HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-146-007
Topic:
Monoclonal Antibodies for the Treatment of Eosinophilic Conditions
Section:
Injections
Effective Date:
August 27, 2018
Issued Date:
September 17, 2018
Last Revision Date:
September 2018
Annual Review:
April 2018
 
 

Benralizumab (FasenraTM) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for add-on maintenance treatment of individuals with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

Mepolizumab (Nucala®) is a humanized monoclonal antibody against interleukin-5 used for the treatment of individuals with severe eosinophilic asthma not well-controlled with inhaled corticosteroids and long-acting beta-agonists or eosinophilic granulomatosis with polyangiitis (EGPA).

Reslizumab (Cinqair®) is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of individuals with severe asthma aged 18 years and older, and with an eosinophilic phenotype.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Benralizumab (Fasenra) may be considered medically necessary as an add-on maintenance treatment for individuals with severe asthma 12 years of age and older with an eosinophilic phenotype when the following criteria are met:

  • The individual meets ALL of the following:
    • A history of 2 or more exacerbations (requiring oral or systemic corticosteroid treatment) in the previous year despite regular treatment with medium or high dose ICS plus a long-acting beta agonist (LABA) with or without oral corticosteroids and additional asthma controller medications; and
    • A documented reduced lung function [pre-bronchodilator forced expiratory volume (FEV1) below 80% in adults, and below 90% in adolescents]; and
    • The individual has the following blood eosinophil count (in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection) greater than or equal to 150 cells/microliter within 6 weeks of initiation of therapy; and
    • Individual is not receiving benralizumab (Fasenra) in combination with mepolizumab (Nucala), omalizumab (Xolair) or reslizumab (Cinqair).

Continuation of therapy with benralizumab (Fasenra) after twelve (12) months may be considered medically necessary for the treatment of an individual with documented severe eosinophilic asthma when the following criteria are met:

  • Treatment with benralizumab (Fasenra) has resulted in clinical improvement as documented by ONE or more of the following:
    • Decreased utilization of rescue medications; or
    • Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in ICS dose or treatment with systemic corticosteroids); or
    • Increase in predicted forced expiratory volume in one second (FEV1) from pretreatment baseline; or
    • Reduction in reported asthma-related symptoms, such as, asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing; and
  • Individual is not receiving benralizumab (Fasenra) in combination with mepolizumab (Nucala), omalizumab (Xolair) or reslizumab (Cinqair).

 

Benralizumab (Fasenra) is considered experimental/investigational for any other indication not listed above. Scientific evidence does not support its use for any other indications.

J3590

J3490

 

 

 

 

 


Mepolizumab (Nucala) may be considered medically necessary as an add-on maintenance treatment for individuals with severe asthma aged 12 years and older with an eosinophilic phenotype when the following criteria are met:

  • The individual meets ONE of the following:
    • A history of 2 or more exacerbations in the previous year despite at least twelve (12) months of high-dose ICS given in combination with at least three (3) months of controller medication (either a LABA, or LTRA, or theophylline), unless the individual is intolerant of, or has a medical contraindication to all of these agents; or
    • Symptoms are inadequately controlled with use of six (6) months of ICS with daily oral glucocorticoids given in combination with a minimum of three (3) months of controller medication (either a LABA, or LTRA, or theophylline), unless the individual is intolerant of, or has a medical contraindication to these agents; and
  • The individual has ONE of the following blood eosinophil counts (in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection):
    • Greater than or equal to 150 cells/microliter within six (6) weeks of initiation of therapy; or
    • Greater than or equal to 300 cells/microliter within twelve (12) months of initiation of therapy.
  • Individual is not receiving mepolizumab (Nucala) in combination with benralizumab (Fasenra), omalizumab (Xolair) or reslizumab (Cinqair).

Continuation of therapy with mepolizumab (Nucala) after twelve (12) months may be considered medically necessary for the treatment of an individual with documented severe eosinophilic asthma when the following criteria are met:

  • Treatment with mepolizumab (Nucala) has resulted in clinical improvement as documented by ONE or more of the following:
    • Decreased utilization of rescue medications; or
    • Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in ICS dose or treatment with systemic corticosteroids); or
    • Increase in predicted forced expiratory volume in one second (FEV1) from pretreatment baseline; or
    • Reduction in reported asthma-related symptoms, such as, asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing; or
    • Patient is not receiving mepolizumab in combination with omalizumab or reslizumab; and
  •  Individual is not receiving mepolizumab (Nucala) in combination with benralizumab (Fasenra), omalizumab (Xolair) or reslizumab (Cinqair).

Mepolizumab (Nucala) may be considered medically necessary for the treatment of individuals 18 years of age or older with eosinophilic granulomatosis with polyangiitis (EGPA) and if ALL of the following are met:

  • Documented history of relapsing disease; and
  • Individual is on a stable dosage of oral prednisolone or prednisone for four (4) weeks; and
  • Individual will be receiving standard of care while on therapy (glucocorticoid treatment (prednisone or prednisolone), with or without immunosuppressive therapy (cyclosporine, leflunomide, azathioprine etc.)

 

Mepolizumab (Nucala) is considered experimental/investigational for any other indication not listed above. Scientific evidence does not support its use for any other indications.

J2182

 

 

 

 

 

 


Reslizumab (Cinqair) may be considered medically necessary as an add-on maintenance treatment for a period of up to twelve (12) months for individuals with severe eosinophilic asthma when ALL of the following criteria are met:

  • Individual is 18 years of age or older; and
  • Is currently being treated with high-dose ICS (with or without oral corticosteroids) plus an additional controller (e.g., LABA, LTRA, or theophylline) medication, unless contraindicated; and 
  • Has a history of 2 or more exacerbations requiring systemic glucocorticoids while being treated with fluticasone propionate at doses of 880 μg or more or its equivalent in the last year; and
  • Has eosinophilic phenotype (blood eosinophils of 400 cells/μL or higher within four (4) weeks of initiation of therapy); and
  • Individual is not receiving Reslizumab (Cinqair) in combination with benralizumab (Fasenra), omalizumab (Xolair) or mepolizumab (Nucala).

Continuation of therapy with Reslizumab (Cinqair) after twelve (12) months may be considered medically necessary for the treatment of an individual with documented severe eosinophilic asthma when the following criteria are met:

  • Treatment with Reslizumab (Cinqair) has resulted in clinical improvement as documented by ONE or more of the following:
    • Decreased utilization of rescue medications; or
    • Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in ICS dose or treatment with systemic corticosteroids); or
    • Increase in predicted FEV1 from pretreatment baseline; or
    • Reduction in reported asthma-related symptoms, such as, asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing; and
  • Individual is not receiving Reslizumab (Cinqair) in combination with benralizumab (Fasenra), omalizumab (Xolair) or mepolizumab (Nucala).  

 

Reslizumab (Cinqair) for the treatment of any other indication not listed above is considered experimental/investigational; there is a lack of scientific documentation supporting its use for any other indication.

J2786

 

 

 

 

 

 


C9466

 

 

 

 

 

 


NOTE: 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 Section

 

ICD-10 Diagnosis Codes

Covered diagnosis codes for all procedure codes

 

J45.50

J45.51

J45.52

J82

 

 

 

 

Additional Covered diagnosis codes for procedure code J2182

 

M30.1

 

 

 

 

 

 


Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of Benralizumab (Fasenra), Mepolizumab (Nucala) or Reslizumab (Cinqair) is 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


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.



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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.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.




    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.