FDA-approved, for example:

•  asthma
•  COPD
•  EIB

Non-FDA-approved, for example:

• eosinophilic esophagitis (budesonide inhalation suspension)
• chronic sinusitis, pansinusitis, rhinitis, nasal polyposis (budesonide inhalation suspension)
• COPD (budesonide inhalation suspension)

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.

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/30 days.

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
  • inadequate response or adverse reaction to one 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

• Documentation of the following is required for the diagnosis of COPD: 
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • requested quantity is ≤ one inhaler/30 days.

• Documentation of the following is required for the diagnosis of asthma: 
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response, adverse reaction, or contraindication to all of the following: Advair, budesonide/formoterol, Dulera, fluticasone/vilanterol; and
  • requested quantity is ≤ one inhaler/30 days.

SmartPA: Claims for Anoro will usually process at the pharmacy within the quantity limit of one inhaler/30 days 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 recent paid pharmacy claim for a nebulized respiratory product and no recent paid pharmacy claims for inhalers; or
    • medical necssity for nebulized formulation; and
  • requested quantity is ≤ 120 mL/30 days.

SmartPA: Claims for arformoterol and formoterol will usually process at the pharmacy within the quantity limit of 120 mL/30 days 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 30 days or has a history of paid MassHealth pharmacy claims for any nebulized solution for ≥ 15 days of therapy within the last 30 days, and there is no history of paid MassHealth pharmacy claims for an inhaler within the last 30 days, and there is no history of paid MassHealth pharmacy claims for an inhaler for ≥ 15 days of therapy within the last 30 days.^†

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 pharmacy without 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.^†

Bevespi and Duaklir

• Documentation of the following is required: 
  • diagnosis of COPD; and
  • member is ≥ 18 years of age; and
  • requested quantity is ≤ one inhaler/30 days; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: Anoro or Stiolto.

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 ≥ 90 days 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/30 days.

budesonide inhalation suspension ≥ 13 years of age

•  Documentation of the following is required for a diagnosis of asthma:      
  • appropriate diagnosis; and
  • one of the following:
    • member has a recent paid pharmacy claim for a nebulized respiratory product and no recent paid pharmacy claims for inhalers; or
    • medical necessity for nebulized formulation.

•  Documentation of the following is required for a diagnosis of eosinophilic esophagitis:
  • prescriber is a specialist (e.g., Allergy/Immunology, Gastroenterology, Otolaryngology, Rhinology, Pulmonology, ENT), and
  • inadequate response, adverse reaction, or contraindication to fluticasone inhalation aerosol or powder.

•  Documentation of the following is required for a diagnosis of chronic sinusitis, pansinusitis, rhinitis, nasal polyposis:
  • prescriber is a specialist (e.g., Allergy/Immunology, Otolaryngology, Rhinology, Pulmonology, ENT), and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to one commercially available intranasal steroid, or
    • clinical rationale for budesonide irrigation/rinse with suspension formulation.

•  Documentation of the following is required for a diagnosis of COPD:
  • prescriber is a specialist (e.g., Pulmonology), and
  • one of the following:
    • member has a recent claim for a nebulized respiratory product and no recent claims for inhalers; 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 30 days or has a history of paid MassHealth pharmacy claims for any nebulized solution for ≥ 15 days of therapy within the last 30 days, and there is no history of paid MassHealth pharmacy claims for an inhaler within the last 30 days, and there is no history of paid MassHealth pharmacy claims for an inhaler for ≥ 15 days of therapy within the last 30 days.^†

fluticasone/salmeterol inhalation powder (generic Airduo Respiclick)

• 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 lower dose of fluticasone/salmeterol; or  
    • member is already receiving another Respiclick formulation; and
  • requested quantity is ≤ one inhaler/30 days.

fluticasone/vilanterol

• Documentation of the following is required for the diagnosis of asthma:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • 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/30 days.
• Documentation of the following is required for the diagnosis of COPD:    
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response, adverse reaction, or contraindication to budesonide/formoterol; and
  • requested quantity is ≤ one inhaler/30 days.

SmartPA: Claims for fluticasone/vilanterol will usually process at the pharmacy within the quantity limit of one inhaler/30 days 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/30 days 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
  • 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 recent paid pharmacy claim for a nebulized respiratory product and no recent paid pharmacy claims for inhalers; or
    • medical necessity for nebulized formulation; and
  • inadequate response, adverse reaction, or contraindication to ipratropium inhalation nebulizer solution; and
  • one of the following:
    • for Lonhala, requested quantity is ≤ 60 mL/30 days; or 
    • for Yupelri, requested quantity is ≤ 90 mL/30 days.

SmartPA: Claims for Lonhala Magnair within the quantity limit of 60 mL/30 days and Yupelri within the quantity limit of 90 mL/30 days 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 30 days or has a history of paid MassHealth pharmacy claims for any nebulized solution for ≥ 15 days of therapy within the last 30 days, there is no history of paid MassHealth pharmacy claims for an inhaler within the last 30 days, there is no history of paid MassHealth pharmacy claims for an inhaler for ≥ 15 days of therapy within the last 30 days, 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
  • inadequate response, adverse reaction, or contraindication to albuterol inhaler (Proair HFA, Proventil, or Ventolin).

Serevent

• Documentation of the following is required:      
  • requested quantity is ≤ one inhaler/30 days; 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 120 days; 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/30 days without a PA request if the member has a history of MassHealth medical claims for COPD.^†

Stiolto

• Documentation of the following is required: 
  • diagnosis of COPD; and
  • member is ≥ 18 years of age; and
  • requested quantity is ≤ one inhaler/30 days.

SmartPA: Claims for Stiolto will usually process at the pharmacy within the quantity limit of one inhaler/30 days without a PA request if the member has a history of MassHealth medical claims for COPD and the member is ≥ 18 years of age.^†

Striverdi

• Documentation of the following is required:   
  • diagnosis of COPD; and
  • member is ≥ 18 years of age; and
  • requested quantity is ≤ one inhaler/30 days.

SmartPA: Claims for Striverdi will usually process at the pharmacy within the quantity limit of one inhaler/30 days 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 90 days 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/30 days.

^†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.