Omvoh

Mirikizumab

• Brand(s): Omvoh
• Dosage Form/Strength: 300 mg/15 mL Vial; 100 mg/mL Pre-Filled Syringe or Prefilled pen
• Effective date: November 4, 2024

Initiation Criteria

For the treatment of moderate to severe ulcerative colitis in patients who meet ALL 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 40–60 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) and is switching to or adding mirikizumab to the treatment regimen;
   OR
   Is unable to use a corticosteroid (e.g. has a contraindication to or experienced intolerable adverse reactions) but patient has experienced an inadequate response to an immunosuppressant (e.g., azathioprine, 6-mercaptopurine), OR another funded biologic (e.g. adalimumab, infliximab, golimumab), OR a funded Janus kinase inhibitor (e.g. tofacitinib, upadacitinib) for the treatment of their ulcerative colitis;
   AND
3. Mirikizumab 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. 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 in first 24 weeks:

Induction Dose: The recommended induction dosage regimen is 300 mg infused intravenously at Week 0, Week 4, and Week 8

Evaluate patients at 12 weeks induction dosing, and if there is an inadequate therapeutic response at week 12 consider extended induction dosing by administering 300 mg at Weeks 12, 16, and 20

Discontinue Omvoh in patients who do not show evidence of therapeutic benefit to extended induction therapy by Week 24.

Maintenance dose: 200 mg subcutaneous every 4 weeks.

Renewal Criteria:

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 of corticosteroid doses by 50% in the first 6 months of treatment with mirikizumab with discontinuation of corticosteroids by 12 months.

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 for renewals:

Maintenance dose: 200 mg subcutaneous every 4 weeks

Exclusion criteria (for Initials and Renewals):

Combination therapy with another biologic* used to treat inflammatory bowel disease will not be funded.

*Note: This includes Jak-2 inhibitors

Approval funding durations:

Initial approval: 7 months

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

Second and subsequent renewals: 2 years with complete discontinuation of corticosteroid treatment