Monoclonal Antibodies for the Treatment of Eosinophilic Conditions (Medicaid Expansion)

Policy ID: ME-I-9146-001-03

Section: Injections

Effective Date: January 01, 2022

Revised Date: January 19, 2023

Revision Effective Date: February 01, 2023

Last Reviewed: January 26, 2023

Applies To: Medicaid Expansion Only

Description

Benralizumab (Fasenra^TM) 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.

Benralizumab (Fasenra) prefilled syringe may be covered on the medical benefit. Benralizumab (Fasenra) autoinjector may be covered on the pharmacy benefit.

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.

Mepolizumab (Nucala) vial may be covered on the medical benefit. Mepolizumab (Nucala) autoinjector and prefilled syringe may be covered on the pharmacy benefit.

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.

Criteria

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

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

Eosinophilic Asthma

The use of benralizumab (Fasenra) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
Must be prescribed by, or in consult with, a pulmonologist or allergist/immunologist; and
The individual must have had at least one exacerbation requiring use of oral corticosteroids in the previous year despite continued compliant use of a high dose inhaled steroid in combination with a long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) as evidenced by paid claims or pharmacy printouts; and
The individual has eosinophilic phenotype with eosinophil count greater than or equal to 150 cells/mcL within the past 90 days; and
The individual will only be on one strength of benralizumab (Fasenra) at a time; and
The individual will NOT be using benralizumab (Fasenra) in combination with another biologic agent (e.g., Xolair, Cinqair, Nucala, Dupixent or Tezspire).

Reauthorization Criteria

Continuation of therapy with benralizumab (Fasenra) prefilled syringe may be considered medically necessary when the following criteria are met:

The prescriber must provide documentation showing that the individual has achieved a significant reduction in asthma exacerbations and utilization of rescue medications since treatment initiation with benralizumab (Fasenra) as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review); and
The individual will only be on one strength of benralizumab (Fasenra) at a time; and
The individual will NOT be using benralizumab (Fasenra) in combination with another biologic agent (e.g., Xolair, Cinqair, Nucala, Dupixent or Tezspire).

The use of benralizumab (Fasenra) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J0517

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

Eosinophilic Asthma

The use of mepolizumab (Nucala) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
Must be prescribed by, or in consult with, a pulmonologist or allergist/immunologist; and
The individual must have had at least one exacerbation requiring use of oral corticosteroids in the previous year despite continued compliant use of a high dose inhaled steroid in combination with a long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) as evidenced by paid claims or pharmacy printouts; and
The individual has eosinophilic phenotype with eosinophil count greater than or 150 cells/mcL within the past 90 days; and
The individual must have had a three (3)-month trial of one (1) preferred anti-IL-5 biologic (Fasenra or Cinqair), as evidenced by paid claims or pharmacy printouts; and
The individual will only be on one strength of mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent (e.g., Xolair, Cinqair, Nucala, Dupixent or Tezspire).

Reauthorization Criteria

Continuation of therapy with mepolizumab (Nucala) prefilled syringe may be considered medically necessary when the following criteria are met:

The prescriber must provide documentation showing that the individual has achieved a significant reduction in asthma exacerbations and utilization of rescue medications since treatment initiation with mepolizumab (Nucala) as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review); and
The individual will only be on one strength mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent (e.g., Xolair, Cinqair, Nucala, Dupixent or Tezspire).

Eosinophilic Granulomatosis with Polyangiitis (EGPA)

The use of mepolizumab (Nucala) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
Must be prescribed by, or in consult with, a pulmonologist, rheumatologist or allergy/immunology specialist; and
The individual must have active, non-severe disease defined as vasculitis without life- or organ-threatening
manifestations (e.g., rhinosinusitis, asthma, mild systemic symptoms, uncomplicated cutaneous disease,
mild inflammatory arthritis); and
The individual must have received at least four (4) weeks of a stable corticosteroid dose to control relapsing or refractory disease; and
The individual must have asthma poorly controlled on moderate doses of inhaled glucocorticoids; and
The individual must have blood eosinophil level greater than or equal 1500 cells per microliter and/or greater than or equal to 10 percent of leukocytes within the previous six (6) weeks, as evidenced by laboratory documentation attached to the request; and
The individual must have at least two (2) of the following:
- Paranasal sinusitis; or
- Pulmonary infiltrates, sometime transient; or
- Histologic evidence of vasculitis with extravascular eosinophils; or
- Multiple mononeuropathy or polyneuropathy; and
The individual will only be on one strength of mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent (e.g., Xolair, Cinqair, Fasenra, Dupixent or Tezspire).

Reauthorization Criteria

Continuation of therapy with mepolizumab (Nucala) prefilled syringe may be considered medically necessary when the following criteria are met:

The individual must have experienced a decrease in relapses* and corticosteroid dose, and an increase of time of remission since starting treatment with the requested medication, as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review).; and
The individual will only be on one strength mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent (e.g., Xolair, Cinqair, Fasenra, Dupixent or Tezspire).

