HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-146-012
Topic:
Monoclonal Antibodies for the Treatment of Eosinophilic Conditions
Section:
Injections
Effective Date:
November 16, 2020
Issued Date:
November 16, 2020
Last Revision Date:
October 2020
Annual Review:
September 2020
 
 

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 (IL-5). IL-5 is the predominant cytokine responsible for the growth and differentiation, recruitment, activation and survival of eosinophils. Mepolizumab binds to IL-5 with a dissociation constant of 100 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface. Inhibition of IL-5 signaling reduces the production and survival of eosinophils.

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

Benralizumab (Fasenra) may be considered medically necessary when the following criteria are met:

  • Individual is 12 years of age or older; and
  • Individual diagnosed with severe asthma with an eosinophilic phenotype; and
  • Benralizumab (Fasenra) will be used as an add-on maintenance treatment; and
  • Individual is currently being treated with medium or high dose ICS plus at least three (3) months of treatment with a long-acting beta agonist (LABA) and additional asthma controller medications (LAMA, LTRA), unless the individual is intolerant of, or has a medical contraindication to all of these agents; and
  • Asthma is classified as uncontrolled or inadequately controlled as defined as ONE of the following:
    • Poor symptom control (e.g., ACQ score consistently greater than 1.5 or ACT consistently less than 20); or
    • A history of two (2) or more exacerbations in the last 12 months requiring oral or systemic corticosteroid treatment; or
    • A documented reduced lung function [pre-bronchodilator forced expiratory volume (FEV1) below 80% in adults, and below 90% in adolescents]; and
  • The individual has ONE of 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 six (6) weeks of initiation of therapy; or
    • Greater than or equal to 300 cells/microliter within twelve (12) months of initiation of therapy; and
  • Initial approval will be for no longer than 12 months; and
  • Individual is not receiving benralizumab (Fasenra) in combination with mepolizumab (Nucala), omalizumab (Xolair) or reslizumab (Cinqair).

Reauthorization Criteria

Continuation of therapy with benralizumab (Fasenra) 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; 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
  • Reauthorization will be for 12 months; or
  • 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.

J0517

 

 

 

 

 

 


Severe Asthma

Mepolizumab (Nucala) may be considered medically necessary when the following criteria are met:

  • Individual aged six (6) years or older; and
  • Individual diagnosed with severe asthma with an eosinophilic phenotype; and
  • Mepolizumab (Nucala) will be used as an add-on maintenance treatment; and
  • Individual is currently being treated with high dose ICS  plus at least three (3) months of treatment with a controller medication (either a LABA, LTRA, or theophylline), unless the individual is intolerant of, or has a medical contraindication to all of these agents; and
  • Asthma is classified as uncontrolled or inadequately controlled as defined as ONE of the following:
    • Poor symptom control (e.g., ACQ score consistently greater than 1.5 or ACT consistently less than 20); or
    • A history of two (2) or more exacerbations requiring oral or systemic corticosteroid treatment; or
    • A documented reduced lung function [pre-bronchodilator forced expiratory volume (FEV1) below 80% in adults, and below 90% in adolescents]; 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; and
  • Initial authorization will be for no longer than 12 months; and
  • Individual is not receiving mepolizumab (Nucala) in combination with benralizumab (Fasenra), omalizumab (Xolair) or reslizumab (Cinqair).

Reauthorization Criteria

Continuation of therapy with mepolizumab (Nucala) 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; 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
  • Reauthorization will be for 12 months; and
  • Individual is not receiving mepolizumab (Nucala) in combination with benralizumab (Fasenra), omalizumab (Xolair) or reslizumab (Cinqair). 

Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Mepolizumab (Nucala) may be considered medically necessary when ALL of the following criteria are met:

  • Individual 18 years of age or older; and
  • Individual diagnosed with eosinophilic granulomatosis with polyangiitis (EGPA)
  • 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.); and
  • Initial authorization will be for a 12 month period.

Reauthorization Criteria

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

  • Treatment with mepolizumab (Nucala) resulted in an improvement of individuals condition; and
  • Reauthorization will be for 12 months.

Hypereosinophilic Syndrome (HES)

Mepolizumab (Nucala) may be considered medically necessary when ALL of the following criteria are met:

  • Individual 12 years of age or older; and
  • Individual diagnosed with HES for greater than or equal to six (6) months; and
  • There is no identifiable non-hematologic secondary cause of HES (e.g., drug hypersensitivity, parasitic helminth infection, HIV infection, non-hematologic malignancy); and
  • Individual does not have FIP1L1-PDGFRα kinase-positive HES; and
  • Individual has experienced at least two (2) HES flares (defined as HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy) within the past 12 months; and
  • Individual has a blood eosinophil count of 1,000 cells/mcL or higher prior to starting mepolizumab (Nucala); and
  • Individual is on stable HES therapy (chronic or episodic oral corticosteroids, immunosuppressive, or cytotoxic therapy) for at least four (4) weeks prior to initiation of mepolizumab (Nucala); and
  • Initial authorization will be for a 12 month period.

Reauthorization Criteria for HES

 

Continuation of therapy with mepolizumab (Nucala) may be considered medically necessary for the treatment of an individual with documented HES when the following criteria are met:

  • Treatment with mepolizumab (Nucala) resulted in a decrease in HES flares; and
  •  Reauthorization will be for 12 months.

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 when the following criteria are met:

  • Individual is 18 years of age or older; and
  • Individual diagnosed with severe asthma with an eosinophilic phenotype; and
  • Reslizumab (Cinqair) will be used as an add-on maintenance treatment; and
  • Individual is currently being treated with high-dose ICS plus at least three (3) months of an additional controller (e.g., LABA, LTRA, or theophylline) medication, unless contraindicated; and 
  • Asthma is classified as uncontrolled or inadequately controlled as defined as ONE of the following:
    • Poor symptom control (e.g., ACQ score consistently greater than 1.5 or ACT consistently less than 20); or
    • A history of two (2) or more exacerbations in the last 12 months requiring oral or systemic corticosteroid treatment; or
    • A documented reduced lung function [pre-bronchodilator forced expiratory volume (FEV1) below 80% in adults, and below 90% in adolescents]; and
  • Has blood eosinophils of 400 cells/μL or higher within four (4) weeks of initiation of therapy; and
  • Initial authorization will be for no longer than 12 months; and
  • Individual is not receiving Reslizumab (Cinqair) in combination with benralizumab (Fasenra), omalizumab (Xolair) or mepolizumab (Nucala).

Reauthorization Criteria

Continuation of therapy with Reslizumab (Cinqair) 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; 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
  • Reauthorization will be for 12 months; 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

 

 

 

 

 

 


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 all Procedure Codes

 

J45.50

J45.51

J45.52

J82.83

J82.89

 

 

Additional Covered Diagnosis Codes for Procedure Code J2182

D72.110

D72.119

 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



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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.