Pharmacy Prior Authorization Criteria

Tysabri (natalizumab)

Indications for Prior Authorization

Tysabri (natalizumab)

• For diagnosis of 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.

• For diagnosis of 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.

  In CD, Tysabri should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-alpha.

Criteria

Tysabri

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Multiple Sclerosis (MS)

• 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) [B]
AND
• One of the following:
• Trial and failure (of a minimum 4-week supply), contraindication, or intolerance to one disease-modifying therapy for MS (e.g., Kesimpta [Ofatumumab], Mavenclad [Cladribine], Avonex [Interferon beta-1a], Betaseron [Interferon beta-1b], Mayzent [Siponimod], Zeposia [ozanimod])
OR
• Patient is not a candidate for any of the drugs listed as prerequisites due to the severity of their multiple sclerosis [2]
OR
• For continuation of prior therapy [2]
AND
• Not used in combination with another disease-modifying therapy for MS
AND
• Prescribed by or in consultation with a neurologist

Tysabri

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Multiple Sclerosis (MS)

• Patient demonstrates 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

Tysabri

Prior Authorization (Initial Authorization)

Length of Approval: 3 Months [D]
For diagnosis of Crohn’s Disease (CD)

• Diagnosis of moderately to severely active Crohn's disease
AND
• Crohn's disease has evidence of inflammation (e.g., elevated C-reactive protein [CRP], elevated erythrocyte sedimentation rate, presence of fecal leukocytes) [1,3]
AND
• Trial and failure, contraindication, or intolerance to one of the following conventional therapies [3, 7]:
• corticosteroids (e.g., prednisone)
• 6-mercaptopurine
• azathioprine
• methotrexate
AND
• Trial and failure, contraindication, or intolerance to a tumor necrosis factor (TNF)-inhibitor (e.g., certolizumab pegol, adalimumab)
AND
• Not used in combination with TNF inhibitors (e.g., certolizumab pegol, adalimumab) or immunosuppressants (e.g., 6-MP, azathioprine, cyclosporine, or methotrexate) [A, C]
AND
• Prescribed by or in consultation with a gastroenterologist

Tysabri

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Crohn’s Disease (CD)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 3, 7]:
• 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 TNF inhibitors (e.g., certolizumab pegol, adalimumab) or immunosuppressants (e.g., 6-MP, azathioprine, cyclosporine, or methotrexate) [A, C]

P & T Revisions

2024-04-30, 2023-10-04, 2023-04-26, 2022-10-24, 2022-05-04, 2021-09-27, 2021-05-10, 2021-01-07, 2020-03-30

References

1. Tysabri Prescribing Information. Biogen Inc. Cambridge, MA. October 2023.
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.

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End Notes

1. To minimize the risk of progressive multifocal leukoencephalopathy, natalizumab must be administered as a monotherapy without concomitant immunosuppressive therapy. Aminosalicylates may be continued during treatment with Tysabri. [1, 3]
2. Of the four disease courses of MS, relapse-remitting MS (RRMS) is characterized primarily by relapse, while secondary-progressive MS (SPMS) has both relapsing and progressive characteristics. Most patients with RRMS eventually develop SPMS. As a person transitions from RRMS to SPMS, the disease begins to worsen more steadily, with or without occasional relapses, slight remissions, or plateaus. As long as the patient continues to have relapses, the SPMS course is considered to be both progressive and relapsing. [4]
3. In the postmarketing setting, additional cases of PML have been reported in multiple sclerosis and Crohn’s disease patients who were receiving no concomitant immunomodulatory therapy. Three factors that are known to increase the risk of PML in Tysabri-treated patients have been identified: 1) Longer treatment duration, especially beyond 2 years. 2) Prior treatment with an immunosuppressant (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate mofetil). 3) The presence of anti-JCV antibodies. Patients who are anti-JCV antibody positive have a higher risk for developing PML. [1]
4. Tysabri should be discontinued in patients with Crohn’s disease who have not experienced therapeutic benefit by 12 weeks of induction therapy. For patients with Crohn’s disease who start Tysabri while on chronic oral corticosteroids, steroid tapering should begin as soon as a therapeutic benefit of Tysabri has occurred. Tysabri should be discontinued if patients cannot be tapered off of oral corticosteroids within six months of starting Tysabri. Other than the initial six-month taper, prescribers should consider discontinuing Tysabri for patients who require additional steroid use that exceeds three months in a calendar year to control their Crohn’s disease. [1]

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Revision History

• 2024-04-30: 2024 UM Annual Review. Consolidated T/F requirement for MS criteria to list drugs as examples instead of listing them out each individually. Updated examples listed for TNF inhibitors to be (e.g., certolizumab pegol, adalimumab). Formatting and background updates.
• 2023-10-04: Program update to standard reauthorization language. No changes to clinical intent
• 2023-04-26: 2023 UM Annual Review. No criteria changes. Updated references
• 2022-10-24: Further clinical detail added to CD reauth criteria
• 2022-05-04: Annual review - updated references.
• 2021-09-27: 2021 UM Annual Review.
• 2021-05-10: 2021 UM Annual Review.
• 2021-01-07: Per formulary strategy, add Kesimpta as a trial and failure option for Multiple Sclerosis.
• 2020-03-30: 2020 UM Annual review. Removed Zinbryta from criteria as drug obsolete. Updated background.

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