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 (Esbriet, Ofev)
• systemic sclerosis-associated interstitial lung disease (Ofev)

Note: The above list may not include all 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.
• 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
  • quantity limit of 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.†

Esbriet and Ofev for idiopathic pulmonary fibrosis

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

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 two oral second-generation antihistamines (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; and
  • 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; and
  • 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; and
  • quantity is ≤ one unit/day.

Ofev for chronic fibrosing interstitial lung diseases with a progressive phenotype

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

Ofev for systemic sclerosis-associated interstitial lung disease

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

zafirlukast

• Documentation of the following is required:
  • diagnosis of asthma; and
  • 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), adverse reaction, or contraindication to either montelukast or zafirlukast; and
  • dose does not exceed 1,200 mg twice daily.

Zyflo

• Documentation of the following is required:
  • diagnosis of asthma; and
  • an inadequate response (for at least 14 days), adverse reaction, or contraindication to either montelukast or zafirlukast; and
  • dose does not exceed 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.