FDA-approved, for example:

• Chronic idiopathic urticaria
• Chronic obstructive pulmonary disease
• 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
• Prurigo nodularis
• Severe Asthma

non-FDA-approved, for example:

• systemic mastocytosis

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

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.

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
  • appropriate dosing (not exceeding 2.28 units every 28 days for Dupixent 200 mg/1.14 mL, and four units every 28 days for Dupixent 300 mg/2 mL); and
  • one of the following:
    • total body surface area (BSA) to be treated is ≥ 10%; or
    • inadequate response or adverse reaction to one other systemic immunomodulatory agent or contraindication to all other systemic immunomodulatory agents for the treatment of atopic dermatitis; or
    • both of the following:
      • inadequate response or adverse reaction to one or contraindication to both of the following: topical tacrolimus, Eucrisa; 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; or
        • treatment area is sensitive area (face or groin); or
        • member is < 12 years of age.

• Documentation of all of the following is required for chronic rhinosinusitis with nasal polyps:
  • appropriate diagnosis; and
  • member is ≥ 12 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 (not exceeding four units every 28 days for Dupixent 300 mg/2 mL); 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 (not exceeding 2.28 units every 28 days for Dupixent 200 mg/1.14 mL, and four units every 28 days for Dupixent 300 mg/2 mL).

• 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 (not exceeding four units every 28 days for Dupixent 300 mg/2 mL).

• 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 (not exceeding four units every 28 days for Dupixent 300 mg/2 mL).

• Documentation of all the following is required for moderate-severe chronic obstructive pulmonary disease (COPD):
  • appropriate diagnosis; and
  • prescriber is a specialist (e.g., pulmonologist, allergist, or immunologist) or consult notes from a specialist are provided; and
  • one of the following:
    • both of the following:
      • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) or adverse reaction to one of the following or any combination of separate inhalers equivalent to one of the following: Bevespi, Duaklir, Stiolto, umeclidinium/vilanterol; and
      • contraindication to the use of an inhaled corticosteroid; or 
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) or adverse reaction to one or any combination of separate inhalers equivalent to one of the following or contraindication to both of the following: Breztri, Trelegy; and
  • evidence of an eosinophilic phenotype (i.e. peripheral blood eosinophil count ≥ 300 cells/μL); and
  • requested agent will be used as adjunctive therapy with either dual or triple inhaled therapy; and
  • appropriate dosing.

SmartPA: Claims for Dupixent (dupilumab) 300 mg/2 mL at a quantity ≤ four units/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 ≤ eight units/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 ≤ 2.28 units/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. 

Fasenra

• 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.

• 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 
  • prescriber is a specialist (e.g., allergist, cardiologist, hematologist, immunologist, pulmonologist, rheumatologist, etc.) or consult notes from a specialist are provided; and 
  • appropriate dosing (not exceeding one unit every 28 days).

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. Claims for Fasenra 30 mg/mL at a quantity ≤ one unit/28 days will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for Fasenra 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. ^†

Nemluvio

• Documentation of all of the following is required for moderate-to-severe AD: 
  • appropriate diagnosis; and
  • prescriber is a specialist (e.g., allergist, immunologist, dermatologist) or consult notes from a specialist are provided; and
  • member is ≥ 12 years of age; and
  • appropriate dosing; and
  • inadequate response or adverse reaction to two or contraindicated to all of the following: Adbry, Dupixent, Ebglyss; and
  • one of the following:
    • total body surface area (BSA) to be treated is ≥ 10%; or
    • inadequate response or adverse reaction to one or contraindicated to all other systemic immunomodulatory agents for the treatment of atopic dermatitis; or
    • both of the following:
      • inadequate response or adverse reaction to one or contraindication to both of the following: Eucrisa, topical tacrolimus; and
      • one of the following:
        • inadequate response or adverse reaction to one potent or superpotent topical corticosteroid or contraindication to all potent or superpotent topical corticosteroids; or
        • treatment area is a senstive area (face/groin).

• For recertification, documentation of positive response to therapy is required; and
• one of the following:
  • request is for every eight-week dosing (after week 16 of therapy); or
  • request is for continued every four-week dosing (after week 16 of therapy) and one of the following:
    • partial response to therapy; or
    • failed trial with every eight-week dosing.

• Documentation of all of the following is required for prurigo nodularis: 
  • appropriate diagnosis; and
  • prescriber is a specialist (e.g., allergist, immunologist, dermatologist) or consult notes from a specialist are provided; and
  • member is ≥ 18 years of age; and
  • one of the following:
    • inadequate response or adverse reaction to one potent or superpotent topical corticosteroid 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 or adverse reaction or contraindication to phototherapy; and
  • inadequate response or adverse reaction or contraindication to Dupixent; and
  • appropriate dosing.

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 (not exceeding one unit every 28 days for Nucala 100 mg/mL and 0.4 units every 28 days for Nucala 40 mg/0.4 mL).

• 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, adverse reaction, or contraindication to Fasenra; 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 (not exceeding three units every 28 days for Nucala 100 mg/mL).

• 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 (not exceeding three units every 28 days for Nucala 100 mg/mL).

• Documentation of all of the following is required for chronic rhinosinusitis with 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 or contraindication to both of the following:
      • intranasal corticosteroids; or
      • oral corticosteroids; or
    • inadequate response or adverse reaction to prior nasal surgery; and
  • appropriate dosing; and
  • requested agent will be used as adjunctive therapy.

SmartPA: Claims for Nucala 100 mg/mL at a quantity ≤ one unit/28 days and claims for Nucala 40 mg/0.4 mL at a quantity ≤ 0.4 units/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 100 mg/mL at a quantity ≤ three units/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 a specialist (e.g., 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 (not exceeding six units every 28 days for the 150 mg vial, four units every 28 days for the 150 mg or 300 mg syringe/auto-injection, and two units every 28 days for the 75 mg syringe/auto-injection).

• Documentation of all of the following is required for chronic rhinosinusitis with 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 or contraindication to both of the following:
      • intranasal corticosteroids; or
      • oral corticosteroids; or
    • inadequate response or adverse reaction to prior nasal surgery; 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.