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Table 64: Asthma/Allergy Monoclonal Antibodies


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Drug Category: Respiratory Tract Agents

Medication Class/Individual Agents: Immunologic Agents

I. Prior-Authorization Requirements

 Asthma/Allergy Monoclonal Antibodies

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

benralizumab Fasenra PA  
dupilumab Dupixent PD PA  
mepolizumab Nucala PA  
omalizumab Xolair PA  
reslizumab Cinqair PA  
tezepelumab-ekko Tezspire PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

 

Benralizumab

  • Benralizumab is a humanized monoclonal antibody (IgG1, κ-class) that directly binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα). It is indicated for the add-on maintenance treatment of patients aged 12 years and older with severe asthma, and with an eosinophilic phenotype. 
  • This agent is initially administered under the care of a healthcare professional. Thereafter, this injectable medication can be self-administered using the autoinjector. 
  • Benralizumab is given subcutaneously (SC) at an initial dose of 30 mg every four weeks for three doses, then 30 mg every eight weeks.

 

Dupilumab

  • Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin (IL)-4 and IL-13 signaling by binding to the IL-4Rα subunit for these complexes. Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and immunoglobulin E (IgE); however, the exact mechanism of action for dupilumab in treating asthma has not been definitively identified. 
  • It is indicated in patients aged six years and older with moderate-to-severe eosinophilic asthma as add-on maintenance therapy, oral corticosteroid (OC)-dependent asthma as add-on maintenance therapy, and in patients with moderate-to-severe atopic dermatitis (AD) not controlled with topical therapies. In addition, this agent has FDA-approval as add-on therapy in adults with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).
  • This medication is administered by SC injection every two weeks with the exception of pediatric patients six to 17 years of age weighing 15 to less than 30 kilograms, the dosage is administered every four weeks.
  • Dupilumab is initially administered under the care of a healthcare professional. Thereafter, this injectable medication can be self-administered. 

  

Omalizumab

  • Omalizumab is a monoclonal antibody indicated for moderate-to-severe persistent asthma in patients ≥ six years of age with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids (ICS). Omalizumab is also indicated for chronic idiopathic urticaria in patients ≥ 12 years of age who remain symptomatic despite histamine-1 (H1) antihistamine treatment as well as for add-on maintenance treatment of nasal polyps in adults with inadequate response to intranasal corticosteroids.
  • For a diagnosis of moderate-to-severe persistent asthma or nasal polyps, omalizumab is administered SC every two-to-four weeks according to weight-based dosing and the levels of serum IgE. For a diagnosis of chronic idiopathic urticaria, omalizumab is administered SC at a dose of 150 mg or 300 mg every four weeks, regardless of weight or IgE level.
  • Omalizumab carries a black-box warning highlighting the risk of anaphylaxis and thus should be administered by a healthcare professional initially for three doses before determining if individuals are appropriate for self-administration.

  

Mepolizumab

  • Mepolizumab is a humanized interleukin-5 (IL-5) antagonist monoclonal antibody indicated for add-on maintenance treatment of patients aged six years and older with severe asthma, and with an eosinophilic phenotype. In addition, this agent is FDA-approved for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA) and for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥ six months without an identifiable non-hematologic secondary cause, and most recently for add-on maintenance treatment of chronic rhinosinusitis with nasal polyps in adults with inadequate response to intranasal corticosteroids.
  • This medication is administered by SC injection every four weeks.
  • It is suggested that this agent be administered by a healthcare professional for anyone < 12 years of age. Patients aged 12 years and older should initially receive their injection under the guidance of a healthcare professional. Following proper training, patients can then self-inject using the prefilled autoinjector or prefilled syringe.

