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.
*Preferred Crohn's Disease agents
Humira® (adalimumab)
infliximab/infliximab biosimilar
Stelara® (ustekinumab)
*Preferred generic Multiple Sclerosis agents
dimethyl fumarate
fingolimod
glatiramer
Natalizumab (Tysabri) may be considered medically necessary when the following criteria are met:
- ONE of the following:
- Information has been provided that the individual has been treated with natalizumab (Tysabri) within the past 90 days; or
- The prescriber states the individual has been treated with natalizumab (Tysabri) within the past 90 days AND is at risk if therapy is changed; or
- The individual has a diagnosis of moderately to severely active Crohn’s Disease (CD) AND ALL of the following:
- Natalizumab (Tysabri) will NOT be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate); and
- ONE of the following:
- The individual has tried and had an inadequate response to ONE conventional agent [i.e., 6-mercaptopurine, azathioprine, corticosteroids (e.g., prednisone, budesonide EC capsule), methotrexate] used in the treatment of CD for at least three (3) months; or
- The individual has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of CD; or
- The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD; or
- The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence or NCCN compendium recommended use 1 or 2a for the treatment of CD; and
- ONE of the following:
- The individual has tried and had an inadequate response to at least ONE preferred biologic agent* for the treatment of CD used for at least three (3) months; or
- The individual has an intolerance or hypersensitivity to ONE preferred biologic agent for the treatment of CD; or
- The individual has an FDA labeled contraindication to ALL preferred biologic agents for the treatment of CD; and
- The individual will NOT be using natalizumab (Tysabri) in combination with a biologic immunomodulator or apremilast (Otezla) for the requested indication; or
- The individual has a diagnosis of a relapsing form of MS AND ALL of the following:
- ONE of the following:
- The individual has a diagnosis of clinically isolated syndrome (CIS) AND ALL of the following:
- The individual had a single event that lasted at least 24 hours; and
- The event was not due to fever or infection; and
- The individual has MS-like brain lesion(s) confirmed by magnetic resonance imaging (MRI); or
- The individual has a diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS); and
- ONE of the following:
- The individual has highly active MS disease activity AND BOTH of the following:
- The individual has greater than or equal to two (2) relapses in the previous year; and
- ONE of the following:
- The individual has greater than or equal to one (1) gadolinium enhancing lesion on MRI; or
- The individual has a significant increase in T2 lesion load compared with a previous MRI; or
- The individual has been treated with at least three (3) MS agents from different drug classes; or
- ONE of the following:
- The individual has tried and had an inadequate response to ONE preferred generic agent* FDA approved for the treatment of the requested indication; or
- The individual has an intolerance or hypersensitivity to ONE preferred generic agent FDA approved for the treatment of the requested indication; or
- The individual has an FDA labeled contraindication to ALL preferred generic agents FDA approved for the treatment of the requested indication; or
- The prescriber has provided information in support of using natalizumab (Tysabri) over ALL preferred generic agents FDA approved for the treatment of the requested indication; and
- The individual will NOT be using natalizumab (Tysabri) in combination with an additional disease modifying agent (DMA) for the requested indication; or
- The individual has another FDA approved indication for natalizumab (Tysabri) and the route of administration; and
- ONE of the following:
- The individual’s age is within FDA labeling for the requested indication for natalizumab (Tysabri); or
- The prescriber has provided information in support of using natalizumab (Tysabri) for the individual’s age for the requested indication; 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.
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 Codes
