Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Natalizumab (Tysabri) may be considered medically necessary when the following criteria is met:
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
- The individual will NOT be using natalizumab (Tysabri) in combination with an additional disease modifying agent (DMA) for MS.
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:
-
A diagnosis of CD;
and
-
Prescribed by or in consultation with a gastroenterologist or provider who specializes in the treatment of CD;
and
-
The individual has failed a three (3)-month trial of vedolizumab (Entyvio), as evidenced by paid claims or printouts;
and
- The individual will NOT be using natalizumab (Tysabri) in combination with an additional disease modifying agent (DMA) for CD.
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 CD 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.
The use of natalizumab (Tysabri) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
