Mass General Brigham Health Plan octreotide Prior Auth

Coverage Criteria and Indications

General and diagnostic framework

Authorization may be granted when ALL of the following general and diagnosis-specific criteria are met:

General requirement: If member is new to the plan (coverage effective date ≤ 90 days), submission of medical records documenting that the member is currently receiving treatment with the requested drug (excluding samples or manufacturer's patient assistance programs); OR authorization may be granted when the diagnosis-specific criteria below are met.

From Coverage Guidelines

Acromegaly (initial therapy)

Acromegaly — Covered when ALL of the following are met

Acromegaly criteria: 1) Diagnosis of acromegaly; 2) Submission of laboratory report indicating member has a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range; 3) Submission of chart notes indicating ONE of the following: (a) inadequate or partial response to surgery or radiotherapy, or (b) clinical reason why surgery or radiotherapy was not performed.

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Neuroendocrine tumors (NETs)

Neuroendocrine tumors (NETs) — Covered when the requested medication is used for one of the following disease sites

NET anatomic sites: Locoregional advanced or metastatic NETs of the GI tract or unresected primary gastrinoma; unresectable or metastatic NETs of the thymus; unresectable or metastatic NETs of the lung; NETs of the pancreas.

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Carcinoid syndrome

Carcinoid syndrome — Covered when ALL of the following are met

Carcinoid syndrome criteria: 1) Diagnosis of carcinoid syndrome; 2) ONE of the following: (a) requested medication will be used as monotherapy; (b) used in combination with telotristat for persistent diarrhea due to poorly controlled carcinoid syndrome; (c) used in combination with other systemic therapy options for persistent symptoms (e.g., flushing or diarrhea) or for progressive disease.

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Vasoactive intestinal peptide tumors (VIPomas)

Vasoactive intestinal peptide tumors (VIPomas) — Covered when ALL of the following are met

VIPoma criteria: Requested medication will be used for management of symptoms related to hormone hypersecretion of VIPomas.

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Meningiomas

Meningiomas — Covered when ALL of the following are met

Meningioma criteria: Requested medication will be used for treatment of unresectable recurrent or progressive meningioma.

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Pheochromocytoma and paraganglioma

Pheochromocytoma and paraganglioma — Covered when ALL of the following are met

Pheo/paraganglioma criteria: Requested medication will be used for treatment of locally unresectable or metastatic pheochromocytoma and paraganglioma.

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Thymomas and thymic carcinomas

Thymomas and thymic carcinomas — Covered when ALL of the following are met

Thymic malignancy criteria: 1) Diagnosis of thymoma or thymic carcinoma; 2) Requested medication will be used as second-line therapy with or without prednisone; 3) ONE of the following: (a) unresectable disease following first-line chemotherapy for potentially resectable locally advanced disease, solitary metastasis, or ipsilateral pleural metastasis; (b) extrathoracic metastatic disease.

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Congenital hyperinsulinism (CHI)

Congenital hyperinsulinism (CHI) — (octreotide and Sandostatin only)

CHI criteria: 1) Diagnosis of congenital hyperinsulinism (persistent hyperinsulinemic hypoglycemia); 2) Member is less than or equal to 1 year of age.

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AIDS-associated diarrhea

AIDS-associated diarrhea — Covered when ALL of the following are met

AIDS-diarrhea criteria: 1) Diagnosis of AIDS-associated severe secretory diarrhea; 2) Antimicrobial (e.g., ciprofloxacin or metronidazole) or anti-motility agents (e.g., loperamide or diphenoxylate and atropine) have become ineffective.

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Bowel obstruction in terminal cancer

Bowel obstruction in terminal cancer — Covered when ALL of the following are met

Bowel obstruction criteria: 1) Diagnosis of inoperable bowel obstruction in terminal cancer; 2) Requested medication is being used for management of gastrointestinal symptoms.

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Chemotherapy- and radiation-induced diarrhea

Chemotherapy- and radiation-induced diarrhea — Covered when ALL of the following are met

Chemo/radiation diarrhea criteria: 1) Member is receiving treatment with chemotherapy or radiation; 2) Member has grade 3 or greater diarrhea according to NCI CTCAE.

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Enterocutaneous fistula

Enterocutaneous fistula — Covered when ALL of the following are met

Enterocutaneous fistula criteria: Requested medication will be used for management of volume depletion related to enterocutaneous fistula.

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Gastroesophageal varices

Gastroesophageal varices — Covered when ALL of the following are met

Variceal bleeding criteria: Requested medication will be used for treatment of acute bleeding of gastroesophageal varices associated with cirrhosis.

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Islet cell tumors

Islet cell tumors — Covered when ALL of the following are met

Islet cell tumor criteria: Requested medication will be used for stabilization of blood glucose levels in patients with functioning islet cell tumors (e.g., insulinomas or glucagonomas).

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Pancreatic fistulas

Pancreatic fistulas — Covered when ALL of the following are met

Pancreatic fistula criteria: Requested medication will be used for prevention or treatment of pancreatic fistulas following pancreatic surgery.

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Pituitary adenoma

Pituitary adenoma — Covered when ALL of the following are met

Pituitary adenoma criteria: Diagnosis of pituitary adenoma.

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Short bowel syndrome

Short bowel syndrome — Covered when ALL of the following are met

Short bowel syndrome criteria: Requested medication will be used for treatment of short bowel syndrome when the daily intravenous fluid requirement is greater than 3 liters.>3 L/day

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Initial Therapy — Indication-specific

Covered when the listed diagnosis is documented

Covered Indications: Diagnosis of pituitary adenoma OR diagnosis of Zollinger-Ellison syndrome OR short bowel syndrome with daily IV fluid requirement > 3 L.

Each indication requires documented diagnosis; short bowel syndrome has fluid threshold

Continuation Therapy

Reauthorization approved when the following are met according to diagnosis

Acromegaly continuation: Submission of laboratory reports or chart notes indicating member's IGF-1 level has decreased or normalized since initiation of therapy; medical records required to demonstrate criteria met.

Documentation requirement updated 05/01/2026

Carcinoid syndrome, VIPomas, AIDS-associated diarrhea, bowel obstruction, chemotherapy/radiation-induced diarrhea, islet cell tumors, Zollinger-Ellison continuation: Member is experiencing clinical benefit as evidenced by improvement or stabilization in clinical signs and symptoms since initiation of therapy.

Clinical benefit documentation required

All other indications continuation: All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.

Continuation for new members requires meeting initial criteria

This prior authorization policy applies to Mass General Brigham Health Plan Commercial/Exchange members under the pharmacy benefit. The policy is a Prior Authorization program and designates octreotide acetate products as specialty medications that must be filled at a contracted specialty pharmacy. MassHealth UPPL is not selected for this document.

The policy was updated to remove Bynfezia from the criteria due to product discontinuation and to clarify that the policy applies to the pharmacy benefit only; it no longer applies to the medical benefit. These changes are reflected in the review history and effective dates noted in the document.

IV fluid requirement (short bowel syndrome)

IV fluid requirement> 3 liters per day

Context of useUsed as threshold for short bowel syndrome coverage criterion (daily intravenous fluid need)

Policy moduleCoverage criteria — Short bowel syndrome

Initial Therapy — Requirements by Diagnosis

Acromegaly — initial therapy requirements (detailed criteria).

Acromegaly initial therapy: 1) Diagnosis of acromegaly; 2) Pretreatment IGF-1 elevated for age/gender per laboratory reference; 3) ONE of: (a) inadequate or partial response to surgery or radiotherapy, or (b) documented clinical reason surgery or radiotherapy was not performed. Submission of laboratory report and chart notes required.

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Initial Therapy — Drug-specific

Initial Therapy — Drug-specific — Initial authorization requires documented diagnosis-specific criteria.

Initial Indications (drug-specific): Documented diagnosis as listed (pituitary adenoma; Zollinger-Ellison syndrome; short bowel syndrome with daily IV fluid requirement > 3 L).

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Continuation / Reauthorization Criteria

Continuation of Therapy

Requests for reauthorization will be approved when the following diagnosis-specific criteria are met:

Documentation Required

Reauthorization documentation — missing information may delay or prevent approval

Reauthorization documentation required: Requests for reauthorization that do not meet the diagnosis-specific continuation criteria (for example, lack of required laboratory reports or absence of documentation of clinical benefit) may be returned or denied.

Provide current and relevant lab reports, imaging, and clinic notes supporting continued therapy.
Include baseline documentation used for initial approval when available.

Prior Authorization

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization and specialty pharmacy fill required

Prior authorization is required for octreotide acetate products under the pharmacy benefit for Commercial/Exchange members; these products are designated specialty medications and must be filled at a contracted specialty pharmacy.

Program type: Prior Authorization; Benefit: Pharmacy Benefit (Commercial/Exchange).
Specialty-only fill: must be dispensed at a contracted specialty pharmacy.

Prior Authorization

Document the diagnosis for prior authorization

Prior authorization will only be approved when a documented diagnosis for the requested indication is provided (examples include pituitary adenoma, short bowel syndrome with daily IV fluids > 3 L, and Zollinger-Ellison syndrome).

Pituitary adenoma: diagnosis documentation required.
Short bowel syndrome: document daily IV fluid requirement greater than 3 liters.
Zollinger-Ellison syndrome: diagnosis documentation required.

Coding and Clinical Thresholds

Short bowel syndrome — IV fluid threshold

Short bowel syndrome definitionApplies when daily intravenous fluid requirement is greater than 3 liters

UsageUsed to determine eligibility for octreotide therapy for short bowel syndrome

Relevant sectionCoverage Criteria — Short bowel syndrome

Pharmacy Quantity Limits

Quantity limit — Mycapssa 20 mg

Mycapssa 20 mg quantity limit120 capsules per 30 days

Benefit typePharmacy benefit

Standard authorization duration12 months for most diagnoses

Quantity limit — Sandostatin LAR Depot 10 mg & 30 mg

Sandostatin LAR Depot 10 mg & 30 mg quantity limit1 kit per 28 days

FormulationLong-acting injectable (LAR) depot

Authorization noteQuantity limit applies on pharmacy benefit

Site of Care and Dispensing

Billing Rule

Fill at contracted specialty pharmacy

Designated specialty medication — octreotide acetate products must be filled at a contracted specialty pharmacy per the policy.

Note

Policy applies to pharmacy benefit with specified quantity limits

Policy updated to apply to the pharmacy benefit only and no longer to the medical benefit; pharmacy quantity limits are specified in the policy (e.g., Mycapssa 20 mg = 120 capsules/30 days, Sandostatin LAR kits and ampule/vial limits).

Policy no longer applies to the medical benefit (review history).
See policy for specific pharmacy quantity limits by product.

Step Therapy and Related Tables

Step	Requirement
1	Members requesting continuation (including new members) must meet all initial authorization criteria before reauthorization.

Background and Drug Information

Octreotide acetate is a synthetic analog of the natural hormone somatostatin that inhibits secretion of growth hormone, glucagon, insulin and multiple gastrointestinal hormones and peptides. It also decreases splanchnic blood flow and is used clinically to control hormone hypersecretion and related gastrointestinal symptoms across a range of endocrine and GI indications.

Definitions

Octreotide acetate — definition and mechanism

DefinitionOctreotide acetate is a somatostatin analog that inhibits growth hormone, glucagon, insulin, and multiple gastrointestinal hormones and decreases splanchnic blood flow.

Pharmacologic actionsSuppresses LH response to GnRH and inhibits release of serotonin, gastrin, VIP, secretin, motilin, and pancreatic polypeptide

Drug classSomatostatin analog

Short bowel syndrome — definition

Short bowel syndrome definitionShort bowel syndrome is defined for coverage purposes when the daily intravenous fluid requirement is greater than 3 liters.

Coverage implicationRequired threshold used in initial authorization criteria for short bowel syndrome

OpenPayer

Octreotide acetate (Sandostatin, Sandostatin LAR, Mycapssa) — Prior Authorization

Coverage Criteria and Indications

Initial Therapy — Requirements by Diagnosis

Continuation / Reauthorization Criteria

Provider Actions and Documentation Requirements

Coding and Clinical Thresholds

Pharmacy Quantity Limits

Site of Care and Dispensing

Step Therapy and Related Tables

Background and Drug Information

Definitions