CurrentNeighborhood Health Plan of Rhode IslandPolicy 1734-A

Octreotide products (injectable and oral) coverage

Defines covered indications, prior authorization documentation, and authorization durations for octreotide products (brand and generic, injectable and oral) for members of Neighborhood Health Plan of Rhode Island when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOctreotide products (injectable and oral) coverage

Policy CodePolicy 1734-A

Change TypeMinor or no change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation (e.g., pretreatment IGF-1 for acromegaly or clinical notes demonstrating benefit) to request coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration for most indications

6 monthsCHI, variceal bleeding, pancreatic fistulas

multipleformulations

>3 L/dayshort bowel criterion

clinical benefitreauthorization requirement

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Coverage Criteria for Octreotide Products

Acromegaly (initial and continuation)

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

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

Initial: lab report demonstrating high pretreatment IGF-1 required; continuation requires documentation of decreased or normalized IGF-1

Acromegaly criteria: 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.

Chart notes documenting prior surgery/radiotherapy failure or clinical contraindication required

Acromegaly criteria: For Mycapssa requests, member has previously responded to and tolerated treatment with octreotide or lanreotide (when applicable).

Prior exposure requirement applies to oral Mycapssa formulations

Neuroendocrine Tumors (NETs)

Authorization of 12 months may be granted for treatment when criteria for the specific NET location are met:

NETs - GI tract, lung, thymus: Authorization of 12 months may be granted for treatment of NETs of the gastrointestinal (GI) tract, lung, and thymus (carcinoid tumors).

Injectable products only

NETs - pancreatic islet cell tumors: Authorization of 12 months may be granted for treatment of NETs of the pancreas (islet cell tumors), including gastrinomas, glucagonomas, and insulinomas.

Injectable products only

Gastroenteropancreatic NETs (GEP-NETs): Authorization of 12 months may be granted for treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Injectable products only

Carcinoid syndrome and VIPomas

Authorization of 12 months may be granted for symptomatic management:

Carcinoid syndrome: Treatment of carcinoid syndrome for symptom control (e.g., diarrhea, flushing).

Injectable products only; effect on tumor size/growth not established

VIPomas: Management of symptoms related to hormone hypersecretion of VIPomas.

Injectable products only

Other covered indications and durations

Other covered indications with specified authorization durations:

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

Injectable products only

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

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).

Duration: 6 months

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

Authorization durations and reauthorization criteria

Authorization may be granted for the following indications with specified durations and reauthorization requirements

6-month authorizations: Authorization of 6 months may be granted for treatment of acute bleeding of gastroesophageal varices associated with cirrhosis, and for prevention and treatment of pancreatic fistulas following pancreatic surgery.

See applicable indication-specific criteria

12-month authorizations: Authorization of 12 months may be granted for pituitary adenoma; short bowel syndrome when the daily intravenous fluid requirement is greater than 3 liters; Zollinger-Ellison syndrome; meningiomas when used in combination with everolimus for surgically inaccessible recurrent or progressive disease; and for continuation of therapy for acromegaly when the member's IGF-1 level has decreased or normalized since initiation of therapy.short bowel > 3 L; IGF-1 decreased/normalized

See applicable indication-specific criteria

Reauthorization for NETs and other listed indications: 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 therapy.

All indications not explicitly listed in this policy are considered experimental/investigational and not medically necessary. Requests for therapies using octreotide products for conditions outside the covered and compendial uses enumerated in this document may be denied.

Members requesting authorization for continuation of octreotide therapy — including newly enrolled members seeking to continue an existing regimen — must meet all requirements specified in the coverage criteria. Failure to meet the coverage criteria for continuation may result in denial of the request.

Use of octreotide products for indications outside the FDA-approved and compendial uses listed in this policy is considered not medically necessary. Providers should not submit requests for off-label uses that are not included in the policy's covered or compendial lists.

Prior Authorization, Documentation, and Continuation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization durations vary by indication (typically 6 or 12 months as specified below).

