CurrentNeighborhood Health Plan of Rhode IslandPolicy 1734-A

Octreotide and Somatostatin Analog Products — Coverage Criteria

Covers FDA-approved and compendial indications for octreotide products (injectable and oral Mycapssa) including acromegaly, neuroendocrine tumors, carcinoid syndrome, VIPomas, and specified GI and endocrine uses; defines prior authorization documentation and duration of authorization for covered indications. Applies to members of Neighborhood Health Plan of Rhode Island (policy payer).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOctreotide and Somatostatin Analog Products — Coverage Criteria

Policy CodePolicy 1734-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required and documentation must include pretreatment IGF-1 for acromegaly and evidence of inadequate/partial response to surgery or radiotherapy or clinical rationale.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

6 monthssome indications

requiredIGF-1 documentation

Grade 3+cancer-related diarrhea

3 L/day

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SBS IV fluid threshold

Coverage Criteria for Octreotide and Related Products

Acromegaly

Covered when ALL of the following are met (Acromegaly - injectable products and Mycapssa):

Acromegaly initial and continuation: Member has a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range

Authorization of 12 months may be granted

Prior surgery or radiotherapy response: 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

Required for initial authorization

Mycapssa-specific requirement: For Mycapssa requests, member has previously responded to and tolerated treatment with octreotide or lanreotide

Applies to oral octreotide (Mycapssa) requests

Neuroendocrine Tumors (NETs)

Covered when criteria for NETs are met (injectable products):

NET tumor sites: Tumors of the gastrointestinal (GI) tract (carcinoid tumor)

Authorization of 12 months may be granted for treatment of GI NETs

NET tumor sites: Tumors of the thymus (carcinoid tumor)

Authorization of 12 months may be granted for treatment of thymic NETs

NET tumor sites: Tumors of the lung (carcinoid tumor)

Authorization of 12 months may be granted for treatment of pulmonary NETs

NET tumor sites: Tumors of the pancreas, including gastrinomas, glucagonomas, and insulinomas

Other covered injectable indications

Covered indications (injectable products) with specified authorization durations and condition-based requirements:

Carcinoid syndrome: Authorization of 12 months may be granted for treatment of carcinoid syndrome

injectable products only

VIPomas: Authorization of 12 months may be granted for management of symptoms related to hormone hypersecretion of VIPomas

injectable products only

Pheochromocytoma and paraganglioma: Authorization of 12 months may be granted for treatment of pheochromocytoma and paraganglioma

injectable products only

Thymomas and thymic carcinomas: Authorization of 12 months may be granted for treatment of thymomas and thymic carcinomas

Indication-specific 12-month authorization criteria

Authorization may be granted for 12 months when the following indication-specific conditions are met:

Pituitary adenoma: Authorization of 12 months may be granted for treatment of pituitary adenoma (injectable products only)

Short bowel syndrome: Authorization of 12 months may be granted for treatment of short bowel syndrome when the daily intravenous fluid requirement is greater than 3 liters (injectable products only)> 3 liters/day

Zollinger-Ellison syndrome: Authorization of 12 months may be granted for treatment of Zollinger-Ellison syndrome (injectable products only)

Acromegaly continuation: Authorization of 12 months may be granted for continuation of therapy for acromegaly when the member's IGF-1 level has decreased or normalized since initiation of therapy

All other indications — continuation requirement

Continuation for all other indications

Continuation for other indications: All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria

Initial authorization criteria are required to be met for continuation

All indications not specifically listed as covered in this policy are considered experimental/investigational and not medically necessary and will not be authorized.

Indications that are not among the FDA‑approved or recognized compendial uses described in this policy are considered experimental/investigational and not medically necessary and are not eligible for coverage.

This policy lists the specific FDA‑approved and compendial indications for octreotide and related somatostatin analogs that may be authorized. Requests for uses outside of those listed will be evaluated as described under the policy but, unless covered by an explicitly stated indication, are not considered medically necessary.

If an indication is not enumerated among the covered uses in this document, the request should be presumed not to meet medical necessity criteria unless documentation demonstrates correspondence to one of the listed covered indications.

Key Thresholds and Severity Definitions

Daily IV fluid requirement — > 3 liters

Daily IV fluid requirementGreater than 3 liters per day

ContextUsed as an authorization threshold for short bowel syndrome (injectable products)

Authorization implicationRequests not meeting >3 L/day risk denial

Cancer-related diarrhea severity — Grade 3 or greater (NCI CTCAE)

Severity thresholdGrade 3 or greater per NCI CTCAE

IndicationCancer-related diarrhea (injectable products)

Authorization implication

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the covered indications listed in this policy. Requests may be denied if the approval criteria are not met or if the member has exclusions to the prescribed therapy.

Prior authorization duration varies by indication (commonly 12 months; 6 months for congenital hyperinsulinism and certain acute indications).

Denial Risk

Missing or Incomplete Documentation May Lead to Denial

Submission of complete documentation is necessary to initiate and support prior authorization and reauthorization requests. Lack of required documentation may result in denial or delay of the request.

Missing documentation that may lead to denial includes: pretreatment IGF-1 for acromegaly, chart notes documenting inadequate or partial response to surgery or radiotherapy, or documentation of clinical benefit on continuation requests.

Definitions and Product Notes

Mycapssa — Oral octreotide formulation indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated octreotide.

IndicationMycapssa (oral octreotide) is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated octreotide or lanreotide

PrerequisitePrior response to and tolerance of octreotide or lanreotide required for Mycapssa requests

Role in coverageApplies to Mycapssa requests for acromegaly maintenance therapy

IGF-1 requirement — Laboratory measurement of insulin-like growth factor-1 (IGF-1) required pretreatment for acromegaly and for continuation to document normalization/decrease.

IGF-1 laboratory measurementLaboratory measurement of insulin-like growth factor-1 (IGF-1) required pretreatment for acromegaly and for continuation to document normalization or decrease

Clinical Background

Somatostatin analogs, including injectable formulations of octreotide and lanreotide and the oral octreotide formulation Mycapssa, act to reduce growth hormone (GH) and insulin‑like growth factor‑1 (IGF‑1) levels in patients with acromegaly and are used to control symptoms of neuroendocrine tumors and carcinoid syndrome.

Policy Revision History

2023policy_publicationLatest

Policy reference 1734-A document (octreotide products) published with indications, authorization durations, and documentation requirements as shown in the source material.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOctreotide and Somatostatin Analog Products — Coverage Criteria

Policy CodePolicy 1734-A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

Authorization of 12 months may be granted for treatment of pancreatic NETs

Well-differentiated grade 3 NETs with favorable biology (e.g., relatively low Ki-67 <55% and somatostatin receptor positive imaging)

Authorization of 12 months may be granted for treatment

GEP-NETs: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

Authorization of 12 months may be granted for treatment of GEP-NETs

injectable products only

Congenital hyperinsulinism (CHI): Authorization of 6 months may be granted for treatment of CHI and persistent hyperinsulinemic hypoglycemia of infancy (octreotide and Sandostatin only)

6-month authorization

AIDS-associated severe secretory diarrhea: Authorization of 12 months may be granted when antimicrobial or anti-motility agents have become ineffective

injectable products only

Inoperable bowel obstruction in cancer: Authorization of 12 months may be granted for management of GI symptoms of inoperable bowel obstruction in members with cancer

injectable products only

Cancer-related diarrhea: Authorization of 12 months may be granted when the member has grade 3 or greater diarrhea per NCI CTCAEGrade 3+

injectable products only

Enterocutaneous fistula: Authorization of 12 months may be granted for management of volume depletion from enterocutaneous fistula

injectable products only

Gastroesophageal varices: Authorization of 6 months may be granted for treatment of acute bleeding of gastroesophageal varices associated with cirrhosis

6-month authorization

Pancreatic fistulas: Authorization of 6 months may be granted for prevention and treatment of pancreatic fistulas following pancreatic surgery

6-month authorization

Pituitary adenoma: Authorization of 12 months may be granted for treatment of pituitary adenoma (injectable products only)

injectable products only

Short bowel syndrome: Authorization of 12 months may be granted when the daily intravenous fluid requirement is greater than 3 liters> 3 liters/day

injectable products only

IGF-1 decreased or normalized

NETs and other listed oncology/GI indications continuation: Authorization of 12 months may be granted for continued treatment when the member is experiencing clinical benefit as evidenced by improvement or stabilization in clinical signs and symptoms since initiation of therapyclinical benefit demonstrated

Includes NETs, carcinoid syndrome, VIPomas, pheochromocytoma/paraganglioma, thymomas/thymic carcinomas, AIDS-associated diarrhea, bowel obstruction, cancer-related diarrhea, and Zollinger-Ellison syndrome (injectable products only)

Authorization may be granted when grade 3+ is documented

Daily IV fluid requirement for short bowel syndrome — > 3 liters

SBS daily IV fluid thresholdGreater than 3 liters per day

IndicationShort bowel syndrome (injectable products)

Authorization durationMay be granted for 12 months when threshold met

IGF-1 response for acromegaly continuation — decreased or normalized since initiation

IGF-1 treatment responseMember's IGF-1 level has decreased or normalized since initiation of therapy

Use caseRequired for authorization of continued acromegaly therapy (12-month reauthorization possible)

DocumentationChart notes or laboratory report must document decreased or normalized IGF-1

Short bowel syndrome authorization threshold — Authorization may be granted when daily IV fluid requirement > 3 liters.

