FDA-approved, for example:

• Crohn’s disease
• Ulcerative colitis

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.
• 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.

budesonide rectal foam

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response (defined by at least three weeks of therapy) or adverse reaction to one or contraindication to both of the following: hydrocortisone enema, hydrocortisone foam.

mesalamine 400 mg delayed-release capsule

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • both of the following:
      • member is ≥ 5 years of age; and
      • agent will be used for treatment of active ulcerative colitis; or
    • member is ≥ 18 years of age; and
  • one of the following:
    • both of the following:
      • member’s current weight is ≥ 24 kg; and
      • inadequate response, adverse reaction, or contraindication to mesalamine 1.2 g delayed-release tablet (Lialda); or
    • member’s current weight is < 24 kg; and
  • appropriate dosing.

mesalamine 800 mg delayed-release capsule

• Documentation of the following is required:
  • member is ≥ 18 years of age; and
  • inadequate response or adverse reaction to one or contraindication to all mesalamine oral formulations available without PA; and
  • appropriate dosing.

mesalamine enema kit

• Documentation of the following is required:
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to mesalamine enema and mesalamine suppository.

Ortikos

• Documentation of the following is required:
  • appropriate diagnosis; and
  • appropriate dosing; and
  • inadequate response or adverse reaction to one or contraindication to all budesonide oral formulations available without PA; and
  • one of the following:
    • member is ≥ 18 years of age; or
    • both of the following:
      • member is ≥ eight years of age; and
      • agent will be used for treatment of active Crohn’s disease.