Prior authorization durations: Typically 12 months for most indications (acromegaly, NETs, carcinoid syndrome, VIPomas, pheochromocytoma/paraganglioma, thymomas/thymic carcinomas, AIDS-associated diarrhea, inoperable bowel obstruction, cancer-related diarrhea, enterocutaneous fistula, pituitary adenoma, short bowel syndrome when IV fluids >3 L/day, Zollinger-Ellison syndrome, meningiomas when used with everolimus). Prior authorization duration of 6 months applies to gastroesophageal varices and pancreatic fistulas. CHI/persistent hyperinsulinemic hypoglycemia: 6 months.

Documentation Required

Documentation Required for Prior Authorization

Submit the specified documentation to initiate prior authorization review. Incomplete documentation may delay or result in denial.

Acromegaly — Initial requests: laboratory report showing high pretreatment IGF-1 for age/gender and chart notes documenting inadequate or partial response to surgery or radiotherapy, or clinical reason for not having surgery/radiotherapy.

Referenced Drugs, Tests, and Key Clinical Thresholds

Referenced drug productsNDC

Sandostatin	octreotide acetate injection (brand)
Bynfezia Pen	octreotide acetate injection (brand)
Mycapssa	octreotide delayed-release capsule (brand)
Sandostatin LAR Depot	octreotide acetate for injectable suspension (long-acting)

IGF-1 (acromegaly)

DefinitionHigh pretreatment IGF-1 for age and/or gender based on the laboratory reference range is required for initial acromegaly authorization.

Initial requirementDocumented high pretreatment IGF-1 is required for diagnosis and authorization of therapy for acromegaly.

Continuation requirementFor continuation of therapy, IGF-1 must have decreased or normalized since initiation of therapy.

NCI CTCAE diarrhea grade

ThresholdGrade 3 or greater per NCI CTCAE is required for cancer-related diarrhea authorization.

ScopeApplies to injectable octreotide products for cancer-related diarrhea.

Drug and Term Definitions

Sandostatin LAR / long-acting injectable

ProductSandostatin LAR (long‑acting octreotide injectable) — indicated for long‑term maintenance in acromegaly and long‑term treatment of carcinoid and VIPoma‑associated severe diarrhea/flushing in patients who responded to and tolerated short‑acting octreotide.

FDA noteSandostatin LAR is indicated for patients who have responded to and tolerated Sandostatin Injection for long‑term maintenance in acromegaly.

LimitationEffect on tumor size/growth in carcinoid syndrome/VIPomas not established (limitations of use).

Mycapssa

ProductMycapssa (oral delayed‑release octreotide capsule) — indicated for long‑term maintenance in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

Prior exposure requirement

Background and Clinical Context

Octreotide products are somatostatin analogues used clinically to reduce growth hormone and insulin-like growth factor-1 in acromegaly and to manage symptoms such as diarrhea and flushing associated with carcinoid syndrome and vasoactive intestinal peptide (VIP)–secreting tumors (VIPomas). Long-acting injectable formulations are commonly used for maintenance therapy in patients who have responded to and tolerated short-acting octreotide; injectable products also have multiple compendial uses across a range of neuroendocrine tumors and gastrointestinal indications.

Policy Revision History

2025-07policy updateLatest

Policy reference materials and package inserts updated (Sandostatin LAR Depot and Sandostatin) and supporting references refreshed; document version referenced as 1734-A for P2025.

2024-11-11reference update

Multiple NCCN and reference access dates recorded for guideline citations used in policy (NCCN compendia and guideline versions accessed).

2024-09

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOctreotide products (injectable and oral) coverage

Policy CodePolicy 1734-A

Change TypeMinor or no change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation (e.g., pretreatment IGF-1 for acromegaly or clinical notes demonstrating benefit) to request coverage.

SourceLink

On This Page

Injectable products only

Inoperable bowel obstruction in cancer: Authorization of 12 months may be granted for management of GI symptoms (e.g., nausea, pain, vomiting) of inoperable bowel obstruction in cancer.

Injectable products only

Cancer-related diarrhea: Authorization of 12 months may be granted for treatment of cancer-related diarrhea when the member has grade 3 or greater diarrhea per NCI CTCAE.NCI CTCAE grade >=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 - acute bleeding: Authorization of 6 months may be granted for treatment of acute bleeding of gastroesophageal varices associated with cirrhosis.

