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 generic agents
dimethyl fumarate
fingolimod
glatiramer
teriflunomide
Ublituximab-xiiy (Briumvi) may be considered medically necessary when
ALL
of the following criteria are met:
-
ONE of the following:
-
Information has been provided that the individual has been treated with ublituximab-xiiy (Briumvi) within the past 210 days
OR
-
The prescriber states the individual has been treated with ublituximab-xiiy (Briumvi) within the past 210 days AND is at risk if therapy is changed
OR
-
ONE of the following:
-
The individual has a diagnosis of a relapsing form of multiple sclerosis (MS) AND BOTH 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 3 MS agents form 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 ublituximab-xiiy (Briumvi) over ALL preferred generic agents FDA approved for the treatment of the requested indication
OR
-
The individual has another FDA approved indication for ublituximab-xiiy (Briumvi) and route of administration
AND
-
If the individual has an FDA approved indication, ONE of the following:
-
The individual's age is within FDA labeling for the requested indication for ublituximab-xiiy (Briumvi)
OR
-
The prescriber has provided information in support of using ublituximab-xiiy (Briumvi) for the individual's age for the requested indication
AND
-
The prescriber is a specialist in the area of the individual's diagnosis (i.e., neurologist), or the prescriber has consulted with a specialist in the area of the individual's diagnosis
AND
- The individual will NOT be using ublituximab-xiiy (Briumvi) in combination with another disease modifying agent (DMA) for the requested indication.
The use of ublituximab-xiiy (Briumvi) 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