 

Reslizumab

  • Reslizumab is another humanized IL-5 antagonist monoclonal antibody indicated for add-on maintenance treatment of adults aged 18 years and older with severe asthma, and with an eosinophilic phenotype. 
  • This agent should be administered in a healthcare setting by a healthcare professional. 
  • It is given via an intravenous infusion at a dosage of 3 mg/kg once every four weeks.
  • Reslizumab carries a black-box warning highlighting the risk of anaphylaxis.

  

Tezepelumab

  • Tezepelumab is a first-in-class monoclonal antibody that blocks the action of thymic stromal lymphopoietin (TSLP). This agent is approved as add-on maintenance treatment of individuals 12 years of age and older with severe asthma.
  • This agent should be administered by SC injection every four weeks by a healthcare professional. 

 

Treatment Guidelines for the Management of Persistent Severe Asthma

  • The National Heart, Lung, and Blood Institute (NHLBI) guidelines recommend consideration of omalizumab as an adjunctive therapy in patients five to 11 years of age with persistent asthma that is inadequately controlled with daily and as needed combination of low-to-medium dose ICS-formoterol. In addition, it recommends that patients who are being considered for omalizumab therapy are referred to an asthma specialist.1
  • According to the 2014 International European Respiratory Society/American Thoracic Society (ERS/ATS) guidelines, persistent severe asthma afflicts five to ten percent of all asthma patients.2 It is important to differentiate these individuals based on their subgroups or phenotypes whenever possible. Eosinophilic asthma is one such subgroup of severe asthma. Patients with severe asthma with an eosinophilic phenotype have both recurrent exacerbations and eosinophilic airway inflammation, which plays a significant part in airway remodeling, hyperresponsiveness, and mucus accumulation.
  • Currently, both the NHLBI and GINA guidelines recommend the addition of a long-acting β-agonist (LABA) to daily inhaled corticosteroid (ICS) therapy for patients whose disease is not well controlled on a low to medium dose of ICS alone. LABAs are contraindicated as either monotherapy for treatment of asthma or for treatment of acute asthma symptoms and asthma exacerbations.1,3 Per GINA, leukotriene modifiers or tiotropium may be added to medium dose ICS-LABA therapy for those not adequately controlled on step 4 therapy. Lastly, patients not adequately controlled on high dose ICS-LABA therapy (step 5) should be referred for phenotypic assessment and evaluated for potential add-on therapy with tiotropium or one of the biologics such as anti-IgE, anti-IL5/5R, or anti-IL4R therapy.3

 

Treatment Guidelines for the Management of Chronic Urticaria

  • The European Academy of Allergy and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum/World Allergy Organization (2009) and the American Academy of Allergy, Asthma and Immunology (2014) recommend that omalizumab be considered in patients with refractory chronic urticaria who have failed first-line treatment options.4,5

 

Treatment Guidelines for the Management of CRSwNP

  • Current guidelines for management of CRSwNP highlight intranasal corticosteroids (INS) as the cornerstone of maintenance treatment. Nasal saline irrigations, shorts courses of oral corticosteroids, or leukotriene antagonists can be used as adjunctive therapy to INS. Sinus surgery is generally reserved for those who have failed to respond to medical therapy. The American Academy of Allergy, Asthma, & Immunology (AAAAI) 2020 have included dupilumab in their recommendation as a potential treatment option for CRSwNP but have yet to include the other FDA-approved agents.6 The EPOS 2020 steering group advises to use dupilumab or mepolizumab in individuals with CRSwNP who have not improved despite other medical or surgical options. Data was not sufficient to advise on the use of anti-IgE in CRSwNP at the time of publication.7 

 

1National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group: 2020 Focused Updates to the Asthma Management Guidelines. National Heart Lung and Blood Institute. 2020 Dec [cited 2022 Mar 31]. Available from: https://www.nhlbi.nih.gov/health-topics/all-publications-and-resources/2020-focused-updates-asthma-management-guidelines.

2Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. Feb 2014;43(2):343-73.

3Global Strategy for Asthma Management and Prevention. [guideline on the internet]. Bethesda (MD): Global Initiative for Asthma (GINA); 2019 [cited 2022 Mar 31]. Available from: https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf.

