Octreotide acetate injection (coverage for acromegaly and other indications)
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This document governs prior-authorization pharmacy benefit coverage criteria for octreotide acetate injection for Mass General Brigham Health Plan commercial/exchange members and specifies specialty pharmacy dispensing and indication-specific requirements.
Updated criteria for acromegaly to require submission of medical records to demonstrate initial and reauthorization criteria have been met.
Removed Mycapssa, Sandostatin LAR and octreotide 10 mg, 20 mg and 30 mg kit from policy as agents are moving to nonformulary status.
Removed Bynfezia from the policy due to product discontinuation and indicated policy no longer applies to the medical benefit.
Indication-specific Coverage Criteria
Acromegaly
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of acromegaly
- Submission of laboratory report indicating member has a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range
ONE of
- Chart notes showing the member had an inadequate or partial response to surgery or radiotherapy
- Chart notes documenting a clinical reason why the member has not had surgery or radiotherapy
Neuroendocrine tumors (NETs)
Covered when the requested medication is being used for one of the following NET scenarios:
ONE of
- Locoregional advanced or metastatic neuroendocrine tumors (NETs) of the gastrointestinal tract or unresected primary gastrinoma
- Unresectable or metastatic NETs of the thymus
- Unresectable or metastatic NETs of the lung
- Neuroendocrine tumors of the pancreas (pancreatic NETs)
Carcinoid syndrome
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of carcinoid syndrome
ONE of
- Requested medication will be used as monotherapy
- Requested medication will be used in combination with telotristat for persistent diarrhea due to poorly controlled carcinoid syndrome
- Requested medication will be used in combination with other systemic therapy options for persistent symptoms such as flushing or diarrhea, or for progressive disease
Vasoactive intestinal peptide tumors (VIPomas)
Covered when ALL of the following are met:
ALL of the following
- Requested medication will be used for management of symptoms related to hormone hypersecretion of VIPomas
Meningiomas
Covered when ALL of the following are met:
ALL of the following
- Requested medication will be used for treatment of unresectable recurrent or progressive meningioma
Pheochromocytoma and paraganglioma
Covered when ALL of the following are met:
ALL of the following
- Requested medication will be used for treatment of locally unresectable or metastatic pheochromocytoma and paraganglioma
Thymomas and thymic carcinomas
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of thymoma or thymic carcinoma
- Requested medication will be used as second-line therapy with or without prednisone
ONE of
- Unresectable disease following first-line chemotherapy for potentially resectable locally advanced disease, solitary metastasis, or ipsilateral pleural metastasis
- Extrathoracic metastatic disease
Congenital hyperinsulinism (CHI)
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of congenital hyperinsulinism (CHI) or persistent hyperinsulinemic hypoglycemia of infancy
- Member is less than or equal to 1 year of age
AIDS-associated diarrhea
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of AIDS-associated severe secretory diarrhea
- Anti-microbial (e.g., ciprofloxacin or metronidazole) or anti-motility agents (e.g., loperamide or diphenoxylate and atropine) have become ineffective
Bowel obstruction in terminal cancer
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of inoperable bowel obstruction in terminal cancer
- Requested medication is being used for management of gastrointestinal symptoms
Chemotherapy- and radiation-induced diarrhea
Covered when ALL of the following are met:
ALL of the following
- Member is receiving treatment with chemotherapy or radiation
- Member has grade 3 or greater diarrhea according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Enterocutaneous fistula
Covered when ALL of the following are met:
ALL of the following
- Requested medication will be used for management of volume depletion for enterocutaneous fistula
Gastroesophageal varices
Covered when ALL of the following are met:
ALL of the following
- Requested medication will be used for treatment of acute bleeding of gastroesophageal varices associated with cirrhosis
Islet cell tumors
Covered when ALL of the following are met:
ALL of the following
- Requested medication will be used for stabilization of blood glucose levels in patients with functioning islet cell tumors (e.g., insulinomas or glucagonomas)
Pancreatic fistulas
Covered when ALL of the following are met:
ALL of the following
- Requested medication will be used for prevention or treatment of pancreatic fistulas following pancreatic surgery
Pituitary adenoma
Covered when the following is met:
ALL of the following
- Diagnosis of pituitary adenoma
Short bowel syndrome
Covered when ALL of the following are met:
ALL of the following
- Requested medication will be used for treatment of short bowel syndrome when the daily intravenous fluid requirement is greater than 3 liters
Initial Authorization Diagnosis List
Examples of diagnoses that meet initial authorization criteria (examples, not exhaustive):
Examples
- Pituitary adenoma
- Short bowel syndrome when daily IV fluid requirement > 3 liters
- Zollinger-Ellison syndrome
Continuation/Reauthorization Criteria
Reauthorization requests will be approved when the diagnosis-specific criteria below are met:
