Product Details

Humira (Pediatric)

Adalimumab
40 mg/0.8 mL
Solution for Injection
Vial Pack for Pediatric Use

DIN/PIN/NPN

09854785

Manufacturer

AbbVie Corporation

Formulary Listing Date

2022-05-31

Unit Price

794.1000

Amount MOH Pays

794.1000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

92:36:00 Disease-Modifying Antirheumatic Agents

Therapeutic Note

NO

ATC Code

L04AB04

Interchangeable Products

NO

LU Clinical Criteria

NO

EAP Criteria

Therapeutic Class	Reimbursement Criteria
Polyarticular Juvenile Idiopathic Arthritis	Etanercept – see Formulary for funded biosimilars Brand(s): Enbrel Dosage Form/Strength: 25 mg/vial, 25 mg and 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options Adalimumab – see Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars Dosage Form/Strength: 40 mg/0.8mL prefilled syringe, 40 mg/0.8mL and and 20 mg/0.2 mL prefilled pens for subcutaneous injection Tociluzumab Brand(s): Actemra Dosage Form/Strength: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL Vial, 162mg/0.9mL Inj (Prefilled syringe), 162mg/0.9mL Auto Injector Rituximab Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (biologic originator for those meeting biosimilar exemption) Dosage Form/Strength: 10 mg/mL intravenous injection 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) Patients with pJIA who are unable to use Erelzi or Brenzys to accommodate weight-based dosing as a result of the syringe format and ability to measure partial syringe doses may request an exemption for Enbrel. For the first-line treatment of polyarticular-course juvenile idiopathic arthritis in patients meeting the following criteria: Patient has active disease (≥ 3 swollen joints and ≥ 5 active joints) despite a trial of optimal dose of subcutaneously administered methotrexate (i.e., 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. 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. Duration of Approval: 5 Year Dosing for Etanercept: The planned dosing regimen should be provided. The maximum recommended dose is 50mg once weekly. Recommended dosing for Adalimumab: - 24 mg/m² (maximum 40 mg) every two weeks; OR - 20 mg every 2 weeks, if the Patient weighs less than 30 kg; OR - 40 mg every 2 weeks, if the Patient weighs more than 30 kg. Recommended dosing for Tocilizumab in combination with Methotrexate: IV dosing regimen: - 10 mg/kg every 4 weeks, if the Patient weighs less than 30 kg; OR - 8 mg/kg every 4 weeks, if the Patient weighs more than or equal to 30 kg. SC dosing regimen: - 162 mg once every 3 weeks if the Patient weighs less than 30 kg - 162 mg once every 2 weeks if the Patient weighs 30 kg or more EAP Drug Request Form: Standard Form for EAP Drug Requests
Rheumatoid Arthritis	Adalimumab – see Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars 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 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 Dosage Form/Strength: 100 mg/vial intravenous infusion 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 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 (400mg/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 40mg every two weeks Anakinra 100mg per day Certolizumab pegol 400mg at 0, 2 and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks. For maintenance dosing, 400mg every 4 weeks may be considered Etanercept 25mg twice weekly or 50mg once weekly Golimumab 50mg once a month Infliximab 3mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3mg/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 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
Dermatology Drugs	Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars Dosage Form/Strength: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection For the treatment of adult patients with active moderate to severe hidradenitis suppurativa who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A total abscess and nodule count of 3 or greater Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III An inadequate response to a 90-day trial of oral antibiotics Prescribed by a practitioner with expertise in the management of patients with HS Note: Treatment with adalimumab should be discontinued if there is no improvement after 12 weeks of treatment First renewal: Requests for renewal should provide objective evidence of a treatment response, defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline at week 12. Subsequent renewal: For renewals beyond the second year, objective evidence of the preservation of treatment effect should be provided (i.e., the current AN (abscess and inflammatory nodule) count and draining fistula count should be compared to the count prior to initiating treatment with adalimumab). Approval duration: Initial approval: 3 months First renewals: 1 year Subsequent renewals: 2 years Recommended dose: The recommended dose is 160 mg initially (week 0), followed by 80 mg at week 2, then 40 mg at week 4, and 40 mg weekly thereafter EAP Drug Request Form: Standard Form for EAP Drug Requests