*Relapse is defined as active vasculitis, active asthma symptoms, active nasal or sinus disease requiring the use of glucocorticoids or immunosuppressants.

Hypereosinophilic Syndrome (HES)

The use of mepolizumab (Nucala) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
Must be prescribed by, or in consult with, a hematologist, or allergy/immunology specialist; and
The individual must have experienced at least two (2) HES flares within the past 12 months despite a (3)-month trial with each of the following:
- Oral corticosteroids; and
- Steroid sparing therapy (e.g., hydroxyurea); and
The individual must have a blood eosinophil count of 1,000 cells/mcL or higher, as evidenced by laboratory documentation attached to the request; and
The individual will only be on one strength of mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent (e.g., Xolair, Cinqair, Fasenra, Dupixent or Tezspire).

Reauthorization Criteria

Continuation of therapy with mepolizumab (Nucala) prefilled syringe may be considered medically necessary when the following criteria are met:

The individual must have experienced a decrease in HES flares* and a blood eosinophil count less than 1000 cells/mcL since starting treatment with the requested medication, as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review); and
The individual will only be on one strength mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent (e.g., Xolair, Cinqair, Fasenra, Dupixent or Tezspire).

*HES flares are defined as worsening of clinical signs and symptoms of HES or increasing eosinophils, resulting in the need to increase OCS or increase/add cytotoxic or immunosuppressive HES therapy.

Nasal Polyps

The use of mepolizumab (Nucala) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
Must be prescribed by, or in consult with, an ear/nose/throat specialist or allergist/immunologist; and
The individual must have had a 12-week trial of intranasal and oral corticosteroid; and
The individual must have bilateral polyps confirmed by sinus CT, sinus MRI, or nasal endoscopy; and
The individual must have documentation of at least two (2) of the following symptoms:
- Nasal obstruction or nasal discharge (anterior/posterior nasal drip); or
- Facial pain or pressure; or
- Reduction in or loss of smell; and
The individual must have had a 90-day trial with a preferred agent (Dupixent or Xolair), as evidenced by paid claims or pharmacy printouts; and
The individual will only be on one strength of mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent (e.g., Xolair, Cinqair, Fasenra, Dupixent or Tezspire).

Reauthorization Criteria

Continuation of therapy with mepolizumab (Nucala) vial may be considered medically necessary when ALL of the following are met:

The prescriber must provide documentation showing that the individual has achieved a significant reduction in nasal polyp size and symptoms since treatment initiation with mepolizumab (Nucala); and
The individual must be receiving intranasal steroids; and
The individual will only be on one strength of mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent (e.g., Xolair, Cinqair, Fasenra, Dupixent or Tezspire).

The use of mepolizumab (Nucala) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J2182

Reslizumab (Cinqair) may be considered medically necessary when the following criteria are met:

Eosinophilic Asthma

The use of omalizumab (Xolair) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
Must be prescribed by, or in consult with, a pulmonologist or allergist/immunologist; and
The individual must have had at least one exacerbation requiring use of oral corticosteroids in the previous year despite continued compliant use of a high dose inhaled steroid in combination with a long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) as evidenced by paid claims or pharmacy printouts; and
The individual has eosinophilic phenotype with eosinophil count greater than or equal to 150 cells/mcL within the past 90 days; and
The individual will only be on one strength of reslizumab (Cinqair) at a time; and
The individual will NOT be using reslizumab (Cinqair) in combination with another biologic agent (e.g., Xolair, Nucala, Fasenra, Dupixent or Tezspire).

Reauthorization Criteria

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

The prescriber must provide documentation showing that the individual has achieved a significant reduction in asthma exacerbations and utilization of rescue medications since treatment initiation with reslizumab (Cinqair) as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review); and
The individual will only be on one strength of reslizumab (Cinqair) at a time; and
The individual will NOT be using reslizumab (Cinqair) in combination with another biologic agent (e.g., Xolair, Nucala, Fasenra, Dupixent or Tezspire).

The use of reslizumab (Cinqair) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J2786

NOTE: Benralizumab (Fasenra) and mepolizumab (Nucala) self-administered products may be covered on the pharmacy benefit.

