Product Details

Emgality

Galcanezumab
120 mg/mL
Solution for Subcutaneous Injection
Single-Use 1-mL Pre-Filled Pen (Preservative-Free)

DIN/PIN/NPN

02491087

Manufacturer

Eli Lilly Canada Inc.

Formulary Listing Date

2023-04-28  

Unit Price

577.8000

Amount MOH Pays

577.8000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

N02CD02

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Migraine Drugs

Galcanezumab

  • Brand(s): Emgality
  • Dosage Form/Strength: 120 mg/mL Prefilled syringe (PFS) and Prefilled pen
  • Effective date: December 1, 2022

Initiation Criteria:

For the prophylaxis of headaches in adults meeting the following criteria:

  1. The patient has a diagnosis of either episodic or chronic migraine according to the International Headache Society criteria, defined as:
    •     Episodic migraine: less than 15 headache days per month for more than 3 months, of which ≥ 4 days per month are with migraine
    •     Chronic migraine: ≥ 15 headache days per month for more than 3 months, of which ≥ 8 days per month are with migraine.

    AND

  2. The patient has experienced an inadequate response1, intolerance, or contraindication to 2 or more oral prophylactic migraine medications2; AND

  3. Galcanezumab is not used in combination with onabotulinum toxin A or another Calcitonin gene-related peptide (CGRP) receptor antagonist; AND

  4. Request must be provided by a physician or nurse practitioner with experience in the management of migraine headaches. 

1Inadequate response is defined as no therapeutic or unsatisfactory effect (less than 30% reduction in frequency of headache days) to an adequate dose and duration of 2 oral prophylactic medications2 where both medications must be of different types/classes. Contraindication or intolerable side effects necessitating discontinuation will be considered for 1 of the 2 drugs only. 

2Oral prophylactic therapy types/classes to be considered include: 

  • Beta blockers 

  • Tricyclic antidepressants 

  • Verapamil or flunarizine 

  • Sodium valproate (or divalproex sodium) 

  • Topiramate 

  • Gabapentin 

Initial requests should contain the following information:

  • Objective measures of baseline migraine headache days (e.g., headache diary) and/or baseline disability measures (i.e., Six-Item Headache Impact Test [HIT-6] score). 

  • List of previously trialed oral prophylactic medications, including dosing regimen, duration of treatment, treatment response and reasons for discontinuation. 

  • Confirmation that the patient is under the care of a physician or nurse practitioner with experience in the management of migraine headaches.

Dosing: As per product monograph

Duration of Approval: 6 months

Renewal criteria:

Objective evidence demonstrating that the patient has achieved or maintained an adequate treatment response, defined as:

  • A reduction of ≥ 50% in frequency of migraine headache days per month compared with baseline; OR 

  • A reduction of ≥ 30% in frequency of migraine headache days per month compared with baseline AND an improvement of ≥ 5 points in the HIT-6 score compared with baseline.

Renewal requests should contain the following information:

  • Outcome measures (i.e. headache diary, HIT-6 score) of the patient’s response to Galcanezumab therapy.

Dosing: As per product monograph

Duration of Approval: 6 months

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph