Canadians living with ulcerative colitis have received significant news, as the drug SKYRIZI® (risankizumab) has received a positive recommendation for public reimbursement and its manufacturer, AbbVie, has taken a major step towards securing that coverage.
Positive Recommendation and Negotiation Milestone
On November 28, 2025, AbbVie announced that Canada’s Drug Agency (CDA-AMC) has issued a positive recommendation for SKYRIZI® to be reimbursed by public drug plans for adults with moderately to severely active ulcerative colitis (UC). This recommendation applies to patients who have had an inadequate response to conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor, provided certain conditions are met.
Concurrently, AbbVie confirmed it has successfully concluded negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) and both parties have signed a Letter of Intent (LOI) regarding the drug's coverage for UC. This marks a critical procedural step in making the treatment more accessible and affordable for patients across the country.
A New Hope for Ulcerative Colitis Patients
This reimbursement recommendation for UC is the second consecutive positive review for SKYRIZI® from the CDA-AMC, following a previous recommendation for Crohn's disease. The decisions are supported by robust evidence from pivotal phase 3 clinical trials, including the INSPIRE and COMMAND studies for UC, and the MOTIVATE, ADVANCE, and FORTIFY studies for Crohn's disease.
The CDA-AMC's process was informed by valuable feedback from 25 Canadian clinicians and two key patient organizations: the GI Society and Crohn’s and Colitis Canada. This ensured that the perspectives and needs of those directly affected by the disease were integral to the review.
Ulcerative colitis is a chronic inflammatory bowel disease that causes persistent inflammation and ulcers in the colon's lining. It leads to debilitating symptoms like frequent diarrhea, abdominal pain, and rectal bleeding, severely impacting patients' quality of life, emotional wellbeing, and productivity. An estimated 120,000 Canadians live with UC, and its prevalence is rising.
Expert and Patient Advocacy Reactions
Medical experts and patient advocates have welcomed the development as a crucial advancement in care. Dr. Christopher Ma, MD, MPH, FRCPC, from the Cumming School of Medicine at the University of Calgary, stated, "UC can be an incredibly debilitating disease and patients need effective, safe treatment options that can help restore quality of life. This is a positive step towards ensuring that Canadians living with UC have access to treatment options that can help them achieve remission and improve their long-term outlook."
Gail Attara, CEO of the Gastrointestinal Society (badgut.org), expressed similar optimism, saying, "We are delighted that the Common Drug Review recommends that the public formularies cover the costs of an additional therapeutic option for ulcerative colitis. This new treatment is so desperately needed. Individuals living with UC are all different, requiring personalized treatment. Having a new therapy offers more hope and a chance to improve the quality of life."
Rami Fayed, Vice President and General Manager of AbbVie Canada, highlighted the collaborative effort, noting, "This is a testament to the mutual commitment of AbbVie and the Health Authorities to improve patient access to innovative medicines for inflammatory bowel disease. AbbVie in Canada is encouraged by the opportunity to work in collaboration with the CDA-AMC and the pCPA throughout this process to provide access to innovative solutions that have the potential to impact eligible patients’ lives."