Duration: 6 months; injectable products only

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

Duration: 6 months; injectable products only

clinical benefit evidenced by improvement or stabilization

Applies to NETs, carcinoid syndrome, VIPomas, pheochromocytoma/paraganglioma, thymomas/thymic carcinomas, AIDS-associated diarrhea, bowel obstruction, cancer-related diarrhea, Zollinger-Ellison syndrome, and meningiomas

Continuation therapy general rule: All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria.

Failure to meet criteria may result in denial

Acromegaly — Continuation requests: laboratory report showing current normalized or decreased IGF-1 since initiation of therapy, or chart notes documenting decreased/normalized IGF-1.

For Mycapssa requests: documentation that the member previously responded to and tolerated treatment with octreotide or lanreotide.

Cancer-related diarrhea: chart notes documenting grade 3 or 4 diarrhea (NCI CTCAE).

Documentation Required

Evidence Needed for Continuation/Reauthorization

Continuation/reauthorization will be granted only when evidence of benefit and all coverage requirements are met.

Acromegaly — Continuation: documentation showing decreased or normalized IGF-1 since treatment initiation; authorization typically for 12 months.
NETs, Carcinoid syndrome, VIPomas, Pheochromocytoma/Paraganglioma, Thymomas/Thymic carcinomas, AIDS-associated diarrhea, Inoperable bowel obstruction, Cancer-related diarrhea, Zollinger-Ellison syndrome, Meningiomas — Continuation/reauthorization: documentation of clinical benefit evidenced by improvement or stabilization in clinical signs and symptoms since initiation of therapy; authorization typically 12 months.
Gastroesophageal varices and Pancreatic fistulas — Continuation: follow-up documentation as clinically appropriate; authorizations typically 6 months.
Short bowel syndrome — Continuation: member must continue to meet requirement of daily IV fluid requirement >3 L/day; authorization typically 12 months.

Documentation Required

Continuation Therapy Requirements

Members requesting continuation (including new members transferring care) must meet all applicable coverage criteria and provide required documentation to support ongoing therapy.

All continuation requests must include the same coverage criteria elements required for initial approval where applicable and the continuation evidence noted above.
Failure to provide required documentation (e.g., pretreatment and/or current IGF-1 for acromegaly, clinical notes demonstrating benefit) may result in denial or delay of reauthorization.

DocumentationChart notes should document NCI CTCAE grade to support prior authorization request.

Daily IV fluid requirement (short bowel syndrome)

ThresholdDaily intravenous fluid requirement greater than 3 liters (>3 L/day) is required for short bowel syndrome authorization.

ScopeApplies to injectable octreotide products for short bowel syndrome.

Authorization durationWhen criterion met, authorization of 12 months may be granted.

For Mycapssa requests, member must have previously responded to and tolerated octreotide or lanreotide.

Use caseApproved for long‑term maintenance following demonstrated response/tolerability to injectable somatostatin analogues.

Short bowel syndrome (authorization criterion)

Authorization conditionTreatment authorization for short bowel syndrome may be granted when the member's daily IV fluid requirement is greater than 3 liters.

Product scopeApplies to injectable octreotide products (short bowel syndrome criterion specified for injectables).

DurationWhen criterion met, authorization of 12 months may be granted.

Acromegaly continuation criterion

Continuation conditionContinuation of therapy for acromegaly is authorized when the member's IGF-1 level has decreased or normalized since initiation of therapy.

DocumentationContinuation requests should include current lab report showing decreased or normalized IGF‑1.

DurationContinuation authorizations are typically issued for 12 months when continuation criteria are met.

Clinical benefit for reauthorization

RequirementReauthorization requires evidence of clinical benefit demonstrated by improvement or stabilization in clinical signs and symptoms since initiation of therapy.

Applies toNETs, carcinoid syndrome, VIPomas, pheochromocytoma/paraganglioma, thymomas, AIDS‑associated diarrhea, bowel obstruction, cancer‑related diarrhea, Zollinger‑Ellison syndrome, and meningiomas (injectable products only).

DocumentationChart notes documenting clinical improvement or stabilization should be submitted for reauthorization requests.

package insert update

Bynfezia Pen package insert (Sun Pharmaceutical) dated September 2024 added to references.

2024-08package insert update

Mycapssa (oral octreotide) package insert (Amryt Pharmaceuticals) dated August 2024 added to references and cited for indications/limitations.

2024-01package insert update

Octreotide acetate for injectable suspension (Teva) package insert dated January 2024 added to references.