Product Details

Xolair

Omalizumab
150 mg/mL
Solution for Subcutaneous Injection
Single-Use 1-mL Pre-Filled Syringe (Preservative-Free)

DIN/PIN/NPN

02459795

Manufacturer

Novartis Pharma Canada Inc.

Formulary Listing Date

2021-11-23  

Unit Price

641.6000

Amount MOH Pays

641.6000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

R03DX05

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Asthma

Omalizumab

  • Brand(s): Xolair
  • Dosage Form/Strength: 150 mg/ vial and 150 mg/mL prefilled syringe
  • Updated: November 23, 2021

For the treatment of severe uncontrolled asthma in patients who meet the following criteria:

  1. Has within the past 12 months required hospitalization for asthma OR has required two or more urgent visits for asthma to a physician or an emergency department OR has had two or more courses of high-dose oral corticosteroids in the past 12 months; AND 

  2. Is age 12 years or older; AND 

  3. Has demonstrated a positive skin test or in vitro reactivity to a perennial aeroallergen; AND

  4. Has a baseline IgE level between 30 and 700 IU/mL (inclusive); AND

  5. Has an actual body weight between 20 kg to 150 kg (inclusive); AND

  6. Is receiving treatment with a high-dose inhaled corticosteroid* in addition to a long- acting inhaled beta 2-agonist. (Note: the patient can be on other concomitant therapies as well); AND

  7. Is deemed to be adherent and is using his/her inhaled corticosteroid and long-acting beta agonist daily as prescribed; AND

  8. Is using proper inhaler technique (with a spacer if required); AND

  9. The request for Xolair is made by the patient’s specialist in respirology or allergy/clinical immunology.
    (Note: Individual consideration can be given for extenuating     circumstances where access to these specialists is not possible.)

*High-dose inhaled corticosteroids are considered the use of more than 1000 mcg of beclomethasone dipropionate (BDP) equivalents daily.

To avoid delays in the assessment of the request, physicians should provide the following information within their request submission:

  1. The number of hospitalizations for asthma in the past 12 months. 

  1. The number of asthma exacerbations requiring urgent visits to a physician or emergency department in the past 12 months. 

  1. The average number of night-time awakenings in a one-week period. (reflective of control in last 12 months). 

  1. The average number of puffs/day of short-acting beta-agonists within a one-week period (reflective of control in last 12 months). 

  1. The number of courses of prednisone (or acute increases in prednisone dose if the patient is already using chronic daily prednisone) for asthma exacerbation in the past 12 months. 

  1. The FEV1 pre and post bronchodilator. 

  1. Patient’s actual body weight. 

  1. The serum IgE level. 

  1. Results of a positive allergy testing by skin prick test or IgE RAST. 

  1. A list of all of the patient’s current asthma medications including drug name and doses. 

  1. Confirmation that the patient’s asthma is currently uncontrolled despite optimal therapy (including confirmation of proper inhaler technique), patient adherence to current therapy, and the removal of allergic and environmental triggers or the reduction of such triggers to the fullest extent possible.

Note that contraindications and intolerance to inhaled corticosteroids and/or long-acting beta agonists will not be considered as a justification to request Xolair funding. 

Duration of Approval: 1 year 

Renewal of requests for Xolair will be considered in patients who have a positive clinical response to the drug and who are expected to continue to do so. Renewals will be considered on a case-by-case basis and should be accompanied by the following information:

  1. The number of hospitalizations for asthma in the past 12 months 

  1. The number of asthma exacerbations requiring urgent visits to a physician or Emergency Department in the past 12 months 

  1. The number of courses of prednisone (or acute increases in prednisone dose if patient is already using chronic daily prednisone) for asthma exacerbations in the past 12 months. 

  1. The number of nighttime awakenings (over a several week period post-introduction of therapy) 

  1. The average number of puffs/day of short-acting beta-agonists used per day (over a several week period post-introduction of therapy) 

  1. The FEV1 pre and post bronchodilator 

  1. All current asthma medications taken by the patient including drug names and dosing schedule. 

Duration of Approval: Up to 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Dermatology Drugs

Omalizumab

  • Brand(s): Xolair
  • Dosage Form/Strength: 150 mg Inj

Initial Criteria: 

For the treatment of moderate to severe chronic idiopathic urticaria (CIU) when prescribed by a specialist (i.e., an allergist, an immunologist, a dermatologist) in patients who meet ALL the following criteria:

  1. Patient must be 12 years of age or older; AND 

  1. Patient must remain symptomatic despite optimum management with available oral therapies. 

Approved regimen: Up to 300 mg every 4 weeks

Duration of Approval: 24 weeks

Renewals will be considered for patients who demonstrate one of the following responses to treatment:

  1. Patient has had a trial of stopping omalizumab treatment after having achieved symptom control for at least 12 weeks while on therapy but who experience symptom relapse during the stoppage period; OR 

  1. Patient has demonstrated improvement but has not been able to achieve complete symptom control for more than 12 consecutive weeks; OR 

  1. Patient has demonstrated a partial response to treatment defined as at least a greater than or equal to 9.5-point reduction in the baseline urticaria activity score over 7 days (UAS7). 

Approved regimen: Up to 300 mg every 4 weeks

Duration of Approval of Renewals: 24 weeks

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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