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

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

• Relapsing forms of MS when ALL of the following are met:
  • Adults 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
  • At least one relapse within the previous year, or at least 2 relapses within the previous 2 years; and
  • An Expanded Disability Status Scale (EDSS) score of 0 to 5.5; and
  • Does not have an active Hepatitis B virus infection; and
  • Individual will not receive a live vaccine for at least four (4) weks prior to and during treatment with ocrelizumab (Ocrevus); and
  • The individual has not had a life-threatening infusion reaction to ocrelizumab (Ocrevus).
• Primary progressive MS when ALL of 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
    • EDSS score of 3 to 6.5; and
    • EDSS pyramidal functional system (FFS) score of 2 or greater; and
    • Does not have an active Hepatitis B virus infection; and
    • The individual has not had a life-threatening infusion reaction to ocrelizumab (Ocrevus).

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.

Ocrelizumab (Ocrevus) may be considered medically necessary for individuals 18 years of age and older when applicable clinical criteria for individual medication policies are met and when administered in a physician’s office not affiliated with a hospital, specialized infusion centers not affiliated with a hospital or in the home.

Outpatient facility (Outpatient Hospital IV Infusion Department or Hospital-based Outpatient Clinical Level of Care) administration may be considered medically necessary if ANY of the following criteria are present to indicate the member is medically unstable for infusions in settings other than an outpatient facility setting:

• Member’s home is considered unsuitable for care by the home infusion provider; or
• Individual’s medical status requires enhanced monitoring beyond that which would routinely be needed for infusion therapy; or
• Previous severe adverse reaction (including but not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure) during or following administration of prescribed medication despite standard pre-medication; or
• Individual is receiving other medications that require close monitoring with a higher level of care (e.g., cytotoxic chemotherapy or blood products); or
• Individual is at high risk for complications due to medication administration (e.g., at risk for post-transplant complications, increased risk of infusion reactions due to presence of circulating antibodies, unstable vascular access, cardiopulmonary condition at risk for severe adverse reactions, unstable renal function with inability to safely tolerate IV volume loads, etc.); or 
• Individual is initiating therapy or re-initiating therapy after a period of at least 6 months with no therapy; or
• Physically and/or cognitively impaired AND a home caregiver is not available to comply with the required treatment regimen and schedule.

Home health services may be considered medically necessary when utilized for the administration of home infusion therapy and when provided by licensed eligible provider. Each case will be addressed on an individual basis. 

The medications identified in this policy will be considered not medically necessary if administered in an unapproved hospital outpatient setting when an approved site of care is a viable option for treatment.

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. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Experimental/Investigational (E/I) services are not covered regardless of place of service. 

Evidence-based guidelines support the administration of injectable medications in alternative sites of care such as the non-hospital physician’s office, non-hospital infusion center or in the home.  Administration of the injectable medications subject to this policy at alternate sites of care is based upon the professional judgment of the provider, and takes into account the clinical appropriateness for each individual member. Requests for administration of any dose of the drugs listed in this policy received from a hospital-based facility, physician’s office or specialized infusion center will be assessed for meeting the policy exception criteria based on the clinical documentation provided by the requesting practitioner.