Canada's Drug Agency Recommends Public Reimbursement for SKYRIZI in Ulcerative Colitis
核心洞察
Canada's Drug Agency (搜索) (CDA-AMC) has issued a positive reimbursement recommendation for SKYRIZI (risankizumab) for adults with moderately to severely active ulcerative colitis (搜索) who have failed conventional therapy, biologics, or JAK inhibitors.
AbbVie (搜索) has successfully concluded negotiations with the pan-Canadian Pharmaceutical Alliance (搜索) (pCPA) and signed a Letter of Intent for SKYRIZI in ulcerative colitis (搜索), advancing patient access to this IL-23 (搜索) inhibitor.
The recommendation was supported by feedback from 25 Canadian clinicians and patient organizations, with approximately 120,000 Canadians estimated to live with ulcerative colitis (搜索).
Canada's Drug Agency (搜索) (CDA-AMC) has recommended SKYRIZI (risankizumab) for public reimbursement in the treatment of adults with moderately to severely active ulcerative colitis (搜索), marking a significant milestone for patient access to this IL-23 (搜索) inhibitor. The recommendation applies to patients who have had an inadequate response, loss of response, or were intolerant to conventional therapy, biologic treatment, or a Janus kinase (JAK) inhibitor, provided certain conditions are met.
Regulatory Milestone and Stakeholder Support
The CDA-AMC's positive recommendation was informed by comprehensive feedback from 25 Canadian clinicians and two patient organizations, including the GI Society (搜索) and Crohn's and Colitis Canada (搜索). This collaborative approach ensured that the voices of those living with ulcerative colitis (搜索) were considered in the decision-making process.
"UC can be an incredibly debilitating disease and patients need effective, safe treatment options that can help restore quality of life," said Dr. Christopher Ma, MD, MPH, FRCPC, from the Cumming School of Medicine at the University of Calgary. "This is a positive step towards ensuring that Canadians living with UC have access to treatments options that can help them achieve remission and improve their long-term outlook."
Commercial Agreement Reached
AbbVie (搜索) has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (搜索) (pCPA) regarding SKYRIZI for ulcerative colitis (搜索), with both parties signing a Letter of Intent (LOI). This agreement represents a crucial step toward ensuring patient access to the therapy across Canadian provinces.
"This is a testament to the mutual commitment of AbbVie (搜索) and the Health Authorities to improve patient access to innovative medicines for inflammatory bowel disease (搜索)," said Rami Fayed, Vice President and General Manager of AbbVie Canada.
Clinical Evidence and Therapeutic Profile
SKYRIZI is a humanized monoclonal antibody that selectively inhibits interleukin-23 (搜索) (IL-23 (搜索)), a key cytokine involved in inflammatory processes. The positive reimbursement recommendation was supported by evidence from pivotal phase 3 clinical trials, including the INSPIRE and COMMAND studies for ulcerative colitis (搜索), as well as the MOTIVATE, ADVANCE, and FORTIFY trials for Crohn's disease (搜索).
This marks the second consecutive positive reimbursement recommendation by the CDA-AMC for SKYRIZI in inflammatory bowel diseases, following the initial approval for Crohn's disease (搜索).
Disease Burden and Patient Impact
Ulcerative colitis (搜索) is a chronic, immune-mediated inflammatory bowel disease (搜索) affecting the large intestine, causing persistent inflammation and ulceration of the colon's lining. Common symptoms include frequent diarrhea, abdominal pain, and rectal bleeding, which can lead to significant impacts on patients' daily lives, emotional wellbeing, and productivity. Approximately 120,000 Canadians are estimated to live with ulcerative colitis, and its prevalence continues to rise across the country.
"We are delighted that the Common Drug Review recommends that the public formularies cover the costs of an additional therapeutic option for ulcerative colitis (搜索). This new treatment is so desperately needed," said Gail Attara, CEO of the Gastrointestinal Society (搜索). "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 by alleviating some symptoms."
Broader Therapeutic Applications
Beyond inflammatory bowel disease (搜索), SKYRIZI is approved in Canada for the treatment of adult patients with moderate to severe plaque psoriasis (搜索) who are candidates for systemic therapy or phototherapy, and for the treatment of adult patients with active psoriatic arthritis (搜索), where it can be used alone or in combination with conventional non-biologic disease-modifying antirheumatic drugs such as methotrexate.