LEMTRADA (alemtuzumab)

LEMTRADA (alemtuzumab)

OFFICE ADMINISTRATION [medical benefit]

Indications for Prior authorization:

All of the following must be met as a condition for coverage:

• Relapsing, remitting MS (RRMS) confirmed by a neurologist

Approved for monotherapy if:

• Patients with RRMS who are poor responders (tried/failed an adequate trial as confirmed by chart note documentation) to at least two first-line treatments (at least one injection and one oral), and Tysabri, and who develop accumulating disability despite therapy, as follows:
  • Injection therapy with interferon beta-1a (Rebif) OR interferon beta-1b (Betaseron) OR glatiramer (Glatopa or Copaxone 40mg)
  • Oral therapy with dimethyl fumarate (Tecfidera) OR teriflunomide (Aubagio) OR fingolimod (Gilenya)
  • IV therapy Tysabri (unless contraindicated)
• For patients at risk of HIV infection: Patient is HIV negative
• This drug may not be used in combination with any other disease modifying therapy for MS, either oral or injectable (e.g., Aubagio, Avonex, Betaseron, Copaxone, Extavia, Gilenya, Glatopa, Rebif, Tecfidera, Tysabri or mitoxantrone)

Dosing and duration of therapy:

• Usual dosage: 12 mg/day IV on 5 consecutive days (total 60 mg); followed 12 months later by 12 mg IV daily for 3 consecutive days (total 36mg).
• Dosage adjustment: serious infusion reaction: consider immediate discontinuation
• Duration of therapy: total duration of therapy is 24 months
• Concomitant therapy: administer antiviral prophylaxis (for herpetic viral infections) beginning on the first day of treatment and continue for at least 2 months after completion of alemtuzumab and until CD4+ lymphocycte count is 200/mm³ or higher.