Product Details
Avsola
Infliximab100 mg/Vial
Powder for Injection
Vial Pack
DIN/PIN/NPN
02496933
Manufacturer
Amgen Canada Inc.
Formulary Listing Date
2020-12-18
Unit Price
493.0000
Amount MOH Pays
493.0000
Coverage Status
Limited Use Product Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
L04AB02
Interchangeable Products
NOLU Clinical Criteria
LU Code | Auth. Period | Clinical Criteria |
---|---|---|
592 | 1 year | For the treatment of rheumatoid arthritis (RA) in 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 B. i) Methotrexate (20mg/week) for at least 3 months, AND 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. The recommended dosing regimen is 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. |
593 | 1 year | For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see notes below) with: I. Age of disease onset less than or equal to 50; AND II. Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND III. 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 IV. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding 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. The recommended dosing regimen is 3 to 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks. |
594 | 1 year | For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) 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 (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. 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 funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks. |
595 | 1 year | For the treatment of severe* 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**. 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. *Severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10 percent, 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. **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 to 30mg/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 BSA involvement, AND - at least a 5-point reduction in DLQI score The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks. |
596 | 1 year | Ulcerative Colitis For the treatment of moderate to severe ulcerative colitis in 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); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) 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 (initial and renewal coverage): - Combination therapy with another biologic 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. |
597 | 1 year | Luminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in 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); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.) 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 (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel 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. |
598 | 1 year | Fistulising Crohn's disease For the treatment of fistulising Crohn's disease in patients who meet the following criteria: - Patient has 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) The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. |
EAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Polyarticular Juvenile Idiopathic Arthritis | Abatacept
Infliximab - See formulary for funded biosimilars
Rituximab
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 polyarticular-course juvenile idiopathic arthritis in patients meeting the following criteria:
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:
EAP Drug Request Form: |
Rheumatoid Arthritis | Adalimumab – see Formulary for funded biosimilars
Anakinra
Certolizumab pegol
Etanercept – see Formulary for funded biosimilars
Golimumab
Infliximab – see Formulary for funded biosimilars
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:
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:
Duration of Approval: EAP Drug Request Form: |
Ankylosing Spondylitis Drugs | Adalimumab – See Formulary for funded biosimilars
Certolizumab
Etanercept – See Formulary for funded biosimilars
Golimumab
Infliximab- See Formulary for funded biosimilars
Secukinumab
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:
*NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable. The information submitted with the request must include the following:
Additional information that should be provided if applicable:
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:
Duration of Approval: First renewal: 1 year; Second and subsequent renewals: 5 years EAP Drug Request Form: |
Inflammatory Bowel Diseases | Infliximab - See formulary for funded biosimilars
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 Infliximab as Remicade. Refer to the ODB formulary for the Limited Use Criteria for Infliximab biosimilars which was updated with the January 2023 ODB Formulary Update. Treatment of moderate to severe (luminal) Crohn’s Disease in patients who have:
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. Recommended dose: Requests for higher doses of infliximab must provide a description of symptoms and HBI score on standard dosing and may include laboratory support of infliximab levels for consideration of case-by-case consideration. Duration of Approval: Pediatric patients will be considered case-by-case. The below criteria are for Infliximab as Remicade. Refer to the ODB formulary for the Limited Use Criteria for Infliximab biosimilars which was updated with the January 2023 ODB Formulary Update. Remicade for fistulizing Crohn's disease: Actively draining perianal or enterocutaneous fistula(e) that have recurred or persist despite a course of:
Recommended dose: Duration of Approval: 6 months If the patient has been using a higher dosing regimen over the past year, the requesting MD must provide the rationale for this dose by comparing the patient’s symptoms on standard dosing and the current dosing. Then the request should be sent for external review. Renewal of funding of patients using Remicade for the treatment of fistulizing Crohn’s Disease will be considered for patients with resolution of fistulae. The planned dosing regimen for the requested biologic should be provided. The recommended dose for the treatment of Crohn’s Disease is 5 mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks with up to 10 mg/kg/dose every 8 weeks being considered on a case-by-case basis. Approval duration of first renewal: 6 months to 1 year pending fistula(e) resolution Approval duration of second and subsequent renewals: 2 years with complete resolution; case-by-case duration with partial resolution Initial induction requests for infliximab for patients with mild Ulcerative Colitis (Mayo score below 6) may be considered for Infliximab as Inflectra on a case-by-case basis through EAP but the submission must include the rationale for coverage. Patients treatment experienced to Remicade and transitioning to public funding must meet the initiation (induction) criteria before consideration of funding of maintenance under renewal criteria will be applied. For the treatment of ulcerative colitis disease in patients who meet the following criteria: Induction (Initiation) Criteria:
Moderate disease:
*The endoscopy procedure must be done within the last year but does not have to be full endoscopy. **Contraindication to Aza/6MP includes pancreatitis, allergic reaction [fever and/or rash and arthritis], malaise, diarrhea and hepatitis Approved Dose: Approval duration: 6 months Severe disease:
*The endoscopy procedure must be done within the last year but does not have to be full endoscopy. **Contraindication to Aza/6MP includes pancreatitis, allergic reaction [fever and/or rash and arthritis], malaise, diarrhea and hepatitis Approval duration: 6 months Dose: Maintenance (Renewal) Criteria for first renewal: After 3 loading doses of Remicade, if Mayo score below 6 AND 50% reduction in prednisone from the starting dose Approval duration: 6 months If After 3 loading doses of Remicade if Mayo score below6 AND patient is no longer on prednisone Approval duration: 12 months Approved Dose: Maintenance (Renewal) Criteria for second and subsequent renewals:
Patients who remain on steroids will be considered on a case-by-case basis. Approval duration: 12 months to up to 2 years for those off steroids Approved Dose: 5 mg/kg/dose up to every 6 weeks 1Note that the endoscopy procedure must be done within the last year but does not have to be full endoscopy. Pediatric patients will be considered case-by-case. EAP Drug Request Form: |
Ocular Treatments | Adalimumab – See Formulary for funded biosimilars
Infliximab – See formulary for funded biosimilars
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:
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. |
Juvenile Spondyloarthritis or Enthesitis-Related Arthritis | Adalimumab – see Formulary for funded biosimilars
Etanercept – see Formulary for funded biosimilars
Infliximab – see Formulary for funded biosimilars
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
The details of imaging reports for severe active disease must provide the following:
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
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:
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: |