Product Details

Evrysdi

Risdiplam
0.75 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

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Metabolic/Genetic Modifiers

Risdiplam

  • Brand(s): Evrysdi
  • Dosage Form/Strength: 0.75 mg/mL (60 mg/bottle) Pwd for oral or enteral Solution
  • Effective date: March 28, 2022

Initiation Criteria:

For the treatment of spinal muscular atrophy (SMA) in patients meeting all the following criteria:

  1. Genetic documentation of 5q SMA homozygous gene deletion, homozygous mutation, or compound heterozygote; AND 

  1. Has genetic documentation of 2 or 3 copies of the SMN2 gene; AND 

  1. Patient is symptomatic; AND 

  1. Aged between 2 months to 7 months (inclusive) OR Is non-ambulatory and aged 8 months to 25 years (inclusive); AND 

  1. Patient is under the care of a specialist experienced in the diagnosis and management of SMA.

Discontinuation Criteria:

Treatment should be discontinued upon meeting any of the following circumstances:

  • There is no demonstrated achievement in, or maintenance of, motor milestone function as assessed using an age-appropriate measurement after treatment initiation in patients aged between 2 months and 2 years at the time of treatment initiation. 

  • There is no demonstrated maintenance of motor function (as assessed using an age-appropriate measurement) after treatment initiation in patients aged between 2 years and 25 years at the time of treatment initiation. 

  • Permanent invasive ventilation is required.

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:

  1. Patients who meet all the initiation criteria but who are ambulatory may be considered on a case-by-case basis. 

  1. Patients who are pre-symptomatic or asymptomatic may be considered on a case- by-case basis. 

  1. Age-appropriate measurements include the Hammersmith Infant Neurological Examination (HINE) Section 2, Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND), Hammersmith Functional Motor Scale- Expanded (HFMSE), and the Revised Upper Limb Module (RULM) Scores. You may submit the evaluations from more than one age-appropriate test to support your renewal request. 

  1. Requests to switch from nusinersen to risdiplam and vice versa will be considered on a case-by-case basis for patients who meet inclusion criteria and who have not met discontinuation criteria on their current SMA treatment.

Exclusion criteria:

  • Patient with SMA type 4 will not be funded. 

  • Patient with more than four (4) SMN2 gene copies will not be funded. 

  • Patient with permanent invasive ventilation (PIV) will not be funded. 

  • Risdiplam is not funded in patients as combination therapy with nusinersen. 

  • Risdiplam is not funded in patients who have received onasemnogene abeparvovec. 

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:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph