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Limited coverage criteria – alemtuzumab

Last updated on March 6, 2025

Generic name

alemtuzumab

Strength & form

12 mg/1.2 mL vial

Special Authority criteria

Approval period

Initial treatment course (12 mg infused daily for 5 consecutive days):

  • As monotherapy for the treatment of relapsing-remitting multiple sclerosis (RRMS), diagnosed according to the current clinical criteria and magnetic resonance imaging (MRI) evidence, for patients 18 years of age and older who meet ALL of the following criteria:
    • Patient has had at least one relapse1 while on at least six months of full and adequate course of treatment with at least two other disease modifying drug therapies within the last 10 years
      AND
    • Patient has a recent (within 90 days) Expanded Disability Status Scale (EDSS) score less than or equal to 5
      AND
    • Special Authority request is submitted by a neurologist from a designated MS clinic and the request is received within 90 days of a recent neurological examination

1 treatment course (5 vials)

Second treatment course (12 mg infused daily for 3 consecutive days, administered 12 months after the initial treatment course):

  • Patient has received the initial treatment course

AND

  • Special Authority request is submitted by a neurologist from a designated MS clinic

1 treatment course (3 vials)

Practitioner exemptions

  • None

Special notes

  • 1A disabling attack/relapse is defined as the appearance of new symptoms or worsening of old symptoms, lasting at least 24 hours in the absence of fever, and preceded by stability for at least one month
  • PharmaCare coverage is limited to a lifetime maximum of eight doses: equivalent to 12 mg infused daily for 5 consecutive days, followed by 12 mg infused daily for 3 consecutive days 12 months later. Treatment doses beyond 8 vials are not eligible for PharmaCare coverage
  • To minimize drug wastage, patients are limited to a maximum of one vial dispensed per day
  • Discontinuation of therapy should be discussed with patients with stable or inactive disease who are 60 years of age or older

Special Authority request form(s)