DraftBlue Cross Blue Shield - TennesseePolicy N/A

Octreotide (Sandostatin LAR) injectable suspension — Coverage Criteria

Defines coverage, prior authorization requirements, and clinical indications for Sandostatin LAR (octreotide acetate for injectable suspension) for Blue Cross Blue Shield Tennessee members when approval criteria are met.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyOctreotide (Sandostatin LAR) injectable suspension — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 31, 202647d

Next Review DateN/A

Key ActionObtain prior authorization and submit required documentation (e.g., pretreatment IGF-1 for acromegaly) to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

6 monthspancreatic fistulas

IncludedFDA‑approved indications

Tennesseestate mandate

7/31/2026effective date

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Coverage Criteria for Octreotide (Sandostatin LAR)

Acromegaly (Initial Approval)

Acromegaly - Authorization of 12 months may be granted when ALL of the following are met

Acromegaly criteria: Member has a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range AND member had an inadequate or partial response to surgery or radiotherapy OR surgery or radiotherapy are not an option.IGF-1: high for age/gender per lab reference

Requires lab report and chart notes documenting inadequate/partial response to surgery or radiotherapy or documentation that surgery/radiotherapy are not an option

Neuroendocrine Tumors (NETs)

Neuroendocrine Tumors (NETs) - Authorization of 12 months may be granted for the following NETs

NET indications: Treatment of NETs of the gastrointestinal (GI) tract, lung, and thymus (carcinoid tumors); gastroenteropancreatic neuroendocrine tumors (GEP-NETs); pancreatic NETs (islet cell tumors) including gastrinomas, glucagonomas, and insulinomas; pheochromocytoma and paraganglioma.

Carcinoid Syndrome

Carcinoid syndrome: Authorization may be granted for treatment of carcinoid syndrome for 12 months.

VIPomas

VIPoma symptom management: Authorization may be granted for management of symptoms related to hormone hypersecretion of VIPomas for 12 months.

Meningiomas (combination therapy)

Meningiomas with everolimus: Authorization of 12 months may be granted when used in combination with everolimus for surgically inaccessible recurrent or progressive disease.

Requires combination use with everolimus for surgically inaccessible recurrent or progressive meningioma

Merkel Cell Carcinoma

Merkel cell carcinoma: Authorization of 12 months may be granted for somatostatin receptor–positive Merkel cell carcinoma as a single agent when the member has a contraindication to anti‑PD‑L1 or anti‑PD‑1 therapy AND either (a) disease progression while on anti‑PD‑L1/PD‑1 therapy or (b) regional disease.

Somatostatin receptor positivity and contraindication to PD‑1/PD‑L1 therapy required; document prior PD‑1/PD‑L1 use or contraindication

Cancer-Related Diarrhea

Cancer-related diarrhea: Authorization of 12 months may be granted for treatment of cancer‑related diarrhea when the member has grade 3 or greater diarrhea according to NCI CTCAE.CTCAE grade >=3

Requires chart notes documenting diarrhea grade

Inoperable Malignant Bowel Obstruction

Inoperable malignant bowel obstruction: Authorization of 12 months may be granted for management of gastrointestinal symptoms (e.g., nausea, pain, vomiting) in members with cancer and inoperable bowel obstruction.

AIDS-Associated Diarrhea

AIDS-associated severe secretory diarrhea: Authorization of 12 months may be granted for treatment of AIDS‑associated severe secretory diarrhea when antimicrobial therapy (e.g., ciprofloxacin or metronidazole) or anti‑motility agents (e.g., loperamide or diphenoxylate with atropine) have become ineffective.

Document prior antimicrobial or anti‑motility treatment failure

Enterocutaneous Fistula

Enterocutaneous fistula: Authorization of 12 months may be granted for management of volume depletion from enterocutaneous fistula.12 months

Document indication and clinical need for management of volume depletion

Pancreatic Fistulas

Pancreatic fistulas: Authorization of 6 months may be granted for prevention and treatment of pancreatic fistulas following pancreatic surgery.6 months

Document surgical context and intended use for prevention or treatment following pancreatic surgery

Enterocutaneous Fistula

Covered when indication-specific authorization criteria are met

Enterocutaneous Fistula: Authorization of 12 months may be granted for management of volume depletion from enterocutaneous fistula.12 months

Document indication-specific criteria as required

Pancreatic Fistulas

Pancreatic Fistulas: Authorization of 6 months may be granted for prevention and treatment of pancreatic fistulas following pancreatic surgery.6 months

Document surgical timing and intent; supports 6‑month authorization

Gastroesophageal Varices

Gastroesophageal Varices: Authorization of 6 months may be granted for treatment of acute bleeding of gastroesophageal varices associated with cirrhosis.6 months

Document acute bleeding episode and cirrhosis diagnosis

Pituitary Adenoma

Pituitary Adenoma: Authorization of 12 months may be granted for treatment of pituitary adenoma.12 months

Document diagnosis of pituitary adenoma

Short Bowel Syndrome

Short Bowel Syndrome: Authorization of 12 months may be granted for treatment of short bowel syndrome in members with large volume stool losses when fluid and electrolyte management is problematic.12 months

Document large volume stool losses and fluid/electrolyte management issues

Zollinger-Ellison Syndrome

Zollinger-Ellison Syndrome: Authorization of 12 months may be granted for treatment of Zollinger‑Ellison syndrome.12 months

Document diagnosis of Zollinger‑Ellison syndrome

Acromegaly and Neuroendocrine/Cancer-Related Indications

Acromegaly - continuation: Authorization of 12 months may be granted for continuation of therapy for acromegaly when the member's IGF‑1 level has decreased or normalized since initiation of therapy.IGF‑1 decreased or normalized

Provide laboratory report showing decreased or normalized IGF‑1 since initiation

Neuroendocrine and other cancer-related indications - continuation: Authorization of 12 months may be granted for continued treatment when the member is experiencing clinical benefit as evidenced by improvement or stabilization in clinical signs and symptoms since initiation of therapy. Applies to NETs, carcinoid syndrome, VIPomas, thymomas, meningiomas, Merkel cell carcinoma, cancer‑related diarrhea, inoperable malignant bowel obstruction, AIDS‑associated diarrhea, and Zollinger‑Ellison syndrome.clinical benefit demonstrated

Document clinical improvement or stabilization since initiation

All Other Indications

All Other Indications - continuation: All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria.

Failure to meet all requirements may result in denial

All indications not specifically listed in this policy are considered experimental/investigational and are not medically necessary. This includes any use of Sandostatin LAR (octreotide acetate for injectable suspension) for diagnoses or indications that are not enumerated in the policy's covered indications section.

BlueCross BlueShield of Tennessee's medical policy complies with Tennessee Code Annotated Section 56-7-2352. Accordingly, off-label uses of FDA-approved drugs may be considered when the off-label use is recognized in a statutorily recognized standard reference compendium or is supported by published peer-reviewed medical literature. Providers should include relevant compendia citations or peer-reviewed literature with prior authorization requests for off-label indications to facilitate review.

Uses of Sandostatin LAR that fall outside FDA-approved indications and the compendial uses listed in this policy are considered not medically necessary. Requests for therapy for unlisted indications are subject to denial as they are deemed outside the scope of covered, evidence-supported uses.

Requests for continuation of Sandostatin LAR that do not meet all applicable coverage criteria — including documentation requirements and evidence of clinical benefit or required biomarker improvement — may be considered not medically necessary. All members, including new members seeking continuation, must satisfy the policy's continuation requirements for authorization to be granted.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the indications listed in this policy. Authorizations are typically granted for 12 months for most listed indications unless a different duration is specified in the coverage criteria. All members (including new members) requesting continuation of therapy must meet all requirements in the coverage criteria; failure to meet continuation criteria may result in denial.

Authorizations typically granted for 12 months for most indications
Some indications have different authorization durations (e.g., pancreatic fistulas and gastroesophageal varices: 6 months)

Denial Risk

Experimental / Investigational — Not Medically Necessary

Use for indications not listed as covered in this policy (including uses outside FDA-approved indications and compendial uses cited in the policy) is considered experimental/investigational and is not medically necessary and may be denied.

Documentation Required

Documentation Required for Prior Authorization

Submit supporting documentation with the prior authorization request. For acromegaly: for initial approval submit a laboratory report showing a high pretreatment IGF-1 level for age/gender and chart notes documenting an inadequate or partial response to surgery or radiotherapy or that surgery/radiotherapy are not an option; for continuation submit recent laboratory report showing normal or decreased IGF-1 or chart notes documenting clinical improvement/stabilization. For cancer-related diarrhea submit chart notes documenting CTCAE grade 3 or 4 diarrhea.

Acromegaly initial: pretreatment IGF-1 lab report + chart notes of inadequate/partial response to surgery or radiotherapy or documentation that surgery/radiotherapy are not an option
Acromegaly continuation: current IGF-1 lab report showing decreased/normalized levels or chart notes documenting improvement/stabilization
Cancer-related diarrhea: chart notes documenting CTCAE grade 3 or 4 diarrhea

Step Therapy

Initial Short‑Acting Octreotide Trial Required

For the FDA acromegaly indication, initial treatment with short‑acting octreotide (Sandostatin Injection/octreotide acetate injection) must be shown to be effective and tolerated prior to approval of long‑acting depot formulations when required by the FDA labeling and the coverage criteria.

Document trial with short‑acting octreotide injection for initial approval when applicable (chart notes documenting response and tolerability)

Prior Authorization

Continuation Criteria Required

Continuation requests (including requests for new members) must meet all coverage requirements for continuation of therapy. For acromegaly continuation, authorization may be granted when the member's IGF‑1 has decreased or normalized since initiation. For NETs, carcinoid syndrome, VIPomas, thymomas, meningiomas, Merkel cell carcinoma, cancer‑related diarrhea, inoperable malignant bowel obstruction, AIDS‑associated diarrhea, and Zollinger‑Ellison syndrome, continuation may be granted when the member is experiencing clinical benefit evidenced by improvement or stabilization in signs and symptoms.

