Steqeyma

For the treatment of *severe plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**.

Claims for the first 6 months must be written by a dermatologist.

Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required.

Patients not responding adequately at 12 weeks should have treatment discontinued.

*Definition of severe plaque psoriasis:

• Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND

• Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND

• Dermatology Life Quality Index (DLQI) score of at least 10.

**Definition of failure, intolerance or contraindication to adequate trials of standard therapies:

• 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND

• 12 week trial of phototherapy (unless not accessible); AND

• 6 month trial of at least 2 systemic, oral agents used alone or in combination
  - Methotrexate 15-30mg per week
  - Acitretin (could have been used with phototherapy)
  - Cyclosporine

Maintenance/Renewal:

After 3 months of therapy, patients who respond to therapy should have:

• At least a 50% reduction in PASI, AND

• at least a 50% reduction in BSA involvement, AND

• at least a 5 point reduction in DLQI score

Recommended dose:

The recommended dose of ustekinumab is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter.

Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients.

For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks.

If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.

For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite:

i) treatment with methotrexate (20mg/week) for at least 3 months; AND

ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months.

If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required.

Maintenance/Renewal:

After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect.

Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology.

The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg.

Ustekinumab may be used alone or in combination with methotrexate (MTX).

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.