NICE grants UK UC patients access to biologic therapies

pharmafield logo - pharma news

The National Institute for Health and Care Excellence (NICE) has recommended REMICADE® (infliximab), HUMIRA® (adalimumab) and SIMPONI® (golimumab) for adult patients with moderately to severely active ulcerative colitis (UC).

NICE has issued its Final Appraisal Document (FAD) recommending the drugs for use on the NHS, within their marketing authorisations, as options for treating moderately to severely active ulcerative colitis (UC) in adults whose disease has responded inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate, or have medical contraindications for, such therapies.

SIMPONI is recommended only if MSD provides the 100mg dose at the same cost as the 50mg dose, as agreed in the patient access scheme.

Additionally, the NICE FAD recommends REMICADE, within its marketing authorisation, as an option for treating severely active UC in children and young people aged 6-17 years whose disease has responded inadequately to conventional therapy, including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate, or have medical contraindications for, such therapies. This is the first time that children with moderately to severely active UC have been granted access to these therapies in the UK. Previously, access was limited to children with acute severe UC as an alternative to ciclosporin, in Scotland only.

Chris Probert, Professor of Gastroenterology at the University of Liverpool, Honorary Consultant Gastroenterologist at Royal Liverpool Hospital, chair of the IBD Committee for the British Society of Gastroenterology and vice-chair of the Clinical Advisers Committee for Crohn’s and Colitis UK, said: “This is great news for our patients with ulcerative colitis. It is the first new class of drugs to be approved by NICE for ulcerative colitis and is a valuable tool in our armamentarium in the fight against ulcerative colitis.”

The NICE recommendation marks a significant step-change in improving access to treatment options for patients with moderately to severely active disease.