Product Details

Cimzia

Certolizumab pegol
200 mg/mL
Solution for Subcutaneous Injection
Single-Use 1-mL Prefilled Autoinjector (Preservative-Free)

DIN/PIN/NPN

02465574

Manufacturer

UCB Canada Inc.

Formulary Listing Date

2018-01-31

Unit Price

736.6950

Amount MOH Pays

736.6950

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

92:36:00 Disease-Modifying Antirheumatic Agents

Therapeutic Note

NO

ATC Code

L04AB05

Interchangeable Products

NO

LU Clinical Criteria

NO

Requirements

EAP Criteria

Therapeutic Class	Reimbursement Criteria
Rheumatoid Arthritis	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: 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
Ankylosing Spondylitis Drugs	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 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 ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with: Age of disease onset 50 years of age or younger; AND Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND BASDAI score of ≥ 4 for at least 4 weeks while on standard therapy; AND A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided. NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable. The information submitted with the request must include the following: A list of current concomitant medications related to the AS/PS, including pain medications (if relevant). Please include dosing regimens. Details of review of radiographic reports for severe active disease. o X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR o MRI report stating the presence of “inflammation” or “edema” of the SI joint o Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts. Additional information that should be provided if applicable: Schober measurement and chest expansion measurement Evidence of restricted spinal mobility If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts. Duration of Approval:* 1 year Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥2 absolute point reduction in BASDAI score. Please provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable). 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 AS/PS are: Adalimumab 40 mg every two weeks Certolizumab 400 mg at 0, 2, and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks or 400 mg every 4 weeks. Etanercept 25 mg twice weekly or 50 mg once weekly Golimumab 50 mg once a month Infliximab 3-5 mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5 mg/kg/dose every 6 to 8 weeks Secukinumab 150 mg SC at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. Duration of Approval: - First renewal: 1 year; - Second and subsequent renewals: 5 years EAP Drug Request Form: Standard Form for EAP Drug Requests
Psoriatic Arthritis Treatments	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, 40 mg/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 (Only for those approved for biosimilar exemption) Dosage Form/Strength: 25 mg/vial and 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 Guselkumab Brand(s): Tremfya Dosage Form/Strength: 100 mg/mL prefilled syringe and Patient controlled injector (AI) Effective date: November 27, 2023 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. Psoriatic Arthritis Initiation Criteria: For the treatment of psoriatic arthritis in patients who have: Severe active disease (≥5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20 mg/week) for at least 3 months and one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months is required. Details of contraindications and intolerances must also be provided. Duration of Approval of initials: 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. Duration of Approval of first renewal: 1 Year The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of psoriatic arthritis are as follows: Adalimumab 40mg every two weeks Certolizumab 400 mg at week 0, 2, 4 then maintenance doses of 200 mg every 2 weeks or 400 mg every 4 weeks Etanercept 25 mg twice weekly or 50mg once weekly Golimumab 50 mg once a month Secukinumab 100 mg subcutaneously at week 0 and 4, then maintenance dose of 100 mg every 8 weeks thereafter. Guselkumab may be used alone or in combination with a conventional DMARD (e.g., methotrexate). Duration of Approval of second and subsequent renewals: 5 years EAP Drug Request Form: Standard Form for EAP Drug Requests

Product Monograph