Eptinezumab-jjmr (Vyepti)

Policy ID: I-9222-001

Section: Injections

Effective Date: April 01, 2023

Revised Date: March 13, 2023

Revision Effective Date: April 01, 2023

Last Reviewed: March 23, 2023

Applies To: Commercial and Medicaid Expansion

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 when ALL of the following criteria are met:

The individual has an FDA labeled indication or compendia supported indication for eptinezumab (Vyepti) and route of administration AND ONE of the following:
- Eptinezumab (Vyepti) is being used for migraine prophylaxis AND ALL of the following:
  - ONE of the following:
    - The individual has a diagnosis of chronic migraine (defined as greater than or equal to 15 headache days per month) AND ALL of the following:
      - Greater than or equal to 15 headache days per month of migraine-like or tension-like headache for a minimum of three (3) months AND
      - Greater than or equal to eight (8) migraine headache days per month for a minimum of three (3) months AND
      - Eptinezumab (Vyepti) is FDA approved for chronic migraine prophylaxis OR
    - The individual has a diagnosis of episodic migraine (defined as less than 15 headache days per month) AND BOTH of the following:
      - ONE of the following:
        The individual has greater than four (4) migraine headache days per month OR
        The individual's migraine headaches last greater than 12 hours OR
        The individual's migraine attacks cause significant disability or diminished quality of life despite appropriate therapy with acute agents only OR
        The individual has contraindications to acute therapies OR
        The individual has tried and received inadequate response to acute therapies OR
        The individual has serious side effects to acute therapies OR
        The individual is at risk of medication overuse headache without preventative therapy AND
      - Eptinezumab (Vyepti) is FDA approved for episodic migraine prophylaxis AND
  - ONE of the following:
    - The individual has tried and had an inadequate response to at least two migraine prophylaxis classes [i.e., anticonvulsants (divalproex, valproate, topiramate), beta blockers (atenolol, metoprolol, nadolol, propranolol, timolol), antidepressants (amitriptyline, venlafaxine), candesartan] after an adequate trial as defined by BOTH of the following:
      - The trial length was at least six (6) weeks at generally accepted doses AND
      - The individual was greater than or equal to 80 percent adherent to the prophylaxis agent during the trial OR
    - The individual has an intolerance or hypersensitivity to therapy with at least two migraine prophylaxis classes listed above OR
    - The individual has an FDA labeled contraindication to ALL migraine prophylaxis agents listed above AND
  - Medication overuse headache has been ruled out AND
  - ONE of the following:
    - The individual has tried and had an inadequate response to TWO (2) injectable CGRPs for migraine prophylaxis [e.g., Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab)] OR
    - The individual has an intolerance or hypersensitivity to TWO (2) injectable CGRPs for migraine prophylaxis [e.g., Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab)] that is not expected to occur with eptinezumab (Vyepti) OR
    - The individual has an FDA labeled contraindication to ALL injectable CGRPs for migraine prophylaxis [i.e., Aimovig (erenumab), Ajovy (fremanezumab), AND Emgality (galcanezumab)] that is not expected to occur with eptinezumab (Vyepti) OR
  - Eptinezumab (Vyepti) is NOT being used for migraine prophylaxis AND
If the individual has an FDA labeled indication, ONE (1) of the following:
- The individual's age is within FDA labeling for the requested indication for eptinezumab (Vyepti) OR
- The prescriber has provided information in support of using eptinezumab (Vyepti) for the individual's age for the requested indication AND
The individual will NOT be using eptinezumab (Vyepti) in combination with another prophylactic CGRP agent.

Reauthorization Criteria

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

The individual has been approved for the requested agent previously through the plan's Medical Drug Review process AND
The individual has an FDA labeled indication or compendia supported indication for the requested agent and route of administration AND ONE (1) of the following:
- ALL of the following:
  - The requested agent is being used for migraine prophylaxis AND
  - The prescriber has provided information indicating improvement in migraine prevention (e.g., reduced migraine headache days, reduced migraine frequency, reduced use of acute abortive migraine medication) with the requested agent AND
  - Medication overuse headache has been ruled out OR
- BOTH of the following:
  - The requested agent is NOT being used for migraine prophylaxis AND
  - The individual has had clinical benefit with the requested agent AND
The individual will NOT be using the requested agent in combination with another prophylactic CGRP agent.

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

J3032

NOTE: Compendia Allowed: DrugDex 1 or 2a level of evidence

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.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J3032

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

Internal Medical Policy Committee 3-23-2023 - Effective April 01, 2023

Adopted New policy
For Commercial only
Replaced I-222 Eptinezumab-jjmr (Vyepti)

Links

References (PDF)

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.

Policy ID: I-222-004

Section: Injections

Effective Date: May 15, 2020

Revised Date: November 30, 2020

Revision Effective Date: March 01, 2021

Last Reviewed: January 20, 2022

Archived Date: March 31, 2023

Applies To: Commercial Only

Description

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

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; b
  - 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.

Procedure Codes

J3032

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J3032

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

Internal Medical Policy Committee 5-19-2020 New policy

Internal Medical Policy Committee 7-22-2020 New C-code, C9063, added to policy

Internal Medical Policy Committee 9-21-2020 Added new code, J3032, to policy, removed C9063

Internal Medical Policy Committee 1-19-2021 Annual review, no clinical content change

Internal Medical Policy Committee 1-20-2022 Annual review, no clinical content change

Links

References (PDF)

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