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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

aclidinium Tudorza PA   - > 1 inhaler/month
glycopyrrolate inhalation powder Seebri PA   - > 1 inhaler/month
glycopyrrolate inhalation solution Lonhala PA  
ipratropium inhalation aerosol Atrovent HFA test  
revefenacin Yupelri PA  
tiotropium inhalation powder Spiriva Handihaler PA   - > 30 units/month
tiotropium inhalation solution Spiriva Respimat PA   - > 1 inhaler/month
umeclidinium Incruse PA   - > 1 inhaler/month

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 patients 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 patients ≥ 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 patients with mild or infrequent symptoms.
  • For Group B patients (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 patients (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 patients (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

albuterol / ipratropium inhalation solution test  
albuterol / ipratropium inhalation spray Combivent test  
budesonide / formoterol Symbicort PA  
fluticasone / salmeterol inhalation aerosol, powder Advair PA  
fluticasone / salmeterol inhalation powder Airduo PA  
fluticasone / vilanterol Breo PA  
fluticasone furoate / umeclidinium / vilanterol Trelegy PA  
glycopyrrolate / formoterol Bevespi PA  
indacaterol / glycopyrrolate Utibron PA  
mometasone / formoterol Dulera PA  
tiotropium / olodaterol Stiolto PA  
umeclidinium / vilanterol Anoro PA  

 Inhaled Respiratory Agents – Corticosteroids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

beclomethasone MDI, breath-actuated Qvar Redihaler PA  
beclomethasone MDI, non-breath actuated Qvar test  
budesonide inhalation powder Pulmicort test  
budesonide inhalation suspension Pulmicort # test  
ciclesonide Alvesco test  
flunisolide inhalation aerosol Aerospan PA  
fluticasone furoate inhalation powder Arnuity PA  
fluticasone propionate inhalation aerosol, powder Flovent test  
fluticasone propionate inhalation powder-Armonair Armonair 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

arformoterol Brovana PA  
formoterol inhalation powder Foradil PA  
formoterol inhalation solution Perforomist PA  
indacaterol Arcapta PA  
olodaterol Striverdi PA  
salmeterol Serevent PA  

 Inhaled Respiratory Agents – Mast Cell Stabilizers

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

cromolyn inhalation test  

 Inhaled Respiratory Agents – Short-Acting Beta Agonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

albuterol inhalation powder Proair Respiclick test  
albuterol inhalation solution Accuneb # test  
albuterol inhaler-Proair HFA Proair HFA BP test  
albuterol inhaler-Proventil Proventil BP test  
albuterol inhaler-Ventolin Ventolin BP PA  
levalbuterol inhalation solution Xopenex PA  
levalbuterol inhaler Xopenex HFA BP test  
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.
 

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.
  • 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).

 

Aerospan, Arnuity, and Qvar Redihaler

  • Documentation of the following is required:      
    • diagnosis of asthma; and
    • one of the following:
      • inadequate response or adverse reaction to one inhaled corticosteroid that does not require a PA; or
      • contraindication to all inhaled corticosteroids that do not require a PA; and
    • one of the following:
      • If the request is for Aerospan or Qvar Redihaler, quantity limit of two inhalers per month; or
      • If request is for Arnuity, quantity limit of one inhaler per month.

SmartPA: Claims for Aerospan and Arnuity will usually process at the pharmacy without a PA request if within the quantity limit (Aerospan, quantity limit of two inhalers per month and Arnuity, quantity limit of one inhaler per month) and the member has a history of paid MassHealth pharmacy claims for at least 90 out of the last 120 days for the requested agent.

 

albuterol inhaler (generic Ventolin)

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

 

Anoro, Bevespi, Stiolto, and Utibron

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

SmartPA: Claims for Anoro, Bevespi, Stiolto, and Utibron 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.

  

Arcapta

  • Documentation of the following is required:      
    • diagnosis of COPD; and
    • member is ≥ 18 years of age; and
    • quantity limit of 30 capsules per month.

SmartPA: Claims for Arcapta will usually process at the pharmacy within the quantity limit of 30 capsules/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.

    

Armonair

  • Documentation of the following is required:      
    • diagnosis of asthma; and
    • one of the following:
      • inadequate response or adverse reaction to Flovent; or
      • member is already receiving another Respiclick formulation; and
    • quantity limit of one inhaler per month.

 

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 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 if the member is ≥ 12 years of age.

