Limited coverage criteria – infliximab for Crohn's disease

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, Remsima SC and Renflexis are covered by PharmaCare.

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

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 Moderately to severely active Crohn's disease For the treatment of adult patients with moderately to severely active Crohn's disease when ALL of the following criteria are met: Special Authority is requested by a gastroenterologist AND Patient has a Harvey-Bradshaw Index of 8 or higher1 AND Patient has had an unsuccessful trial of steroids for their current Crohn's disease activity. The trial must include a steroid dose equivalent to oral prednisone 40 mg or more daily taken for at least 14 consecutive days. Unsuccessful trial is defined as one of the following: Inadequate response to steroids2 Adequate response while on steroids, but with recurrence of disease following tapering or withdrawal of steroids3 Inability to complete steroid course due to intolerance or contraindication4 Fistulizing Crohn's disease For the treatment of adult patients with active fistulizing Crohn's disease when ALL of the following criteria are met: Special Authority is requested by a gastroenterologist AND Patient has had an inadequate response or intolerance to a course of ciprofloxacin for a minimum of 3 consecutive weeks at maximally tolerated doses, or has a contraindication to ciprofloxacin	12 weeks
Renewal Moderately to severely active Crohn's disease For the continued treatment of adult patients with moderately to severely active Crohn's disease when ALL of the following criteria are met: Special Authority is requested by a gastroenterologist AND Patient has a Harvey-Bradshaw Index decrease of at least 4 points, or Total Harvey-Bradshaw Index is 5 points or less Fistulizing Crohn's disease For the continued treatment of adult patients with active fistulizing Crohn's disease when ALL of the following criteria are met: Special Authority is requested by a gastroenterologist AND Patient has demonstrated an improvement in the number of and/or severity of fistulae	1 year

Practitioner exemptions

• None

Special notes

• ¹Moderately to severely active Crohn's disease as defined by a Harvey-Bradshaw Index of 8 or higher following completion of a course of steroids (equivalent to oral prednisone 40 mg or more daily for a minimum of 14 consecutive days)
• ²Inadequate response to steroids is defined as displaying a lack of symptomatic response to therapy
• ³Steroid dependence is 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
• ⁴The patient's contraindication to steroid therapy or intolerance/adverse effects to a course of steroids (equivalent to oral prednisone 40 mg or more daily for a minimum of 14 consecutive days) must be specified in the Special Authority request for infliximab
• For initial requests for patients who are able to complete a 14-day course of steroids, the patient's Harvey-Bradshaw Index must be completed after a course of at least 14 consecutive days of steroid therapy and prior to their initiation of infliximab therapy
• For initial requests for patients who have had prior surgery or surgeries (such as ostomy, pouch, or prior resection), the patient's usual number of liquid bowel movements and Harvey-Bradshaw Index worksheet must be submitted with each Special Authority coverage request for infliximab
• 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 needed is detailed on the forms linked below

Special Authority request form(s)

• Log in to eForms
• HLTH 5368 – Biologics for Moderate to Severe Active Crohn's or Fistulizing Crohn's Disease: Initial/switch (PDF, 1.2MB)
• HLTH 5495 – Biologics for Moderate to Severe Active Crohn's or Fistulizing Crohn's Disease: Renewal (PDF, 1.3MB)
• HLTH 5374 – Worksheet (Based on Harvey-Bradshaw Index) (PDF, 514KB)