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
*Preferred brand agents
Aubagio® (teriflunomide)
Avonex® (interferon b-1a)
Betaseron® (interferon b-1b)
Gilenya® (fingolimod)
Kesimpta® (ofatumumab)
Mavenclad® (cladribine)
Mayzent® (siponimod)b
Plegridy® (peginterferon b-1a)
Rebif® (interferon b-1a)
Vumerity® (diroximel fumarate)
Zeposia® (ozanimod)
Alemtuzumab (Lemtrada) may be considered medically necessary when the following criteria are met:
- ONE of the following:
- Information has been provided that indicates the individual has been treated with alemtuzumab (Lemtrada) within the past 90 days; or
- The prescriber states that the individual has been treated with alemtuzumab (Lemtrada) within the past 90 days AND is at risk if therapy is changed; or
- The individual has a diagnosis of a relapsing form of multiple sclerosis (MS), to include relapsing-remitting disease or active secondary progressive disease 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 from different drug classes; or
- BOTH of the following:
- 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 alemtuzumab (Lemtrada) over ALL preferred generic agents FDA approved for the treatment of the requested indication; and
- ONE of the following:
- The individual has tried and had an inadequate response to ONE preferred brand agent* FDA approved for the treatment of the requested indication; or
- The individual has an intolerance or hypersensitivity to ONE preferred brand agent FDA approved for the treatment of the requested indication; or
- The individual has an FDA labeled contraindication to ALL preferred brand agents FDA approved for the treatment of the requested indication; or
- The prescriber has provided information in support of using alemtuzumab (Lemtrada) over ALL preferred brand agents FDA approved for the treatment of the requested indication; or
- The individual has another FDA approved indication and route of administration for alemtuzumab (Lemtrada); and
- ONE of the following:
- The individual’s age is within FDA labeling for the requested indication for alemtuzumab (Lemtrada); or
- The prescriber has provided information in support of using alemtuzumab (Lemtrada) for the individual’s age and requested indication; and
- The individual will be receiving anti-viral prophylaxis for herpetic viral infections; 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 alemtuzumab (Lemtrada) in combination with an additional disease modifying agent (DMA) for the requested indication; and
- ONE of the following:
- The individual has NOT received treatment with alemtuzumab (Lemtrada); or
- The individual has received treatment with alemtuzumab (Lemtrada) AND BOTH of the following:
- The prescriber has provided the number of doses and treatment courses the individual has received; and
- The individual has NOT received 2 or more treatment courses with alemtuzumab (Lemtrada).
The use of alemtuzumab (Lemtrada) 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
