Formulary Management of Targeted Immune Modulators in Ulcerative Colitis

Key Messages

• Health Canada has approved 7 targeted immune modulators for the treatment of adults with moderate to severe ulcerative colitis, which include 5 biologics (adalimumab, infliximab, golimumab, ustekinumab, and vedolizumab) and 2 small molecules (tofacitinib and ozanimod). Biosimilars for adalimumab and infliximab and generics for tofacitinib are currently available in the Canadian market; however, although their patent protection has expired, there are no biosimilars for golimumab and ustekinumab.
• All targeted immune modulators have undergone pan-Canadian Pharmaceutical Alliance negotiations and concluded with a Letter of Intent except for ustekinumab, which is the only targeted immune modulator not included on any public formularies for ulcerative colitis. Coverage is consistent across all drug plans except for golimumab and tofacitinib, which is not covered by all jurisdictions for ulcerative colitis.
• Most public drug plans have implemented or have announced a biosimilar policy to promote the use of biosimilars over originator biologics. The listing status for targeted immune modulators in ulcerative colitis is similar across public drug plans; however, there is heterogeneity in criteria requirements for prior treatments and diagnosis definitions.
• Considering these factors and the emergence of new data, it would be important to reassess these drugs and evaluate their place in therapy. Further research, such as horizon scanning, utilization analyses, and long-term effectiveness and safety studies, is warranted for targeted immune modulators to ensure the appropriate use of these drugs in the treatment of moderate to severe ulcerative colitis.