Wezlana I.V.

For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria:

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

B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week);
OR
Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine);
OR
Conventional treatment with a corticosteroid is contraindicated;

AND

C. Ustekinumab 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.

The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinunab IV 520mg).

The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter.

Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose.

Maintenance/Renewal:

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 or discontinuation of corticosteroids.

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

Exclusion criteria (initial and renewal coverage):

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

Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.

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

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

B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week);
OR
Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate);
OR
Conventional treatment with a corticosteroid is contraindicated;

AND

C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy.

The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg).

The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose.

Maintenance/Renewal:

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 (initial and renewal coverage):

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

Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case- by-case basis through the Exceptional Access Program.

Patients with fistulising Crohn’s disease may be considered on a case-by-case basis through the Exceptional Access Program.