The National Institute for Health and Clinical Excellence (NICE) no recomienda el uso de Belimumab (Benlysta®) en el tratamiento del lupus.

The National Institute for Health and Clinical Excellence (NICE) has today (30 September) opened its public consultation on the use of belimumab (Benlysta) for treating systemic lupus erythematosus. In the draft guidance, NICE is provisionally unable to recommend belimumab for treating adult patients with active autoantibody-positive systemic lupus erythematosus, where patients have a high degree of disease activity despite the individual receiving standard therapy, in line with the drug’s marketing authorisation.

Systemic lupus erythematosus (SLE) is an incurable autoimmune condition which mainly affects women, with the condition being more common in women of African Caribbean origin than any other group. 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 likely to consist of non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and/or immunosuppressants such as rituximab in some cases.

The draft recommendations are available for consultation; NICE has not yet issued final guidance to the NHS. Until final guidance is issued NHS bodies should make decisions locally on the funding of specific treatments.

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. The evidence considered did not persuade the Committee that belimumab was good value for money compared to standard care, as the cost per year of improved health is very high. It was also considered relevant to compare belimumab with rituximab, because some people with severe disease currently receive rituximab, although it isn’t licensed for this use. However, there were no reliable data to show the relative efficacy of belimumab compared with rituximab.

«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. We welcome comments on this draft recommendation as part of the consultation.»

Acerca de Juan Antonio Chassaigne

Profesor Titular de Farmacología, Universidad Nacional Experimental "Francisco de Miranda" y Hospital "Dr. Rafael Calles Sierra", IVSS / UNEFM

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