CurrentNeighborhood Health Plan of Rhode IslandPolicy Reference number 2092-A

Somatuline Depot (lanreotide) coverage for acromegaly, neuroendocrine tumors, carcinoid syndrome, pheochromocytoma/paraganglioma, Zollinger-Ellison syndrome

Policy defines covered indications (FDA and compendia) for lanreotide (Somatuline Depot / lanreotide injection) when prior authorization criteria are met, required documentation for initial and continuation requests, and typical authorization duration (12 months).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySomatuline Depot (lanreotide) coverage for acromegaly, neuroendocrine tumors, carcinoid syndrome, pheochromocytoma/paraganglioma, Zollinger-Ellison syndrome

Policy CodePolicy Reference number 2092-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit required documentation for prior authorization: for initial requests provide a high pretreatment IGF-1 lab report and chart notes showing inadequate/partial response to or reason for not having surgery/radiotherapy; for continuation provide labs showing decreased/normalized IGF-1 or chart notes documenting clinical benefit.

POLICY UPDATE CHANGES

No material changes

8Named Covered Indications

12Authorization Duration (months)

2092-AReference Document Number

Coverage Summary

This policy covers FDA-approved and compendial indications for Somatuline Depot (lanreotide) and lanreotide injection as detailed in the referenced compendium and package labeling. Indications include treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), acromegaly, and carcinoid syndrome among other neuroendocrine tumor (NET) and related diagnoses.

The policy scope includes both FDA-labeled uses and compendial uses (NCCN Drugs & Biologics Compendium). It defines required documentation for prior authorization, criteria for initial and continued therapy, and explicitly lists indications considered experimental/investigational and not medically necessary.

When the specified criteria are met, typical authorizations (initial and continuation) are granted for 12 months.

Authorization Criteria

Covered Indications and Approval Criteria

Authorizations of 12 months may be granted when the specified criteria for each indication are met:

Covered Indications (ANY of the following)

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs): Treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs to improve progression-free survival.
Authorization of 12 months may be granted for treatment of GEP-NETs.
Acromegaly: Long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
Member must have a high pretreatment IGF-1 level for age and/or gender based on laboratory reference range. Authorization of 12 months may be granted.
Carcinoid syndrome: Treatment of adults with carcinoid syndrome to reduce frequency of short-acting somatostatin analog rescue therapy.
Authorization of 12 months may be granted for treatment of carcinoid syndrome.
Tumors of the pancreas (islet cell tumors): Tumors of the pancreas including gastrinomas, glucagonomas, insulinomas, and VIPomas.
Authorization of 12 months may be granted.
Tumors of the gastrointestinal tract, thymus, and lung (carcinoid tumors): Tumors of the gastrointestinal tract (carcinoid tumor), thymus (carcinoid tumor), and lung (carcinoid tumor).
Authorization of 12 months may be granted for these NET sites.
Well-differentiated grade 3 NETs with favorable biology (example: relatively low Ki-67 < 55%, somatostatin receptor positive imaging).Ki-67 < 55% (example)
Authorization of 12 months may be granted for well-differentiated grade 3 NETs with favorable biology (not of gastroenteropancreatic origin).
Pheochromocytoma and paraganglioma.
Authorization of 12 months may be granted.
Zollinger-Ellison syndrome.
Authorization of 12 months may be granted.

Acromegaly Initial Approval Criteria

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

High pretreatment IGF-1: Member has a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range.High for age and/or gender based on laboratory reference range
Prior surgery/radiotherapy or reason for not having it: 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.

Acromegaly Continuation Criteria

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

IGF-1 response: 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.Normal or decreased/normalized IGF-1 since initiation

NETs, Carcinoid Syndrome, Pheochromocytoma/Paraganglioma, Zollinger-Ellison - Continuation Criteria

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

Clinical benefit: Member is experiencing clinical benefit as evidenced by improvement or stabilization in clinical signs and symptoms since starting therapy.
Provide chart notes documenting improvement or stabilization to support reauthorization.

Exclusions / Not Medically Necessary

All other indications not listed above:

Exclusions / Not Medically Necessary: All other indications are considered experimental/investigational and not medically necessary.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Submission of documentation is required to initiate prior authorization review for both initial and continuation requests. For initial approval, provide a laboratory report showing a high pretreatment IGF-1 level for age and/or gender and chart notes documenting an inadequate or partial response to surgery or radiotherapy or a clinical reason the member has not had surgery/radiotherapy. For continuation, provide a laboratory report showing current IGF-1 levels that are normal or decreased/normalized, or chart notes documenting clinical benefit (improvement or stabilization).

Pretreatment IGF-1 laboratory report (high for age/gender)
Chart notes documenting inadequate/partial response to surgery or radiotherapy or clinical reason for not having surgery/radiotherapy (initial)
For continuation: laboratory report showing normal or decreased/normalized IGF-1 or chart notes documenting clinical benefit (improvement or stabilization)

Documentation Required

Documentation of clinical benefit for continuation

For reauthorization of therapy for NETs, carcinoid syndrome, pheochromocytoma/paraganglioma, and Zollinger-Ellison syndrome, provide chart notes demonstrating that the member is experiencing clinical benefit since starting therapy. Acceptable documentation includes notes showing improvement or stabilization in clinical signs and symptoms.

Prior Authorization

Authorization duration

Typical authorization periods granted are 12 months for both initial approvals and continuations when the applicable criteria are met.

12 months

Background, Evidence & Definitions

FDA-approved indications and compendial uses include treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; long-term treatment of acromegalic patients with inadequate response to or who cannot be treated with surgery or radiotherapy; and treatment of adults with carcinoid syndrome to reduce frequency of short-acting somatostatin analog rescue therapy.

Compendial uses (NCCN) and other covered NET-related indications include tumors of the pancreas (islet cell tumors including gastrinomas, glucagonomas, insulinomas, VIPomas), tumors of the gastrointestinal tract, thymus, and lung (carcinoid tumors), well-differentiated grade 3 NETs with favorable biology, as well as pheochromocytoma/paraganglioma and Zollinger-Ellison syndrome.

Evidence and references cited in the policy include Somatuline Depot and lanreotide package inserts (Ipsen June 2019; Cipla Dec 2021), the CLARINET clinical trial (Caplin et al., N Engl J Med. 2014), and clinical guideline sources including the NCCN Drugs & Biologics Compendia, Endocrine Society acromegaly guideline, and AACE guidance.

Documentation requirements referenced include pretreatment and on-treatment IGF-1 laboratory reports and clinical chart notes to support initial and continuation approvals.

Term	Definition
GEP-NETs
Gastroenteropancreatic neuroendocrine tumors
IGF-1
Insulin-like growth factor-1
Authorization of 12 months
Typical approval length when criteria are met

Somatuline Depot (lanreotide acetate injection)	Brand reference; policy covers Somatuline Depot / lanreotide injection per listed indications
Lanreotide Injection	Generic/other manufacturer reference

OpenPayer

Somatuline Depot (lanreotide) coverage for acromegaly, neuroendocrine tumors, carcinoid syndrome, pheochromocytoma/paraganglioma, Zollinger-Ellison syndrome

Coverage Summary

Authorization Criteria

Codes Referenced

Provider Actions & Prior Authorization

Background, Evidence & Definitions

Revision History