ALL of the following
- Acromegaly: Submission of laboratory reports or chart notes indicating the member's IGF-1 level has decreased or normalized since initiation of therapy
ALL of the following
- Carcinoid syndrome, VIPomas, AIDS-associated diarrhea, bowel obstruction in terminal cancer, chemotherapy- or radiation-induced diarrhea, islet cell tumors, and Zollinger-Ellison syndrome: Documentation of clinical benefit demonstrated by improvement or stabilization in signs and symptoms since therapy initiation
ALL of the following
- All other indications (including new members): Member must meet all initial authorization criteria to qualify for continuation of therapy
Authorization Durations and Pharmacy Quantity Limits
Authorization durations and pharmacy quantity limits:
ALL of the following
- Initial approvals for congenital hyperinsulinism, pancreatic fistulas, or gastroesophageal varices: 6 months
- Authorizations for all other diagnoses: 12 months
- Reauthorizations: 12 months
Initial Therapy Requirements
Initial Therapy Criteria
Initial authorization requires diagnosis-specific documentation. Examples below summarize required documentation by diagnosis:
Diagnosis-specific initial requirements
- Pituitary adenoma: Diagnosis of pituitary adenoma
- Short bowel syndrome: Medication intended for short bowel syndrome when daily IV fluid requirement > 3 liters
- Zollinger-Ellison syndrome: Diagnosis of Zollinger-Ellison syndrome
Reauthorization and Continuation Requirements
Continuation Therapy Criteria
Reauthorization (continuation) requirements differ by diagnosis as follows:
ALL of the following
- Acromegaly: Submission of laboratory reports or chart notes indicating the member's IGF-1 level has decreased or normalized since initiation of therapy
ALL of the following
- Neuroendocrine and secretory-diarrhea indications (carcinoid syndrome, VIPomas, AIDS-associated diarrhea, bowel obstruction in terminal cancer, chemotherapy- or radiation-induced diarrhea, islet cell tumors, Zollinger-Ellison syndrome): Documentation of clinical benefit demonstrated by improvement or stabilization in signs and symptoms since therapy initiation
ALL of the following
- All other indications (including new members): Member must meet all initial authorization criteria to qualify for continuation of therapy
Provider Requirements and Actions
Obtain prior authorization and use contracted specialty pharmacy
Prior authorization is required for octreotide acetate injection and the medication is designated specialty and must be filled at a contracted specialty pharmacy. Contact numbers are provided for medical and pharmacy benefit prior authorization and fax in the policy.
- Program type: Prior Authorization required
- Benefit: Pharmacy benefit (specialty)
- Specialty dispensing: must be filled at a contracted specialty pharmacy
- Contact: Medical Benefit Phone 833-895-2611 / Fax 888-656-6671; Pharmacy Benefit Phone 800-711-4555 / Fax 844-403-1029
Submit medical records for members new to the plan (≤ 90 days)
For members new to the plan (coverage effective date ≤ 90 days), submit medical records documenting that the member is currently receiving treatment with the requested drug (excluding samples or manufacturer patient assistance programs) or meet the diagnosis-specific initial criteria.
- Applies when coverage effective date is less than or equal to 90 days
- Medical records must document current treatment with the requested drug (excluding samples or PAP)
Meet diagnosis-specific reauthorization and documentation requirements
Reauthorization will be approved when diagnosis‑specific continuation criteria are met; for acromegaly, submit laboratory reports or chart notes showing the member's IGF-1 has decreased or normalized since therapy initiation.
- Acromegaly continuation requires lab reports or chart notes documenting decreased/normalized IGF-1 since treatment start
- Other listed indications require evidence of clinical benefit (improvement or stabilization) as specified in continuation criteria
Confirm one of the covered diagnoses for initial authorization
Ensure the requested indication matches an acceptable covered diagnosis; examples include pituitary adenoma, short bowel syndrome (daily IV fluid requirement > 3 liters), and Zollinger‑Ellison syndrome.
- Pituitary adenoma — diagnosis required
- Short bowel syndrome — daily intravenous fluid requirement > 3 liters
- Zollinger‑Ellison syndrome — diagnosis required
Drug Formulations and Quantity Limits
Documentation, Tests and Definitions
Dispensing and Site-of-Care Requirements
Dispense through contracted specialty pharmacy
Designated specialty octreotide acetate must be dispensed by a contracted specialty pharmacy; do not dispense outside the contracted specialty pharmacy network for this pharmacy‑benefit specialty medication.
- Medication is designated specialty and must be filled at a contracted specialty pharmacy
Policy Change Log
Removed Mycapssa, Sandostatin LAR and octreotide 10 mg, 20 mg and 30 mg kit from the policy as these agents are moving to nonformulary status.
Updated acromegaly criteria to require submission of medical records to demonstrate initial and reauthorization criteria have been met.
Removed Bynfezia from the policy due to product discontinuation and indicated the policy no longer applies to the medical benefit.
Defined infant for the diagnosis of congenital hyperinsulinism (CHI)/persistent hyperinsulinemic hypoglycemia of infancy.
Transitioned from SGM to Custom Criteria and added Mycapssa capsules and Bynfezia pen to the criteria.
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