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
Treatment Guidelines for the Management of Persistent Severe Asthma
Treatment Guidelines for the Management of Chronic Urticaria
Treatment Guidelines for the Management of CRSwNP
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 2019 Oct 29]. 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); 2019 [cited 2019 Oct 29]. Available from: https://ginasthma.org/wp-content/uploads/2019/06/GINA-2019-main-report-June-2019-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. 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. |
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
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 (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 ≥ six years of age; 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
- one of the following:
- inadequate response or adverse reaction to topical tacrolimus or Eucrisa; or
- contraindication to topical tacrolimus and Eucrisa; and
- dose is appropriate.
- 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); 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 ≥ 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 (i.e., allergist, immunologist, pulmonologist); and
- dose is appropriate (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), 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: 12/2020
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Last updated 01/11/21