Remsima SC

For the treatment of rheumatoid arthritis (RA) in adult patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments:

A.  i) Methotrexate (20mg/week) for at least 3 months, AND
    ii) leflunomide (20mg/day) for at least 3 months, in addition to
   iii) an adequate trial of at least one combination of DMARDs for 3 months; OR

B.  i) Methotrexate (20mg/week) for at least 3 months, AND
    ii) leflunomide in combination with methotrexate for at least 3 months; OR

C.  i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.)

Maintenance/Renewal:

After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year.

For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.

Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology.

Recommended dose: Refer to the product monograph for full instructions.

Loading dose of 120mg subcutaneous (SC) at week 0, 1, 2, 3, and 4, followed by maintenance with 120mg SC infliximab every 2 weeks thereafter.

OR

If intravenous loading doses of infliximab are given to initiate treatment, 2 intravenous infusions of infliximab 3mg/kg should be given 2 weeks apart, and the first dose of 120mg infliximab SC should be initiated 4 weeks after the second IV infliximab dose.

Maintenance dose: 120mg SC once every 2 weeks.

Infliximab SC should be given in combination with methotrexate.

Note: There is insufficient information available to inform the use of appropriate SC dosing in patients who are using infliximab intravenously at doses greater than 3mg/kg for rheumatoid arthritis.

I. For the treatment of moderate to severe ulcerative colitis in adult patients who meet the following criteria:

A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease);

AND

B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week);

OR

Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine) and subcutaneous (SC) infliximab is used as a steroid-sparing option in the maintenance setting;

OR

Conventional treatment with a corticosteroid is contraindicated;

AND

C. SC infliximab is being used in the maintenance setting after completing an induction regimen with intravenously administered infliximab;

OR

II. SC infliximab is being used in the maintenance setting in a patient stabilized on intravenous infliximab** in the maintenance setting.

*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.

**Note that there is insufficient information to inform the use and appropriate dosing of infliximab SC in patients who are using infliximab intravenously at doses greater than 5mg/kg for ulcerative colitis.

Approved doses:

120mg SC every 2 weeks as maintenance dosing.

The recommended maintenance dosing regimen is 120mg (given as one subcutaneous injection) once every 2 weeks, starting 4 weeks following completion of an induction regimen. For patients who have been on maintenance therapy with intravenous infliximab and who are switching to subcutaneous infliximab maintenance therapy, the first dose of subcutaneous infliximab may be administered 8 weeks after the last infliximab intravenous infusion.

Maintenance/Renewal:

Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids.

Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy.

Exclusion criteria (Applies to both initial and renewal coverage):

- Combination therapy with other advanced treatment options such as, biological treatments, sphingosine-1-phosphate receptor modulators, or JAK inhibitors used to treat inflammatory bowel disease will not be funded.

Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.

I. For the treatment of moderate to severe (luminal) Crohn's disease in adult patients who meet the following criteria:

A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease);

AND

B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week);

OR

Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate) and infliximab subcutaneous (SC) is used as a steroid-sparing option in the maintenance setting;

OR

Conventional treatment with a corticosteroid is contraindicated;

AND

C. SC infliximab is being used in the maintenance setting after completing an induction regimen with intravenously administered infliximab

OR

II. SC infliximab is being used in the maintenance setting in a patient stabilized on intravenous infliximab** in the maintenance setting.

Approved doses:

120mg SC every 2 weeks as maintenance dosing.

The recommended maintenance dosing regimen is 120mg (given as one subcutaneous injection) once every 2 weeks, starting 4 weeks following completion of an induction regimen. For patients who have been on maintenance therapy with intravenous infliximab and who are switching to subcutaneous infliximab maintenance therapy, the first dose of subcutaneous infliximab may be administered 8 weeks after the last infliximab intravenous infusion.

**Note that there is insufficient information to inform the use and appropriate dosing of infliximab SC in patients who are using infliximab intravenously at doses greater than 5mg/kg for Crohn's disease.

Maintenance/Renewal:

Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids.

Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy.

Exclusion criteria (Applies to both initial and renewal coverage):

- Combination therapy with other advanced treatment options such as, biological treatments, or JAK inhibitors used to treat Crohn's disease will not be funded.

Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.