FDA-approved, for example:

• asthma (montelukast, zafirlukast, zileuton extended-release, Zyflo)
• allergic rhinitis (montelukast)
• chronic obstructive pulmonary disease (roflumilast tablet)
• 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)

Non-FDA-approved, for example:

• eosinophilic esophagitis (montelukast)
• urticaria (montelukast)

Note: The above lists 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.

montelukast granules

• Documentation of the following is required for the diagnosis of allergic rhinitis:
  • appropriate diagnosis; and
  • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to one oral second-generation antihistamine (i.e., loratadine, cetirizine, fexofenadine); and 
  • inadequate response (defined as ≥ 14 days of therapy), 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
    • 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
    • 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 eosinophilic esophagitis:
  • appropriate diagnosis; 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: topical budesonide, topical fluticasone.
• Documentation of the following is required for the diagnosis of Exercise-Induced Bronchospasm (EIB):
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: one short-acting beta agonist inhaler (albuterol or levalbuterol), 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
    • 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 urticaria:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to two or contraindication to all second-generation antihistamines; and
  • medical necessity for the granule formulation as noted by one of the following:
    • member is < two years of age; or
    • inadequate response or adverse reaction to montelukast chewable tablets.

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 534 mg, requested quantity is ≤ three 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 of the following: cyclophosphamide, mycophenolate; and
  • requested quantity is ≤ two units/day.

roflumilast tablet

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

SmartPA: Claims for roflumilast 500 mg tablet (≤ 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 120 days for a combination long-acting beta agonist/inhaled corticosteroid or a long-acting bronchodilator and an inhaled corticosteroid.†

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
  • inadequate response (defined as ≥ 14 days of therapy) or adverse reaction to one or contraindication to both of the following: montelukast, zafirlukast; and
  • inadequate response (defined as ≥ 14 days of therapy) 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
  • inadequate response (defined as ≥ 14 days of therapy) 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.