Omlyclo

For the treatment of adults with severe uncontrolled asthma who meet the following criteria:

1. Patient is 12 years of age or older;

AND

2. Diagnosed with severe asthma that is not controlled despite treatment with a highdose inhaled corticosteroid, defined as greater than or equal to 500mcg of fluticasone propionate or equivalent daily*, in addition to a long-acting inhaled beta 2-agonist;

*Note: Check dose comparison tables for high-dose inhaled corticosteroid equivalency comparisons for various inhaled corticosteroids.

Omalizumab will not be funded as a first line treatment for uncontrolled asthma and patients must try other conventional therapies for asthma that include a corticosteroid inhaler before being prescribed a biologic treatment.

Proper inhaler technique (with a spacer if required/appropriate) and adherence to prescribed treatment should be confirmed. Patients may also be on other concomitant therapies.

AND

3. In the past 12 months, inadequately controlled asthma has resulted in at least one of the following:

• Hospitalization for asthma

• Two or more urgent care visits to a physician/nurse practitioner or emergency department for asthma exacerbations.

• Use of two or more courses of high-dose oral corticosteroids (e.g. prednisone) or increase in the dose of chronic prednisone treatment to manage asthma exacerbations;

AND

4. Patient has demonstrated a positive skin test or in vitro reactivity to a perennial aeroallergen (e.g. positive allergy testing by skin prick test or IgE RAST);

Note: Removal or reduction of allergic and environmental triggers of asthma to the fullest extent possible should be attempted.

AND

5. Has a baseline Immunoglobulin E (IgE) level between 30IU/mL and 700IU/mL inclusive prior to start of omalizumab;

Note: Serum total IgE levels increase following administration of omalizumab due to formation of omalizumab:IgE complexes. Elevated serum total IgE levels may persist for up to 1 year following discontinuation of omalizumab. Serum total IgE levels obtained less than 1 year following discontinuation may not reflect steady state free IgE levels and should not be used to reassess the dosing regimen in asthma patients.

AND

6. Has an actual body weight between 20 to 150kg inclusive (Refer to Omlyclo product monograph for dosing in individuals 12 years of age and older by IgE level and weight);

AND

7. Prescribed by or in consultation with a specialist in respirology or allergy/clinical immunology.

8. Omalizumab is not being used in combination with another biologic drug used for the treatment of asthma.

Renewal of omalizumab is provided for patients who have responded to treatment by improving asthma control compared to baseline before omalizumab was initiated. Depending on the baseline parameters, this may be evidenced by clinical improvements of one or more of the following;

• Decreased utilization of rescue medications [as determined by reduction in nighttime awakenings or reduction in average number of puffs/day of short-acting beta-agonists (SABA)]; OR

• Decreased frequency of asthma exacerbations (as determined by reduction in exacerbations that require hospitalization and/or urgent care visits to a hospital emergency department or physician/nurse practitioner clinic.); OR

• Reduction in asthma exacerbations that require adding or increasing doses of corticosteroids; OR

• Increase in percent predicted FEV-1 from pre-treatment baselines.

Recommended dose: Omalizumab 75 to 375mg administered SC every 2 to 4 weeks

For the treatment of moderate to severe chronic idiopathic urticaria (CIU) in patients who meet all the following criteria:

1. Patient is 12 years of age or older;

AND

2. Diagnosed with moderate to severe CIU [Weekly urticaria activity score (UAS7) of 16 or greater];

AND

3. Remains symptomatic despite management with optimal doses of standard oral therapies for CIU (e.g. histamine H1 receptor antagonists [e.g. cetirizine, desloratadine, loratadine, fexofenadine]);

AND

4. Omalizumab is not being used in combination with another biologic drug used for the treatment of CIU;

AND

5. Prescribed by a specialist (e.g. allergist, immunologist, dermatologist, etc.).

Recommended dose: 300mg SC every 4 weeks

Note the following guidance:

Severe urticaria - UAS7 of 28 to 42

Moderate urticaria - UAS7 of 16 to 27

Mild urticaria – UAS7 of 7 to 15

Well-controlled urticaria – UAS7 of 1 to 6

Urticaria-free – UAS7 of 0 (zero)

Patients who achieve symptom control for at least 12 weeks while on therapy should have a trial of stopping treatment.

All patients new to the Ontario Drug Benefit (ODB) Program should meet the RFU Code for initiation.

Renewal of funding of omalizumab will be provided for the treatment of chronic idiopathic urticaria (CIU) in patients who meet the following criteria:

1. Patient is 12 years of age or older;

AND

2. Omalizumab is prescribed by a specialist (e.g. allergist, immunologist, dermatologist, etc.);

AND

3. Omalizumab is not being used in combination with another biologic drug used for the treatment of CIU;

AND

4. Patient’s response to omalizumab previously funded under the ODB program meets at least ONE of the following criteria:

i. Has achieved symptom control on omalizumab and tried stopping therapy but experienced symptom relapse of their urticaria while off treatment.

ii. Has experienced a partial improvement in response with omalizumab treatment by demonstrating a reduction of the weekly urticaria activity score (UAS7) by 9.5 points or more but patient has not been able to achieve complete symptom control for more than 12 consecutive weeks.

iii. Has responded to omalizumab in the past but has been rediagnosed with moderate to severe CIU with UAS7 of 16 or higher.

Notes:

1. Patients who achieve complete symptom control for at least 12 weeks while on therapy should have a trial of stopping treatment to establish whether the condition has gone into spontaneous remission.
2. Patients must demonstrate a minimum response to omalizumab for CIU by reducing the UAS7 score by at least 9.5 points from baseline before initiation of omalizumab for CIU.

Note the following guidance:

Urticaria-free – UAS7 of 0 (zero)

Well-controlled urticaria – UAS7 of 1 to 6

Mild urticaria – UAS7 of 7 to 15

Moderate urticaria - UAS7 of 16 to 27

Severe urticaria - UAS7 of 28 to 42

Recommended dose: 300mg every 4 weeks