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Table 40: Respiratory Agents - Oral


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Drug Category: Respiratory Tract Agents

Medication Class/Individual Agents: Respiratory Agents - Oral

I. Prior-Authorization Requirements

 Oral Respiratory Agents – Leukotriene Modifiers

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

montelukast granules Singulair PA   M90
montelukast tablet, chewable tablet Singulair test   # , M90
zafirlukast Accolate PA   M90
zileuton Zyflo PA  
zileuton extended-release PA  

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.

 

Contraindications:

  • All agents: hypersensitivity to any component
  • roflumilast:
    • moderate-to-severe liver impairment
  • zileuton:
    • active liver disease
    • persistent liver enzyme elevations three or more times the upper limit of normal

 Warnings:

  • montelukast
    • Should not be used to treat an acute asthma attack: member should have short-acting beta-agonist
    • Should not be abruptly substituted for steroids
    • Neuropsychiatric events (e.g., agitation, aggressive behavior, depression, suicidal ideation, etc.) have been reported with use of this agent
    • Eosinophilic conditions (e.g., vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy) may present in asthmatic members taking montelukast)
    • Chewable tablets contain phenylalanine
  • nintedanib
    • Do not use in moderate or severe liver impairment
    • Increased risk of bleeding
    • Increased risk of gastrointestinal perforation
  • pirfenidone
    • Liver enzyme elevations three times the upper limit of normal
    • Photosensitivity reaction or rash
  • roflumilast
    • Should not be used to treat an acute asthma attack
    • May be associated with unexplained weight loss
    • Use with potential cytochrome P450 enzyme inducers may decrease roflumilast concentrations
    • Psychiatric events including suicidality have been reported with this agent. Use with caution in those with history of depression and/or suicidal thoughts
  • zafirlukast
    • Liver disease
    • Not for reversal of bronchospasm in acute asthma
  • zileuton
    • Alcohol intake of substantial quantities
    • Liver disease
    • Not for reversal of bronchospasm in acute asthma
    • Neuropsychiatric events (e.g., sleep disorders and behavior changes) have been reported with use of this agent
 

 Oral Respiratory Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

roflumilast Daliresp PA  
theophylline test   M90

 Oral Respiratory Agents – Pulmonary Fibrosis Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

nintedanib Ofev PA  
pirfenidone Esbriet PA   A90

 Oral Respiratory Agents – Short-Acting Beta Agonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

albuterol syrup, tablet test   A90
metaproterenol tablet, syrup 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.
 
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.
 
M90 Effective 12/19/22, mandatory 90-day supply. After dispensing up to a 30-day supply initial fill, dispensing in a 90-day supply is required. May not include all strengths or formulations. Quantity limits and other restrictions may also apply. Prior to 12/19/22, allowable 90-day supply and dispensing in up to a 90-day supply is allowed.
 

II. Therapeutic Uses

FDA-approved, for example:

  • asthma (montelukast, zafirlukast, zileuton extended-release, Zyflo)
  • allergic rhinitis (montelukast)
  • chronic obstructive pulmonary disease (Daliresp)
  • exercise-induced bronchospasm (montelukast)
  • chronic fibrosing interstitial lung diseases with a progressive phenotype (Ofev)
  • idiopathic pulmonary fibrosis (Ofev, pirfenidone)
  • systemic sclerosis-associated interstitial lung disease (Ofev)

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 the member's condition and requested medication (see below).

  

Daliresp

  • Documentation of the following is required:
    • diagnosis of Chronic Obstructive Pulmonary Disease (COPD); and 
    • an inadequate response, adverse reaction, or contraindication to one long-acting bronchodilator (long-acting beta-agonist, long-acting anticholinergic) within the last four months; and
    • an inadequate response, adverse reaction, or contraindication to one inhaled corticosteroid within the last four months; and
    • requested quantity is ≤ one unit/day.

SmartPA: Claims for Daliresp (≤ one unit/day) will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for a diagnosis of chronic obstructive pulmonary disease and the member has a history of paid MassHealth pharmacy claims within the last four months for a combination long-acting beta agonist/inhaled corticosteroid or a long-acting bronchodilator and an inhaled corticosteroid.†

   

montelukast granules

  • Documentation of the following is required for the diagnosis of allergic rhinitis:
    • appropriate diagnosis; and
    • an inadequate response (for at least 14 days), adverse reaction, or contraindication to one oral second-generation antihistamine (i.e., loratadine, cetirizine, fexofenadine); and 
    • an inadequate response (for at least 14 days), adverse reaction, or contraindication to one intranasal antihistamine or intranasal corticosteroid; and
    • medical necessity for the granule formulation as noted by one of the following:
      • member is < two years of age; or
      • an inadequate response or adverse reaction to montelukast chewable tablets; and
    • requested quantity is ≤ one unit/day.
  • Documentation of the following is required for the diagnosis of asthma:
    • appropriate diagnosis; and
    • medical necessity for the granule formulation as noted by one of the following:
      • member is < two years of age; or
      • an inadequate response or adverse reaction to montelukast chewable tablets; and
    • requested quantity is ≤ one unit/day.
  • Documentation of the following is required for the diagnosis of Exercise-Induced Bronchospasm (EIB):
    • appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to one short-acting beta agonist inhaler (albuterol or levalbuterol) or low dose inhaled corticosteroid-formoterol; and
    • medical necessity for the granule formulation as noted by one of the following:
      • member is < two years of age; or
      • an inadequate response or adverse reaction to montelukast chewable tablets; and
    • requested quantity is ≤ one unit/day.

 

Ofev and pirfenidone for idiopathic pulmonary fibrosis

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • for pirfenidone 267 mg, requested quantity is ≤ nine units/day; or
      • for pirfenidone 801 mg, requested quantity is ≤ three units/day; or 
      • for Ofev, requested quantity is ≤ two units/day.

 

 

Ofev for chronic fibrosing interstitial lung diseases with a progressive phenotype

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • requested quantity is ≤ two units/day.

  

Ofev for systemic sclerosis-associated interstitial lung disease

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to both mycophenolate and cyclophosphamide;and
    • requested quantity is ≤ two units/day.

 

zafirlukast

  • Documentation of the following is required:
    • diagnosis of asthma; and
    • requested quantity is ≤ two units/day.

SmartPA: Claims for zafirlukast (≤ two units/day) will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for a diagnosis of asthma, or paid MassHealth pharmacy claims for a short/long acting inhaled beta agonist for ≥ 90 days of therapy in the last 120 days, or paid MassHealth pharmacy claims for an inhaled corticosteroid in the last 90 days.†

 

zileuton extended-release

  • Documentation of the following is required:
    • diagnosis of asthma; and
    • an inadequate response (for at least 14 days) or adverse reaction to one or contraindication to both of the following: montelukast, zafirlukast; and
    • an inadequate response (for at least 14 days) or adverse reaction to Zyflo; and
    • requested dose is ≤ 1,200 mg twice daily.

 

Zyflo

  • Documentation of the following is required:
    • diagnosis of asthma; and
    • an inadequate response (for at least 14 days) or adverse reaction to one or contraindication to both of the following: montelukast, zafirlukast; and
    • requested dose is ≤ 600 mg four times daily.

   

 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: 03/2004

Last Revised Date: 09/2022


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Last updated 10/31/22

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