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Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 726 For the treatment of adults with severe uncontrolled asthma who meet the following criteria: 1. Patient is 12 years of age or older; AND 2. Diagnosed with severe asthma that is not controlled despite treatment with a high-dose inhaled corticosteroid, defined as greater than or equal to 500mcg of fluticasone propionate or equivalent daily*, in addition to a long-acting inhaled beta 2-agonist; *Note: Check dose comparison tables for high-dose inhaled corticosteroid equivalency comparisons for various inhaled corticosteroids. Omalizumab will not be funded as a first line treatment for uncontrolled asthma and patients must try other conventional therapies for asthma that include a corticosteroid inhaler before being prescribed a biologic treatment. Proper inhaler technique (with a spacer if required/appropriate) and adherence to prescribed treatment should be confirmed. Patients may also be on other concomitant therapies. AND 3. In the past 12 months, inadequately controlled asthma has resulted in at least one of the following: - Hospitalization for asthma - Two or more urgent care visits to a physician/nurse practitioner or emergency department for asthma exacerbations. - Use of two or more courses of high-dose oral corticosteroids (e.g. prednisone) or increase in the dose of chronic prednisone treatment to manage asthma exacerbations; AND 4. Patient has demonstrated a positive skin test or in vitro reactivity to a perennial aeroallergen (e.g. positive allergy testing by skin prick test or IgE RAST); Note: Removal or reduction of allergic and environmental triggers of asthma to the fullest extent possible should be attempted. AND 5. Has a baseline Immunoglobulin E (IgE) level between 30IU/mL and 700IU/mL inclusive prior to start of omalizumab; Note: Serum total IgE levels increase following administration of omalizumab due to formation of omalizumab:IgE complexes. Elevated serum total IgE levels may persist for up to 1 year following discontinuation of omalizumab. Serum total IgE levels obtained less than 1 year following discontinuation may not reflect steady state free IgE levels and should not be used to reassess the dosing regimen in asthma patients. AND 6. Has an actual body weight between 20 to 150kg inclusive (Refer to Omlyclo product monograph for dosing in individuals 12 years of age and older by IgE level and weight); AND 7. Prescribed by or in consultation with a specialist in respirology or allergy/clinical immunology. 8. Omalizumab is not being used in combination with another biologic drug used for the treatment of asthma. Renewal of omalizumab is provided for patients who have responded to treatment by improving asthma control compared to baseline before omalizumab was initiated. Depending on the baseline parameters, this may be evidenced by clinical improvements of one or more of the following; - Decreased utilization of rescue medications [as determined by reduction in nighttime awakenings or reduction in average number of puffs/day of short-acting beta-agonists (SABA)]; OR - Decreased frequency of asthma exacerbations (as determined by reduction in exacerbations that require hospitalization and/or urgent care visits to a hospital emergency department or physician/nurse practitioner clinic.); OR - Reduction in asthma exacerbations that require adding or increasing doses of corticosteroids; OR - Increase in percent predicted FEV-1 from pre-treatment baselines. Recommended dose: Omalizumab 75 to 375mg administered SC every 2 to 4 weeks. Coverage limit: LU Authorization Period: 1 year Reason for Use code 727 For the treatment of moderate to severe chronic idiopathic urticaria (CIU) in patients who meet all the following criteria: 1. Patient is 12 years of age or older; AND 2. Diagnosed with moderate to severe CIU [Weekly urticaria activity score (UAS7) of 16 or greater]; AND 3. Remains symptomatic despite management with optimal doses of standard oral therapies for CIU (e.g. histamine H1 receptor antagonists [e.g. cetirizine, desloratadine, loratadine, fexofenadine]); AND 4. Omalizumab is not being used in combination with another biologic drug used for the treatment of CIU; AND 5. Prescribed by a specialist (e.g. allergist, immunologist, dermatologist, etc.). Recommended dose: 300mg SC every 4 weeks Note the following guidance: Severe urticaria - UAS7 of 28 to 42 Moderate urticaria - UAS7 of 16 to 27 Mild urticaria - UAS7 of 7 to 15 Well-controlled urticaria - UAS7 of 1 