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Table 22: Acromegaly, Carcinoid Syndrome, and Cushing's Syndrome Agents


A    B    C    D    E    F    G    H    I    J    K    L    M    N    O    P    Q    R    S    T    U    V    W    X    Y    Z


Drug Category: Endocrine/metabolic and Gastrointestinal Agents

Medication Class/Individual Agents: Acromegaly Agents, Carcinoid Syndrome Agents, and Cushing's Syndrome Agents

I. Prior-Authorization Requirements

 Acromegaly, Carcinoid Syndrome, and Cushing's Syndrome Agents – Carcinoid Syndrome Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

telotristat ethyl Xermelo PA  

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.

  • Guidelines from Association of Clinical Endocrinologists for the treatment of acromegaly recommend surgery as a primary treatment option for acromegaly and reserve medical therapy for use in members with persistent disease following surgery.1,2
  • Pharmacologic options for the treatment of acromegaly include: somatostatin analogs, growth hormone receptor antagonists and dopamine analogs.1,2
  • For additional information regarding the management of dopamine analogs, please see: Table 48 - Antiparkinsonian Agents.
  • Guidelines from the Endocrine Society for the treatment of Cushing’s syndrome recommend surgical resection of primary lesions as initial treatment of underlying Cushing’s disease.3
  • For members with adrenocorticotrophic hormone (ACTH)-dependent Cushing’s syndrome who underwent a noncurative surgery or who were not candidates for surgery, there are several second-line treatment options including: repeat transsphenoidal surgery, radiotherapy, medical therapy, and bilateral adrenalectomy.3
  • Pharmacologic options for the treatment of Cushing’s syndrome include glucocorticoid receptor-directed agents (e.g. mifepristone), pituitary-directed agents (e.g. cabergoline and pasireotide), and steroidogenesis inhibitors (e.g. ketoconazole and mitotane).3

1 Katznelson L, Laws ER Jr, Melmed S, Molitch ME, Murad MH, Utz A, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Nov;99(11):3933-51.

2 Katznelson L, Atkinson JL, Cook DM, Ezzat SZ, Hamrahian AH, Miller KK et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of acromegaly–2011 update. Endocr Pract. 2011 Jul-Aug;17 Suppl 4:1-44.

3Nieman LK, Biller BM, Findling JW, Murad MH, Newell-Price J, Savage MO, et al; Endocrine Society. Treatment of Cushing's Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015 Aug;100(8):2807-31.

 

 Acromegaly, Carcinoid Syndrome, and Cushing's Syndrome Agents – Cortisol Receptor Blocker

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

levoketoconazole Recorlev PA  
mifepristone 300 mg Korlym PA   A90

 

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

osilodrostat Isturisa PA  

 Acromegaly, Carcinoid Syndrome, and Cushing's Syndrome Agents – Growth Hormone Receptor Antagonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

pegvisomant Somavert PA  

 Acromegaly, Carcinoid Syndrome, and Cushing's Syndrome Agents – Somatostatin Analogs

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

lanreotide Somatuline test  
lanreotide test  
octreotide capsule Mycapssa PA  
octreotide injectable suspension Sandostatin LAR test  
octreotide injection Sandostatin test   #
octreotide prefilled syringe Bynfezia test  
pasireotide Signifor PA  
pasireotide injectable suspension Signifor LAR PA   MB
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Acromegaly (Mycapssa, Signifor LAR, Somavert)
  • Carcinoid syndrome diarrhea (Xermelo)
  • Cushing's disease (Isturisa, Signifor, Signifor LAR)
  • Hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance (mifepristone 300 mg)

Note: the above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

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.

Isturisa

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

  

mifepristone 300 mg

  • 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 at this time; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: cabergoline, ketoconazole tablet, Lysodren; and
    • requested quantity is ≤ four tablets/day.

 

Mycapssa

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is under the care of an endocrinologist; and
    • member has responded to and tolerated treatment with octreotide or lanreotide; and
    • requested quantity is ≤ four capsules/day.

   

Recorlev

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

 

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 at this time; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: cabergoline, ketoconazole tablet, Lysodren; and
    • requested quantity is ≤ two vials/day.

  

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
    • requested quantity is ≤ one kit or vial/30 days; 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 available without 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 available without 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 at this time; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: cabergoline, ketoconazole tablet, Lysodren; and
    • requested quantity is ≤ one kit or vial/30 days.

  

Somavert

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is under the care of an endocrinologist; and
    • requested quantity is ≤ one vial/day; 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 available without 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 available without 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
    • requested quantity is ≤ three tablets/day.


Original Effective Date: 04/2003

Last Revised Date: 05/2024


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Last updated 05/16/24

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