Octreotide (Sandostatin LAR) injectable suspension — Coverage Criteria
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria for Octreotide (Sandostatin LAR)
Acromegaly (Initial Approval)
Acromegaly - Authorization of 12 months may be granted when ALL of the following are met
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
Carcinoid Syndrome
VIPomas
Meningiomas (combination therapy)
Requires combination use with everolimus for surgically inaccessible recurrent or progressive meningioma
Merkel Cell Carcinoma
Somatostatin receptor positivity and contraindication to PD‑1/PD‑L1 therapy required; document prior PD‑1/PD‑L1 use or contraindication
Cancer-Related Diarrhea
Requires chart notes documenting diarrhea grade
Inoperable Malignant Bowel Obstruction
AIDS-Associated Diarrhea
Document prior antimicrobial or anti‑motility treatment failure
Enterocutaneous Fistula
Document indication and clinical need for management of volume depletion
Pancreatic Fistulas
Document surgical context and intended use for prevention or treatment following pancreatic surgery
Enterocutaneous Fistula
Covered when indication-specific authorization criteria are met
Document indication-specific criteria as required
Pancreatic Fistulas
Document surgical timing and intent; supports 6‑month authorization
Gastroesophageal Varices
Document acute bleeding episode and cirrhosis diagnosis
Pituitary Adenoma
Document diagnosis of pituitary adenoma
Short Bowel Syndrome
Document large volume stool losses and fluid/electrolyte management issues
Zollinger-Ellison Syndrome
Document diagnosis of Zollinger‑Ellison syndrome
Acromegaly and Neuroendocrine/Cancer-Related Indications
Provide laboratory report showing decreased or normalized IGF‑1 since initiation
Document clinical improvement or stabilization since initiation
All Other Indications
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 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)
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 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
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)
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
Submit documentation of short‑acting octreotide response and tolerability for initial approval
Initial therapy durations
Initial authorization durations vary by indication.
Continuation Therapy Criteria
Continuation Therapy (Acromegaly)
Continuation therapy documentation for acromegaly
Required for renewal
Continuation therapy criteria
Continuation authorizations may be granted when members demonstrate clinical benefit or specific biomarker improvement.
Provide laboratory documentation
Provide chart notes documenting improvement or stabilization
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
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