Product Details

Nucala

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

DIN/PIN/NPN

02492997

Manufacturer

GlaxoSmithKline Inc., GlaxoSmithKline Consumer Health Care

Formulary Listing Date

2026-04-30  

Unit Price

2,499.1800

Amount MOH Pays

2,499.1800

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

R03DX09

Interchangeable Products

NO  

LU Clinical Criteria

NO  

Requirements


EAP Criteria

 
Therapeutic Class Reimbursement Criteria
Asthma

Mepolizumab

  • Brand(s): Nucala
  • Dosage Form/Strength: 100 mg/mL Injection (Prefilled syringe, Prefilled Autoinjector)
  • Effective date: March 15, 2018: 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
Ear, Nose and Throat (ENT) Treatments

Mepolizumab

  • Brand(s): Nucala
  • Dosage Form/Strength: 100 mg/mL Inj. (Prefilled autoinjector, Prefilled safety syringe (PFSS))
  • Effective date: June 11, 2024

Severe chronic rhinosinusitis with nasal polyps

Initiation Criteria:

For the treatment of severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients meeting the following criteria:

  1. 18 years of age or older;
    AND
  2. Has documented endoscopically or CT-confirmed bilateral nasal polyps (Note 1);
    AND
  3. Confirmation that the patient has undergone at least 1 prior surgical intervention for nasal polyps or has a contraindication to surgery (please include a description of the contraindication);
    AND
  4. Mepolizumab is being used as add-on maintenance therapy with intranasal corticosteroids (INCS);
    AND
  5. CRSwNP is inadequately controlled with refractory symptoms despite use of inhaled nasal corticosteroids at maximally tolerated doses for 3 months;
    AND
  6. Provides a completed copy of the baseline assessment of CRSwNP prior to initiation of mepolizumab using the Sino-nasal Outcome Test-22 (SNOT-22) or the endoscopic nasal polyp score (NPS) (Note 2);
    AND
  7. Request is submitted by an otolaryngologist, allergist, respirologist, or by a physician with expertise in the treatment of severe CRSwnP.

Notes:

  1. The endoscopic or CT report must be submitted with all initial requests. Patients who do not have bilateral disease should undergo a biopsy.
  2. A baseline assessment of CRSwNP using the SNOT-22 or endoscopic NPS must be completed prior to initiation of mepolizumab treatment as this will be used to confirm severe CRSwNP and to evaluate the patient’s response to treatment if renewal of reimbursement is requested.

Exclusion Criteria: Patients with chronic rhinosinusitis without nasal polyps will not be funded.

First Renewal:

Renewal of funding will be considered in patients who demonstrate a clinically meaningful response compared to baseline defined as one of the following:

  1. A decline in the SNOT 22 score by at least 8.9 points compared to baseline;
    OR
  2. A 1-point or greater decrease in the endoscopic NPS compared with baseline NPS score.

Second and subsequent renewal:

Ongoing renewal of funding will be considered in patients who continue to demonstrate and maintain a clinically meaningful response compared with baseline results

Recommended dose: 100 mg administered subcutaneously once every 4 weeks

Approval duration of initial and renewals: 1 year

Product Monograph

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