Product Details
Galafold
Migalastat123 mg
Capsule
DIN/PIN/NPN
02468042
Manufacturer
Innomar Strategies, Inc.
Formulary Listing Date
2019-05-13
Unit Price
1700.0000
Amount MOH Pays
1700.0000
Coverage Status
Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
A16AX14
Interchangeable Products
NOLU Clinical Criteria
NOEAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Metabolic/Genetic Modifiers | Migalastat
EAP Initiation criteria: For the treatment of Fabry disease (FD) in adult patients who meet ALL the following criteria:
1Refer to Canadian Fabry Disease treatment guidelines 2017 at http://www.garrod.ca/wp-content/uploads/Canadian-FD-Treatment-Guidelines-2017.pdf
2Definition of an amenable mutation: mutation that increases activity of alpha galactosidase A in an in vitro cell culture system (human embryonic kidney or HEK cells) by 1.2 times the baseline activity with an absolute value for enzyme activity of 3% or greater when compared with wildtype values. 3Enzyme replacement therapies (ERT) for Fabry disease (e.g., agalsidase alfa [Replagal, agalsidase beta [Fabrazyme]) Exclusion criteria:
Note: Patients should be monitored every 6 months or more frequently during the first 3 to 5 years of treatment. Recommended dose: 123 mg every other day Approval duration: 6 months Renewal criteria: Renewals will be considered on a case-by-case basis in individuals who:
Requests for ongoing reimbursement should include information related to the patient’s renal and cardiac function, cerebrovascular events, hospitalizations or emergency room visits for FD-related issues, health related quality of life measures as evaluated through a valid HRQL test (SF-36), gastrointestinal symptoms, pain measures, and other relevant clinical outcomes from treatment. Please address the patient’s adherence/compliance with treatment and any adverse effects / toxicities from treatment with migalastat. The Fabry disease expert panel may be consulted for renewal recommendations. |