Description

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 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; 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 one or more preferred multiple sclerosis agents.

Preferred agents:

Aubagio (teriflunomide)
Avonex (interferon beta-1a)
Betaseron (interferon beta-1b)
Copaxone (glatiramer)
glatiramer
Gilenya (fingolimod)
Mavenclad (cladribine)
Plegridy (peginterferon beta-1a)
Rebif (interferon beta-1a)
Tecfidera (dimethyl fumarate)

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
  • 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
  • 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

Natalizumab (Tysabri) is not indicated for the treatment of chronic progressive multiple sclerosis.

Natalizumab (Tysabri) is available only through a special restricted distribution program called the TOUCH Prescribing Program. Natalizumab (Tysabri) must be administered only to individuals with MS or individuals with CD registered in the MS TOUCH Prescribing or CD TOUCH Prescribing Program, respectively.

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

NA