Limited Coverage Drugs – Alemtuzumab

Generic Name:

alemtuzumab

Strength:

12 mg/1.2 mL

Form:

vial

Special Authority Criteria

Approval Period

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

As second-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (RRMS), diagnosed according to the current clinical criteria1 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 two disabling attacks2 of multiple sclerosis (MS), with at least one attack in the previous (1) year

AND

  • Patient has had at least one relapse2 while on at least six months of full and adequate course of treatment with at least one MS disease modifying drug therapy 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

  • Drug is prescribed 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)3,4

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

  • Drug is prescribed by a neurologist from a designated MS clinic.

1 treatment course (3 vials)3,4

Practitioner Exemptions

  • No practitioner exemptions.

Special Notes

  1. The current clinical criteria for the diagnosis of MS are the McDonald criteria, as of October 26, 2010.

  2. A 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.

  3. PharmaCare coverage is limited to a lifetime maximum of eight doses: equivalent to 12mg infused daily for 5 consecutive days, followed by 12mg infused daily for 3 consecutive days 12 months later. Treatment doses beyond 8 vials are not eligible for PharmaCare coverage.

  4. To minimize drug wastage, patients are limited to a maximum of one vial dispensed per day.

Special Authority Request Form(s)