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.

Abatacept

• Brand(s): Orencia
• Dosage Form/Strength: 250 mg/15 mL vial (Note that the SC injection is not approved for this indication)

Infliximab - See formulary for funded biosimilars

• Brand(s): Avsola, Inflectra, Renflexis Biosimilars); Remicade (Originator)
• Dosage Form/Strength: 100 mg/vial

Rituximab

• Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (biologic originator for those meeting biosimilar exemption)
• Dosage Form/Strength: 10 mg/mL intravenous injection

Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx

Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions.

Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document).

It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023.

For the treatment of polyarticular-course juvenile idiopathic arthritis in patients meeting the following criteria:

1. Patient has active disease (a minimum of 3 (three) swollen joints and a total of 5 active joints); AND

2. Patient has had an inadequate response to a three-month course of methotrexate administered subcutaneously at a dosage of at least 15 mg/m² per week for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate the nature of the intolerance or contraindication must be described in detail.; AND

3. Patient has had an inadequate response to a three-month course of etanercept OR adalimumab OR tociluzumab. If the patient is unable to tolerate or has a contraindication to etanercept OR adalimumab OR tociluzumab, the nature of the intolerance or contraindication must be described in detail.

Duration of Approval: 1 Year

Renewals will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count. For renewals beyond the second year, objective evidence of preservation of treatment effect should be provided. (i.e., the current joint count should be compared to the count prior to initiating treatment with the biologic agent)

Duration of Approval: 5 Year

Approved Dose:

• Abatacept refer to the Orencia product monograph for dosing information

• Infliximab dose up to 6 mg/kg/dose at 0, 2 and 6 weeks followed by maintenance of up to 6 mg/kg/dose every 8 weeks

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Adalimumab – see Formulary for funded biosimilars

• Brand(s): Humira (Only for those approved for biosimilar exemption)
• Dosage Form/Strength: 40 mg/0.8mL prefilled syringe, 40 mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection

Anakinra

• Brand(s): Kineret
• Dosage Form/Strength: 100 mg /0.67 mL subcutaneous injection

Certolizumab pegol

• Brand(s): Cimzia
• Dosage Form/Strength: 200 mg/mL prefilled syringe and autoinjector

Etanercept – see Formulary for funded biosimilars

• Brand(s): Enbrel (Only for those approved for biosimilar exemption)
• Dosage Form/Strength: 25 mg and/or 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options

Golimumab

• Brand(s): Simponi
• Dosage Form/Strength: 50 mg/0.5 mL prefilled syringe and autoinjector

Infliximab – see Formulary for funded biosimilars

• Brand(s): Remicade (Only for those approved for biosimilar exemption)
• Dosage Form/Strength: 100 mg/vial intravenous infusion

Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx

Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions.

Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document).

It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g., manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023.

For the treatment of rheumatoid arthritis in patients who have:

1. Severe active disease (≥ 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) despite the optimal use of various formulary disease-modifying anti-rheumatic drugs (DMARDs)*.

   *Optimal use of DMARDs include:

• Methotrexate (20 mg/week) for at least 3 months and leflunomide (20 mg/day) for at least 3 months in addition to an adequate trial (3 months) of at least one combination of DMARDs;

  OR

• Methotrexate (20 mg/week) for at least 3 months and leflunomide in combination with methotrexate for at least 3 months.

  Note: If the patient could not receive adequate trial(s) of methotrexate and/or leflunomide due to contraindication(s) or intolerance(s), the nature of contraindication(s) or intolerance(s) must be provided along with details of trials of other DMARDs or clear rationale why other DMARDs cannot be considered.

  OR

• Methotrexate (20mg/week), sulfasalazine (2 GM/day) and hydroxychloroquine (400 mg/day)* for at least 3 months. If the patient could not receive an adequate trial of methotrexate, sulfasalazine and hydroxychloroquine due to intolerance, then the above DMARD trial criteria must be met.

  *Hydroxychloroquine is based by weight up to 400 mg per day

Duration of Approval: 1 Year

Renewal will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided.

The planned dosing regimen for the requested biologic should be provided.

The recommended doses for the treatment of rheumatoid arthritis are as follows:

• Adalimumab 40 mg every two weeks

• Anakinra 100 mg per day

• Certolizumab pegol 400 mg at 0, 2 and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks. For maintenance dosing, 400 mg every 4 weeks may be considered

• Etanercept 25 mg twice weekly or 50 mg once weekly

• Golimumab 50 mg once a month

• Infliximab 3 mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3 mg/kg/dose every 8 weeks up to a maximum of six maintenance doses per year

Duration of Approval:
- First Renewal: 1 Year
- Subsequent Renewals: 5 Years

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Adalimumab – See Formulary for funded biosimilars

• Brand(s): Humira and formulary listed biosimilars
• Dosage Form/Strength: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection

Certolizumab

• Brand(s): Cimzia
• Dosage Form/Strength: 200 mg/mL prefilled syringe and autoinjector

Etanercept – See Formulary for funded biosimilars

• Brand(s): Enbrel and formulary listed biosimilars
• Dosage Form/Strength: 25mg/vial and 50mg prefilled syringe for subcutaneous injection

Golimumab

• Brand(s): Simponi
• Dosage Form/Strength: 50 mg/0.5 ml prefilled syringe and autoinjector

Infliximab- See Formulary for funded biosimilars

• Brand(s): Remicade and formulary listed biosimilars
• Dosage Form/Strength: 100mg/10mL intravenous infusion

Secukinumab

• Brand(s): Cosentyx
• Dosage Form/Strength: 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen

Infliximab - See formulary for funded biosimilars

• Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator)
• Dosage Form/Strength: 100mg/vial Injection for Infusion

Adalimumab – See Formulary for funded biosimilars

• Brand(s): Humira (Only for those approved for biosimilar exemption)
• Dosage Form/Strength: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection

Infliximab – See formulary for funded biosimilars

• Brand(s): Remicade (Only for those approved for biosimilar exemption)
• Dosage Form/Strength: 100 mg/Vial Injection for infusion

Adalimumab – see Formulary for funded biosimilars

• Brand(s): Humira (Only for those approved for biosimilar exemptions)
• Dosage Form/Strength: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection

Etanercept – see Formulary for funded biosimilars

• Brand(s): Enbrel (Only for those approved for biosimilar exemptions)
• Dosage Form/Strength: 25mg/vial, 50 mg prefilled syringe for subcutaneous injection

Infliximab – see Formulary for funded biosimilars

• Brand(s): Remicade (Only for those approved for biosimilar exemptions)
• Dosage Form/Strength: 100 mg/vial

Updated: March 29, 2021