 

Breo

  • Documentation of the following is required:      
    • diagnosis of COPD; or
    • diagnosis of asthma and one of the following:       
      • inadequate response to an inhaled or oral corticosteroid within the last four months; or
      • stable therapy within the last four months; or  
      • asthma that is classified as moderate-to-severe persistent; and
    • member is ≥ 18 years of age; and
    • quantity limit of one inhaler per month.

SmartPA: Claims for Breo 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 an inhaled or oral corticosteroid, Breo, Dulera, fluticasone/salmeterol inhalation aerosol, powder, or Symbicort within the past four months or, for the 100 mcg/25 mcg strength formulation only, if the member (≥ 18 years of age) has a history of MassHealth medical claims for COPD.

 

Brovana and Perforomist

  •  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
      • clinical rationale for nebulized formulation; and
    • quantity limit of 120 mL per month.

SmartPA: Claims for Brovana and Perforomist 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.

 

Dulera

  • Documentation of the following is required:
    • diagnosis of asthma and one of the following: 
      • inadequate response to an inhaled or oral corticosteroid within the last four months; or
      • stable therapy within the last four months; or  
      • asthma that is classified as moderate-to-severe persistent; and
    • quantity limit of one inhaler per month.

  

fluticasone/salmeterol inhalation aerosol, powder (generic Advair) and Symbicort

  • Documentation of the following is required:      
    • diagnosis of COPD; or
    • diagnosis of asthma and one of the following:       
      • inadequate response to an inhaled or oral corticosteroid within the last four months; or
      • stable therapy within the last four months; or  
      • asthma that is classified as moderate-to-severe persistent; and
    • quantity limit of one inhaler per month.

SmartPA: Claims for fluticasone/salmeterol inhalation aerosol, powder (generic Advair) and Symbicort 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 or if the member has a history of MassHealth medical claims for asthma and a history of paid MassHealth pharmacy claims for an inhaled or oral corticosteroid, Breo, Dulera, fluticasone/salmeterol inhalation aerosol, powder, or Symbicort within the past four months.

  

fluticasone/salmeterol inhalation powder (generic Airduo)

  • 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 necessity of lower dose of fluticasone/salmeterol; or  
      • member is already receiving another Respiclick formulation; and
    • quantity limit of one inhaler per month.

 

Foradil and Serevent

  • Documentation of the following is required:      
    • quantity limit of 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 concurrently with an inhaled corticosteroid.

SmartPA: Claims for Foradil and 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.

    

Incruse > 1 inhaler/month, Seebri > 1 inhaler/month, Spiriva Handihaler > 30 units/month, and Tudorza > 1 inhaler/month

  • Documentation of the following is required:
    • diagnosis of COPD; and
    • an inadequate response to the requested agent dosed at standard dosing; and
    • an inadequate response, adverse reaction, or contraindication to a long-acting beta agonist; and
    • an inadequate response, adverse reaction, or contraindication to an inhaled corticosteroid.

 

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:
      • age ≤ 12 years of age; or
      • clinical rationale 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
      • clinical rationale for nebulized formulation; and
    • an inadequate response, adverse reaction, or contraindication to ipratropium inhalation nebulizer solution; and
    • quantity limit of 60 mL per month for Lonhala or 90 mL per month for Yupelri.

SmartPA: Claims for Lonhala Magnair and Yupelri will usually process at the pharmacy within the quantity limit of 60 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, 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. 

 

Spiriva Respimat > 1 inhaler/month

  • Documentation of the following is required:
    • for requests for the 2.5 mcg/actuation formulation, diagnosis of COPD; and 
    • for requests for the 1.25 mcg/actuation formulation, diagnosis of asthma; and
    • an inadequate response to the requested agent dosed at standard dosing; and
    • an inadequate response, adverse reaction, or contraindication to a long-acting beta agonist; and
    • an inadequate response, adverse reaction, or contraindication to an inhaled corticosteroid.

 

Striverdi

  • Documentation of the following is required:   
    • diagnosis of COPD; and
    • member is ≥ 18 years of age; and
    • quantity limit of 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 COPD; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • inadequate response to ≥ three months of the separate agents Breo and Incruse once daily; or
      • adverse reaction to the separate agents Breo and Incruse once daily; or
      • clinical rationale why member cannot utilize the combination of the separate agents Breo and Incruse once daily; and
    • quantity limit of 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: 08/2019


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Last updated 10/09/19