4Bernstein JA, Lang DM, Khan DA, Craig T, Dreyfus D, Hsieh F, et al. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol. 2014;133(5):1270-7.

5Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, Brzoza Z, Canonica GW, Church MK, Gimenez-Arnau AM, et al. EAACI/GA2LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria: the 2013 revision and update. Allergy. 2018 Jul;73(7):1393-1414.

6Dykewicz, MS, Wallace, DV, Amrol, DJ, Baroody, FM,  Bernstein, JA, et al. Rhinitis 2020: A Practice parameter update. J Allerg Clinical Immun. 2020 Oct. 146(4):721-767. Available from:https://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20and%20Parameters/Rhinitis-2020-A-practice-parameter-update.pdf.

7Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. 2020 Feb;58(29): 1-481. Available from: https://www.rhinologyjournal.com/Rhinology_issues/manuscript_2353.pdf.

 
Table Footnotes
PD Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Chronic idiopathic urticaria
  • Eosinophilic granulomatosis with polyangiitis
  • Hypereosinophilic syndrome
  • Moderate-to-severe allergy-related asthma
  • Moderate-to-severe eosinophilic asthma
  • Moderate-to-severe atopic dermatitis (AD)
  • Nasal polyps
  • Oral corticosteroid (OCS)-dependent asthma
  • Severe Asthma

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

 

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

  

Cinqair

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • member is symptomatic despite receiving one of the following:
      • combination inhaler containing an inhaled corticosteroid and a long-acting β-agonist; or
      • combination of an inhaled corticosteroid and a long-acting β-agonist inhaler as separate inhalers; or
      • chronic oral corticosteroids; and 
    • evidence of an eosinophilic phenotype (i.e., peripheral blood eosinophil count ≥ 400 cells/μL, elevated sputum eosinophils or FeNO); and
    • prescriber is an asthma specialist (e.g., allergist, immunologist, pulmonologist) or consult notes from a specialist are provided; and
    • appropriate dosing (3 mg/kg intravenously every four weeks).

SmartPA: Claims for Cinqair will usually pay at the pharmacy without a PA request if the member has a history of medical claims for severe eosinophilic asthma and paid MassHealth pharmacy claims for Cinqair for at least 84 days in the past 120 days.

 

Dupixent

  • Documentation of all of the following is required for moderate-to-severe AD:
    • appropriate diagnosis; and
    • member is ≥ six years of age; and
    • prescriber is a specialist (e.g., allergist, immunologist, or dermatologist) or consult notes from a specialist are provided; and
    • inadequate response or adverse reaction to one superpotent or potent topical corticosteroid, or contraindication to all superpotent or potent topical corticosteroids; and
    • inadequate response or adverse reaction to topical tacrolimus or Eucrisa, or contraindication to both topical tacrolimus and Eucrisa; and
    • appropriate dosing.
  • Documentation of all of the following is required for nasal polyps:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is a specialist (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or consult notes from a specialist are provided; and
    • one of the following:
      • inadequate response or adverse reaction to one oral corticosteroid; or
      • inadequate response or adverse reaction to one intranasal corticosteroid; or
      • inadequate response or adverse reaction to prior nasal surgery; or
      • contraindication to both oral corticosteroids and intranasal corticosteroids; and
    • appropriate dosing; and
    • requested agent will be used as adjunctive therapy.
  • Documentation of all of the following is required for moderate-to-severe eosinophilic asthma or OCS-dependent asthma:
    • appropriate diagnosis; and
    • member is ≥ six years of age; and
    • member is symptomatic despite receiving one of the following:
      • combination inhaler containing an inhaled corticosteroid and a long-acting β-agonist; or
      • combination of an inhaled corticosteroid and a long-acting β-agonist inhaler as separate inhalers; or
      • chronic oral corticosteroids; and 
    • one of the following:
      • evidence of an eosinophilic phenotype (i.e., peripheral blood eosinophil count ≥ 150 cells/μL, elevated sputum eosinophils or FeNO); or
      • member is receiving chronic oral corticosteroids; or
      • member has concomitant AD or CRSwNP; and
    • prescriber is an asthma specialist (e.g., allergist, immunologist, pulmonologist) or consult notes from a specialist are provided; and
    • appropriate dosing.

