Product Details

Cosentyx

Secukinumab
150 mg/mL
Solution for Injection
1-mL Single-Use Prefilled SensoReady Pen

DIN/PIN/NPN

09857548

Manufacturer

Novartis Pharma Canada Inc.

Formulary Listing Date

2016-08-30

Unit Price

934.0400

Amount MOH Pays

934.0400

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

84:36:00 Miscellaneous Skin and Mucous Membrane Agents

Therapeutic Note

NO

ATC Code

L04AC10

Interchangeable Products

NO

LU Clinical Criteria

LU Code	Auth. Period	Clinical Criteria
476	1 year	For the treatment of severe (see Note 1 below) plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. The recommended dose for Cosentyx is 300mg subcutaneously at weeks 0, 1, 2 and 3, and then monthly starting at week 4. A maintenance dose of 300mg every 2 weeks may be considered for adult patients with a body weight of 90kg or higher. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved doses, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Note 1: Definition of severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND - Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND - Dermatology Life Quality Index (DLQI) score of at least 10. Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: - 6-month trial of at least 3 topical agents including vitamin D analogues and steroids, AND - 12-week trial of phototherapy (unless not accessible), AND - 6-month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - At least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5-point reduction in DLQI score

EAP Criteria

Therapeutic Class	Reimbursement Criteria
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 Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions. It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval. Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at 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 (see below). 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 of this document) 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 400mg 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 50mg once a month Infliximab 3-5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/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 and formulary listed biosimilars 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 and formulary listed biosimilars 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 Secukinumab Brand(s): Cosentyx Dosage Form/Strength: 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions. It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval. Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at 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 (see below). 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 of this document) 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 (20mg/day) or sulfasalazine (1g 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 4weeks Etanercept 25 mg twice weekly or 50mg once weekly Golimumab 50 mg once a month Secukinumab 150mg SC at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. If a patient is an anti-TNF-alpha inadequate responder and continues to have active psoriatic arthritis, consider using the 300 mg SC dose. For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis (i.e., 300 mg SC at weeks 0, 1, 2, and 3, followed by monthly maintenance dosing starting at week 4) Duration of Approval of second and subsequent renewals: 5 years EAP Drug Request Form: Standard Form for EAP Drug Requests

Product Monograph