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 (MS), diagnosed according to clinical criteria1 and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist from a designated MS clinic, for patients who meet ALL of the following criteria:

  • The patient has failed to respond2 to a full and adequate course of treatment with at least one other disease modifying therapy, OR has contraindications or intolerance3 to these therapies.

AND

  • The patient has had a significant increase in T2 lesion load compared to a previous MRI scan4 OR at least one gadolinium-enhancing lesion.

AND

  • The patient has had at least two MS attacks5 in the previous year.

1 Year

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.

1 Year

Special Notes

  1. For the purposes of assessing PharmaCare Special Authority, the clinical criteria for the diagnosis of MS are the 2010 McDonald criteria.
  2. 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 AND at least one attack/relapse occurring during that therapy (MRI report does not need to be submitted with the request).
  3. 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.
  4. MRI lesion evidence is defined as three or more new lesions.
  5. An attack 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.

Practitioner Exemptions

  • None

Special Authority Request Form(s)