Skyrizi

Risankizumab

• Brand(s): Skyrizi
• Dosage Form/Strength: 600 mg/10 mL, 360 mg/2.4 mL Injection
• Effective date: April 12, 2024

Moderate to severe luminal Crohn's disease

Initiation Criteria:

For the treatment of moderate to severe luminal Crohn's disease in adult patients who meet ALL of the following criteria:

1. Has a Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn’s disease);
   AND
2. Has failed conventional treatment with a corticosteroid (prednisone 40–60 mg/day [or equivalent]) for a minimum of 14 days (or an intravenous corticosteroid for 1 week);
   OR
   Has responded to or has stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate) and is requiring maintenance using a corticosteroid-free treatment;
   OR
   Has a contraindication to corticosteroids which prevents the use of initial conventional treatment with corticosteroids;
   AND
3. Risankizumab is being used to induce remission or as a steroid-sparing maintenance therapy.

Note:

1. Patients with mild Crohn’s disease (e.g., HBI less than 7) may be considered on a case-by-case basis but the application must include the rationale for coverage and other relevant details.

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., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids.

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

Exclusion criteria (for Initials and Renewals):

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

Approved Initial and Maintenance dose:

The recommended dose is 600 mg administered by intravenous infusion at Week 0, Week 4, and Week 8, followed by 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter as maintenance.

Approval Durations:
- Initial approval: 6 months
- First EAP renewal: 1 year
- Second and subsequent EAP renewals: 2 years

Fistulising Crohn’s Disease with Concomitant Luminal Disease

Initiation Criteria:

For the treatment of fistulising Crohn’s disease with concomitant luminal disease in patients who meet ALL the following criteria:

1. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred or persist despite a course of
   o appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and immunosuppressive therapy (e.g., azathioprine or 6-mercaptopurine) (Note 1)
   OR
   o appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and adalimumab or infliximab with or without an immunosuppressive therapy
   AND
2. Harvey Bradshaw Index (HBI) score greater than or the same as 7 (or other validated disease activity score confirming moderate to severe disease)

Note:

1. Patients should have received a trial of an anti-tumour necrosis factor (anti-TNF) therapy (e.g., infliximab or adalimumab) for their fistulizing Crohn’s disease.

Renewal Criteria

Maintenance therapy is funded for patients who met the initiation criteria and who achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Please include information describing the patient’s fistula(e) resolution (e.g., partial or complete resolution) and HBI score.

Exclusion criteria (for Initials and Renewals):

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

Approved Initial and Maintenance dose:

The recommended dose is 600 mg administered by intravenous infusion at Week 0, Week 4, and Week 8, followed by 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter as maintenance.

Approval durations:
- Initial approval: 6 months
- First renewal: 6 months to 1 year pending fistula(e) resolution
- Second and subsequent renewals: 2 years with complete resolution

The duration of approval for patients with partial resolution will be provided on a case-by-case basis.

EAP Drug Request Form: 

Standard Form for EAP Drug Requests