Ocrelizumab (Ocrevus)

Section: Injections
Effective Date: April 01, 2020
Revised Date: March 09, 2020
Last Reviewed: March 16, 2020

Description

Ocrelizumab (Ocrevus®) is a CD20-directed cytolytic antibody indicated for relapsing or primary progressive forms of multiple sclerosis (MS).

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.

Ocrelizumab (Ocrevus) may be considered medically necessary for the treatment ofEITHERof the following conditions:

  • Relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, whenALLof the following are met:
    • Individuals 18 years of age or older;and
    • A diagnosis of relapsing forms of multiple sclerosis as defined by an MRI of the brain showing abnormalities consistent with MS;and
    • Prescribed by, or in consultation with, a neurologist or provider who specializes in the treatment of MS; and
    • Does not have an active Hepatitis B virus infection;and
    • Individual will not receive a live vaccine for at least four (4) weeks prior to and during treatment with ocrelizumab (Ocrevus);and
    • The patient's medication history indicates trials and failures of at least two preferred multiple sclerosis agents*
    • The individual has not had a life-threatening infusion reaction to ocrelizumab (Ocrevus); or
  • Primary progressive MS whenALLof the following are met:
    • Adults 18 years of age; and
    • Individual will not receive a live vaccine for at least four (4) weeks prior to and during treatment with ocrelizumab (Ocrevus);and
    • A diagnosis of primary progressive multiple sclerosis (PPMS) based on the McDonald criteria:
      • Note: McDonald criteria defined as:
        • One or more years in which neurologic symptoms typical of multiple sclerosis progressively worsen and at least 2 of the following:
          • Evidence of lesion dissemination in space in the brain based on greater than or equal to 1 T2 lesions in at least 1 area characteristic for MS periventricular, juxtacortical, or infratentorial; Gadolinium enhancement of lesions is not required; or
          • Evidence of lesion dissemination in space in the spinal cord based on greater than or equal to 2 T2 lesions in the cord (Gadolinium enhancement of lesions is not required); or
          • A documented history or presence of an elevated CSF IgG index or CSF oligoclonal band;and
    • Does not have an active Hepatitis B virus infection; and
    • The individual has not had a life-threatening infusion reaction to ocrelizumab (Ocrevus).

*Preferred agents:

  • Aubagio (teriflunomide)
  • Avonex (interferon beta-1a)
  • Betaseron (interferon beta-1b)
  • Copaxone (glatiramer)
  • glatiramer
  • Gilenya (fingolimod)
  • Mavenclad (cladribine)
  • Mayzent (siponimod)
  • Plegridy (peginterferon beta-1a)
  • Rebif (interferon beta-1a)
  • Tecfidera (dimethyl fumarate)

Ocrelizumab (Ocrevus) is considered experimental/investigational for any other indication, and therefore, non-covered. Scientific evidence does not support its use for any other indications.

Procedure Codes

J2350

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

G35

Professional Statements and Societal Positions Guidelines

NA

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