Press statement on NICE’s Announcement on Belimumab

LUPUS UK is extremely disappointed that NICE has refused to recommend Belimumab for treatment for lupus patients experiencing a high degree of disease activity who have not responded to other treatments.

”This is a real tragedy as it leaves patients, who have found other drugs ineffectual in controlling this complicated serious condition, with no approved alternatives. Belimumab has been studied in two large global trials that show it to be effective in controlling lupus disease. Indeed, it is the only drug that has been licensed for the treatment of lupus in the past 50 years. NICE recognised that young women of child-bearing age are particularly in need of better therapy as they face a higher risk of complications. Now patients have to face this disappointment and their clinicians have a lot less room for manoeuvre in this difficult-to-treat population of patients. There is no approved option and many will therefore suffer a ‘post-code lottery’ of what drug they can be given and others will need to be continued on unacceptably high doses of steroids in the long-term. Steroids are not always effective and leave these patients vulnerable to increased risk of coronary heart disease, diabetes, osteoporosis, cataracts and infections” says Professor Ian Bruce, Central Manchester Foundation Trust and Professor of Rheumatology at the University of Manchester.

“This is a phenomenal setback for some of these patients who will have their lives seriously shortened or impaired without effective treatment; they will be unable to work and find it difficult to have children or be involved in an active life” says Jane Dunnage, Chair of LUPUS UK. “We call on the NHS to commission trials into better treatments for this disabling condition so that clear evidence will be available regarding the efficacy of drugs for the UK population. As the national charity for people living with lupus, we have funded £2m of research, but our resources cannot stretch to the costs involved in undertaking the large scale clinical trials which are vitally necessary.”

Figures presented to NICE estimated that between 1,500-3,000 patients need better drugs, and trials of Belimumab showed that the majority of patients benefitted after using the treatment. The quality of their lives improved dramatically: they could keep working, raise families and continue with most activities whilst living with a condition which affects many organs within the body, and most importantly reduce the amount of steroid medication taken. “Sadly, the NICE Appraisal Committee seem to have been bogged down in a miasma of economic modelling and not fully appreciated the fact that this small number of lupus patients are left between a rock and a hard place without any effective treatment” said Jane Dunnage.

Belimumab has already been approved by the European Medicines Agency (EMA) and the Federal Drug Administration (FDA) for use in lupus when patients do not respond to other treatments. Only steroids and anti-malarial medications are licensed for use in lupus within the NHS, and NICE recognised that patients are desperate for more effective treatments. Chemotherapy is used for many people with lupus in order to reduce the amount of steroids used, but none of these drugs are effective for some people with the most aggressive form of lupus.

5 Replies

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  • rubbish rubbish rubbish

  • yes agree - very disappointing and makes me very angry! This isn't right.

    M

  • Was Lupus UK offered the possibility of making a submission to the NIHCE for consideration in the appraisal process?

  • Hi John_and_Susan,

    Yes, LUPUS UK was very vocal and deeply involved with the appraisal process.

  • Nice should hang there heads in shame for a while we had hope now we have nothing, when other illnesses have so many treatments pills n potions, I have 30 tablets in the morning along with all the rest of the days pills. Soooooo disappointing angry loupie here x

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