Product Details

Mayzent

Siponimod
0.25 mg
Tablet


DIN/PIN/NPN

02496429

Manufacturer

Novartis Pharma Canada Inc.

Formulary Listing Date

2022-03-25  

Unit Price

22.3285

Amount MOH Pays

22.3285

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AA42

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Multiple Sclerosis Drugs

Siponimod

  • Brand(s): Mayzent
  • Dosage Form/Strength: 0.25 mg, 2 mg tablet
  • Effective Date: March 25, 2022

For the treatment of secondary progressive multiple sclerosis (SPMS) in patients who meet the following criteria: 

  1. Documented history of relapsing-remitting multiple sclerosis (RRMS); AND 

  1. Diagnosis of active SPMS disease as evidenced by the ALL the following:
    i)     The patient has had one year of disability progression (retrospectively or prospectively determined) independent of clinical relapse;
    AND
    ii)     Patient has experienced one (1) or more clinical attacks/relapses in the last 2 years AND/OR Patient has imaging features characteristic of multiple sclerosis inflammatory activity (e.g. New T2 lesions, gadolinium enhanced lesions) in the last year;

    AND 

  1. A recent1 Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5 prior to initiation of siponimod; AND 

  1. The drug request is from a neurologist experienced in the management of SPMS from one of the MS Society recognized Ontario MS clinics2 or includes a consult note from a neurologist from one of these clinics supporting the diagnosis and the treatment with siponimod; AND 

  1. Siponimod is not being used as combination therapy with other disease-modifying treatments (DMTs) used to treat multiple sclerosis. 

1A “recent” score is an EDSS evaluated within the prior 6 months. Consideration will be provided for results from a neurological exam within the prior 12 months upon confirmation that the patient’s clinical status has not deteriorated. 

2MS Society recognized Ontario MS clinics at the following website: https://mssociety.ca/about-ms/diagnosing-ms/ms-clinics 

  • Hamilton MS Clinic HHS, McMaster University 
  • Kingston MS Clinic, Kingston General Hospital 
  • London MS Clinic, London Health Sciences Centre
  • Ottawa MS Research clinic, Ottawa Hospital General Campus
  • Ottawa Pediatric MS Clinic, CHEO
  • Toronto MS Clinic, St Michael’s Hospital
  • Toronto Pediatric MS Clinic, The Hospital for Sick Children
  • Sunnybrook Health Sciences Centre
  • Guelph MS Clinic
  • Thunder Bay MS Clinic, St Joseph’s Care Group

*Note: Requests for patients who are under the care of a community neurologist working outside of one of the MS Society recognized Ontario MS clinics can be considered on a case-by-case basis. 

Renewal Criteria:
Ongoing funding will be provided for those who continue to benefit from treatment and who have an Expanded Disability Status Scale (EDSS) score less than 7.0. 

Duration of Approval of Initials and Renewals: 12 months 

Approved Dose: Dose titration to the daily maintenance dose of 2 mg daily

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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