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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 694 For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Eylea HD. Coverage will not be provided for patients who have failed to respond to other anti-VEGF agents. Recommended Dose: Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 8 to 16 weeks. Coverage limit: LU Authorization Period: 1 year Reason for Use code 695 For the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Eylea HD. Coverage will not be provided for patients who have failed to respond to other anti-VEGF agents. Recommended Dose: Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 8 to 16 weeks. Coverage limit: LU Authorization Period: 1 year

Eylea HD · DIN 02554798 Manufacturer: Bayer Inc., Health Care Division; listing date 2025-07-31 Health Canada: Marketed since 2025-04-07 · brand EYLEA HD · ATC S01LA05 AFLIBERCEPT · form Solution · route Intravitreal · ingredients AFLIBERCEPT 8 MG/0.07ML · company Bayer inc · schedule Schedule d, Prescription

DIN 02554798: Eylea HD Raw flags: sec12=Y, sec3=Y Item: 523600154; group id 610; item number 1572; lccId 00404; manufacturer id BAH Source form: Inj Sol-0.07mL Pref Syr; strength: 8mg/0.07mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1250.0000; ministry $1250.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02554798 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104362

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