Natalizumab (Tysabri)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

Monotherapy for patients with relapsing forms of Multiple Sclerosis (RRMS)

  • Tysabri monotherapy is recommended for patients who have had an inadequate response to or are unable to tolerate, alternative MS therapies:
    • RRMS confirmed by a neurologist
    • failure of one of the following products: Avonex, Betaseron, Copaxone, or Rebif

Crohn’s Disease (Adult)

  • Diagnosis of moderate to severe Crohn’s Disease confirmed by GI specialist
  • Patient does not have perforation, abscess, or obstruction; AND
  • Patient must fail Anti-TNF therapy unless contraindicated:
    • Failure is defined as 1) patient not in remission and 2) patient has failed 1 to 3 doses of Remicade induction therapy or has failed Remicade Maintenance therapy (two or more exacerbations requiring steroids), or has clinically significant adverse reaction to Remicade
  • For continuation of therapy documentation of effectiveness is required at 12 weeks and then again at 6 months. Patient must not be on oral maintenance steroids

This medication is Not Approvable for the following condition(s):

  • Primary or secondary progressive multiple sclerosis
  • Combination therapy for RRMS
  • Combination therapy with immunosuppressants or anti-TNF agents for Crohn’s disease
  • Non-FDA approved indications unless there is sufficient documentation of efficacy and safety in the published literature

Dosing:

RRMS 

  • 300 mg IV q4 weeks

Crohn’s

  • 300 mg IV q4 weeks
  • Induction = 12 weeks
  • Maintenance: six months with renewal

 

Last review date: December 2, 2013