Product Details

Lemtrada

Alemtuzumab
12 mg/1.2 mL
Concentrate for solution for infusion
Single-Use 2-mL Vial (Preservative-Free)

DIN/PIN/NPN

02418320

Manufacturer

Sanofi Genzyme, a Division of Sanofi-Aventis Canada Inc.

Formulary Listing Date

2019-04-10  

Unit Price

1085.9258

Amount MOH Pays

1085.9258

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AA34

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Multiple Sclerosis Drugs

Alemtuzumab

  • Brand(s): Lemtrada
  • Dosage Form/Strength: 12 mg/ 1.2 mL Solution for IV infusion
  • Effective date: July 6, 2016; Updated February 17, 2022

Initiation criteria:

As monotherapy for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in adult patients with active disease at the approved dosage provided that the following criteria have been met: 

  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 

  1. The patient has either:
    i)
    Failed to respond to full and adequate courses of at least TWO of the following therapies*: interferon, glatiramer acetate, dimethyl fumarate, or teriflunomide, or ocrelizumab;
    OR

    ii)
    has a documented intolerance or contraindication to two or more of the therapies listed above.

    AND 

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

  1. Patient has had a significant increase in T2 lesion load compared with that from a previous MRI scan (i.e., 3 or more new lesions) OR at least one gadolinium-enhancing lesion;

    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
    Guelph MS clinic, Guelph ON
    Thunder Bay MS Clinic, St Joseph’s Care Group

    *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 (please include MRI and relevant history with your request).

  2. The patient has a current Expanded Disability Status Scale (EDSS) score less than or equal to 6.0. 

Exclusion Criteria: No reimbursement if the patient satisfies any of the following exclusion criteria: 

  • the patient is receiving combination therapy of Lemtrada with other disease modifying therapies, such as Aubagio, Avonex, Betaseron, Copaxone, Extavia, Rebif, Extavia, Tysabri, Gilenya and Tecfidera; 

  • the patient has an EDSS greater than 7.0 

  • the patient is less than 18 years old. 

Dosage: 12mg/day for two treatment courses.
- Initial course: 12mg/day for 5 consecutive days (60mg total dose).
- Second course: 12mg/day for 3 consecutive days (36mg total dose) administered 12 months after the initial treatment course.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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