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Table 23: Respiratory Agents - Inhaled


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Drug Category: Respiratory Tract Agents

Medication Class/Individual Agents: Respiratory Inhalants

I. Prior-Authorization Requirements

 Inhaled Respiratory Agents – Anticholinergics

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

aclidinium Tudorza test  
glycopyrrolate inhalation solution Lonhala PA  
ipratropium inhalation aerosol Atrovent HFA test  
revefenacin Yupelri PA  
tiotropium inhalation powder Spiriva Handihaler test   BP, A90
tiotropium inhalation solution Spiriva Respimat test  
umeclidinium Incruse test  

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.

 

Quick-relief medications:

  • Inhaled short-acting beta2-agonists (SABAs) are no longer recommended as reliever medication for adults and adolescents ≥ 12 years of age.
  • Inhaled corticosteroid (ICS)-formoterol is the preferred AIR for adults and adolescents ≥ 12 years of age.
  • Alternative option for AIR is to give an ICS whenever as needed SABA is used.
  • Overuse of SABAs increases the risk of asthma exacerbations.

 

Maintenance medications:

Asthma:

  • The Global Initiative for Asthma (GINA) guidelines recommend the use of ICS-formoterol as the preferred maintenance treatment for adults and adolescents ≥ 12 years of age.
  • GINA recommends the use of low dose ICS for children ≤ 11 years of age. The addition of a leukotriene receptor agonist (LTRA) can be considered for some children. 
  • For children six to 11 years of age inadequately controlled with low dose ICS or low dose ICS plus LTRA, consideration can be given to starting low dose ICS-formoterol, increasing ICS to medium dose, or starting very low dose ICS-formoterol.
  • GINA also recommends consideration for phenotypic assessment for potential add-on biologics in severe cases of asthma not adequately controlled on maintenance inhalers.

 

Chronic obstructive pulmonary disease (COPD):

  • The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline states that inhaled bronchodilators are preferred for the management of COPD.
  • Short-acting, as-needed bronchodilators are recommended as a first choice for members with mild or infrequent symptoms.
  • For Group B members (i.e., those with moderate-to-severe symptoms and low exacerbation risk), a long-acting muscarinic antagonist (LAMA) plus a long-acting beta agonist (LABA) is recommended as first-line treatment.
  • The recommended first choice therapy for Group E members (i.e., those with ≥ two moderate exacerbations or ≥ one leading to hospitalization) is a LABA plus LAMA inhaler. If exacerbations are persistent, or blood eosinophils are ≥ 300, an ICS can be added to the LABA plus LAMA regimen.

The incidence of oral candidiasis with ICS may be reduced by using a spacer/holding chamber and rinsing the mouth with water after inhalation.

 

Exercise-induced bronchospasm (EIB):

  • Inhaled ICS-formoterol, ICS-SABA or SABA can be given prior to or during exercise as needed.
 

 Inhaled Respiratory Agents – Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

aclidinium / formoterol Duaklir PA  
albuterol / ipratropium inhalation solution test   A90
albuterol / ipratropium inhalation spray Combivent test  
albuterol/budesonide Airsupra PA  
budesonide / formoterol Symbicort test   BP, A90
budesonide / glycopyrrolate / formoterol Breztri PA  
fluticasone / salmeterol inhalation powder-Airduo Digihaler Airduo Digihaler PA  
fluticasone / salmeterol inhalation powder-Airduo Respiclick Airduo Respiclick PA   BP, A90
fluticasone / salmeterol inhalation-Advair Advair test   BP, A90
fluticasone / vilanterol Breo test   BP, A90
fluticasone furoate / umeclidinium / vilanterol Trelegy PA  
glycopyrrolate / formoterol Bevespi PA  
mometasone / formoterol Dulera test   BP
tiotropium / olodaterol Stiolto PA  
umeclidinium / vilanterol Anoro test  