    

Fasenra

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 12 years of age; and
    • member is symptomatic despite receiving one of the following:
      • combination inhaler containing an inhaled corticosteroid and a long-acting β-agonist; or
      • combination of an inhaled corticosteroid and a long-acting β-agonist inhaler as separate inhalers; or
      • chronic oral corticosteroids; and 
    • evidence of an eosinophilic phenotype (i.e., peripheral blood eosinophil count ≥ 150 cells/μL, elevated sputum eosinophils or FeNO); and 
    • prescriber is an asthma specialist (e.g., allergist, immunologist, pulmonologist) or consult notes from a specialist are provided; and 
    • appropriate dosing (30 mg every four weeks for three doses, then 30 mg every eight weeks).

SmartPA: Claims for Fasenra will usually pay at the pharmacy without a PA request if the member has a history of medical claims for severe eosinophilic asthma and paid MassHealth pharmacy claims for Fasenra for at least 84 days in the past 120 days. †

  

Nucala

  • Documentation of all of the following is required for severe eosinophilic asthma: 
    • appropriate diagnosis; and
    • member is ≥ six years of age; and
    • member is symptomatic despite receiving one of the following:
      • combination inhaler containing an inhaled corticosteroid and a long-acting β-agonist; or
      • combination of an inhaled corticosteroid and a long-acting β-agonist inhaler as separate inhalers; or
      • chronic oral corticosteroids; and 
    • evidence of an eosinophilic phenotype (i.e., peripheral blood eosinophil count ≥ 150 cells/μL, elevated sputum eosinophils or FeNO); and 
    • prescriber is an asthma specialist (e.g., allergist, immunologist, pulmonologist) or consult notes from a specialist are provided; and 
    • appropriate dosing (100 mg subcutaneously every four weeks if 12 years of age or older; 40 mg subcutaneously every four weeks if six to 11 years of age).
  • Documentation of all of the following is required for eosinophilic granulomatosis with polyangiitis: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response (defined as ≥ 30 days of therapy), adverse reaction, or contraindication to one systemic glucocorticoid; and 
    • inadequate response (defined as ≥ 30 days of therapy) or adverse reaction to one or contraindication to both azathioprine and methotrexate; and
    • prescriber is a specialist (e.g., allergist, cardiologist, hematologist, immunologist, pulmonologist, rheumatologist, etc.) or consult notes from a specialist are provided; and 
    • appropriate dosing (300 mg subcutaneously every four weeks).
  • Documentation of all of the following is required for hypereosinophilic syndrome:
    • appropriate diagnosis; and
    • documentation of diagnosis without an identifiable non-hematologic secondary cause; and
    • member is 12 years of age; and
    • inadequate response (defined as ≥ 30 days of therapy), adverse reaction, or contraindication to one systemic glucocorticoid; and 
    • inadequate response (defined as ≥ 30 days of therapy) or adverse reaction to one of the following or contraindication to all of the following: hydroxyurea, methotrexate, interferon alfa; and
    • prescriber is a specialist (e.g., allergist, cardiologist, GI, hematologist, immunologist, pulmonologist, etc.) or consult notes from a specialist are provided; and
    • appropriate dosing (300 mg subcutaneously every four weeks).
  • Documentation of all of the following is required for nasal polyps:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is a specialist (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or consult notes from a specialist are provided; and
    • inadequate response, adverse reaction, or contraindication to one oral corticosteroid; and
    • inadequate response, adverse reaction, or contraindication to one intranasal corticosteroid; and
    • appropriate dosing; and
    • requested agent will be used as adjunctive therapy.

