NICE unable to recommend Benlysta

GSK’s Benlysta (belimumab) has not been recommended in draft guidance for treating systemic lupus erythematosus (SLE).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