Patients with moderately to severely active ulcerative colitis, residing in the United Kingdom, now have access to several new drugs thanks to the Final Appraisal Document (FAD) from the National Institute for Health and Care Excellence (NICE). REMICADE® (infliximab), HUMIRA® (adalimumab) and SIMPONI®(golimumab) will be available to UC patients who have not achieved adequate treatment response to traditional therapy, such as corticosteroids, mercaptopurine or azathioprine, or patients who cannot tolerate or are contraindicated for conventional treatment. The marketing of Simponi, however, is conditional in that MSD should price the 100mg dose similarly with the 50mg dose.
“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,” said Chris Probert, a 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. “Hopefully most patients will not require such drugs, but it is a great comfort to know that we can use them when we need to.”
The FAD recommends Remicade as a treatment for severe UC in younger patients, aged 6 to 17 years old, who are not responding to or cannot tolerate conventional treatment. The new NICE FAD marks the first time pediatric UC patients in the UK will have access to these new treatments, as the drug was originally approved for children as an alternative to cyclosporin, in Scotland. Additionally, the FAD allows significant improvement in the country’s range of treatment options for patients with moderately to severely active UC, as former NICE policy restricted biologics to hospital use and only for severe UC. If not for the new NICE FAD, many would have no choice but to elect surgery upon failure of traditional therapies.
The approval comes not long after the publication of findings from a recently completed study, titled, “UC CARES” or Ulcerative Colitis Condition, Attitude, Resources and Educational study, which examined the level of unmet needs among patients living with UC, and their dissatisfaction with currently available treatment options. A great majority of 250 patients across 11 countries in Europe reported available therapies were ineffective.
Both Simponi and Remicade for UC are covered in over 25 European countries, and in the USA and Argentina. Both are marketed by Janssen.