Eptinezumab-jjmr (Vyepti)

Effective Date: May 15, 2020
Revised Date: May 04, 2020
Last Reviewed: May 19, 2020

Description

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-jjmr (Vyepti) is a preventive treatment of migraines.

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.

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 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
  • Eptinezumab (Vyepti) is not administered concomitantly with any other CGRP therapy; and
  • Initial authorization is valid for six (6) 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 4 days from baseline; or
    • Chronic migraines: a reduction in migraine days per month by at least 5 days from baseline; and
  • Subsequent annual reauthorizations are subject to sustained improvements noted above.

The use of eptinezumab (Vyepti) for any other indication than listed above is considered experimental/investigational and therefore, not covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.

Procedure Codes

J3590

Outpatient HCPCS (C Codes)

C9399

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

G43.001

G43.009

G43.011

G43.019

G43.101

G43.109

G43.111

G43.119

C43.401

C43.409

G43.411

G43.419

G43.501

G43.509

G43.511

G43.519

G43.701

G43.709

G43.711

G43.719

G43.801

G43.809

G43.811

G43.819

G43.901

G43.909

G43.911

G43.919

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Original Effective Date 5-15-2020

Internal Medical Policy Committee 5-19-2020 New policy

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.