Manager, GSK UK, says the recommendations are “devastating decisions for patients with lupus whose disease is currently uncontrolled by existing therapies”.
SLE is an incurable autoimmune condition which currently affects around 15,000 people in England and Women – 90% of whom are women.
Benlysta is the first new treatment licensed in the UK for lupus in half a century after the European Commission granted marketing authorisation in July 2011.
But NICE questioned the health benefit for patients and the cost of the treatment in relation to its clinical effectiveness after analysing evidence and consulting with people with the condition and clinical specialists.
Sir Andrew Dillon, NICE Chief Executive, commented: “Whilst recognising the severity of the disease, the Committee concluded that based on this evidence, belimumab could not be considered a good use of NHS resources compared with current clinical practice.”
GSK insist that failure to recommend Benlysta sees patients being left behind those from Germany and Spain, where the treatment is already approved for use. “We remain committed to creating solutions that will help ensure that the small number of patients across the UK who we believe will benefit most, are able to access this important new medicine,” Simon Jose said.