Inflammatory Bowel Diseases	Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars Dosage Form/Strength: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection 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) The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab biosimilars which was updated with the January 2023 ODB Formulary Update. For the treatment of fistulising Crohn’s disease with concomitant luminal disease in patients who meet the following criteria: Patient with actively draining perianal or enterocutaneous fistula(e) that have recurred or persist despite a course of appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) AND immunosuppressive therapy (e.g. azathioprine or 6-mercaptopurine) AND Harvey Bradshaw Index (HBI) score ≥ 7 The dose that will be considered is Adalimumab 160 mg at week zero, 80 mg at week two, followed by 40 mg every two weeks. Duration of Approval: 3 months Renewal will be considered based on the response to therapy. The dose that will be considered on renewals is Adalimumab 40 mg every two weeks. All requests for higher doses will not be approved. Duration of Approval: 3 months to 1 year pending fistula(e) resolution Second Renewal: 2 years for 2nd renewal of requests with complete resolution Case-by-case duration for renewal of requests with partial resolution. Pediatric patients will be considered case-by-case. *The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab biosimilars which was updated with the January 2023 ODB Formulary Update.* Treatment of moderate to severe (luminal) Crohn’s Disease in patients who have: HBI (Harvey Bradshaw Index) score ≥7; AND Failed to respond to conventional treatment with glucocorticoids (prednisone 40mg/day or equivalent for at least 2 weeks or dose cannot be tapered to below prednisone 20 mg/day or equivalent); AND Failed to respond to an immunosuppressive agent (azathioprine, 6-mercaptopurine, methotrexate, or cyclosporine) tried for at least 3 months. Note:* Any intolerance(s) or contraindication(s) to treatment with required alternative(s) must be described in detail. If the patient has HBI below 7, the request will be reviewed by external medical experts when the following information is provided: bloodwork (with hematocrit, hemoglobin, C reactive protein, ESR, platelets, and ferritin levels); supporting endoscopy; details of weight loss; and a list of narcotic analgesics being used. Duration of Approval:* 6 months Renewal will be considered for patients with 50% reduction in HBI from pre-treatment as well as improvement of symptoms (e.g., absence of bloody diarrhea and weight stabilization or increase) and no longer using steroids. Biochemical improvements may also be required. The planned dosing regimen for the requested biologic should be provided. The recommended dose: Adalimumab: 160mg at week 0; 80mg at week 2; followed by 40mg every two weeks Duration of Approval: - First renewal: 1 year Second and - Subsequent renewals: 2 years Pediatric patients will be considered case-by-case. *The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab biosimilars which was updated with the January 2023 ODB Formulary Update.* For the treatment of ulcerative colitis disease in adult patients¹ who meet the following criteria: Induction Criteria: Mild disease: Mayo score below 6; AND Patients with mild disease will be considered on a case-by-case basis BUT submission must include the rationale for coverage Moderate disease: Mayo score between 6 and 10 (inclusive); AND Endoscopic* subscore of 2; AND Failed 2 weeks of oral prednisone at daily doses ≥40mg (or a 1-week course of IV equivalent) AND 3 months of azathioprine (AZA)/ 6-mercaptopurine (6MP) (or where the use of immunosuppressants is contraindicated); OR Stabilized with 2 weeks of oral prednisone at daily dose ≥ 40mg (or a 1 week course of IV equivalent) but the prednisone dose cannot be tapered despite 3 months of AZA/ 6MP (or where the use of immunosuppressants is contraindicated) Severe disease: Mayo score > 10; AND Endoscopic* subscore of ≥ 2; AND Failed 2 weeks of oral prednisone at daily dose ≥ 40mg (or 1 week IV equivalent); OR Stabilized with 2 weeks oral prednisone ≥ 40mg (or 1 week of IV equivalent) but the prednisone dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated) Initial Approval: 6 months at 160 mg initially administered at week 0, followed by 80mg at week 2, then 40 mg every other week thereafter. The endoscopy procedure must be done within the 12 months prior to initiation of treatment. Maintenance Criteria:* After 8 weeks of adalimumab therapy: Mayo score below 6; AND 50% reduction in prednisone from the starting dose Approval: 6 months at 40mg every other week. If patient is completely off steroids: Approval: 12 months at 40 mg every other week. Subsequent renewals: Mayo score below 6; AND Must be completely off steroids Approval: 2 years at 40mg every other week. (Patients who remain on steroids will be considered on a case-by-case basis) ¹Pediatric patients will be considered case-by-case. EAP Drug Request Form: Standard Form for EAP Drug Requests
