Natalizumab (Tysabri)

Office administered

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.
  • Coverage is not Authorized for
    • 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

Recommend Dosing Regimen

RRMS: 300 mg IV q4 weeks

Crohn’s: 300 mg IV q4 weeks

               induction = 12 weeks

               maintenance: six months with renewal

Western Health Advantage Pharmacy and Therapeutics Committee

Approved/Revised: July 2008 Reviewed: December 2013 Reviewed: Mercy Medical Group