Limited coverage drugs – infliximab for ulcerative colitis

Last updated on January 21, 2025

Special Authority requests can now be submitted online. It's simple and quick!

PharmaCare covers infliximab biosimilar products for psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PsO), Crohn's disease (CD), ulcerative colitis (UC) and rheumatoid arthritis (RA).

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Generic name		infliximab
Brand name	Strength		Form
Avosla^™	100 mg/vial		powder for solution
Inflectra^©	100 mg/vial		powder for solution
Renflexis^©	100 mg/vial		powder for solution
Remsima^™	120 mg/mL		pre-filled pen for subcutaneous injection

Special Authority criteria	Approval period
Initial For the treatment of adult patients with moderate to severe ulcerative colitis when ALL of the following criteria are met: Special Authority is requested by a gastroenterologist AND Patient has a partial Mayo score¹ of at least 4 for the sum of stool frequency, rectal bleeding, and physician's global assessment, and Patient has a rectal bleeding subscore of at least 2 AND Patient has had a trial of 5-ASA products for a minimum of 4 weeks AND Patient has had a course of steroids equivalent to oral prednisone 40 mg or more daily for a minimum of 14 days², or Patient is unable to complete a course of steroids equivalent to oral prednisone 40 mg or more daily for a minimum of 14 days due to contraindications(s) or intolerance(s)/adverse event(s)	12 weeks
Renewal For the continued treatment of adults patients with moderate to severe ulcerative colitis when ALL of the following criteria are met: Special Authority is requested by a gastroenterologist AND Patient has a partial Mayo score reduction from baseline of at least 2 for the sum of stool frequency, rectal bleeding, and physician's global assessment, and With a decrease in baseline rectal bleeding subscore of at least 1, or a rectal bleeding subscore of 0 or 1	1 year

Special Authority criteria

Approval period

Initial

For the treatment of adult patients with moderate to severe ulcerative colitis when ALL of the following criteria are met:

Special Authority is requested by a gastroenterologist

AND

Patient has a partial Mayo score¹ of at least 4 for the sum of stool frequency, rectal bleeding, and physician's global assessment, and
- Patient has a rectal bleeding subscore of at least 2

AND

Patient has had a trial of 5-ASA products for a minimum of 4 weeks

AND

Patient has had a course of steroids equivalent to oral prednisone 40 mg or more daily for a minimum of 14 days², or
- Patient is unable to complete a course of steroids equivalent to oral prednisone 40 mg or more daily for a minimum of 14 days due to contraindications(s) or intolerance(s)/adverse event(s)

12 weeks

Renewal

For the continued treatment of adults patients with moderate to severe ulcerative colitis when ALL of the following criteria are met:

Special Authority is requested by a gastroenterologist

AND

Patient has a partial Mayo score reduction from baseline of at least 2 for the sum of stool frequency, rectal bleeding, and physician's global assessment, and
- With a decrease in baseline rectal bleeding subscore of at least 1, or a rectal bleeding subscore of 0 or 1

1 year

Practitioner exemptions

None

Special notes

¹Patient's partial Mayo score must be completed after their course of therapy of 5-ASA and steroids and prior to their initiation with infliximab therapy
²Patient must be either steroid resistant (displaying a lack of symptomatic response to therapy) or steroid dependent (defined as: unable to withdraw oral corticosteroid within 3 months of initiation without a recurrence of symptoms; a symptomatic relapse within 3 months of stopping; or the need for 2 or more courses of corticosteroids within 1 year)
PharmaCare coverage will not be provided for infliximab in combination with a biologic drug, a janus kinase (JAK)-inhibitor, or a sphingosine 1-phosphate (S1P) receptor modulator for ulcerative colitis
PharmaCare coverage of maintenance therapy of intravenous (IV) infliximab is limited to dosages of 5 mg/kg every 8 weeks. PharmaCare covers a maximum of a 56-day supply per fill of intravenous infliximab
PharmaCare coverage of maintenance therapy of subcutaneous (SC) infliximab is limited to dosages of 120 mg every 2 weeks. PharmaCare covers a maximum of a 28-day supply per fill of subcutaneous infliximab
Additional information expected to assist with the processing of coverage requests is detailed on the forms linked below (and on the eForms published online)

Special Authority request forms

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Limited coverage drugs – infliximab for ulcerative colitis

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