Table 64: Asthma/Allergy Monoclonal Antibodies
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Respiratory Tract Agents
Medication Class/Individual Agents: Immunologic Agents
I. Prior-Authorization Requirements
Asthma/Allergy Monoclonal Antibodies |
Clinical Notes |
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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
Dupilumab
Omalizumab
Mepolizumab
Reslizumab
Tezepelumab
Treatment Guidelines for the Management of Persistent Severe Asthma
Treatment Guidelines for the Management of Chronic Urticaria
Treatment Guidelines for the Management of CRSwNP
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. |
| 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.
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