All members requesting continuation must meet the specific continuation criteria in the policy
Clinical benefit should be documented in chart notes (improvement or stabilization) and, where applicable, relevant labs (e.g., IGF‑1 for acromegaly)

Initial Therapy Criteria

Initial Therapy Requirement

Initial requirement for long-acting formulation in acromegaly

Initial octreotide trial: Long‑acting Sandostatin LAR is indicated only in patients in whom initial treatment with short‑acting Sandostatin/octreotide injection has been shown to be effective and tolerated.Demonstrated effectiveness and tolerability to short‑acting octreotide

Submit documentation of short‑acting octreotide response and tolerability for initial approval

Initial therapy durations

Initial authorization durations vary by indication.

Pancreatic fistulas initial: Authorization of 6 months may be granted for prevention and treatment of pancreatic fistulas following pancreatic surgery.6 months

Gastroesophageal varices initial: Authorization of 6 months may be granted for treatment of acute bleeding of gastroesophageal varices associated with cirrhosis.6 months

Enterocutaneous/Short bowel/Zollinger‑Ellison initial: Authorization of 12 months may be granted for enterocutaneous fistula, short bowel syndrome, and Zollinger‑Ellison syndrome.12 months

Continuation Therapy Criteria

Continuation Therapy (Acromegaly)

Continuation therapy documentation for acromegaly

Continuation acromegaly: For continuation, provide laboratory report indicating normal current IGF‑1 levels or chart notes indicating that the member's IGF‑1 level has decreased or normalized since initiation of therapy.IGF‑1: normal or decreased vs baseline

Required for renewal

Continuation therapy criteria

Continuation authorizations may be granted when members demonstrate clinical benefit or specific biomarker improvement.

Acromegaly continuation: IGF‑1 level has decreased or normalized since initiation of therapy.IGF‑1 decreased or normalized

Provide laboratory documentation

Neuroendocrine/cancer indications continuation: Member is experiencing clinical benefit evidenced by improvement or stabilization in clinical signs and symptoms since initiation of therapy.clinical benefit demonstrated

Provide chart notes documenting improvement or stabilization

Denial Risk

Transfers/new members: must meet all continuation criteria

Continuation or reauthorization requests for members transferring care or new to the plan must satisfy all coverage criteria in this policy; lacking required documentation or criteria may lead to denial.

Step Therapy Requirements

Step	Requirement	Notes
1
Trial of short-acting octreotide (Sandostatin injection/octreotide acetate injection) demonstrating effectiveness and tolerability prior to approval of long-acting Sandostatin LAR
Per FDA indication, long-acting Sandostatin LAR is indicated only in patients in whom initial treatment with short-acting octreotide has been shown to be effective and tolerated; documentation should include clinical notes describing response and tolerability.

Background

Sandostatin LAR (octreotide acetate for injectable suspension) is a long-acting formulation of octreotide used for long-term maintenance therapy in conditions such as acromegaly following demonstration of response and tolerability to short-acting octreotide. It is also used to control symptoms in carcinoid syndrome and VIPomas and for a variety of compendial oncology and gastrointestinal indications where symptom control is the therapeutic goal.

Definitions and Limitations of Use

Limitations of Use

Scope of limitationSandostatin LAR has not been shown to affect tumor size, growth rate, or development of metastases in patients with carcinoid syndrome or VIPomas.

Clinical implicationUse for symptom control (diarrhea, flushing in carcinoid syndrome; profuse watery diarrhea in VIPomas) remains appropriate, but tumor-directed effects should not be expected.

Source guidanceStatement mirrors the product Limitations of Use in the Sandostatin LAR prescribing information.

Enterocutaneous Fistula

DefinitionEnterocutaneous fistula: a pathologic connection between the intestinal tract and the skin resulting in external drainage of enteric contents.

Role of octreotideOctreotide (Sandostatin LAR) may be authorized for management of volume depletion from enterocutaneous fistula; authorization of 12 months may be granted.

Clinical goalTherapy is intended to reduce enteric secretions and manage fluid/electrolyte losses rather than to close the fistula.

Short Bowel Syndrome

DefinitionShort bowel syndrome: condition following significant bowel resection causing large-volume stool losses with problematic fluid and electrolyte management.

Authorization contextOctreotide (Sandostatin LAR) authorization of 12 months may be granted for members with short bowel syndrome and large-volume stool losses when fluid and electrolyte management is problematic.

Therapeutic intentUse aims to reduce stool output and assist in stabilization of fluid/electrolyte status, not to reverse underlying anatomic loss of bowel length.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyOctreotide (Sandostatin LAR) injectable suspension — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 31, 202647d

Next Review DateN/A

Key ActionObtain prior authorization and submit required documentation (e.g., pretreatment IGF-1 for acromegaly) to support approval.

SourceLink

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