Product Details

Kesimpta

Ofatumumab
20 mg/0.4 mL
Solution for Subcutaneous Injection
Single-Use 0.4-mL Pre-filled SensoReady Pen (Preservative-Free)

DIN/PIN/NPN

02511355

Manufacturer

Novartis Pharma Canada Inc.

Formulary Listing Date

2022-03-25  

Unit Price

2208.3300

Amount MOH Pays

2208.3300

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AA52

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Multiple Sclerosis Drugs

Ofatumumab

  • Brand(s): Kesimpta
  • Dosage Form/Strength: 20 mg/0.4 mL pre-filled pen for injection
  • Effective date: March 25, 2022

Initiation Criteria:

For the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in patients who meet all the following criteria:

  1. 18 years of age or older; AND

  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 attacks 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:
    a)     Additional clinical attack
    b)     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)
    c)     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:
    a)     Additional clinical attack implicating different CNS site
    b)     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

  2. An Expanded Disability Status Scale (EDSS) score of less than 6.0; AND

  1. Evidence of active disease defined as at least ONE of the following:
    • One relapse during the previous year
    • Two relapses during the previous 2 years
    • A positive gadolinium (Gd)-enhancing magnetic resonance imaging (MRI) scan during the year before starting treatment with ofatumumab

    AND 

  1. Ofatumumab is used as monotherapy; AND

  1. The drug request is from a neurologist experienced in the management of RRMS from one of the MS Society recognized Ontario MS clinics3 or includes a consult note from a neurologist from one of these clinics supporting the diagnosis. 

3MS Society recognized Ontario 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
  • Thunder Bay MS Clinic (35 Algoma Street North, Thunder Bay, ON) 

*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. 

Exclusion criteria: 

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

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

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. 

When requesting renewal of funding, information that should be provided should include: 

  • Date and details of the most recent neurological examination and EDSS scores to support ongoing benefit from therapy. 

  • Clinical details of the date and onset of clinical attacks/relapses 

  • Information to support that the patient is stable/not demonstrating a sub-optimal response 

Duration of Approvals for initial and renewals: 12 months 

Renewal requests where patients have experienced more than 1 attack in the past year will be externally reviewed.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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