CurrentNeighborhood Health Plan of Rhode IslandPolicy 2092-A

lanreotide (Somatuline Depot) coverage

Defines coverage and prior authorization requirements for lanreotide (Somatuline Depot) for FDA-approved and compendial endocrine and neuroendocrine indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policylanreotide (Somatuline Depot) coverage

Policy CodePolicy 2092-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrior authorization required; authorizations may be granted for up to 12 months for covered indications when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

FDA + compendialcovered indications

IGF-1lab required for acromegaly

brand & genericproduct scope

Coverage Criteria for lanreotide (Somatuline Depot)

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Acromegaly criteria: Member has a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range.high per lab reference

Supported by required documentation: laboratory report of pretreatment IGF‑1.

Prior treatment requirement: Member had an inadequate or partial response to surgery or radiotherapy OR there is a clinical reason why the member has not had surgery or radiotherapy.N/A

Document inadequate/partial response or clinical reason/contraindication in chart notes.

Neuroendocrine Tumors (NETs)

Authorization of 12 months may be granted for treatment when the tumor type is one of the following:

Covered NET types: NET of the gastrointestinal (GI) tract, lung, and thymus (carcinoid tumors).N/A

Authorization may be granted for each listed NET type.

Covered NET types: NET of the pancreas (islet cell tumors), including gastrinomas, glucagonomas, insulinomas, and VIPomas.N/A

Authorization may be granted for each listed NET type.

Covered NET types: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs).N/A

Authorization may be granted for each listed NET type.

Pheochromocytoma and Paraganglioma

Authorization of 12 months may be granted for treatment when requested for these diagnoses.

Pheochromocytoma/Paraganglioma: Member has pheochromocytoma or paraganglioma and treatment with lanreotide is requested.N/A

Compendial use; document diagnosis in chart notes.

Zollinger-Ellison Syndrome

Authorization of 12 months may be granted for treatment when requested for this diagnosis.

Zollinger-Ellison syndrome: Member has Zollinger‑Ellison syndrome and treatment with lanreotide is requested.N/A

Compendial use; document diagnosis in chart notes.

Continuation / Reauthorization

Authorization of 12 months may be granted for continuation when the following apply:

Acromegaly continuation: For acromegaly, the member's IGF‑1 level has decreased or normalized since initiation of therapy.decreased or normalized IGF‑1

Requires laboratory report or chart notes documenting change in IGF‑1.

Other indications continuation: For NETs, carcinoid syndrome, pheochromocytoma/paraganglioma, and Zollinger‑Ellison syndrome, the member is experiencing clinical benefit as evidenced by improvement or stabilization in clinical signs and symptoms since starting therapy.clinical improvement or stabilization

Documented in chart notes.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization required; authorizations may be granted for up to 12 months for covered indications when criteria are met.

Authorization of up to 12 months may be granted for covered indications when criteria are met (e.g., acromegaly, NETs, carcinoid syndrome, pheochromocytoma/paraganglioma, Zollinger‑Ellison syndrome).

Documentation Required

Surgery/Radiotherapy Requirement for Acromegaly

For initial approval for acromegaly, the member must have had an inadequate or partial response to surgery or radiotherapy OR there must be a documented clinical reason why the member has not undergone surgery or radiotherapy.

Member had inadequate/partial response to surgery or radiotherapy OR clinical reason documented for not having surgery or radiotherapy.

Documentation Required

Required Documentation for Acromegaly

Submission of the following information is necessary to initiate the prior authorization review for acromegaly: - Initial approval: laboratory report showing elevated pretreatment insulin-like growth factor-1 (IGF-1) for age/gender and chart notes documenting inadequate/partial response to surgery or radiotherapy or a clinical reason for not having surgery or radiotherapy. - Continuation: laboratory report showing normalized or decreased IGF-1 or chart notes documenting that the member's IGF-1 has decreased or normalized since initiation of therapy.

Initial: pretreatment IGF‑1 lab report and chart notes of inadequate/partial response to surgery/radiotherapy or clinical reason for not undergoing.
Continuation: current IGF‑1 lab report showing normalization or chart notes documenting decreased/normalized IGF‑1 since treatment start.

Denial Risk

Non‑Covered Indications

Requests for indications not listed (i.e., not FDA‑approved or compendial uses) are considered experimental/investigational and will be denied as not medically necessary.

All other indications are considered experimental/investigational and not medically necessary.

Product and Laboratory Coding

Referenced productmixed

Somatuline Depot / lanreotide acetate

Drug product referenced (brand and generic; all dosage forms and strengths unless otherwise stated).

IGF-1 — Lab requirement and interpretation notes (pretreatment elevated; continuation requires decreased or normalized IGF-1)

Required pretreatment IGF-1Laboratory report showing a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range.

Continuation IGF-1 requirementFor continuation, laboratory report showing current normal IGF-1 levels or chart notes documenting that IGF-1 has decreased or normalized since therapy initiation.

Documentation context for initial approvalChart notes must document inadequate or partial response to surgery or radiotherapy OR a clinical reason why surgery/radiotherapy was not performed.

Definitions

IGF-1 — Insulin-like growth factor-1; laboratory measurement required to document elevated pretreatment level for acromegaly initiation and decreased/normalized level for continuation.

DefinitionInsulin-like growth factor-1 (IGF-1); laboratory measurement required to document elevated pretreatment level for acromegaly initiation and decreased/normalized levels for continuation.

Initial measurement purposeConfirms high pretreatment IGF-1 for age/gender per lab reference to support treatment initiation for acromegaly.

Follow-up measurement purposeDemonstrates decreased or normalized IGF-1 after therapy to support continuation/reauthorization.

Background

Lanreotide (Somatuline Depot) is a long‑acting somatostatin analog used in endocrine and neuroendocrine conditions. In clinical practice it is employed to control excess growth hormone activity in acromegaly and to treat various neuroendocrine tumor types to improve progression‑free survival and manage symptoms such as those of carcinoid syndrome. Compendial uses listed in this policy include treatment of neuroendocrine tumors of the gastrointestinal tract, lung, thymus, and pancreas (islet cell tumors and GEP‑NETs), as well as select endocrine conditions such as pheochromocytoma/paraganglioma and Zollinger‑Ellison syndrome.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policylanreotide (Somatuline Depot) coverage

Policy CodePolicy 2092-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrior authorization required; authorizations may be granted for up to 12 months for covered indications when criteria are met.

SourceLink

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