FDA-approved, for example:

• Acromegaly (Signifor LAR, Somavert)
• Carcinoid syndrome diarrhea (Xermelo)
• Cushing's disease (Signifor, Signifor LAR)
• Hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance (Korlym)

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).

Korlym

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • member has failed surgical intervention (reoccurrence after surgery or failed tumor removal); or
    • surgical interventions are not an option; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: cabergoline, ketoconazole tablet, Lysodren; and
  • quantity requested is ≤ 120 units/month.

Signifor

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • member has failed surgical intervention (reoccurrence after surgery or failed tumor removal); or
    • surgical interventions are not an option; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: cabergoline, ketoconazole tablet, Lysodren; and

  • quantity requested is ≤ 60 units/month.

Signifor LAR

• Documentation of all of the following is required for a diagnosis of acromegaly:
  • appropriate diagnosis; and
  • member is under the care of an endocrinologist; and
  • quantity requested is ≤ one kit or vial/month; and
  • one of the following:
    • member has persistent or recurring disease following surgery and/or radiation; or
    • member is not a candidate for surgery; and
  • one of the following:
    • inadequate response or adverse reaction to one somatostatin analog that does not require PA; or
    • contraindication to somatostatin analogs; and
  • one of the following:
    • member has moderate-to-severe disease symptoms; or
    • member has mild disease and one of the following:
      • inadequate response or adverse reaction to one dopamine analog (e.g., cabergoline, bromocriptine) in combination with a somatostatin analog; or
      • adverse reaction to one somatostatin analog that does not require PA; or
      • contraindication to dopamine analogs.

• Documentation of all of the following is required for a diagnosis of Cushing's disease:
  • appropriate diagnosis; and
  • one of the following:
    • member has failed surgical intervention (reoccurrence after surgery or failed tumor removal); or
    • surgical interventions are not an option; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: cabergoline, ketoconazole tablet, Lysodren; and
  • quantity requested is ≤ one kit or vial/month.

Somavert

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is under the care of an endocrinologist; and
  • quantity requested is ≤ 30 vials/month; and
  • one of the following:
    • member has persistent or recurring disease following surgery and/or radiation; or
    • member is not a candidate for surgery; and
  • one of the following:
    • inadequate response or adverse reaction to one somatostatin analog that does not require PA; or
    • contraindication to somatostatin analogs; and
  • one of the following:
    • member has moderate-to-severe disease symptoms; or
    • member has mild disease and one of the following:
      • inadequate response or adverse reaction to one dopamine analog (e.g., cabergoline, bromocriptine) in combination with a somatostatin analog; or
      • adverse reaction to one somatostatin analog that does not require PA; or
      • contraindication to dopamine analogs.

Xermelo

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • inadequate response to one somatostatin analog therapy; and
  • requested agent will be given in combination with somatostatin analog therapy; and
  • quantity requested is ≤ 90 units/month.