Zeposia

Ozanimod

• Brand(s): Zeposia
• Dosage Form/Strength: Starter pack of 0.23 mg and 0.46 mg capsules, 0.92 mg capsules
• Effective date: April 10, 2024

Induction (initiation) criteria:

For the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who meet the following criteria:

1. Has 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
2. Has failed conventional treatment with a corticosteroid (prednisone 40 to 60 mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week);
   OR
   Has responded to or has been stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine);
   OR
   Has a contraindication to corticosteroids which prevents the use of initial conventional treatment with corticosteroids;
   AND
3. Ozanimod 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.

Notes:

1. Patients with mild ulcerative colitis disease (e.g., Mayo score less than 6) may be considered on a case-by-case basis. Application must include the rationale for coverage and other relevant details.

Approved Dose:

0.23 mg once daily on days 1 to 4, then 0.49 mg once daily on days 5 to 7, then 0.92 mg once daily on day 8 and thereafter.

Approved Duration of Initials: 6 months

Renewal (Maintenance) criteria:

Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission.

Maintenance therapy is funded for patients who meet the Ministry initiation criteria, AND whose disease activity scores have been reduced (e.g. Mayo score less than 6) along with improvements in endoscopic findings (as possible), and at least a 50% reduction in the dose of corticosteroid compared with the baseline dose prior to initiation of ozanimod following the first 6 months of treatment with ozanimod, and with discontinuation of corticosteroids after the first year of treatment of ozanimod.

Patients who remain on corticosteroids following the first year of treatment will be considered on a case-by-case basis.

Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy.

Approved Dose: 0.92 mg once daily

Exclusion Criteria for both Initials and Renewals: Ozanimod will not be funded if it is used in combination with other Janus kinase (JAK) inhibitors or other biologic DMARDs to treat the patient's UC.

Approved Duration of first renewal: 6 months to 1 year depending on whether the patient is able to reduce and/or discontinue corticosteroid treatment.

Approved duration of second and subsequent renewals: 12 months

EAP Drug Request Form:

Standard Form for EAP Drug Requests