Authorization triggerAuthorization may be granted when the patient's daily IV fluid requirement is greater than 3 liters

Applicable productsInjectable octreotide products

Typical durationAuthorization of 12 months may be granted when threshold is met

Acromegaly continuation criterion — Continuation authorized when IGF-1 decreased or normalized since initiation.

Continuation criterionContinuation authorized when the member's IGF-1 level has decreased or normalized since initiation of therapy

Applicable toAcromegaly continuation (injectable products and Mycapssa where applicable)

Authorization durationAuthorization of 12 months may be granted for continuation when criterion met

IGF-1 requirement — Laboratory measurement of IGF-1 required pretreatment and for continuation to document normalization/decrease.

IGF-1 laboratory measurementLaboratory measurement of insulin-like growth factor-1 (IGF-1) required pretreatment and for continuation to document normalization or decrease

Initial documentationPretreatment laboratory report indicating high IGF-1 for age/gender

Continuation documentationLaboratory report showing normal or decreased IGF-1 or chart notes documenting decrease/normalization

Documentation Required

Required Documentation for Prior Authorization

Provide the following documentation with initial and continuation prior authorization requests to allow timely review.

Initial approval — Acromegaly: laboratory report showing elevated pretreatment insulin-like growth factor-1 (IGF-1) for age/gender per lab reference range, and chart notes documenting inadequate or partial response to surgery or radiotherapy OR a clinical reason why surgery or radiotherapy was not performed. For Mycapssa (oral octreotide) requests: documentation member previously responded to and tolerated injectable octreotide or lanreotide.
Initial approval — Cancer-related diarrhea (injectable products only): chart notes documenting Grade 3 or 4 diarrhea per NCI CTCAE.
Continuation requests — Acromegaly: laboratory report showing current normal IGF-1 or chart notes documenting that IGF-1 has decreased or normalized since therapy initiation.
Continuation requests — Other indications (NETs, carcinoid syndrome, VIPomas, pheochromocytoma/paraganglioma, thymic tumors, AIDS-associated diarrhea, bowel obstruction, cancer-related diarrhea, Zollinger-Ellison syndrome): documentation of clinical benefit (improvement or stabilization of clinical signs/symptoms) since initiation of therapy.
Short bowel syndrome (injectable products only): documentation that daily intravenous fluid requirement is greater than 3 liters to qualify for authorization.
Indication-specific duration: note the authorization period requested (e.g., 12 months for most injectable indications; 6 months for congenital hyperinsulinism and certain acute indications such as gastroesophageal variceal bleeding or pancreatic fistula prevention).

Documentation Required

Continuation (Reauthorization) Documentation Requirements

For continuation (reauthorization) requests, submit objective evidence of benefit or meet the initial authorization criteria if applicable. For acromegaly reauthorizations specifically, provide IGF-1 results demonstrating decreased or normalized levels or clinical notes documenting symptomatic improvement/stabilization.

All members requesting continuation of therapy for indications not covered under specific continuation rules must meet all initial authorization criteria.
When clinical benefit is not documented, the request may be denied.
Include recent laboratory reports and relevant clinic notes with dates and provider signature where available.

Initial requirementPretreatment lab report showing high IGF-1 for age/gender

Continuation evidenceReport showing decreased or normalized IGF-1 since therapy initiation

Short bowel syndrome authorization threshold — Authorization may be granted when the patient's daily intravenous fluid requirement is greater than 3 liters.

Authorization thresholdAuthorization may be granted when the patient's daily intravenous fluid requirement is greater than 3 liters

IndicationShort bowel syndrome (injectable products only)

Typical durationAuthorization of 12 months may be granted when threshold is met

Acromegaly continuation criterion — Continuation authorized when the member's IGF-1 level has decreased or normalized since initiation of therapy.

Continuation authorizationContinuation authorized when the member's IGF-1 level has decreased or normalized since initiation of therapy

Applies toAcromegaly continuation (injectable products and Mycapssa where applicable)

DocumentationLaboratory report or chart notes must document IGF-1 decrease/normalization