Limited coverage criteria – infliximab for ulcerative colitis

Last updated on April 2, 2025

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Inflectra^® discontinuation; Remdantry^™ and Ifixi^® listings

Effective April 1, 2025, the Inflectra^®-branded infliximab product will be discontinued. Starting that same day, Remdantry^™ will be marketed by Celltrion Healthcare under the same Health Canada-assigned DIN (02419475), as it is the same product.

Between April 1 and September 30, 2025, Pfizer Canada ULC will continue to distribute Inflectra. During that period, pharmacies must dispense Inflectra under PIN 66128531 for it to be eligible for PharmaCare coverage.

As of October 1, 2025, Inflectra will no longer be a PharmaCare benefit.

Also on April 1, 2025, the infliximab biosimilar Ixifi® will be marketed by Pfizer Canada ULC under DIN 02523191.

Avsola^® and Renflexis^™ continue to be available as intravenous infliximab biosimilar options, and Remsima^™SC continues to be available as a subcutaneous option.

Patient transition

April 1, 2025

As soon as it is discontinued on April 1, 2025, the Inflectra-branded product will not be covered for new patients, and Special Authority (SA) requests for infliximab will only be approved for Avsola, Ixifi, Remdantry, Remsima SC or Renflexis.

Existing patients who have been dispensed the Inflectra-branded product in the previous 3 months and have PharmaCare coverage for Inflectra, will have transitional coverage until September 30, 2025. This will allow time to switch to Avsola, Ixifi, Remdantry, Remsima SC or Renflexis.

April 1 to September 30, 2025

During this 6-month period, existing patients with PharmaCare coverage for Inflectra must switch to Avsola, Ixifi, Remdantry, Remsima SC or Renflexis.

October 1, 2025

Inflectra-branded product is no longer available and therefore not an eligible PharmaCare benefit. Only Avsola, Ixifi, Remdantry, RemsimaSC and Renflexis are covered by PharmaCare.

More information about the Inflectra discontinuation and patient transition is available in the April 2025 PharmaCare Newsletter.

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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).

Return to Special Authority drug list

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

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

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