Lanreotide (Somatuline® Depot) coverage
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Defines prior authorization, coverage criteria, and documentation requirements for lanreotide (Somatuline® Depot) for FDA‑approved and compendial indications for BlueCross BlueShield of Tennessee members.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Acromegaly (Initial therapy)
Authorization of 12 months may be granted for the treatment of acromegaly when ALL of the following criteria are met:
12-month authorization may be granted
inv-02: Acromegaly (Continuation therapy)
Continuation of therapy for acromegaly:
Authorization of 12 months may be granted; submit current laboratory report showing normalized or decreased IGF-1 or chart notes documenting improvement.
inv-03: Neuroendocrine Tumors (NETs)
Authorization of 12 months may be granted for treatment of the following neuroendocrine tumor indications:
12-month authorization may be granted
inv-04: Carcinoid Syndrome
Carcinoid syndrome:
inv-05: Zollinger-Ellison Syndrome
Zollinger-Ellison syndrome:
inv-06: Continuation Therapy for NETs/Carcinoid/Zollinger-Ellison
Continuation for NETs, Carcinoid Syndrome, and Zollinger-Ellison Syndrome:
Authorization of 12 months may be granted
All other indications for lanreotide (Somatuline® Depot) that are not listed as FDA‑approved or recognized compendial uses are considered experimental/investigational and not medically necessary.
Use of lanreotide for indications that are not included in the FDA‑approved labeling or in recognized compendia is considered not medically necessary (i.e., experimental/investigational) and will not be covered.
Initial Therapy Criteria
inv-16: Initial therapy (Acromegaly)
Initial authorization requirements for acromegaly:
12-month authorization may be granted; submit laboratory report showing elevated IGF-1 and supporting clinical notes.
Continuation Therapy Criteria
inv-17: Continuation therapy
Continuation therapy — required evidence for reauthorization:
Provide current laboratory report showing normalized or decreased IGF-1 or chart notes documenting IGF-1 improvement; 12-month reauthorization may be granted.
Provide clinical notes documenting symptom improvement or stabilization; 12-month reauthorization may be granted.
Coding and Laboratory Requirements
Provider Actions and Authorization
Prior Authorization Required
Prior authorization is required for lanreotide (Somatuline® Depot). When criteria are met, authorizations may be granted for up to 12 months.
- Authorization length: 12 months when criteria met
- Prior authorization required
Step Therapy Requirement
Step therapy applies. See the Step Therapy Requirements for Provider-Administered Specialty Medications guide.
- Refer to: https://www.bcbst.com/docs/providers/Comm_BC_PAD_Step_Therapy_Guide.pdf
Documentation Required for Continuation
For continuation requests, submit current laboratory report showing normal or decreased IGF-1 or chart notes documenting decreased/normalized IGF-1 since therapy initiation.
- Required for continuation: IGF-1 lab report or chart notes documenting decreased/normalized IGF-1
Documentation Required for Initial Approval
For initial prior authorization requests, submit pretreatment laboratory report showing elevated IGF-1 and chart notes documenting inadequate or partial response to surgery or radiotherapy, or documentation that surgery/radiotherapy are not options.
- Required for initial approval: elevated pretreatment IGF-1 lab report
- Chart notes documenting inadequate/partial response to or contraindication for surgery or radiotherapy
Provider Action: Appropriate Indications
Use lanreotide for indications that are FDA‑approved or supported by compendia (e.g., acromegaly, neuroendocrine tumors including GI, pancreatic, lung/thymus carcinoid tumors, GEP‑NETs, pheochromocytoma/paraganglioma, carcinoid syndrome, and Zollinger‑Ellison syndrome). All other indications are considered experimental/investigational and not medically necessary.
- Compendial uses: NETs (GI, lung, thymus), pancreatic NETs, GEP‑NETs, pheochromocytoma/paraganglioma, Zollinger‑Ellison syndrome, carcinoid syndrome, acromegaly
- All other indications = experimental/investigational; not medically necessary
Provider Actions: Authorization Criteria and Continuation Documentation
Provider actions and clinical criteria summary: - Acromegaly: Authorization up to 12 months may be granted when member has elevated pretreatment IGF‑1 for age/gender and either had inadequate/partial response to surgery or radiotherapy, or surgery/radiotherapy are not options. For continuation, authorization up to 12 months may be granted when IGF‑1 has decreased or normalized since therapy initiation. - Neuroendocrine Tumors (NETs): Authorization up to 12 months may be granted for NETs of the pancreas (including gastrinoma, glucagonoma, insulinoma, VIPoma), GI tract, lung, thymus (carcinoid tumors), gastroenteropancreatic NETs, and pheochromocytoma/paraganglioma. - Carcinoid Syndrome and Zollinger‑Ellison Syndrome: Authorization up to 12 months may be granted. - Continued treatment (NETs, Carcinoid Syndrome, Zollinger‑Ellison): Reauthorization up to 12 months may be granted when member is experiencing clinical benefit (improvement or stabilization of signs/symptoms).
- Acromegaly: initial and continuation criteria and 12‑month authorization
- NETs, Carcinoid Syndrome, Zollinger‑Ellison: 12‑month initial and continuation authorizations when clinical benefit shown
Step Therapy Requirements
| Step Therapy Requirement |
|---|
| Step Therapy applies per the external 'Step Therapy Requirements for Provider Administered Specialty Medications' guide; providers must follow that document for step requirements. |
Definitions
Background
Lanreotide (Somatuline® Depot) is a long‑acting somatostatin analog used in the management of neuroendocrine and related tumors. Compendial uses include treatment of neuroendocrine and adrenal tumors such as tumors of the gastrointestinal tract, lung, and thymus (carcinoid tumors); tumors of the pancreas (islet cell tumors); gastroenteropancreatic neuroendocrine tumors (GEP‑NETs); and pheochromocytoma and paraganglioma. Lanreotide is also used for Zollinger‑Ellison syndrome.
Site of Care
Infusion center: follow compendia for regimens/dosing; no site‑of‑care restriction
Refer to standard reference compendia for appropriate regimens, dosing, contraindications, precautions and monitoring when planning administration in an infusion/administration center; the policy does not impose an explicit site‑of‑care restriction.
- Use resources such as NCCN, Drugdex (Micromedex), or AHFS for regimen, dosing, contraindication, and monitoring guidance.
- No explicit site‑of‑care restriction is stated in the policy.
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