Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Natalizumab (Tysabri) may be considered medically necessary for EITHER of the following conditions:
Multiple Sclerosis (MS)
- As monotherapy for relapsing forms of MS to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults, when ALL of the following are met:
- A diagnosis of a relapsing form of MS as defined by an MRI of the brain showing abnormalities consistent with MS; and
- The prescriber is a specialist in the area of the individual's diagnosis (e.g., neurologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; 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
- Natalizumab (Tysabri) is given in accordance with all the requirements set forth by the TOUCH™ prescribing program; and
- Previous medication history indicates trials and failure of at least one preferred multiple sclerosis agents or there is a documented intolerance, FDA labeled contraindications or hypersensitivity to all preferred multiple sclerosis agents.
Preferred agents:
Aubagio (teriflunomide)
Avonex (interferon beta-1a)
Betaseron (interferon beta-1b)
Copaxone (glatiramer)
glatiramer
Gilenya (fingolimod)
Mavenclad (cladribine)
Mayzent (siponimod)
Plegridy (peginterferon beta-1a)
Rebif (interferon beta-1a)
Tecfidera (dimethyl fumarate)
Vumerity (diroximel fumarate)
Zeposia (ozanimod)
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 one conventional therapy or is unable to tolerate all conventional CD therapies (e.g. oral corticosteroids, 6-metrcaptopurine, azathioprine, methotrexate, sulfasalazine); and
- Previous medication history indicates trials and failure of one of the preferred biologic agents [Humira (adalimumab), Remicade (infliximab) or Stelara (ustekinumab)] or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to one preferred biologic agent [Humira (adalimumab), Remicade (infliximab) or Stelara (ustekinumab)]; and
- Natalizumab (Tysabri) will not be used in combination with immunosuppressants or inhibitors of TNF-alpha; and
- The prescriber is a specialist in the area of the individual's diagnosis (e.g., gastroenterologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
- Natalizumab (Tysabri) is given in accordance with all the requirements set forth by the TOUCH prescribing program.
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