 Inhaled Respiratory Agents – Corticosteroids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

beclomethasone inhaler Qvar Redihaler PA  
budesonide inhalation powder Pulmicort test  
budesonide inhalation suspension Pulmicort PA   - ≥ 13 years # , A90
ciclesonide inhaler Alvesco PA  
fluticasone furoate inhalation powder Arnuity test  
fluticasone propionate inhalation aerosol PA   - ≥ 12 years A90
fluticasone propionate inhalation powder PA   A90
fluticasone propionate inhalation powder-Armonair Digihaler Armonair Digihaler PA  
mometasone 110 mcg inhalation powder Asmanex Twisthaler PA   - ≥ 12 years
mometasone 220 mcg inhalation powder Asmanex Twisthaler PA   - < 12 years
mometasone inhalation aerosol Asmanex HFA test  

 Inhaled Respiratory Agents – Long-Acting Beta Agonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

arformoterol Brovana PA   A90
formoterol Perforomist PA  
olodaterol Striverdi PA  
salmeterol Serevent test  

 Inhaled Respiratory Agents – Mast Cell Stabilizers

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

cromolyn inhalation test   A90

 Inhaled Respiratory Agents – Short-Acting Beta Agonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

albuterol inhalation powder-Proair Digihaler Proair Digihaler PA  
albuterol inhalation powder-Proair Respiclick Proair Respiclick test  
albuterol inhalation solution Accuneb test   # , A90
albuterol inhaler PA  
albuterol inhaler-Proair HFA Proair HFA test   BP, A90
albuterol inhaler-Proventil Proventil test   BP, A90
albuterol inhaler-Ventolin Ventolin test   BP, A90
levalbuterol inhalation solution PA   A90
levalbuterol inhaler Xopenex HFA test   # , A90
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  •  asthma
  •  COPD
  •  EIB

Non-FDA-approved, for example:

  • eosinophilic esophagitis (budesonide inhalation suspension, fluticasone priopionate inhalation aerosol)
  • chronic sinusitis, pansinusitis, rhinitis, nasal polyposis (budesonide inhalation suspension)
  • COPD (budesonide inhalation suspension)

 

Note: The above lists may not include all FDA-approved and non-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.
  • 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.

 

Airduo Digihaler

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to both of the following: fluticasone/salmeterol inhalation aerosol, powder (generic Advair), fluticasone/salmeterol inhalation powder (generic Airduo Respiclick); and
    • requested quantity is ≤ one inhaler/30 days.

   

Airsupra

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to budesonide/formoterol; or
      • inadequate response or adverse reaction to the separate agents: albuterol and Pulmicort (budesonide inhalation powder) used concomitantly as needed; or
      • clinical rationale why the member cannot utilize the combination of the separate agents albuterol and Pulmicort (budesonide inhalation powder) concomitantly as needed.

    

albuterol inhaler

  • Documentation of the following is required:
    • diagnosis of asthma, COPD, or EIB; and
    • medical records documenting an inadequate response or adverse reaction to an albuterol product available without PA.

   

Alvesco, Armonair Digihaler, fluticasone propionate inhalation aerosol ≥ 12 years of age, fluticasone propionate inhalation powder, Qvar Redihaler

  • Documentation of the following is required:      
    • diagnosis of asthma; and
    • inadequate response or adverse reaction to two or contraindication to all inhaled corticosteroids available without PA.

SmartPA: Claims for Alvesco and Qvar Redihaler will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days.

  

arformoterol and formoterol

  •  Documentation of the following is required:      
    • diagnosis of COPD; and
    • member is ≥ 18 years of age; and
    • one of the following:      
      • member has a recent paid pharmacy claim for a nebulized respiratory product and no recent paid pharmacy claims for inhalers; or
      • medical necessity for nebulized formulation; and
    • requested quantity is ≤ 120 mL/30 days.

SmartPA: Claims for arformoterol and formoterol will usually process at the pharmacy within the quantity limit of 120 mL/30 days without a PA request if the member (≥ 18 years of age) has a history of MassHealth medical claims for COPD, has a history of paid MassHealth pharmacy claims for a nebulized solution within the last 30 days or has a history of paid MassHealth pharmacy claims for any nebulized solution for ≥ 15 days of therapy within the last 30 days, and there is no history of paid MassHealth pharmacy claims for an inhaler within the last 30 days, and there is no history of paid MassHealth pharmacy claims for an inhaler for ≥ 15 days of therapy within the last 30 days.

 

Asmanex Twisthaler 110 mcg in members ≥ 12 years of age

  • Documentation of the following is required:
    • diagnosis of asthma; and
    • clinical rationale for use of 110 mcg strength in members ≥ 12 years of age. 

SmartPA: Claims for Asmanex Twisthaler 110 mcg will usually process at the pharmacy without a PA request if the member is < 12 years of age.

  

Asmanex Twisthaler 220 mcg in members < 12 years of age

  • Documentation of the following is required:
    • diagnosis of asthma; and
    • clinical rationale for use of 220 mcg strength in members < 12 years of age. 

SmartPA: Claims for Asmanex Twisthaler 220 mcg will usually process at the pharmacy without a PA request if the member is ≥ 12 years of age.

 

Bevespi and Duaklir

  • Documentation of the following is required: 
    • diagnosis of COPD; and
    • member is ≥ 18 years of age; and
    • requested quantity is ≤ one inhaler/30 days; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: Anoro, Stiolto.

SmartPA: Claims for Bevespi and Duaklir will usually process at the pharmacy within the quantity limit of one inhaler/30 days without a PA request if the member (≥ 18 years of age) has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days.

 

Breztri

  •  Documentation of the following is required: 
    • diagnosis of COPD; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • inadequate response (defined as ≥ 90 days of therapy) or adverse reaction to the separate agents Bevespi and Pulmicort inhalation powder twice daily; or
      • clinical rationale why member cannot utilize the combination of the separate agents Bevespi and Pulmicort inhalation powder twice daily; and
    • requested quantity is ≤ one inhaler/30 days.

SmartPA: Claims for Breztri will usually process at the pharmacy within the quantity limit of one inhaler/30 days without a PA request if the member (≥ 18 years of age) has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days.

 

budesonide inhalation suspension ≥ 13 years of age

  •  Documentation of the following is required for a diagnosis of asthma:      
    • appropriate diagnosis; and
    • one of the following:
      • member has a recent paid pharmacy claim for a nebulized respiratory product and no recent paid pharmacy claims for inhalers; or
      • medical necessity for nebulized formulation.
  •  Documentation of the following is required for a diagnosis of eosinophilic esophagitis:
    • appropriate diagnosis; and
    • prescriber is a specialist (e.g., allergy/immunology, gastroenterology, otolaryngology, rhinology, pulmonology, ENT).
  •  Documentation of the following is required for a diagnosis of chronic sinusitis, pansinusitis, rhinitis, nasal polyposis:
    • appropriate diagnosis; and
    • prescriber is a specialist (e.g., allergy/immunology, otolaryngology, rhinology, pulmonology, ENT), and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to one commercially available intranasal steroid, or
      • clinical rationale for budesonide irrigation/rinse with suspension formulation.
  •  Documentation of the following is required for a diagnosis of COPD:
    • appropriate diagnosis; and
    • prescriber is a specialist (e.g., pulmonology), and
    • one of the following:
      • member has a recent claim for a nebulized respiratory product and no recent paid pharmacy claims for inhalers; or
      • medical necessity for nebulized formulation. 

 

SmartPA: Claims for budesonide inhalation suspension will usually process at the pharmacy without a PA request if the member is ≥ 13 years of age and has a history of paid MassHealth pharmacy claims for a nebulized solution within the last 30 days or has a history of paid MassHealth pharmacy claims for any nebulized solution for ≥ 15 days of therapy within the last 30 days, and there is no history of paid MassHealth pharmacy claims for an inhaler within the last 30 days, and there is no history of paid MassHealth pharmacy claims for an inhaler for ≥ 15 days of therapy within the last 30 days.

 

fluticasone priopionate inhalation aerosol ≥ 12 years of age

  • Documentation of the following is required:
    • diagnosis of eosinophilic esophagitis; and
    • prescriber is a specialist (e.g., allergy/immunology, gastroenterology, otolaryngology, rhinology, pulmonology, ENT).

