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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

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 patients 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 patients 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

mifepristone Korlym PA  

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

pegvisomant Somavert PA  

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

lanreotide Somatuline test  
octreotide Sandostatin # test  
octreotide injectable suspension Sandostatin LAR test  
pasireotide Signifor PA  
pasireotide injectable suspension Signifor LAR PA  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization 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.
 

II. Therapeutic Uses

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.

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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.
  • 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.


Original Effective Date: 04/2003

Last Revised Date: 10/2019


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Last updated 11/25/19