HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-200-005
Topic:
Calcitonin Gene-Related Peptide (CGRP) Inhibitors
Section:
Injections
Effective Date:
October 1, 2023
Issued Date:
October 1, 2023
Last Revision Date:
September 2023
Annual Review:
September 2023
 
 

Calcitonin gene-related peptide (CGRP) is a molecule that is synthesized in neurons, which has been implicated in different pain processes including migraine, and functions as a vasodilator. Targeted therapy with CGRP inhibitors have demonstrated efficacy in reducing monthly migraine days.

Policy Position

Initial Authorization Criteria:

Chronic and Episodic Migraines

The use of erenumab-aooe (Aimovig™), fremanezumab-yfrm (Ajovy®), or galcanezumab-gnlm (Emgality®) may be considered medically necessary for individuals 18 years of age and older when all 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
  • 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):
      • Acceptable only if the diagnosis is chronic migraines; or
      • Serotonin-norepinephrine reuptake inhibitors; or
      • Tricyclic antidepressants; and
  • Initial authorization is valid for six (6) months.

Episodic Cluster Headaches

The use of galcanezumab-gnlm (Emgality) 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 episodic cluster headache characterized by severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes when left untreated; and
  • The individual is experiencing attack frequency of at least one attack every other day during a cluster period.

Reauthorization Criteria:

Continuation of therapy with erenumab-aooe (Aimovig), fremanezumab-yfrm (Ajovy), or galcanezumab-gnlm (Emgality) 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; or
    • For galcanezumab-gnlm (Emgality) only for episodic cluster headaches: a reduction in the number of mean weekly cluster headaches from baseline; and
  • Subsequent annual reauthorizations are subject to sustained improvements noted above.

The use of CGRP inhibitors for indications other than those listed above will be denied as not medically necessary.

J3590

J3031

 

 

 

 

 

 




Related Policies

Refer to Medical Policy I-222, Eptinezumab (Vyepti), for additional information.

Refer to Pharmacy Policy J-730 CGRP Inhibitors for additional information. 


Covered Diagnosis Codes for J3031, J3590

 

G43.001

G43.009

G43.011

G43.019

G43.101

G43.109

G43.111

G43.119

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

 

 

 

 

Covered Diagnosis Codes for J3590 (galcanezumab-gnlm [Emgality]) ONLY

G44.011

G44.019

 

 

 

 

 



Place of Service: Outpatient

The use of Calcitonin Gene-Related Peptide (CGRP) Inhibitors are typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.



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.