Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Natalizumab (Tysabri) may be considered medically necessary for EITHER of the following conditions:
Multiple Sclerosis (MS)
As monotherapy for relapsing forms of MS when ALL of the following are met:
- A diagnosis of relapsing forms of MS as defined by an MRI of the brain showing abnormalities consistent with MS; and
- Prescribed by or in consultation with a neurologist or provider who specializes in the treatment of MS; and
- Individual has had anti-JCV antibody testing prior to initiating treatment with natalizumab (Tysabri) and annually thereafter; and
- Not to be used in combination with any other MS therapies; and
- In accordance with all the requirements set forth by the TOUCH prescribing program.
Crohn's Disease (CD)
As therapy for inducing and maintaining clinical response and remission in individuals 18 years of age and older with moderately to severely active CD with evidence of inflammation when ALL of the following are met:
- Diagnosis of CD; and
- Individual has had an inadequate response to, or are unable to tolerate conventional CD therapies (e.g., oral corticosteroids or immunosuppressants); and
- Individual has had an inadequate response to, or is unable to tolerate inhibitors of TNF-alpha; and
- Prescribed by or in consultation with a gastroenterologist or provider who specializes in the treatment of CD; and
- Natalizumab (Tysabri) will not be used in combination with immunosuppressants or inhibitors of TNF-alpha; and
- In accordance with all the requirements set forth by the TOUCH prescribing program.
Reauthorization Criteria
- The individual has an FDA approved indication for natalizumab (Tysabri); and
- The individual has had clinical benefit from treatment with natalizumab (Tysabri); and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., gastroenterologist for the diagnosis of Crohn’s Disease or neurologist for the diagnosis of MS) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual will NOT be using natalizumab (Tysabri) in combination with an additional disease modifying agent (DMA) for the requested indication.
Natalizumab (Tysabri) is considered experimental/investigational and, therefore, non-covered for all other indications. Scientific evidence does not support its use for any other indication.
Procedure Codes