to 6 Urticaria-free - UAS7 of 0 (zero) Patients who achieve symptom control for at least 12 weeks while on therapy should have a trial of stopping treatment. Coverage limit: LU Authorization Period: 6 Months Reason for Use code 728 All patients new to the Ontario Drug Benefit (ODB) Program should meet the RFU Code for initiation. Renewal of funding of omalizumab will be provided for the treatment of chronic idiopathic urticaria (CIU) in patients who meet the following criteria: 1. Patient is 12 years of age or older; AND 2. Omalizumab is prescribed by a specialist (e.g. allergist, immunologist, dermatologist, etc.); AND 3. Omalizumab is not being used in combination with another biologic drug used for the treatment of CIU; AND 4. Patient's response to omalizumab previously funded under the ODB program meets at least ONE of the following criteria: - Has achieved symptom control on omalizumab and tried stopping therapy but experienced symptom relapse of their urticaria while off treatment. - Has experienced a partial improvement in response with omalizumab treatment by demonstrating a reduction of the weekly urticaria activity score (UAS7) by 9.5 points or more but patient has not been able to achieve complete symptom control for more than 12 consecutive weeks. - Has responded to omalizumab in the past but has been rediagnosed with moderate to severe CIU with UAS7 of 16 or higher. Notes: 1. Patients who achieve complete symptom control for at least 12 weeks while on therapy should have a trial of stopping treatment to establish whether the condition has gone into spontaneous remission. 2. Patients must demonstrate a minimum response to omalizumab for CIU by reducing the UAS7 score by at least 9.5 points from baseline before initiation of omalizumab for CIU. Note the following guidance: Urticaria-free - UAS7 of 0 (zero) Well-controlled urticaria - UAS7 of 1 to 6 Mild urticaria - UAS7 of 7 to 15 Moderate urticaria - UAS7 of 16 to 27 Severe urticaria - UAS7 of 28 to 42 Recommended dose: 300mg every 4 weeks Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Xolair; DOSAGE FORM/ STRENGTH: 150 mg vial and 150 mg/mL prefilled syringe and 75 — 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 Omalizumab Brand(s): Xolair DOSAGE FORM/ STRENGTH: 150 mg vial and 150 mg/mL prefilled syringe and 75 mg/0.5mL prefilled syringe (Asthma indication only) Effective date: December 28, 2011; Updated April 27, 2017 (CIU) Updated: November 23, 2021 (PFS format), October 30, 2023 (new PFS) For the treatment of severe uncontrolled asthma in patients who meet the following criteria: • Has within the past 12 months required hospitalization for asthma OR has required two or more urgent visits for asthma to a physician or an emergency department OR has had two or more courses of high-dose oral corticosteroids in the past 12 months; AND • Is age 12 years or older; AND • Has demonstrated a positive skin test or in vitro reactivity to a perennial aeroallergen; AND • Has a baseline IgE level between 30 and 700 IU/mL (inclusive) ; AND • Has an actual body weight between 20 kg to 150 kg (inclusive); AND • Is receiving treatment with a high-dose inhaled corticosteroid* in addition to a long- acting inhaled beta 2-agonist. (Note: the patient can be on other concomitant therapies as well); AND • Is deemed to be adherent and is using his/her inhaled corticosteroid and long-acting beta agonist daily as prescribed; AND • Is using proper inhaler technique (with a spacer if required); AND • The request for Xolair is made by the patient’s specialist in respirology or allergy/clinical immunology. (Note: Individual consideration can be given for extenuating circumstances where access to these specialists is not possible.) * High-dose inhaled corticosteroids are considered the use of more than 1000 mcg of beclomethasone dipropionate (BDP) equivalents daily. 66 Omalizumab Brand(s): Xolair DOSAGE FORM/ STRENGTH: 150 mg vial, 150 mg/mL PFS, 75mg/0.5 mL PFS (asthma only) To avoid delays in the assessment of the request, physicians should provide the following information within their request submission. 1. The number of hospitalizations for asthma in the past 12 months. 2. The number of asthma exacerbations requiring urgent visits to a physician or emergency department in the past 12 months. 3. The average number of night-time awakenings in a one week period. (reflective of control in last 12 months). 4. The average number of puffs/day of short-acting beta-agonists within a one week period (reflective of control in last 12 months). 