TYSABRI (natalizumab)

TYSABRI (natalizumab)

Office-Administration – intravenous (IV) infusion

Indications for Prior Authorization:

Multiple Sclerosis (MS): Indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML). When initiating and continuing treatment with Tysabri, physicians should consider whether the expected benefit of Tysabri is sufficient to offset this risk. 

Crohn’s Disease (CD): Indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active CD with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. Limitation of Use: In CD, Tysabri should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-alpha.

Coverage Criteria:

For diagnosis of multiple sclerosis (MS):

• Documented diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions); AND
• Prescribed by or in consultation with a neurologist; AND
• One of the following:
  • Trial and failure, contraindication, or intolerance to ONE of the following disease-modifying therapies for MS:
    • interferon beta-1a injection (e.g., Avonex, Rebif) 
    • interferon beta-1b injection (e.g., Betaseron) 
    • glatiramer acetate injection (e.g., Copaxone, Glatopa, generic glatiramer acetate) 
  • Patient is not a candidate for any of the drugs listed as prerequisites due to the severity of their multiple sclerosis.
  • For continuation of prior therapy; AND
• Not used in combination with another disease-modifying therapy for MS.

For diagnosis of Crohn’s Disease (CD):

• Documented diagnosis of moderately to severely active CD; AND 
• Prescribed by or in consultation with a gastroenterologist; AND
• One of the following:
  • Frequent diarrhea and abdominal pain 
  • At least 10% weight loss 
  • Complications such as obstruction, fever, abdominal mass 
  • Abnormal lab values (e.g., C-reactive protein [CRP]) 
  • CD Activity Index (CDAI) greater than 220; AND
• Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies:
  • 6-mercaptopurine, 
  • azathioprine, 
  • corticosteroids (e.g., prednisone, methylprednisolone), 
  • methotrexate; AND
• Trial and failure, contraindication, or intolerance to a tumor necrosis factor (TNF)-inhibitor (e.g., Cimzia [certolizumab pegol], Humira [adalimumab], infliximab); AND
• Not used in combination with an immunosuppressant (e.g., 6-MP, azathioprine, cyclosporine, or methotrexate); AND
• Not used in combination with a TNF-inhibitor (e.g., Enbrel [etanercept], Humira [adalimumab], or infliximab)

Reauthorization Criteria:

For diagnosis of MS:

• Documentation of positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression); AND
• Not used in combination with another disease-modifying therapy for MS; AND
• Prescribed by or in consultation with a neurologist.

For diagnosis of CD:

• Documentation of positive clinical response to therapy as evidenced by at least one of the following:
  • Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline 
  • Reversal of high fecal output state; AND
• Not used in combination with an immunosuppressant (e.g., 6-MP, azathioprine, cyclosporine, or methotrexate); AND
• Not used in combination with a TNF-inhibitor (e.g., Enbrel [etanercept], Humira [adalimumab], or infliximab).

Dosing:

MS, CD:

• 300 mg infused intravenously (IV), every four weeks.

Coverage Duration:

MS:

• Initial: 1 year
• Reauthorization: 1 year

CD:

• Initial: 3 months
  • In CD, discontinue Tysabri in patients that have not experienced therapeutic benefit by 12 weeks of induction therapy, and in patients that cannot discontinue chronic concomitant steroids within six months of starting therapy.
• Reauthorization: 1 year

Authorization is not covered for the following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee:

• Primary or secondary progressive multiple sclerosis
• Combination therapy for RRMS
• Combination therapy with immunosuppressants or anti-TNF agents for Crohn’s disease

Additional Information:

Review History:

• 12/02/2013 – criteria reviewed.
• 01/01/2023 - Update prerequisite drugs for MS, CD; add symptom requirements for MS, CD; add reauthorization criteria for MS, CD

References:

1. Tysabri Prescribing Information. Biogen Inc. Cambridge, MA. December 2021. 
2. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline: Disease-modifying therapies for adults with multiple sclerosis. Neurology 2018;90:777-788. 
3. Lichtenstein GR, Loftus EV, Isaacs KL, et al. Management of Crohn's disease in adults. Am J Gastroenterol. 2018;113:481-517. 
4. National Multiple Sclerosis Society. Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed April 11, 2022. 
5. FDA Drug Safety Communication: New risk factor for progressive multifocal leukoencephalopathy (PML) associated with Tysabri (natalizumab). January 20, 2012. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm288186.htm. Accessed April 11, 2022. 
6. Nelson SML, Nguyen TM, McDonald J, MacDonald JK. Natalizumab for induction of remission in Crohn's disease. Cochrane Database of Systematic Reviews 2018, Issue 8. Art. No.: CD006097. DOI: 10.1002/14651858.CD006097.pub3. 
7. Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021;160(7):2496-2508.