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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
benralizumab Fasenra PA  
dupilumab Dupixent PA  
mepolizumab Nucala PA  
omalizumab Xolair PA  
reslizumab Cinqair 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 new 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 should be administered in a health care setting by a health care professional. Benralizumab is given subcutaneously 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 IgE; however, the exact mechanism of action for dupilumab in treating asthma has not been definitively identified. It is indicated in patients aged 12 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 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 subcutaneous (SC) injection every two weeks.
  • Dupilumab is initially administered under the care of a medical 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.
  • For a diagnosis of moderate-to-severe persistent asthma, omalizumab is administered subcutaneously every two-to-four weeks according to weight based dosing and the levels of serum immunoglobulin E (IgE). For a diagnosis of chronic idiopathic urticaria, omalizumab is administered subcutaneously 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.

  

Mepolizumab

  • Mepolizumab is a humanized interleukin-5 (IL-5) antagonist monoclonal antibody indicated for add-on maintenance treatment of patients aged 12 years and older with severe asthma, and with an eosinophilic phenotype. It is suggested that this agent be administered by a health care professional. Mepolizumab is given subcutaneously at a dose of 100 mg once every four weeks.

 

Reslizumab

  • Reslizumab is another humanized interleukin-5 (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 health care setting by a health care 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.

  

Treatment Guidelines for the Management of Persistent Severe Asthma

  • Consensus guidelines have not yet been updated to include recommendations for the use of mepolizumab or reslizumab for the management of severe asthma with an eosinophilic subtype.1-3
  •  The 2007 National Heart, Lung and Blood Institute (NHLBI) guidelines recommend omalizumab as an adjunctive therapy in patients ≥12 years of age with allergies and severe persistent asthma that is inadequately controlled with the combination of high-dose ICS and long-acting β2-agonist.1 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 β2-agonist (LABA) to daily inhaled corticosteroids (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. Short-acting β-agonists are the drug of choice for acute asthma exacerbations and OCs are generally used in short courses for moderate or severe exacerbations. In addition, leukotriene modifiers (e.g., montelukast, zafirlukast and zileuton) may be added to ICS therapy as an alternative to adding LABAs among patients with moderate-to-severe asthma.1,3

 

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 such as H1 antihistamines, H2 antihistamines, and leukotriene modifiers.4,5

 

Treatment Guidelines for the Management of CRSwNP

  • Current guidelines for management of CRSwNP recommend a brief course of oral glucocorticoids (up to 14 days) with or without oral antibiotics. Nasal saline irrigation, intranasal glucocorticoids with or without antileukotriene agents is also recommended and can be continued as maintenance therapy. Sinus surgery is generally reserved for those who have failed to respond to medical therapy. Guidelines have not been updated to include recommendations for dupliumab.6-8

 

1United States Department of Health and Human Services National Heart, Lung, and Blood Institute. Expert Panel Report 3: Guidelines for the diagnosis and management of asthma [guideline on the Internet]. NHLBI 2007 [cited 2015 Dec 27]. Available from: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf.

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); 2015 [cited 2015 Dec 27]. Available from: http://www.ginasthma.org/local/uploads/files/GINA_Report_2015_Aug11.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. 2014 Jul;69(7):868-87.

6Orlandi RR, Kingdom TT, Hwang PH, Smith TL, Alt JA, Baroody FM, et al. International consensus statement on allergy and rhinology: rhinosinusitis. International Forum of Allergy & Rhinology. 2016 Feb;6(1): S22-S209.

7Fokkens WJ, Lund V, Bachert C, Mullol J, Bjermer L, Bousquet J, et al. European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA): Consensus on biologics for CRSwNP with or without asthma. 2019. Doi:10.1111/all.13875.

8Peters AT, Spector S, Hsu J, Hamilos DL, Baroody FM, Chandra RK, et al. American Academy of Allergy, Asthma, and Immunology (AAAAI), American College of Allergy, Asthma and Immunology (ACAAI) and Joint Council of Allergy, Asthma and Immunology (JCAAI): Diagnosis and management of rhinosinusitis- A practice parameter, update. Ann Allergy Asthma Immunol. 2014;113:347-385.

 
Table Footnotes

II. Therapeutic Uses

FDA-approved, for example:

  • Chronic idiopathic urticaria
  • CRSwNP
  • Eosinophilic granulomatosis with polyangiitis
  • Moderate-to-severe allergy-related asthma
  • Moderate-to-severe eosinophilic asthma
  • Moderate-to-severe AD
  • Oral corticosteroid-dependent asthma
  • Severe eosinophilic 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 (i.e., allergist, immunologist, pulmonologist); and
    • dose is appropriate (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 ≥ 12 years of age; and
    • dose is appropriate; and
    • prescriber is an allergist, immunologist, or dermatologist, or provides consultation notes from an allergist, immunologist, or dermatologist; and
    • one of the following:
      • inadequate response, or adverse reaction to one superpotent or potent topical corticosteroid; or
      • contraindication to all superpotent or potent topical corticosteroids; and
    • one of the following:
      • inadequate response or adverse reaction to one systemic immunomodulatory agent; or
      • contraindication to all systemic immunomodulatory agents; and
    • inadequate response, adverse reaction, or contraindication to topical tacrolimus.
  • Documentation of all of the following is required for CRSwNP:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is a specialist (i.e., allergist, immunologist, pulmonologist); and
    • inadequate response, adverse reaction, or contraindication to one oral corticosteroid; and
    • inadequate response, adverse reaction, or contraindication to one intranasal corticosteroid; and
    • inadequate response, adverse reaction, or contraindication to one leukotriene antagonist; and
    • dose is appropriate; and
    • requested agent will be used as adjunctive therapy.
  • Documentation of all of the following is required for moderate-to-severe eosinophilic asthma or OC-dependent asthma:
    • 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 
    • one of the following:
      • evidence of an eosinophilic phenotype (i.e., peripheral blood eosinophil count ≥ 150 cells/μL, elevated sputum eosinophils or FeNO) and inadequate response, adverse reaction, or contraindication to Nucala; or
      • member is receiving chronic oral corticosteroids; or
      • member has concomitant AD or CRSwNP; and
    • prescriber is an asthma specialist (i.e., allergist, immunologist, pulmonologist); and
    • dose is appropriate.

    

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 (i.e., allergist, immunologist, pulmonologist); and 
    • dose is appropriate (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 ≥ 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 (i.e., allergist, immunologist, pulmonologist); and 
    • dose is appropriate (100 mg subcutaneously every four weeks).
  • 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), adverse reaction, or contraindication to azathioprine or methotrexate; and
    • prescriber is a specialist (i.e., allergist, immunologist, pulmonologist, rheumatologist); and 
    • dose is appropriate (300 mg subcutaneously every four weeks).

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.†

   

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 leukotriene antagonist; 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
    • for initial requests, starting dose of ≤ 150 mg every four weeks or clinical rationale for using a starting dose > 150 mg every four weeks; and 
    • prescriber is an allergist/immunologist or dermatologist, or provides consultation notes from an allergist/immunologist or dermatologist regarding the diagnosis and treatment recommendation.

 

  • 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 (i.e., allergist, immunologist, pulmonologist); and 
    • if the request is for the 150 mg syringe, medical necessity for the requested formulation instead of the 150 mg vial formulation; and
    • dose is appropriate (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).

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: 10/2019

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Last updated 11/08/19