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
- Tysabri monotherapy is recommended for patients who have had an inadequate response to or are unable to tolerate, alternative MS therapies
- 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