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 Codes J0517, J2182 and J2786

J45.50

J45.51

J45.52

J82.83

J82.89

Additional Covered Diagnosis Codes for Procedure Code J2182

D72-110

D72.119

J33.0

J33.1

J33.8

J33.9

M30.1

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021-Effective January 01, 2022

Adopted Medicaid Expansion specific policy -

Internal Medical Policy Committee 1-20-2022

Added criteria for Fasenra and Nucala due to healthcare administered products; and
Update Cinqair criteria; and
Added combination therapy criteria

Internal Medical Policy Committee 1-26-2023 Effective February 01, 2023

Updated criteria for all indications for Fasenra, Nucala and Cinqair
Added Tezspire as a combination agent
Added diagnosis codes for J2182
Updated experimental/investigational statement

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: ME-I-9146-001-02

Section: Injections

Effective Date: January 01, 2022

Revised Date: January 19, 2022

Revision Effective Date: January 24, 2022

Last Reviewed: January 20, 2022

Archived Date: January 31, 2023

Applies To: Medicaid Expansion Only

Description

Benralizumab (Fasenra) prefilled syringe may be covered on the medical benefit. Benralizumab (Fasenra) autoinjector may be covered on the pharmacy benefit.

Mepolizumab (Nucala) vial may be covered on the medical benefit. Mepolizumab (Nucala) autoinjector and prefilled syringe may be covered on the pharmacy benefit.

Criteria

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

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

Eosinophilic Asthma

The individual must meet label recommendations for indication and age; and
Must be prescribed by, or in consult with, a pulmonologist or allergist/immunologist; and
The individual must have had at least one exacerbation despite continued compliant use of a high dose inhaled steroid in combination with a long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) as evidenced by paid claims or pharmacy printouts; and
The individual has eosinophilic phenotype with eosinophil count ≥ 150 cells/mcL within the past 90 days; and
The individual will only be on one strength of benralizumab (Fasenra) at a time; and
The individual will NOT be using benralizumab (Fasenra) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Nucala), injectable IL-4 inhibitor (Dupixent)].

Initial Authorization: 3 months

Reauthorization Criteria

Continuation of therapy with benralizumab (Fasenra) prefilled syringe may be considered medically necessary when the following criteria are met:

The prescriber must provide documentation showing that the individual has achieved a significant reduction in asthma exacerbations and utilization of rescue medications since treatment initiation; and
The individual will only be on one strength of benralizumab (Fasenra) at a time; and
The individual will NOT be using benralizumab (Fasenra) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Nucala), injectable IL-4 inhibitor (Dupixent)].

Continuation Authorization: 12 months

Benralizumab (Fasenra) 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.

Procedure Codes

J0517

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

Eosinophilic Asthma

The individual must meet label recommendations for indication and age; and
Must be prescribed by, or in consult with, a pulmonologist or allergist/immunologist; and
The individual must have had at least one exacerbation despite continued compliant use of a high dose inhaled steroid in combination with a long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) as evidenced by paid claims or pharmacy printouts; and
The individual has eosinophilic phenotype with eosinophil count ≥ 150 cells/mcL within the past 90 days; and
The individual must have had a 3-month trial of one (1) preferred Eosinophilic Asthma agent (Fasenra, Dupixent or Xolair), as evidenced by paid claims or pharmacy printouts; and
The individual will only be on one strength of mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].

Initial Authorization: 3 months

Reauthorization Criteria

Continuation of therapy with mepolizumab (Nucala) prefilled syringe may be considered medically necessary when the following criteria are met:

The prescriber must provide documentation showing that the individual has achieved a significant reduction in asthma exacerbations and utilization of rescue medications since treatment initiation; and
The individual will only be on one strength mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].

Continuation Authorization: 12 months

Eosinophilic granulomatosis with polyangiitis (EGPA)

The individual must be 18 years of age or older; and
The prescription must be written by, or in consultation with, a hematologist, pulmonologist, or allergy/immunology specialist; and
The individual must have a diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) characterized by:
- The individual has asthma poorly controlled on moderate doses of inhaled glucocorticoids; and
- The individual has a greater than blood eosinophilia > 1000 cells/mcL or 10% eosinophils on the differential leukocyte count, as evidenced by laboratory documentation attached to the request; and
- Two of more of the following:
  - Mononeuropathy (including multiplex) or polyneuropathy; or
  - Pulmonary infiltrates; or
  - Paranasal sinus abnormality; or
  - Eosinophilic vasculitis, perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation; or
  - Glomerulonephritis; or
  - Alveolar hemorrhage; or
  - Palpable purpura; or
  - Myocardial infarction due to coronaritis; or
  - Anti-neutrophil cytoplasmic antibody (ANCA) positivity; and
The individual must have had relapsing or recurring disease requiring systemic corticosteroids in previous year despite a 3-month trial with good compliance of one (1) of the following medication, as evidenced by paid claims or pharmacy printouts:
- Cyclophosphamide; or
- Azathioprine; or
- Methotrexate; or
- Leflunomide; and
The individual will only be on one strength of mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].

Initial Authorization: 6 months

Reauthorization Criteria

Continuation of therapy with mepolizumab (Nucala) prefilled syringe may be considered medically necessary when the following criteria are met:

The individual must have experienced and maintained clinical benefit since starting treatment with mepolizumab (Nucala), as evidenced by medical documentation (e.g. chart notes) attached to the request (subject to clinical review); and
The individual will only be on one strength mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].