SmartPA: Claims for Nucala at a quantity ≤ one vial/28 days will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for Nucala for at least 84 days in the past 120 days and a MassHealth history of medical claims for severe eosinophilic asthma. Claims for Nucala at a quantity ≤ three vials/28 days will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for Nucala for at least 84 days in the past 120 days and a MassHealth history of medical claims for eosinophilic granulomatosis with polyangiitis or hypereosinophillic syndrome. 

 

Tezspire

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 12 years of age; and
    • member is symptomatic despite receiving one of the following:
      • combination inhaler containing an inhaled corticosteroid and a long-acting β-agonist; or
      • combination of an inhaled corticosteroid and a long-acting β-agonist inhaler as separate inhalers; or
      • chronic oral corticosteroids; and  
    • prescriber is an asthma specialist (e.g., allergist, immunologist, pulmonologist) or consult notes from a specialist are provided; and 
    • appropriate dosing.

SmartPA: Claims for Tezspire will usually pay at the pharmacy without a PA request if the member has a history of medical claims for severe persistent asthma and paid MassHealth pharmacy claims for Tezspire for at least 84 days in the past 120 days. †

   

Xolair

  • Documentation of all of the following is required for chronic idiopathic urticaria:   
    • appropriate diagnosis; and
    • member is ≥ 12 years of age; and
    • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to at least two different histamine1 antihistamines; and 
    • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to a histamine1 antihistamine in combination with a histamine2 antihistamine; and 
    • if the request is for the 150 mg syringe, medical necessity for the requested formulation instead of the 150 mg vial formulation; and
    • appropriate dosing; and
    • prescriber is an allergist/immunologist or dermatologist or consult notes from a specialist are provided.
  • Documentation of all of the following is required for moderate-to-severe allergy-related asthma: 
    • appropriate diagnosis; and
    • member is ≥ six years of age; and
    • member is symptomatic despite receiving one of the following:
      • combination inhaler containing an inhaled corticosteroid and a long-acting β-agonist; or
      • combination of an inhaled corticosteroid and a long-acting β-agonist inhaler as separate inhalers; or
      • chronic oral corticosteroids; and
    • baseline serum IgE between 30 IU/mL to 700 IU/mL; and 
    • evidence of specific allergic sensitivity (i.e., positive skin test or radioallergosorbent test [RAST] for IgE); and 
    • prescriber is an asthma specialist (e.g., allergist, immunologist, pulmonologist) or consult notes from a specialist are provided; and 
    • if the request is for the 150 mg syringe, medical necessity for the requested formulation instead of the 150 mg vial formulation; and
    • appropriate dosing (75 to 375 mg subcutaneously every two to four weeks; not exceeding six units/28 days for the 150 mg vial, four units/28 days for the 150 mg syringe, and two units/28 days for the 75 mg syringe).
  • Documentation of all of the following is required for nasal polyps:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is a specialist (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or consult notes from a specialist are provided; and
    • inadequate response, adverse reaction, or contraindication to one oral corticosteroid; and
    • inadequate response, adverse reaction, or contraindication to one intranasal corticosteroid; and
    • appropriate dosing; and
    • if the request is for the Xolair 150 mg syringe, medical necessity for the 150 mg syringe instead of the 150 mg vial; and
    • requested agent will be used as adjunctive therapy

SmartPA: Claims for Xolair at a quantity ≤ six units/28 days for the 150 mg vial, and ≤ two units/28 days for the 75 mg syringe will usually process at the pharmacy without a PA request if the member has a MassHealth history of medical claims for moderate-to-severe allergy-related asthma and a history of paid MassHealth pharmacy claims for Xolair for at least 84 days in the past 120 days.


Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 07/2012

Last Revised Date: 05/2022


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Last updated 05/09/22

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