NICE’s decision not to recommend the use of Benlysta (belimumab) for the treatment of systemic lupus erythematosus (SLE) in final draft guidance has been called ‘devastating’ by GSK.

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.

GSK’s Benlysta (belimumab) has not been recommended in draft guidance for treating systemic lupus erythematosus (SLE).

Questions were raised by NICE’s independent Appraisal Committee over concerns about the medication’s cost and clinical effectiveness against standard treatment options.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says evidence “did not persuade the Committee that belimumab was good value for money”.

A Patient Access Scheme had been agreed between GSK and the DH for the treatment, although details of the agreement have been kept confidential at the request of Glaxo.

SLE is an incurable autoimmune condition, which mainly affects women. There are believed to be around 15,000 people in England and Wales with SLE, nine-out-of-ten are female.

The whole body is affected by SLE as the immune system attacks healthy parts of tissue and organs which may lead to serious internal damage.

It is a complex, poorly-understood condition and may be difficult to diagnose as symptoms are often similar to more common conditions.

“Systemic lupus erythematosus (SLE) is a debilitating condition which severely affects an individual’s quality of life,” said Professor Longson. “NICE’s independent appraisal committee has looked very carefully at the evidence provided on the use of belimumab for treating SLE, including the views of people with the condition, those who represent them, and clinical specialists.”

Although it is not licensed, certain patients with severe cases of the disease are treated with MabThera (rituximab). The Committee considered it relevant to compare Benlysta with MabThera, however NICE says there is no reliable data to show the relative efficacy between the two.

“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,” added Professor Longson.

The decision is now open for consultation.