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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
NICE OKs biologics for the treatment of ulcerative colitis, changing its preliminary guidance that recommended against their use.
In a landmark decision, the National Institute for Health and Care Excellence (NICE) announced on Dec. 15, 2014 that it will improve access to treatment options for patients with moderate to severe ulcerative colitis (UC) and will recommend the use of biologics for the condition. This decision expands the treatment options to include Remicade (infliximab), Humira (adalimumab), and Simponi (golimumab).
The additional treatment options provide an alternative to colectomy, which is removal of part of the colon. Previous NICE recommendations only allowed for biologics for those hospitalized with UC. Prior to this shift in the treatment paradigm, those with moderate to severe UC faced surgery if conventional therapies such as corticosteroids, mercaptopurine, or azathioprine failed.
“We know that [biologics] can be life-transforming for people who live with these extremely debilitating symptoms, and who have had problems or no success with other tretaments and may be facing surgery,” said Helen Terry, director of policy at Crohn’s and Colitis UK, in a press release.
Meanwhile, biosimilars for Remicade have come to market in Europe, Japan, and India and are offered at a discount to Remicade, which had global sales of $8.4 billion in 2013 according to EvaluatePharma.
The change of heart by NICE appears to be somewhat of a trend. Earlier this December the agency reversed its previous decision on use and reimbursement for Johnson & Johnson's anti-inflammatory drug Stelara for the treatment of psoriatic arthritis, because of a new discount offer. However, NICE will only recommend Stelara for patients unable to use other medications or who have had inadequate responses to other therapies.
Source: PR Newswire