Limited Coverage Drugs - Natalizumab

Generic Name

natalizumab

Strength

300 mg per 15 mL

Form

vial

Special Authority Criteria

Approval Period

Initial:

As third-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (MS), diagnosed according to the current 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:

  • Patient has failed to respond2 to full and adequate courses of treatment with at least two other disease modifying therapies, OR has contraindications or intolerance3 to these therapies

AND

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

AND

  • Patient has had at least two disabling attacks5 of MS in the previous one year.

1 Year
Renewal: 
  • Prescribed by a neurologist from a designated MS clinic

AND

  • For the treatment of patients with relapsing-remitting multiple sclerosis, 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

Practitioner Exemptions

  • None

Special Notes

  1. The current clinical criteria for the diagnosis of MS are the McDonald criteria, as of October 26, 2010.
  2. Failure to respond to full and adequate course is defined as: a trial of at least six months each with two or more first line MS disease modifying drug therapies AND experienced at least one disabling attack/relapse while on 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 injection site.
  4. MRI lesion evidence is defined as: three or more new lesions.
  5. A disabling 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.

Special Authority Request Form(s)