On World Lupus Day, the National Institute for Health and Care Excellence (NICE) announced a positive recommendation for GSK’s Benlysta® (belimumab) for use in adult patients with active autoantibody positive systemic lupus erythematosus (SLE ) with a high degree of disease activity despite standard therapy.1
Lupus is a chronic, debilitating and potentially fatal autoimmune disorder in which the body’s immune system wrongly identifies healthy cells, tissues and organs as foreign invaders, resulting in the body creating autoantibodies, which attack and destroy healthy cells, tissues, and organs.
Following a Health Technology Assessment, NICE has recommended the medicine is made available on the NHS under a managed access agreement between GSK and NHS England. This agreement needs to be completed before patients will be able to access Benlysta®, which is the first biologic medicine licensed for lupus anywhere in the world. Benlysta® works by targeting certain immune cells that make lupus active.
The terms of the agreement include the requirement for the treatment to be reviewed by NICE after three years, during which period the British Isles Lupus Assessment Group will collect further data on behalf of GSK, including efficacy, safety, resource use and patient reported outcomes to demonstrate the level of benefit Benlysta® can offer to people with lupus in the UK.
Commenting on the decision, Dr Stephen McDonough, GSK’s UK and Ireland Medical Director, said: “This is good news for eligible adult patients in England and Wales living with lupus. Today’s decision follows a lengthy process but our objective has always been for patients to gain access to this important and innovative treatment. While NICE haven’t given the medicine a full, unconditional recommendation, I’m delighted our medicine is one step closer to helping patients with this chronic and life-altering disease.”
Benlysta® was granted marketing authorisation by the European Commission in July 2011. GSK first put forward a submission to NICE in April 2011, which received a non-recommendation in April 2012. Following a successful appeal by GSK, NICE’s appraisal committee was asked to re-evaluate their decision. Since this time, Benlysta® has been through another four committee meetings where several new submissions of evidence have been reviewed.
The Summary of Product Characteristics1 for Benlysta® is available at: http://www.medicines.org.uk/emc/medicine/24769
- Benlysta EU Summary of Product Characteristics 2014 [online]. Available from: http://www.medicines.org.uk/emc/medicine/24769 [Last accessed: April 2016].