CurrentNeighborhood Health Plan of Rhode IslandPolicy 2092-A

Lanreotide (Somatuline Depot / Lanreotide Injection) coverage for acromegaly and neuroendocrine/neuroendocrine-related indications

Defines covered indications, documentation and prior authorization criteria for lanreotide (Somatuline Depot / Lanreotide Injection) including FDA-approved uses (acromegaly, GEP-NETs, carcinoid syndrome) and specified compendial uses; applies to prior authorization review and reauthorization for members of Neighborhood Health Plan of Rhode Island (managed by CVS Caremark).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLanreotide (Somatuline Depot / Lanreotide Injection) coverage for acromegaly and neuroendocrine/neuroendocrine-related indications

Policy CodePolicy 2092-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation: for initial acromegaly requests include a pretreatment IGF-1 laboratory report and chart notes documenting inadequate/partial response to or reason for not having surgery/radiotherapy; for continuation or non-acromegaly indications include lab results or chart notes demonstrating clinical benefit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12typical authorization period

3primary FDA-approved indications referenced

5compendial/other supported indications

Covered Indications and Authorization Criteria

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General coverage / Indications

The following FDA-approved indications and compendial uses are considered covered when approval criteria are met and the member has no exclusions:

Covered indications (any of the following)

Long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
Treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
Treatment of adults with carcinoid syndrome to reduce frequency of short-acting somatostatin analog rescue therapy.
Lanreotide Injection: Long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
Compendial uses including neuroendocrine tumors (GI tract, lung, thymus), pancreatic NETs (including gastrinomas, glucagonomas, insulinomas, VIPomas), pheochromocytoma and paraganglioma, and Zollinger-Ellison syndrome.

Acromegaly — initial authorization

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

ALL of the following

Member has a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range.
Pretreatment laboratory report required.
ANY of the following
- Inadequate or partial response to surgery or radiotherapy.
- Clinical reason documented for not having surgery or radiotherapy.

Authorization duration: 12 months.

NETs, carcinoid syndrome, pheochromocytoma/paraganglioma, Zollinger-Ellison syndrome — initial authorization

Authorization of 12 months may be granted for each condition when the indication matches the listed tumor types or syndrome:

ANY of the following

NETs of the gastrointestinal tract, lung and thymus (carcinoid tumors).
NETs of the pancreas (islet cell tumors), including gastrinomas, glucagonomas, insulinomas, and VIPomas.
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Carcinoid syndrome.
Pheochromocytoma and paraganglioma.

Continuation / reauthorization criteria

Authorization of 12 months may be granted for continuation when evidence of response or benefit is provided:

ANY of the following

For acromegaly: the member's IGF-1 level has decreased or normalized since initiation of therapy.
Current laboratory report showing normal IGF-1 or chart notes documenting decrease/normalization required.
For NETs, carcinoid syndrome, pheochromocytoma/paraganglioma, and Zollinger-Ellison syndrome: member is experiencing clinical benefit as evidenced by improvement or stabilization in clinical signs and symptoms since starting therapy.
Chart notes documenting clinical benefit required.

Exclusions / Not covered

Uses not listed as FDA-approved or compendial are considered:

ALL of the following

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

Prior Authorization and Documentation Requirements

Prior Authorization

Prior authorization required with documentation

Submit prior authorization with required documentation before initiating or continuing lanreotide. For initial requests for acromegaly include a laboratory report showing a 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 performed. For continuation requests for acromegaly include a current laboratory report showing normalized or decreased IGF-1 since therapy initiation or chart notes documenting that the member's IGF-1 has decreased or normalized.

Initial (acromegaly): laboratory report with high pretreatment IGF-1 for age/gender + chart notes of inadequate/partial response to surgery/radiotherapy OR clinical reason for not having surgery/radiotherapy.
Continuation (acromegaly): current lab report showing normal/decreased IGF-1 compared to baseline OR chart notes documenting decreased/normalized IGF-1 since initiation.

Documentation Required

Documentation of clinical benefit for non-acromegaly indications

For reauthorization of therapy for NETs, carcinoid syndrome, pheochromocytoma/paraganglioma, or Zollinger-Ellison syndrome, submit chart notes demonstrating that the member is experiencing clinical benefit, evidenced by improvement or stabilization in clinical signs and symptoms since starting lanreotide.

Provide chart documentation of improvement or stabilization in clinical signs and symptoms for the specific non-acromegaly indication being treated.
Reauthorization may be granted for 12 months when clinical benefit is demonstrated.

Clinical and Administrative Context

Lanreotide (Somatuline Depot / Lanreotide Injection) is a long-acting somatostatin analog indicated for treatment of endocrine disorders and neuroendocrine tumors consistent with FDA-labeled indications and recognized compendia. The policy covers the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy, and treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. It also covers use for adults with carcinoid syndrome, where lanreotide reduces the need for short-acting somatostatin rescue therapy (FDA indications).

In addition to the FDA-approved indications, the policy aligns with compendial sources (for example, NCCN and the product package inserts) to support other neuroendocrine-related uses. Compendial uses included in the coverage criteria are NETs of the gastrointestinal tract, lung, and thymus (carcinoid tumors); pancreatic NETs (including gastrinomas, glucagonomas, insulinomas, and VIPomas); as well as pheochromocytoma and paraganglioma and Zollinger-Ellison syndrome. Uses not listed as FDA-approved or compendial are considered experimental/investigational and not medically necessary.

The policy requires prior authorization with documentation to demonstrate that members meet indication-specific criteria. For acromegaly, required documentation includes a pretreatment laboratory report showing a high IGF-1 for age and/or gender and evidence of inadequate/partial response to or a clinical reason for not pursuing surgery or radiotherapy. For continuation of therapy, documentation must show clinical benefit—for acromegaly this is an IGF-1 that has decreased or normalized, and for NETs and related syndromes chart notes must document improvement or stabilization of signs and symptoms. Typical authorization periods are for 12 months when criteria are met.