Eptinezumab-jjmr (Vyepti™) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. Administered intravenously, eptinezumab (Vyepti) is a preventive treatment of migraines.

The use of eptinezumab (Vyepti) may be considered medically necessary for individuals 18 years of age and older when ALL of the following criteria are met:

• The individual has a diagnosis of ONE (1) of the following:
  • Episodic migraine defined as 4 to 14 headache days per month; or
  • Chronic migraine defined as 15 or more headache days per month of which eight (8) or more are migraine days; and
• Prescribed by or in consultation with a headache specialist, neurologist, or provider with experience treating migraines; and
• The prescriber attests to ALL of the following:
  • Baseline average monthly migraine days; and
  • The headaches are not caused by medication rebound or overutilization or due to lifestyle factors; and
  • The individual has experienced therapeutic failure or intolerance to one (1) agent from two (2) different prophylactic migraine medication classes or all are contraindicated:
    • Alpha-agonists; or
    • Angiotensin-converting-enzyme inhibitors or angiotensin II receptor blockers; or
    • Anti-epileptic drugs; or
    • Beta-blockers; or
    • Calcium channel blockers; or
    • Onabotulinum toxin A (Botox):
      • Note: Acceptable only if the diagnosis is chronic migraines; or
    • Serotonin-norepinephrine reuptake inhibitors; or
    • Tricyclic antidepressants; and
• If the treatment plan is to use two chemically distinct CGRP inhibitors in combination for preventive and acute use, the prescriber attests that the benefits of therapy outweigh the risks of concurrent use of both medications; and
• Initial authorization is valid for 12 months.

Reauthorization Criteria:

Continuation of therapy with eptinezumab (Vyepti) may be considered medically necessary when ALL of the following are met:

• Documentation that the individual has experienced a reduction in ONE (1) of the following:
  • Reduction in the number of migraine days per month by at least 50% from baseline; or
  • Episodic migraines: a reduction in migraine days per month by at least four (4) days from baseline; or
  • Chronic migraines: a reduction in migraine days per month by at least five (5) days from baseline; and
• Subsequent annual reauthorizations are subject to sustained improvements noted above.

The use of eptinezumab (Vyepti) not meeting the criteria as indicated in this policy is considered not medically necessary.

Eptinezumab (Vyepti) 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 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.

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.