NICE says no to lupus treatment
pharmafile | September 30, 2011 | News story | Sales and Marketing | Benylsta, GSK, Lupus, NICE
NICE has rejected GSK’s new lupus treatment Benlysta in draft guidance.
Co-developed with biotech company HGS, the drug has been hailed as a major advance for patients with the hard to treat autoimmune disease.
But NICE’s preliminary appraisal has concluded that the benefits of the drug are too few in relation to its high price.
Benlysta (belimumab) is licensed as an add-on treatment for people with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity despite standard therapy.
The drug’s annual cost was estimated by NICE to be £10,918 in the first year of treatment and £10,138 in subsequent years. GSK has already agreed a patient access scheme with the Department of Health, but this discount is commercial-in-confidence.
Systemic lupus erythematosus (SLE) is an incurable autoimmune condition which mainly affects women, and is more common in women of African Caribbean origin. In SLE, the whole body is affected as the immune system attacks healthy tissue and organs, and can lead to serious organ damage – for example to the kidneys and heart.
SLE is complex, poorly-understood and can be difficult to diagnose as symptoms can be similar to other more common conditions. Standard therapy for SLE is usually consists of non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and/or immunosuppressants such as rituximab (Roche’s MabThera) in some cases.
Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “Systemic lupus erythematosus (SLE) is a debilitating condition which severely affects an individual’s quality of life. 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.”
She added that the Committee was not persuaded the drug was good value for money compared to standard care, and said the cost per year of improved health was very high.
Some patients with the condition receive off-label MabThera, and NICE’s appraisal committee therefore considered the relative efficacy of Benlysta compared to MabThera. However NICE concluded there were no reliable data to allow such a comparison.
Andrew McConaghie
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