Product Details
Evrysdi
Risdiplam0.75 mg/mL
Powder for Oral Solution
DIN/PIN/NPN
02514931
Manufacturer
Hoffmann-La Roche Limited
Formulary Listing Date
2022-03-28
Unit Price
193.9725
Amount MOH Pays
193.9725
Coverage Status
Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
M09AX10
Interchangeable Products
NOLU Clinical Criteria
NOEAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Metabolic/Genetic Modifiers | Risdiplam
Initiation Criteria: For the treatment of spinal muscular atrophy (SMA) in patients meeting all the following criteria:
Discontinuation Criteria: Treatment should be discontinued upon meeting any of the following circumstances:
It should be noted that the decision to discontinue reimbursement should be based on 2 assessments separated by no longer than a 12-week interval, with the first evaluation taken close to (i.e., within 3 months) of the date of renewal of funding. The second assessment is only required for patients who demonstrated a decline in motor milestones/motor function at the time of the first evaluation. Notes:
Exclusion criteria:
Renewal criteria: Renewal of funding will be considered for patients who do not meet any of the exclusion criteria AND who have not demonstrated any of the stopping/discontinuation criteria while on therapy. Funded Dose: Age and weight appropriate doses of 0.2 mg/kg to 0.25 mg/kg up to a maximum dose of 5 mg daily. Approval Duration of Initials and Renewals: 12 months EAP Drug Request Form: |