Product Details

Mavenclad

Cladribine
10 mg
Tablet


DIN/PIN/NPN

02470179

Manufacturer

EMD Serono

Formulary Listing Date

2020-04-28  

Unit Price

3212.0000

Amount MOH Pays

3212.0000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AA40

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Multiple Sclerosis Drugs

Cladribine

  • Brand(s): Mavenclad
  • Dosage Form/Strength: 10 mg tablet

Initiation Criteria:

For the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in adult patients with active disease meeting ALL the following criteria: 

  1. 18 years of age or older

  1. Diagnosis of RRMS is in accordance with the McDonald 2017 criteria demonstrating dissemination of lesions in the central nervous system in space and time meeting the following:
    i) 2 or more attacks1 and clinical evidence of 2 or more lesions2;
    OR

    ii)
    2 or more attacks1 and clinical evidence of 1 lesion with clear historical evidence of prior attack involving lesion in different location;

    1If the patient has experienced only one attack, the patient must meet ONE of the additional criteria of dissemination in time in the list below:
    Additional clinical attack
    Simultaneous presence of both enhancing and non-enhancing, symptomatic or asymptomatic MS-typical MRI lesions; OR new T2 or enhancing MRI lesion compared to baseline scan (without regard to timing of baseline scan)
    Presence of cerebrospinal fluid (CSF)-specific oligoclonal bands

    2If the patient has evidence of only one lesion the patient must meet ONE of the additional criteria of dissemination in space in the list below:
    Additional clinical attack implicating different CNS site
    1 or more MS-typical T2 lesions in 2 or more areas of the Central Nervous System (CNS): periventricular, cortical, juxtacortical, infratentorial or spinal cord

    AND

  1. Failure or documented intolerance to at least one of an interferon OR glatiramer acetate OR dimethyl fumarate OR teriflunomide OR ocrelizumab; AND

  1. Patient has experienced a clinical relapse and/or new MS lesions in the last 2 years; AND 

  1. Patient has an EDSS score less than 6.0 before start of therapy; AND

  1. Cladribine is used as monotherapy for the treatment of RRMS; AND

  1. The drug request is from a neurologist experienced in the management of RRMS or includes a consult note from a neurologist from an MS clinic* recognized by the MS Society of Canada supporting the diagnosis.

    Requests from community neurologists not working with an MS Clinic will be considered case-by-case. (Please include MRI reports or labwork to support the diagnosis pf RRMS aligned with McDonald 2017 criteria.)

    *Note: Requests for patients who is 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. Submit MRI and relevant history with your request. 

Exclusion criteria: 

  1. Combination therapy with another disease modifying therapy for RRMS will not be reimbursed. 

  1. Patients with an EDSS score equal to or greater than 7.0 

Dosage: Refer to the Mavenclad product monograph for dosing regimen based on body weight. 

Taken as two treatment courses over 2 years. Each treatment course consists of 2 treatment weeks, which are one month apart at the beginning of each treatment year. 

1.75 mg/kg per year administered as a treatment course in year 1 and a second treatment course starting 12 months after the first course in the respective year upon monitoring for recovery of lymphocytes before the second course of treatment is administered in accordance with prescribing information. 

The recommended cumulative dose of is 3.5 mg/kg body weight over 2 years (1.75 mg/kg per year).

Approval Duration: Two treatment courses over 2 years are funded

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph