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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
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 selective beta2-agonists are therapy of choice for relief of acute symptoms.
  • Increasing use of short-acting beta2- agonists or use of more than one canister/month may indicate over reliance on this drug and inadequate asthma control.
  • Daily scheduled use of short-acting beta2-agonists is generally not recommended.
  • Long-acting beta2-agonists, such as formoterol and salmeterol, are not recommended for treatment of acute symptoms or exacerbations.

 

Maintenance medications:

Asthma:

  • Inhaled corticosteroids (ICS) are considered the most effective treatment for the symptoms of persistent asthma.
  • The National Heart, Lung, and Blood Institute (NHLBI) and World Health Organization (WHO) guidelines recommend ICS as first-line asthma-controller medications.
  • Inhaled long-acting beta2-agonists (LABAs) are recommended only as an add-on therapy to an ICS in members with uncontrolled asthma.
  • The Global Initiative for Asthma (GINA) also recommends consideration for the use of inhaled tiotropium as a new add-on option for Steps 4 and 5 in members ≥ 18 years of age with a history of asthma exacerbations.

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) or LABA is recommended as first-line treatment.
  • The recommended first choice therapy for Group C members (i.e., those who experience few symptoms but have a high risk of exacerbations) is a single long-acting bronchodilator (LAMA preferred). If exacerbations are persistent, then a second long-acting agent such as a LABA can be added. An alternative regimen consists of a LABA plus an ICS.
  • For Group D members (i.e., those with moderate-to-severe symptoms and a high risk of exacerbations), a LABA/LAMA combination is preferred. If further exacerbations occur, individuals can be switched to a LABA/ICS combination, or alternatively, triple therapy with a LABA/LAMA/ICS.

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 short-acting beta2-agonists are the treatment of choice.
 

 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  
budesonide / formoterol Symbicort test   BP, A90
budesonide / glycopyrrolate / formoterol Breztri PA  
fluticasone / salmeterol inhalation aerosol Advair test  
fluticasone / salmeterol inhalation powder-Advair Advair test   BP, A90
fluticasone / salmeterol inhalation powder-Airduo Digihaler Airduo Digihaler PA  
fluticasone / salmeterol inhalation powder-Airduo Respiclick Airduo Respiclick PA   A90
fluticasone / vilanterol Breo PA   BP, A90
fluticasone furoate / umeclidinium / vilanterol Trelegy PA  
glycopyrrolate / formoterol Bevespi PA  
mometasone / formoterol Dulera test   BP
tiotropium / olodaterol Stiolto PA  
umeclidinium / vilanterol Anoro PA  

 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 PA  
fluticasone propionate inhalation aerosol Flovent test   BP, A90
fluticasone propionate inhalation powder Flovent test  
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 PA  

 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 PA  
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 Xopenex PA   A90
levalbuterol inhaler Xopenex HFA test   # , A90
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization 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

Note: The above list may not include all 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).

 

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 powder (generic Advair), fluticasone/salmeterol inhalation powder (generic Airduo Respiclick); and
    • requested quantity is ≤ one inhaler per month.

   

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, Arnuity, and Qvar Redihaler

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

SmartPA: Claims for Alvesco, Arnuity, 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.

  

Anoro, Bevespi, and Stiolto

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

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

 

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 claim for a nebulized respiratory product and no claims for inhalers within the last month; or
      • medical necssity for nebulized formulation; and
    • requested quantity is ≤ 120 mL per month.

SmartPA: Claims for arformoterol and formoterol will usually process at the pharmacy within the quantity limit of 120 mL/month 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 month, and has no history of paid MassHealth pharmacy claims for an inhaler within the last month.

 

Armonair Digihaler

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to Arnuity; and
    • inadequate response, adverse reaction, or contraindication to fluticasone propionate inhalation aerosol or powder.

 

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 pharmacywithout 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.

 

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 at least three months 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 per month.

 

budesonide inhalation suspension ≥ 13 years of age

  •  Documentation of the following is required:      
    • diagnosis of asthma; and
    • one of the following:
      • member has a claim for a nebulized respiratory product and no claims for inhalers within the last month; 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 month and has no history of paid MassHealth pharmacy claims for an inhaler within the last month.

  

Duaklir

  • Documentation of the following is required: 
    • diagnosis of COPD; and
    • member is ≥ 18 years of age; and
    • requested quantity is ≤ one inhaler per month; and
    • an inadequate response or adverse reaction to one or contraindication to all of the following: Anoro, Bevespi, Stiolto.

    

fluticasone/salmeterol inhalation powder (generic Airduo Respiclick)

  • Documentation of the following is required:
    • diagnosis of asthma; and
    • one of the following: 
      • an 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 per month.

 

fluticasone/vilanterol

  • Documentation of the following is required for the diagnosis of asthma:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • an inadequate response or adverse reaction to one or contraindication to both of the following: budesonide/formoterol, fluticasone/salmeterol inhalation aerosol, powder (generic Advair); and
    • requested quantity is ≤ one inhaler per month.
  • Documentation of the following is required for the diagnosis of COPD:    
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • an inadequate response, adverse reaction, or contraindication to budesonide/formoterol; and
    • requested quantity is ≤ one inhaler per month.

SmartPA: Claims for fluticasone/vilanterol will usually process at the pharmacy within the quantity limit of one inhaler/month without a PA request if the member (≥ 18 years of age) has a history of MassHealth medical claims for asthma and a history of paid MassHealth pharmacy claims for budesonide/formoterol or fluticasone/salmeterol inhalation aerosol or powder (generic Advair). Claims for fluticasone/vilanterol will also usually process at the pharmacy within the quantity limit of one inhaler/month without a PA request if the member (≥ 18 years of age) has a history of paid MassHealth pharmacy claims of the requested agent for 90 out of the last 120 days of the requested agent, or has a history of MassHealth medical claims for COPD and a history of paid MassHealth pharmacy claims for budesonide/formoterol.

 

levalbuterol solution

  • Documentation of the following is required:
    • diagnosis of asthma, COPD, or EIB; and
    • an 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. 

 

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 claim for a nebulized respiratory product and no claims for inhalers within the last month; or
      • medical necessity for nebulized formulation; and
    • an inadequate response, adverse reaction, or contraindication to ipratropium inhalation nebulizer solution; and
    • for Lonhala, requested quantity is ≤ 60 mL/month or for Yupelri, 90 mL/month .

SmartPA: Claims for Lonhala Magnair within the quantity limit of 60 mL/month and Yupelri within the quantity limit of 90 mL/month 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 month, has no history of paid MassHealth pharmacy claims for an inhaler within the last month and has a history of paid MassHealth pharmacy claims for ipratropium inhalation nebulizer solution. 

 

Proair Digihaler and Proair Respiclick

  • Documentation of the following is required:
    • diagnosis of asthma, COPD, or EIB; and
    • an inadequate response, adverse reaction, or contraindication to albuterol inhaler (Proair HFA, Proventil, or Ventolin).

   

Serevent

  • Documentation of the following is required:      
    • quantity limit is ≤ one inhaler per month; and
    • one of the following:      
      • diagnosis of COPD; or
      • all of the following:
        • diagnosis of asthma or EIB; and
        • inadequate response to monotherapy with an inhaled corticosteroid within the last four months; and
        • requested agent is going to be used in combination with an inhaled corticosteroid.

SmartPA: Claims for Serevent will usually process at the pharmacy within the quantity limit of one inhaler/month without a PA request if the member has a history of MassHealth medical claims for COPD.


Striverdi

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

SmartPA: Claims for Striverdi will usually process at the pharmacy within the quantity limit of one inhaler/month 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 three months of therapy) or adverse reaction to the separate agents fluticasone/vilanterol and Incruse once daily; or
      • clinical rationale why member cannot utilize the combination of the separate agents fluticasone/vilanterol and Incruse once daily; and
    • requested quantity is ≤ one inhaler per month.

 

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: 10/2022


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Last updated 10/31/22

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