   

fluticasone/salmeterol inhalation powder (generic Airduo Respiclick)

  • Documentation of the following is required:
    • diagnosis of asthma; and
    • one of the following: 
      • inadequate response or adverse reaction to fluticasone/salmeterol inhalation aerosol, powder (generic Advair); or
      • clinical rationale for lower dose of fluticasone/salmeterol; or  
      • member is already receiving another Respiclick formulation; and
    • requested quantity is ≤ one inhaler/30 days.

 

levalbuterol solution

  • Documentation of the following is required:
    • diagnosis of asthma, COPD, or EIB; and
    • inadequate response, adverse reaction, or contraindication to inhaled albuterol solution; and
    • one of the following:
      • member is < 13 years of age; or
      • medical necessity for nebulized formulation. 

Smart PA: Claims for levalbuterol solution will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days.

 

Lonhala and Yupelri

  •  Documentation of the following is required:      
    • diagnosis of COPD; and
    • member is ≥ 18 years of age; and
    • one of the following:      
      • member has a recent paid pharmacy claim for a nebulized respiratory product and no recent paid pharmacy claims for inhalers; or
      • medical necessity for nebulized formulation; and
    • inadequate response, adverse reaction, or contraindication to ipratropium inhalation nebulizer solution; and
    • one of the following:
      • for Lonhala, requested quantity is ≤ 60 mL/30 days; or 
      • for Yupelri, requested quantity is ≤ 90 mL/30 days.

SmartPA: Claims for Lonhala within the quantity limit of 60 mL/30 days and Yupelri within the quantity limit of 90 mL/30 days will usually process at the pharmacy without a PA request if the member (≥ 18 years of age) has a history of MassHealth medical claims for COPD, has a history of paid MassHealth pharmacy claims for a nebulized solution within the last 30 days or has a history of paid MassHealth pharmacy claims for any nebulized solution for ≥ 15 days of therapy within the last 30 days, there is no history of paid MassHealth pharmacy claims for an inhaler within the last 30 days, there is no history of paid MassHealth pharmacy claims for an inhaler for ≥ 15 days of therapy within the last 30 days, and has a history of paid MassHealth pharmacy claims for ipratropium inhalation nebulizer solution. 

 

Proair Digihaler

  • Documentation of the following is required:
    • diagnosis of asthma, COPD, or EIB; and
    • inadequate response, adverse reaction, or contraindication to an albuterol product available without prior authorization  (Proair HFA, Proair Respiclick, Proventil, or Ventolin).

    

Stiolto

  • Documentation of the following is required: 
    • diagnosis of COPD; and
    • member is ≥ 18 years of age; and
    • requested quantity is ≤ one inhaler/30 days.

 

SmartPA: Claims for Stiolto will usually process at the pharmacy within the quantity limit of one inhaler/30 days without a PA request if the member has a history of MassHealth medical claims for COPD and the member is ≥ 18 years of age.

 

Striverdi

  • Documentation of the following is required:   
    • diagnosis of COPD; and
    • member is ≥ 18 years of age; and
    • requested quantity is ≤ one inhaler/30 days.

SmartPA: Claims for Striverdi will usually process at the pharmacy within the quantity limit of one inhaler/30 days without a PA request if the member has a history of MassHealth medical claims for COPD and the member is ≥ 18 years of age.

  

Trelegy

  • Documentation of the following is required:      
    • diagnosis of asthma or COPD; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • inadequate response (defined as at least 90 days of therapy) or adverse reaction to the separate agents fluticasone/vilanterol and Incruse once daily; or
      • inadequate response (defined as at least 90 days of therapy) or adverse reaction to the separate agents Anoro and Arnuity once daily; or
      • clinical rationale why member cannot utilize the combination of the separate agents fluticasone/vilanterol and Incruse once daily or Anoro and Arnuity once daily; and
    • requested quantity is ≤ one inhaler/30 days.

SmartPA: Claims for Trelegy will usually process at the pharmacy within the quantity limit of one inhaler/30 days without a PA request if the member (≥ 18 years of age) has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 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: 12/2006

Last Revised Date: 05/2024


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Last updated 05/16/24

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