Product Details

Nucala

Mepolizumab
100 mg/mL
Powder for Solution for Subcutaneous Injection
Single-Use 100-mg Vial Pack (Preservative-Free)

DIN/PIN/NPN

02449781

Manufacturer

GlaxoSmithKline Inc., GlaxoSmithKline Consumer Health Care

Formulary Listing Date

2023-04-28  

Unit Price

2207.7400

Amount MOH Pays

2207.7400

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

R03DX09

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Asthma

Mepolizumab

  • Brand(s): Nucala
  • Dosage Form/Strength: 100 mg/mL Injection (Vial, Prefilled syringe, Prefilled Autoinjector)
  • Updated: July 23, 2019

For the treatment of severe eosinophilic asthma in adult patients who meet ALL the following criteria:

  1. Patient is at least 18 years old; AND 

  1. Mepolizumab is being used as an add-on maintenance therapy; AND 

  1. Patient is inadequately controlled with high dose inhaled corticosteroids, defined as greater than or equal to 500mcg of fluticasone propionate or equivalent daily, and one or more additional asthma controller(s), such as long-acting beta-agonists; AND 

  1. Patient has a blood eosinophil count equal to or greater than 300 cell/µL within the past 12 months, and has experienced two or more clinically significant asthma exacerbations, defined as worsening of asthma resulting in administration of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospitalization, in the past 12 months;
    OR
    Patient has a blood eosinophil count of equal to or greater than 150 cells/µL, and is receiving maintenance treatment with oral corticosteroids, defined as greater than the equivalent of prednisone 5 mg per day; AND

  1. Patient is not using any other biologics to treat asthma, such as benralizumab or omalizumab; AND

  1. Patient has completed a baseline assessment of asthma symptom control using a validated asthma control questionnaire such as the Asthma Control Questionnaire (ACQ) or the Asthma Control Test (ACT) prior to initiation with Nucala.

  1. Request is submitted by a specialist in respirology, or allergy/clinical immunology, or by a physician with expertise in the treatment of asthma, unless the request confirms that the Patient does not have access to such specialists, in which case the request may be submitted by an Authorized Prescriber

Initial approval duration: 1 year

Renewals will be considered on a case-by-case basis for patients who do not meet any of the following stopping criteria:

  1. Patient’s 12-month follow-up asthma control questionnaire score using the same validated asthma control questionnaire completed at baseline does not show improvement, such as a decrease of less than 0.5 points on the ACQ or an increase of less than 3 points on the ACT; 

  1. Patient’s subsequent asthma control questionnaire scores have not been maintained at the score seen following the first 12-months of therapy; 

  1. the number of clinically significant exacerbations, defined as worsening of asthma resulting in administration of systemic corticosteroids for at least 3 days, an emergency room visit or hospitalization, has increased within the previous 12 months; and 

  1. Patient failed to achieve or maintain at least a 25 per cent decrease from baseline in the maintenance oral corticosteroid dose at 12 months of initiation of mepolizumab and thereafter. 

Renewal approval duration: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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