(Source: Pharma Times 2014-12-14）
The National Institute for Health and Care Excellence has reversed a previous guidance and recommended use on the NHS of three big-selling biologics - Merck & Co’s Remicade and Simponi and AbbVie’s Humira - for treating moderately to severely active ulcerative colitis.
The cost watchdog has issued its final appraisal document to allow use of Remicade (infliximab), Simponi (golimumab) and Humira (adalimumab) within their marketing authorisations, as options for UC. Specifically, they can be prescribed for adults whose disease has responded inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate these drugs.
Simponi is recommended only if Merck provides the 100mg dose at the same cost as the 50mg dose, as agreed in the patient access scheme. Also the NICE FAD has backed Remicade as an option for severely active UC in children and young people aged six-17.
This is the first time children 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 and in Scotland only.
Previously NICE restricted the use of biologics only for those hospitalised with severe UC, and issued guidance rejected them in September. However, after working with stakeholders, the agency has now changed that and Merck notes that the decision offers “a much-needed alternative to colectomy”.
Chris Probert at the University of Liverpool noted that “this is great news for our patients [as] it is the first new class of drugs to be approved by NICE for UC and is a valuable tool in our armamentarium in the fight” against the disease. He added that “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”.
Helen Terry, director of policy at Crohn’s and Colitis UK, echoed Prof Probert’s comments, saying “we know that these drugs can be life-transforming for people who live with these extremely debilitating symptoms, and who have had problems or no success with other treatments and may be facing surgery. We very much welcome this landmark decision”.
Last month, Takeda’s Entyvio (vedolizumab) became the first biologic to get a provisional yes from NICE as a maintenance therapy for UC.
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