NICE has today issued its final appraisal determination recommending three biological drugs for moderate to severe Ulcerative Colitis where conventional treatments (such as steroids, mercaptopurine or azathioprine) have failed.
We applaud NICE decision to ensure access to additional treatment options for people with UC
This will enable people in this situation, who have very limited options currently, to access infliximab, adalimumab or golimumab as maintenance therapy.
This is fantastic news for people with moderate to severe Ulcerative Colitis as it gives them much-needed additional treatment options. We know that these drugs can be life-transforming for people who live with these distressing and debilitating symptoms, who have had problems or no success with other treatments and may be facing surgery. We very much welcome this landmark decision.
In its interim guidance of 24th September 2014, NICE did not recommend the treatments, but has revised this decision, having fully considered all the evidence presented by individuals and patient and professional organisations, as well as that provided by the manufacturers.
Crohn's & Colitis UK presented a large number of powerful individual submissions to NICE as part of its contribution to the evaluation and nominated patient experts to participate in the Committee discussions. The patient experts helped the Committee to understand the real life experience of having Ulcerative Colitis and their participation was highly valued.
I am delighted by this decision from NICE. Infliximab has been hugely important to me in that it has allowed me to regain control of my life. I was also very happy to be involved with the appraisal process and felt that what I had to say was listened to by the committee. It is great to know that, going forward, more people with Ulcerative Colitis will reap the benefits of these treatments as I have done.
For more information on this release or interviews with Helen Terry or a patient case study, please contact Christian Rogers on 01428 607627 or email media@crohnsandcolitis.org.uk
Note to Editors:
- Infliximab (Remicade), adalimumab (Humira) and golimumab (Simponi) work by targeting a protein in the body called TNF-alpha (tumour necrosis factor-alpha). TNF alpha is naturally produced as part of our immune response, to help fight infections by temporarily causing inflammation in affected areas. Over-production of this protein is thought to be partly responsible for the type of chronic (ongoing) inflammation found in IBD. Infliximab, adalimumab and golimumab bind to TNF-alpha, helping to prevent inflammation and relieve symptoms. These drugs and others are known as 'anti-TNFs'.
- This recommendation brings access to anti-TNF drugs in line with guidelines for Crohn's Disease. NICE guidance TA187, published in May 2010, covers infliximab and adalimumab as maintenance therapy.
- Vedolizumab (Entyvio) is another biological treatment currently being appraised by NICE for Ulcerative Colitis and Crohn's Disease. Vedolizumab works in a different way by blocking white blood cells, rather than binding to TNF-alpha cells. NICE issued interim guidance on 26th November recommending vedolizumab for moderate to severe Ulcerative Colitis, when conventional treatments have failed, except where people have previously been treated with anti-TNF drugs. Public consultation on this is open until 5pm, 17th December. The Appraisal Consultation Document for vedolizumab for Crohn's Disease has not yet been issued and is expected late December/early January.
- Ulcerative Colitis (UC) is a debilitating form of inflammatory bowel disease (IBD) that causes inflammation and ulceration in the inner lining of the large intestine (colon) or rectum (proctitis).The most common symptoms of UC include abdominal pain and bloody diarrhoea. People with UC may also experience fatigue, weight loss, loss of appetite and rectal bleeding. Around 146,000 people in the UK live with ulcerative colitis. Each year, between 6,000 and 12,000 people are diagnosed with the condition, with the peak age of diagnosis between the ages of 15 and 25 years, followed by a smaller peak between 55 and 65 years.
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