Continuation Authorization: 12 months

Hypereosinophilic Syndrome

The individual must be 12 years of age or older; and
The prescription must be written by, or in consultation with, a hematologist, or allergy/immunology specialist; and
The individual must have a diagnosis of hypereosinophilic syndrome (HES) characterized by the following:
- The individual must have experienced hypereosinophilic syndrome for ≥6 months; and
- The provider must attest that there is no identifiable nonhematologic secondary cause; and
The individual must have experienced at least 2 HES flares within the past 12 months despite continued compliant use of oral corticosteroids and/or steroid sparing therapy (e.g. hydroxyurea); and
The individual must have a blood eosinophil count of 1,000 cells/mcL or higher, as evidenced by laboratory documentation attached to the request; and
The individual will only be on one strength of mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].

Initial Authorization: 6 months

Reauthorization Criteria

Continuation of therapy with mepolizumab (Nucala) prefilled syringe may be considered medically necessary when the following criteria are met:

The individual must have experienced and maintained clinical benefit since starting treatment with mepolizumab (Nucala), as evidenced by medical documentation (e.g. chart notes) attached to the request (subject to clinical review); and
The individual will only be on one strength mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].

Continuation Authorization: 12 months

Nasal Polyps

The individual must meet label recommendations for indication and age; and
Must be prescribed by, or in consult with, an ear/nose/throat specialist or allergist/immunologist; and
The individual must have had a 12-week trial of intranasal or oral corticosteroid; and
The individual must have bilateral polyps confirmed by sinus CT, sinus MRI, or nasal endoscopy; and
The individual must have documentation of at least two (2) of the following symptoms:
- Nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); or
- Facial pain/pressure; or
- Reduction or loss of smell; and
The individual must have had a 90-day trial with a preferred agent (Dupixent or Xolair), as evidenced by paid claims or pharmacy printouts; and
The individual will only be on one strength of mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].

Initial Authorization: 3 months

Reauthorization Criteria

Continuation of therapy with mepolizumab (Nucala) vial may be considered medically necessary when ALL of the following are met:

The prescriber must provide documentation showing that the individual has achieved a significant reduction in nasal
polyp size and symptoms since treatment initiation; and
The individual must be receiving intranasal steroids; and
The individual will only be on one strength of mepolizumab (Nucala) at a time; and
The individual will NOT be using mepolizumab (Nucala) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Cinqair, Fasenra), injectable IL-4 inhibitor (Dupixent)].

Continuation Authorization: 12 months

Mepolizumab (Nucala) 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.

Procedure Codes

J2182

Reslizumab (Cinqair) may be considered medically necessary when the following criteria are met:

Eosinophilic Asthma

The individual must meet label recommendations for indication and age; and
Must be prescribed by, or in consult with, a pulmonologist or allergist/immunologist; and
The individual must have had at least one exacerbation despite continued compliant use of a high dose inhaled steroid in combination with a long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) as evidenced by paid claims or pharmacy printouts; and
The individual has eosinophilic phenotype with eosinophil count ≥ 150 cells/mcL within the past 90 days; and
The individual will only be on one strength of reslizumab (Cinqair) at a time; and
The individual will NOT be using reslizumab (Cinqair) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Fasenra, Nucala), injectable IL-4 inhibitor (Dupixent)].

Reauthorization Criteria

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

The prescriber must provide documentation showing that the individual has achieved a significant reduction in asthma exacerbations and utilization of rescue medications since treatment initiation; and
The individual will only be on one strength of reslizumab (Cinqair) at a time; and
The individual will NOT be using reslizumab (Cinqair) in combination with another biologic agent [e.g., Xolair, injectable IL-5 inhibitor (Fasenra, Nucala), injectable IL-4 inhibitor (Dupixent)].

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.

Procedure Codes

J2786

Benralizumab (Fasenra) and mepolizumab (Nucala) self-administered products may be covered on the pharmacy benefit.

Procedure Codes

J0517

J2182

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes J0517, J2182 and J2786

J45.50

J45.51

J45.52

J82.83

J82.89

Additional Covered Diagnosis Codes for Procedure Code J2186

D72.110

D72.119

M30.1

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021 Adopted Medicaid Expansion specific policy effective 1-1-2022

Internal Medical Policy Committee 1-20-2022 Added criteria for Fasenra and Nucala due to healthcare administered products, update Cinqair criteria and added combination therapy criteria

Links

References (PDF)

Disclaimer

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Monoclonal Antibodies for the Treatment of Eosinophilic Conditions (Medicaid Expansion)

Description

Criteria

Procedure Codes

Procedure Codes

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Codes

Procedure Codes

Procedure Codes

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer