Limited coverage drugs – infliximab for Crohn's disease

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
Avsola^™	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 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 The 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

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
- The 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 expected to assist with the processing of coverage requests is detailed on the forms linked below (and on the eForms published online)

Special Authority requests

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Limited coverage drugs – infliximab for Crohn's disease

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