Alemtuzumab (Lemtrada®) Notification

• Alemtuzumab (Lemtrada®) intravenous infusion for administration by a healthcare professional 

• For treatment of adults with relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease. Due to its safety profile, use is generally reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.
•  Limitations of use: Not for use in patients with clinically isolated syndrome (CIS) due to its safety profile

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval:

1. The patient is 18 years of age or older; AND
2. The patient has a diagnosis of a relapsing form of multiple sclerosis (MS), to include relapsing-remitting disease or active secondary progressive disease; AND
3. The patient must still either be able to walk at least a few steps with or without aid, or alternatively must have some functional arm/ hand use consistent with performing activities of daily living; AND
4. ONE of the following:
   1. The patient has highly active MS disease activity AND BOTH of the following [medical record documentation required]:
      1. The patient has greater than or equal to 2 relapses in the previous year; AND 
      2. ONE of the following: 
         1. The patient has greater than or equal to 1 gadolinium enhancing lesion on MRI; OR 
         2. The patient has a significant increase in T2 lesion load compared with a previous MRI; OR
   2. The patient has been treated with at least three MS agents from different drug classes (see “MS Disease Modifying Agents drug classes” table below) [medical record documentation required]; OR 
   3. ONE of the following:
      1. The patient has tried and had an inadequate response to at least TWO disease-modifying drugs for multiple sclerosis, AND one of which must be the following: dimethyl fumarate (generic Tecfidera), fingolimod (generic Gilenya), glatiramer acetate (generic Copaxone), or teriflunomide (generic Aubagio) [medical record documentation required]; OR
      2. The patient has an intolerance or hypersensitivity to at least TWO disease-modifying drugs for multiple sclerosis, AND one of which must be the following: dimethyl fumarate (generic Tecfidera), fingolimod (generic Gilenya), glatiramer acetate (generic Copaxone), or teriflunomide (generic Aubagio) [medical record documentation required]; OR
      3. The patient has an FDA labeled contraindication to ALL other disease-modifying drugs for multiple sclerosis [medical record documentation required]; AND
5. The patient is NOT receiving the requested agent in combination with two or more disease-modifying drugs for multiple sclerosis, including glatiramer (Copaxone, Glatopa), interferon beta-1b (Betaseron, Extavia), interferon beta-1a (Avonex, Rebif), peginterferon beta-1a (Plegridy), fingolimod (Gilenya, Tascenso ODT), teriflunomide (Aubagio), dimethyl fumarate (Tecfidera), monomethyl fumarate (Bafiertam), ofatumumab (Kesimpta), alemtuzumab (Lemtrada), siponimod (Mayzent), cladridine (Mavenclad), ocrelizumab (Ocrevus), ponesimod (Ponvory), natalizumab (Tysabri), diroximel fumarate (Vumerity), ozanimod (Zeposia), and ublituximab-xiiy (Briumvi); AND 
6. The prescriber is a specialist in the area of the patient’s diagnosis (i.e., neurologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND 
7. The requested quantity does NOT exceed the maximum units allowed for the duration of approval.

Duration of Approval: 365 days (1 year)

Continuation Criteria for Approval:

1. .The patient was approved through Blue Cross NC initial criteria for approval; OR 
2. The patient would have met initial criteria for approval at the time they started therapy; AND
3. The patient has had clinical benefit while receiving treatment with the requested agent (e.g., disease stability and/or improvement); AND
4. The patient is NOT receiving the requested agent in combination with two or more disease-modifying drugs for multiple sclerosis, including glatiramer (Copaxone, Glatopa), interferon beta-1b (Betaseron, Extavia), interferon beta-1a (Avonex, Rebif), peginterferon beta-1a (Plegridy), fingolimod (Gilenya, Tascenso ODT), teriflunomide (Aubagio), dimethyl fumarate (Tecfidera), monomethyl fumarate (Bafiertam), ofatumumab (Kesimpta), alemtuzumab (Lemtrada), siponimod (Mayzent), cladridine (Mavenclad), ocrelizumab (Ocrevus), ponesimod (Ponvory), natalizumab (Tysabri), diroximel fumarate (Vumerity), ozanimod (Zeposia), and ublituximab-xiiy (Briumvi); AND 
5. The prescriber is a specialist in the area of the patient’s diagnosis (i.e., neurologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND
6. The requested quantity does NOT exceed the maximum units allowed for the duration of approval.

Duration of Approval: 365 days (1 year)

All information referenced is from FDA package insert unless otherwise noted below.

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

July 2023: Criteria change: Added requirement that one of the two required trial and failure MS agents is a generic product [dimethyl fumarate (generic Tecfidera), fingolimod (generic Gilenya), glatiramer acetate (generic Copaxone), or teriflunomide (generic Aubagio)], or allow for presence of highly active MS disease activity, or previous treatment with at least 3 MS agents from different drug classes. Added requirement of some walking or functional arm/hand use within initial criteria, and added no concurrent use with two or more diseasemodifying MS drugs. Added specialist requirement. Added continuation criteria to policy. Adjusted policy formatting and added reference table with drug classes of MS disease modifying agents. Updated maximum units specific to initial and continuation therapy. Policy notification given 5/2/2023 for effective date 7/1/2023.

June 2021: Criteria change: Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.