5. The number of courses of prednisone (or acute increases in prednisone dose if the patient is already using chronic daily prednisone) for asthma exacerbation in the past 12 months. 6. The FEV1 pre and post bronchodilator. 7. Patient’s actual body weight. 8. The serum IgE level. 9. Results of a positive allergy testing by skin prick test or IgE RAST. 10. A list of all of the patient’s current asthma medications including drug name and doses. 11. Confirmation that the patient’s asthma is currently uncontrolled despite optimal therapy (including confirmation of proper inhaler technique), patient adherence to current therapy, and the removal of allergic and environmental triggers or the reduction of such triggers to the fullest extent possible. 67 Omalizumab Brand(s): Xolair DOSAGE FORM/ STRENGTH: 150 mg/ vial, 150 mg/mL PFS, 75mg/0.5 mL PFS (asthma only) Note that contraindications and intolerance to inhaled corticosteroids and/or long-acting beta agonists will not be considered as a justification to request Xolair funding. Duration of Approval: 1 year Renewal of requests for Xolair will be considered in patients who have a positive clinical response to the drug and who are expected to continue to do so. Renewals will be considered on a case-by-case basis and should be accompanied by the following information: 1. The number of hospitalizations for asthma in the past 12 months 2. The number of asthma exacerbations requiring urgent visits to a physician or Emergency Department in the past 12 months 3. The number of courses of prednisone (or acute increases in prednisone dose if patient is already using chronic daily prednisone) for asthma exacerbations in the past 12 months. 4. The number of nighttime awakenings (over a several week period post-introduction of therapy) 5. The average number of puffs/day of short-acting beta-agonists used per day (over a several week period post-introduction of therapy) 6. The FEV1 pre and post bronchodilator 7. All current asthma medications taken by the patient including drug names and dosing schedule. Duration of Approval: Up to 1 year 68 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 66, record 43, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Xolair; DOSAGE FORM/ STRENGTH: 150 mg Injection and 150 mg/mL prefilled syringe — 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 Omalizumab Brand(s): Xolair DOSAGE FORM/ STRENGTH: 150 mg Injection and 150 mg/mL prefilled syringe Effective date: December 28, 2011 (Asthma); Updated: April 27, 2017 (CIU) Initial Criteria: For the treatment of moderate to severe chronic idiopathic urticaria (CIU) when prescribed by a specialist (i.e. an allergist, an immunologist, a dermatologist) in patients who meet ALL the following criteria; i) Patient must be 12 years of age or older; AND ii) Patient must remain symptomatic despite optimum management with available oral therapies. Approved regimen: Up to 300 mg every 4 weeks Duration of Approval: 24 weeks Renewals will be considered for patients who demonstrate one of the following responses to treatment; i) Patient has had a trial of stopping omalizumab treatment after having achieved symptom control for at least 12 weeks while on therapy but who experience symptom relapse during the stoppage period; OR ii) Patient has demonstrated improvement but has not been able to achieve complete symptom control for more than 12 consecutive weeks; OR iii) Patient has demonstrated a partial response to treatment defined as at least a greater than or equal to 9.5 point reduction in the baseline urticaria activity score over 7 days (UAS7). Approved regimen: Up to 300 mg every 4 weeks Duration of Approval of Renewals: 24 week 113 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 113, record 70, corpus 2025-01-01; name match only, not an eligibility decision

Omlyclo · DIN 02553813 Manufacturer: Celltrion Inc.; listing date 2025-08-29 Health Canada: Marketed since 2025-03-04 · brand OMLYCLO · ATC R03DX05 OMALIZUMAB · form Solution · route Subcutaneous · ingredients OMALIZUMAB 150 MG/1ML · company Celltrion inc. · schedule Schedule d, Prescription

DIN 02553813: Omlyclo Raw flags: sec12=Y, sec3=Y Item: 920000798; group id 945; item number 2248; lccId 00415; manufacturer id CEI Source form: Inj Sol-1mL Pref Syr Pk; strength: 150mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $384.9600; ministry $384.9600 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02553813 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104272

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