HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-222-007
Topic:
Eptinezumab-jjmr (Vyepti)
Section:
Injections
Effective Date:
May 13, 2024
Issued Date:
May 13, 2024
Last Revision Date:
March 2024
Annual Review:
March 2024
 
 

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.

Policy Position

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.

J3032

 

 

 

 

 

 




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.

J3032

 

 

 

 

 

 




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.


Covered Diagnosis Codes for Procedure Code J3032

G43.001

G43.009

G43.011

G43.019

G43.101

G43.109

G43.111

G43.119

G43.401

G43.409

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

G43.E01

G43.E09

G43.E11

G43.E19

 

 

 



Place of Service: Outpatient - Infusion

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.



The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.