Belimumab (Benlysta) has been approved for the treatment of SLE by NICE

Belimumab (Benlysta) has been approved for the treatment of SLE by NICE

The National Institute for Health and Care Excellence (NICE) recently completed their appraisal of belimumab (Benlysta) as a treatment for active auto-antibody positive systemic lupus erythematosus (SLE). We are pleased to report that they have recommended the treatment as an option to be added to standard therapy for some patients.


“Belimumab is an important treatment for many people living with lupus who have the most serious disease. It is good to know that we can continue to use this therapy to reduce lupus disease activity and improve quality of life for those who need it. Belimumab allows us to treat disease that is resistant to more standard forms of therapy and fulfils an important unmet need.”
Prof Chris Edwards (Consultant Rheumatologist, University Hospital Southampton)


“What great news! After many years of not being able to control my lupus through the standard treatments, I was given access to belimumab. In a matter of months, I began to get some relief from my symptoms and I generally felt more able to deal with day-to-day life. I am pleased to say the 2.5 years on belimumab have been the most stable my lupus has been in many years. I have also found this treatment much easier to tolerate because it fits around my life more easily by having shorter infusion times and I have experienced no side-effects from the drug either. It is such a relief knowing I can continue to rely on this treatment to help manage my lupus. I also hope today’s news brings hope to other people with lupus who may be struggling right now. Thanks to LUPUS UK and the clinicians who have fought for this treatment and made sure patient voices were heard.”
Abbie (A person living with lupus)


“We are delighted that this treatment will continue to be available, both for those currently benefitting from it and for those accessing it in the future. For some people, this treatment can dramatically improve their quality of life. We also hope this will pave the way for more new lupus treatments to enter the market.”
Paul Howard (Chief Executive, LUPUS UK)


What is belimumab (Benlysta)?
Belimumab, which is also known by the trade name Benlysta, is a type of drug called a biological therapy. It was the first newly developed treatment for lupus in over 50 years, created by GlaxoSmithKline (GSK).

In lupus, the immune system is dysfunctional and produces harmful antibodies that attack the body’s own tissues. Belimumab works by reducing the activity of a type of white blood cell, called B-cells, that produce these antibodies. This reduces the inflammation that causes the symptoms of lupus.

Like all medications, there are possible risks and side-effects associated with belimumab. Your doctor should discuss these with you before beginning any course of treatment.

Belimumab is taken in addition to other treatment for lupus and is either administered as an intravenous infusion, or sub-cutaneous injection (which can be self-administered).


Who can have belimumab (Benlysta)?
You will not be offered belimumab if:

  • your lupus isn’t active.
  • you haven’t tried other treatments appropriate for your condition first (standard therapy).


The new recommendation from NICE is for belimumab to be offered if:

  • you are positive for at least one serological biomarker (positive anti-dsDNA or low complement)
  • you have high disease activity despite standard therapy (defined as a SELENA-SLEDAI score of 10 or more)


You will then be able to continue the treatment beyond 24 weeks if your disease activity improves sufficiently (SELENA-SLEDAI improves by 4 or more). You can learn more about the SELENA-SLEDAI score used to assess disease activity, HERE.


Where does this NICE recommendation apply?
NHS England is legally obliged to fund and resource medicines and treatments recommended by NICE’s technology appraisals. Patients have the right to drugs and treatments that have been recommended, if their doctor believes they are clinically appropriate. Where NICE recommended a treatment ‘as an option’, NHS England must make sure it is available within three months of the recommendation’s publication.

The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within two months of the publication of the recommendation.

Scotland has their own institution, The Scottish Medicines Consortium (SMC), for recommending treatments to their NHS. Patients under NHS Scotland currently have some limited access to belimumab through a Patient Access Scheme (PAS) which remains under review.

There is no Northern Ireland equivalent to NICE or the SMC. In practice, most NICE decisions are implemented locally, meaning that a positive NICE decision should lead to reimbursement in Northern Ireland.


Further Reading
The full Final Appraisal Document from NICE is available to read HERE. This document provides full details of their recommendation, including the rationale for reaching their decision.


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