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); 2023 [cited 2024 Feb 22]. Available from: https://ginasthma.org/wp-content/uploads/2023/07/GINA-2023-Full-report-23_07_06-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. |
| MB | This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable. |
II. Therapeutic Uses
FDA-approved, for example:
- Chronic idiopathic urticaria
- Eosinophilic granulomatosis with polyangiitis
- Hypereosinophilic syndrome
- IgE-mediated food allergy
- 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
non-FDA-approved, for example:
- systemic mastocytosis
Note: The above list may not include all FDA-approved and non-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.
- Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
- 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.
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 28 days).
Dupixent
- Documentation of all of the following is required for moderate-to-severe AD:
- appropriate diagnosis; and
- member is ≥ six months 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 one or contraindication to both of the following: topical tacrolimus, 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 (300 mg subcutaneously every 14 days); 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.
- Documentation of all the following is required for prurigo nodularis:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- prescriber is a specialist (e.g., allergist, immunologist, dermatologist) or consult notes from a specialist are provided; and
- one of the following:
- inadequate response or adverse reaction to one or contraindication to all potent or superpotent topical corticosteroids; or
- inadequate response or adverse reaction to one or contraindication to all intralesional corticosteroids; or
- inadequate response, adverse reaction, or contraindication to phototherapy; and
- appropriate dosing (loading dose of 600 mg subcutaneously followed by 300 mg subcutaneously every other week).
- Documentation of all the following is required for eosinophilic esophagitis:
- appropriate diagnosis; and
- member is ≥ one year of age; and
- prescriber is a specialist (e.g., allergist, hematologist, immunologist, gastroenterologist) or consult notes from a specialist are provided; and
- member weighs ≥ 15 kg; and
- inadequate response (defined as ≥ 60 days of therapy) or adverse reaction to one or contraindication to all proton pump inhibitors; and
- inadequate response (defined as ≥ 30 days of therapy) or adverse reaction to one or contraindication to both of the following: budesonide, fluticasone propionate; and
- appropriate dosing.
SmartPA: Claims for Dupixent (dupilumab) 300 mg/2 mL at a quantity ≤ two syringes/28 days will usually process and pay at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for Dupixent for at least 84 days out of the last 120 days and a MassHealth history of medical claims for moderate to severe atopic dermatitis, moderate to severe eosinophilic asthma, nasal polyps, or prurigo nodularis. Claims for Dupixent (dupilumab) 300 mg/2 mL at a quantity ≤ four syringes/28 days will usually process and pay at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for Dupixent for at least 84 days out of the last 120 days and a MassHealth history of medical claims for eosinophilic esophagitis. Claims for Dupixent (dupilumab) 200 mg/1.14 mL at a quantity ≤ two syringes/28 days will usually process and pay at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for Dupixent for at least 84 days out of the last 120 days and a MassHealth history of medical claims for moderate to severe atopic dermatitis or moderate to severe eosinophilic asthma. Claims for Dupixent (dupilumab) 100 mg/0.67 mL at a quantity ≤ two syringes/28 days will usually process and pay at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for Dupixent for at least 84 days out of the last 120 days and a MassHealth history of medical claims for moderate to severe eosinophilic asthma.
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 out of the last 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) or adverse reaction to one or contraindication to all systemic glucocorticoids; and
- inadequate response (defined as ≥ 30 days of therapy) or adverse reaction to one or contraindication to both of the following: azathioprine, 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
- diagnosis without an identifiable non-hematologic secondary cause; and
- member is ≥ 12 years of age; and
- inadequate response (defined as ≥ 30 days of therapy) or adverse reaction to one or contraindication to all systemic glucocorticoids; and
- inadequate response (defined as ≥ 30 days of therapy) or adverse reaction to one 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 or adverse reaction to one or contraindication to all oral corticosteroids; and
- inadequate response or adverse reaction to one or contraindication to all intranasal corticosteroids; 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 out of the last 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 out of the last 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 out of the last 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) or adverse reaction to at least two or contraindication to all 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
- for the 150 mg or 300 mg syringe or auto-injection, medical necessity for the requested formulation instead of the 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 IgE-mediated food allergy:
- appropriate diagnosis; and
- prescriber is an allergist or immunologist or consult notes from an allergist or immunologist are provided; and
- member is ≥ one year of age; and
- baseline serum IgE between 30 IU/mL to 1,850 IU/mL; and
- evidence of specific allergic sensitivity (i.e., positive skin test or radioallergosorbent test [RAST] for IgE); and
- appropriate dosing; and
- for the 150 mg or 300 mg syringe or auto-injection, medical necessity for the requested formulation instead of the vial formulation.
- 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
- for the 150 mg or 300 mg syringe or auto-injection, medical necessity for the requested formulation instead of the 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 or 300 mg syringe/auto-injection, and two units/28 days for the 75 mg syringe/auto-injection).
- 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 or adverse reaction to one or contraindication to all oral corticosteroids; and
- inadequate response or adverse reaction to one or contraindication to all intranasal corticosteroids; and
- appropriate dosing; and
- for the 150 mg or 300 mg syringe or auto-injection, medical necessity for the requested formulation instead of the vial; and
- requested agent will be used as adjunctive therapy
- Documentation of all of the following is required for systemic mastocytosis:
- appropriate diagnosis; and
- prescriber is a specialist (e.g., hematologist, oncologist, allergist/immunologist) or consult notes from a specialist are provided; and
- appropriate dosing; and
- for the 150 mg or 300 mg syringe or auto-injection, medical necessity for the requested formulation instead of the vial; and
- inadequate response, adverse reaction, or contraindication to all of the following: corticosteroids, histamine1 antihistamine and histamine2 antihistamine.
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/auto-injection 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 out of the last 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: 07/2024
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Last updated 07/11/24