CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lanreotide Injection Somatuline Depot 2092 A Sgm P2023

Defines medical necessity criteria, documentation requirements, and authorization durations for lanreotide (Somatuline Depot / Lanreotide Injection) for FDA-approved indications and select compendial uses (acromegaly, neuroendocrine tumors, carcinoid syndrome, pheochromocytoma/paraganglioma, Zollinger-Ellison syndrome).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLanreotide Injection Somatuline Depot 2092 A Sgm P2023

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit required documentation to initiate prior authorization: lab report showing high pretreatment IGF-1 and chart notes for initial acromegaly; for continuation submit lab report showing decreased/normalized IGF-1 or chart notes documenting clinical benefit for NETs and other indications.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

6Covered Indications listed

1Reference number shown

Coverage Summary

This policy defines medical necessity criteria and documentation requirements for lanreotide (Somatuline Depot / Lanreotide Injection). Lanreotide is covered with criteria for FDA-approved indications and select compendial uses, including: acromegaly; neuroendocrine tumors (NETs) — including gastrointestinal (GI), pancreatic (islet cell), lung, and thymus carcinoid tumors, GEP-NETs, and select well-differentiated grade 3 NETs with favorable biology; carcinoid syndrome; pheochromocytoma and paraganglioma; and Zollinger‑Ellison syndrome. Authorization for initial and continued therapy may be granted for up to 12 months when the specified criteria and documentation requirements are met.

Thresholds and stats

IGF-1 threshold (initial)High pretreatment IGF-1 for age/gender per laboratory reference range

IGF-1 threshold (continuation)Decreased or normalized IGF-1 since initiation of therapy (laboratory report required)

Ki-67 note for well-differentiated G3 NETsRelatively low Ki-67 (<55%) noted as favorable biology (SSR positive imaging also cited)

Covered Indications listed (stats)6

Reference number shown (stats)1 (reference number 2092-A shown in source)

Initial Therapy Criteria

Initial Authorization - Carcinoid Syndrome

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

Indication: carcinoid syndrome

No additional numeric criteria provided

Initial Authorization - Pheochromocytoma and Paraganglioma

Authorization of 12 months may be granted for treatment when indication present.

Indication: pheochromocytoma and paraganglioma

No additional numeric criteria provided

Initial Authorization - Zollinger-Ellison syndrome

Authorization of 12 months may be granted for treatment when indication present.

Indication: Zollinger-Ellison syndrome

No additional numeric criteria provided

Continuation / Reauthorization Criteria

Continuation / Reauthorization - Acromegaly

Authorization of 12 months may be granted for continuation when ALL of the following are met:

Member's IGF-1 level has decreased or normalized since initiation of therapyRequires laboratory report showing decreased or normalized IGF-1

Provider Actions

Prior Authorization

Prior authorization required for initial and continuation therapy

Prior authorization is required for both initial and continuation therapy with lanreotide (Somatuline Depot/lanreotide injection). Submit required documentation to initiate PA: for initial acromegaly include a laboratory report indicating high pretreatment IGF-1 for age/gender and chart notes documenting an inadequate or partial response to surgery or radiotherapy or a clinical reason why surgery/radiotherapy was not done. For continuation, submit laboratory report showing decreased or normalized IGF-1 or chart notes documenting clinical benefit (improvement or stabilization) for NETs and other covered indications. See documentation specifics below.

Acromegaly
Neuroendocrine tumors (NETs) — GI, pancreatic, lung, thymus, well-differentiated grade 3 with favorable biology, GEP‑NETs
Carcinoid syndrome
Pheochromocytoma/paraganglioma
Zollinger‑Ellison syndrome

Documentation Required

Documentation of clinical response or lab values

For initial acromegaly approval, provide a laboratory report showing high pretreatment IGF‑1 (above the laboratory reference range for age/gender) plus chart notes documenting an inadequate/partial response to surgery or radiotherapy or a clinical reason surgery/radiotherapy was not performed. For continuation of acromegaly, provide a laboratory report showing decreased or normalized IGF‑1 since starting therapy. For continuation/reauthorization of NETs, carcinoid syndrome, pheochromocytoma/paraganglioma, and Zollinger‑Ellison syndrome, provide chart notes documenting clinical benefit evidenced by improvement or stabilization in clinical signs and symptoms since initiation of therapy.

Applicable Codes and References

Referenced internal/reference numbersmixed

2092-A

Reference number for lanreotide injection policy / Somatuline Depot

Key references include the package inserts for Somatuline Depot and Lanreotide Injection, the NCCN Drugs & Biologics Compendium and NCCN Clinical Practice Guidelines, and pivotal clinical literature such as the CLARINET trial (Caplin et al., N Engl J Med. 2014) supporting lanreotide use in enteropancreatic neuroendocrine tumors.

Definitions & Background

Scope: This policy covers FDA-approved indications for Somatuline Depot and lanreotide injection and select compendial uses (NETs including GI, pancreatic, lung, thymus; carcinoid syndrome; pheochromocytoma/paraganglioma; Zollinger‑Ellison). For acromegaly, required documentation for initial approval includes a laboratory report showing a high pretreatment IGF‑1 for age/gender and chart notes documenting inadequate/partial response to or clinical reason for not having surgery or radiotherapy; continuation requires documentation of decreased or normalized IGF‑1. For NETs and the other covered compendial indications, continuation requires chart notes documenting clinical benefit (improvement or stabilization). All other indications are considered experimental/investigational and not medically necessary.

Definitions

High pretreatment IGF-1IGF-1 level above laboratory reference range for age and gender

Clinical benefitImprovement or stabilization in clinical signs and symptoms since initiation of therapy

Well-differentiated grade 3 NETs with favorable biologyNETs not of GEP origin with relatively low Ki-67 (<55%) and somatostatin receptor positive imaging

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLanreotide Injection Somatuline Depot 2092 A Sgm P2023

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Lanreotide Injection Somatuline Depot 2092 A Sgm P2023

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Provider Actions

Applicable Codes and References

Definitions & Background

Revision History