Limited coverage drugs – natalizumab

Generic name

natalizumab

Strength

300 mg/15 mL

Form

concentrate for solution for IV infusion

Special Authority criteria

Approval period

Initial:

As second-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (RRMS) which is diagnosed according to the current clinical criteria and magnetic resonance imaging (MRI) evidence.

This drug is for the treatment of patients 18 years of age and older who meet ALL of the following criteria:

  • Patient has failed to respond1 to a full and adequate course of treatment with at least one other disease modifying therapy, OR has contraindications or intolerance2 to two other therapies

AND

  • Patient has had a significant increase in T2 lesion load compared to a previous MRI scan3 OR at least one gadolinium-enhancing lesion

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

15 months

Renewal:

  • When prescribed by a neurologist from a designated MS clinic

AND

  • For the treatment of patients with relapsing-remitting MS, a lack of neutralizing antibodies, and who have demonstrated continued therapeutic benefit outweighing any potential risks, as shown by relapse rate, EDSS, MRI scan, or overall clinical impression

24 months

Practitioner exemptions

  • None

Special notes

  1. Failure to respond to a full and adequate course is defined as a trial of at least six months with one or more first-line MS disease modifying drug therapies at least one attack/relapse occurring during that therapy (MRI report does not need to be submitted with the request).
  2. Intolerance is defined as documented serious adverse effects or contraindications that are incompatible with further use of that class of drug. Intolerance does not include skin reactions at the injection site.
  3. MRI lesion evidence is defined as three or more new lesions.
  4. 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)