Limited coverage criteria – vedolizumab

 

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Generic name	vedolizumab
Strength & form	300 mg/vial solution for infusion 108 mg/0.68 mL single-use pre-filled pen, single-use pre-filled syringe

Special Authority criteria	Approval period
Moderate to severe active Crohn's disease, according to established criteria, when a Special Authority request is submitted by a gastroenterologist	Initial (induction period): 3 doses Renewal: 1 year
Moderate to severe ulcerative colitis, according to established criteria, when a Special Authority request is submitted by a gastroenterologist	initial (induction period): 3 doses Renewal: 1 year

Practitioner exemptions

• None

Special notes

• Established criteria are provided in the SA forms below
• PharmaCare covers a maximum of 56 days per fill for vedolizumab intravenous infusion and 28 days for vedolizumab subcutaneous formulation
• PharmaCare coverage of vedolizumab is limited to 300 mg every 8 weeks, or 108 mg every 2 weeks at maintenance dosing.  Loading doses are covered at 300 mg at 0, 2 and 6 weeks

Special Authority request form(s)

• Log in to eForms

Crohn's disease

• HLTH 5368 - Biologics for Moderate to Severe Active Crohn's Disease: Initial/Switch (PDF, 1.15MB)
• HLTH 5374 - Worksheet (Based on Harvey-Bradshaw Index) (PDF, 514KB)
• HLTH 5495 - Biologics for Moderate to Severe Active Crohn's or Fistulizing Crohn's Disease: Renewal (PDF, 1.27MB)

Ulcerative colitis

• HLTH 5388 - Biologics for Ulcerative Colitis: Initial/Switch (PDF, 662KB)
• HLTH 5497 - Biologics for Ulcerative Colitis: Renewal (PDF, 1.22MB)