Ocular Treatments	Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars 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 and formulary listed biosimilars Dosage Form/Strength: 100 mg/Vial Injection for infusion 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 severe non-infectious ocular inflammatory disease (OID) in patients meeting one of the following criteria: Experienced failure, intolerance, or contraindication to oral corticosteroid (or topical corticosteroid for anterior uveitis) and failure or intolerance to at least one immunosuppressive therapy; OR For the treatment of chronic Juvenile Idiopathic Arthritis (JIA)-associated uveitis after failure or intolerance to a first-line immunosuppressive agent; OR For patients who have immediately vision-threatening OID and do not meet the above criteria, where consultation notes/ letter from an ophthalmologist expert specializing in OIDs (who may be the requesting physician) confirm the severity of the patient’s condition and indicate detailed rationale for an immediate biologic therapy (e.g., ocular inflammation associated with Behcet’s disease; severe non- necrotizing scleritis; necrotizing scleritis; etc.); AND Patient must be followed by a uveitis specialist, a retina specialist familiar with ocular inflammatory diseases, or a pediatric ophthalmologist. Approved Dose: Adalimumab 40 mg subcutaneous every 1 to 2 weeks. Infliximab 5-10 mg/kg IV at weeks 0, 2, 6 and maintenance every 4-8 weeks Duration of Approval: 1 year Renewals will be considered for requests where consultation notes or a letter is provided by the requesting physician to confirm that treatment has resulted in improvement/stability of vision and other treatment goals (e.g., remission from/control of ocular inflammation) have been met. Duration of Approval: 2 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
Juvenile Spondyloarthritis or Enthesitis-Related Arthritis	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 Etanercept – see Formulary for funded biosimilars Brand(s): Enbrel and formulary listed biosimilars Dosage Form/Strength: 25mg/vial, 50 mg prefilled syringe for subcutaneous injection Infliximab – see Formulary for funded biosimilars Brand(s): Remicade and formulary listed biosimilars Dosage Form/Strength: 100 mg/vial Updated: March 29, 2021 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 juvenile spondyloarthritis (JSpA) or enthesitis-related arthritis (ERA) in patients who meet the following criteria for either axial or peripheral disease: Axial Disease Age of disease onset ≤ 16 years; AND Low back pain and stiffness for > 3 months that improve with exercise and not relieved by rest; AND Failure to respond to or documented intolerance to adequate trials of 2 nonsteroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND BASDAI score of ≥ 4 after at least 4 weeks of standard NSAID therapy; AND Imaging evidence of severe active disease by X-ray, CT scan or MRI The details of imaging reports for severe active disease must provide the following: X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR MRI report stating the presence of “inflammation” or “edema” or “erosion” of the SI joint. Actual imaging reports must be submitted with the request. If the imaging reports do not specify the above findings, the request will be reviewed by external medical experts. The imaging interpretation report from the radiologist or rheumatologist may be submitted along with radiographic report. 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. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Peripheral Disease Age of disease onset ≤ 16 years; AND ≥ 5 active sites of inflammation attained by a combination of swollen/active joints and/or enthesitis sites (tenderness or swelling at entheseal insertion) Failure or intolerance to at least one DMARD (sulfasalazine 50 mg/kg/day- maximum 2 grams, or methotrexate 15 mg/m²/week-maximum 25 mg per week) for at least 3 months. Renewals will be considered for patients with objective evidence of at least a 20% reduction in active sites over the previous year. There should also be an improvement in number of enthesitis sites. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Requests that do not meet these criteria will undergo external review. The planned dosing regimen for the requested biologic should be provided. The recommended dose for the treatment of JSpA/ERA is as follows: Etanercept 0.4mg/kg (max 25 mg) twice weekly or 0.8mg/kg (max 50 mg) once weekly Infliximab 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6-8 weeks Adalimumab: - If Less than 30 kg, 20 mg SC every 2 weeks - If Greater than or equal to 30 kg, 40 mg SC every 2 weeks Requests for higher doses will be considered on a case-by-case basis. Duration of Approval of Initials and Renewals: 1 Year EAP Drug Request Form: Standard Form for EAP Drug Requests

Product Monograph