Look up one drug

Reason for Use code 658 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 16 weeks is appropriate. Patients not responding adequately at 16 weeks should have treatment discontinued. *Definition of 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. **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 16 weeks 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 Approvals will only allow for standard dosing for guselkumab. The recommended dosing regimen is 100mg administered subcutaneously at week 0 and week 4, followed by maintenance dosing every 8 weeks thereafter, as approved by Health Canada. If the patient has not responded adequately after 16 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Tremfya; DOSAGE FORM/ STRENGTH: 100 mg/mL prefilled syringe and Patient controlled — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 409 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 (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 50 mg once weekly • Golimumab 50 mg once a month • Guselkumab 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 410 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 409, record 241, corpus 2025-01-01; name match only, not an eligibility decision

Tremfya One-Press · DIN 02487314 Manufacturer: Janssen Inc.; listing date 2024-01-31 Health Canada: Marketed since 2019-05-20 · brand TREMFYA ONE-PRESS · ATC L04AC16 GUSELKUMAB · form Solution · route Subcutaneous · ingredients GUSELKUMAB 100 MG/1ML · company Janssen inc · schedule Prescription, Schedule d

DIN 02487314: Tremfya One-Press Raw flags: sec12=Y, sec3=Y Item: 849200013; group id 871; item number 2108; lccId 00374; manufacturer id JAN Source form: Inj Sol-1mL Autoinj (Preservative-Free); strength: 100mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $3059.7400; ministry $3059.7400 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02487314 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97748

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02487314

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 658 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 16 weeks is appropriate. Patients not responding adequately at 16 weeks should have treatment discontinued. *Definition of 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. **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 16 weeks 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 Approvals will only allow for standard dosing for guselkumab. The recommended dosing regimen is 100mg administered subcutaneously at week 0 and week 4, followed by maintenance dosing every 8 weeks thereafter, as approved by Health Canada. If the patient has not responded adequately after 16 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent. Coverage limit: LU Authorization Period: 1 year Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 409 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 (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 50 mg once weekly • Golimumab 50 mg once a month • Guselkumab 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 410 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 409, record 241, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Tremfya · DIN 02469758 Manufacturer: Janssen Inc.; listing date 2023-11-30 Health Canada: Marketed since 2017-11-27 · brand TREMFYA · ATC L04AC16 GUSELKUMAB · form Solution · route Subcutaneous · ingredients GUSELKUMAB 100 MG/1ML · company Janssen inc · schedule Schedule d, Prescription

DIN 02469758: Tremfya Raw flags: sec12=Y, sec3=Y Item: 849200012; group id 871; item number 2109; lccId 00374; manufacturer id JAN Source form: Inj Sol-1mL Pref Syr (Preservative-Free); strength: 100mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $3059.7400; ministry $3059.7400 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02469758 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95860

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02469758

Shortage record checked 2026-09-13T08:10:21.292534+00:00