CurrentNeighborhood Health Plan of Rhode IslandPolicy 1734-A

Octreotide products (injectable and oral) — Coverage and Prior Authorization Criteria

Clinical coverage and prior authorization criteria for octreotide products (including Sandostatin, Bynfezia Pen, Mycapssa, Sandostatin LAR) for multiple indications; governs authorization decisions for Neighborhood Health Plan of Rhode Island members. Applies to covered indications when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOctreotide products (injectable and oral) — Coverage and Prior Authorization Criteria

Policy CodePolicy 1734-A

Change TypeNo material changes noted

Effective Date

Next Review Date

Key ActionObtain prior authorization with required clinical documentation (e.g., pretreatment IGF-1 for acromegaly, evidence of clinical benefit for NETs) to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration for most adult indications

6 monthsselect indications duration

Severalcovered compendial uses listed

>3 L/dayshort bowel syndrome IV threshold

Multiple

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Indication-specific Coverage Criteria

Acromegaly

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

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

Documented pretreatment laboratory report required for initial authorization.

Acromegaly initial/maintenance 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 should document prior surgical/radiation attempts or clinical rationale for not performing these procedures.

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

Prior documentation of response and tolerability to octreotide or lanreotide required.

Neuroendocrine Tumors (NETs)

Authorization of 12 months may be granted when treating the following NETs (injectable products only):

NET types: NETs of the gastrointestinal tract, lung, and thymus (carcinoid tumors).

Injectable octreotide products only.

NET types: NETs of the pancreas (islet cell tumors), including gastrinomas, glucagonomas, and insulinomas.

Injectable octreotide products only.

NET types: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Injectable octreotide products only.

Carcinoid Syndrome

Authorization of 12 months may be granted for:

Carcinoid syndrome: Treatment of carcinoid syndrome with injectable octreotide products.

Injectable products only.

Vasoactive Intestinal Peptide Tumors (VIPomas)

Authorization of 12 months may be granted for:

VIPomas: Management of symptoms related to hormone hypersecretion of vasoactive intestinal peptide tumors (VIPomas) with injectable octreotide products.

Injectable products only.

Pheochromocytoma and Paraganglioma

Authorization of 12 months may be granted for:

Pheochromocytoma and Paraganglioma: Treatment of pheochromocytoma and paraganglioma with injectable octreotide products.

Injectable products only.

Thymomas and Thymic Carcinomas

Authorization of 12 months may be granted for:

Thymomas/Thymic carcinomas: Treatment of thymomas and thymic carcinomas with injectable octreotide products.

Injectable products only.

Congenital Hyperinsulinism (CHI)/PHHI

Authorization of 6 months may be granted for:

Congenital hyperinsulinism (CHI)/PHHI: Treatment of congenital hyperinsulinism/persistent hyperinsulinemic hypoglycemia of infancy with octreotide or Sandostatin in infants.

Duration limited to 6 months per policy.

AIDS-Associated Diarrhea

Authorization of 12 months may be granted for:

AIDS-associated severe secretory diarrhea: Treatment when anti-microbial (e.g., ciprofloxacin, metronidazole) or anti-motility agents (e.g., loperamide, diphenoxylate/atropine) have become ineffective.

Injectable products only.

Inoperable Bowel Obstruction in Cancer

Authorization of 12 months may be granted for:

Inoperable bowel obstruction: Management of gastrointestinal symptoms (e.g., nausea, pain, vomiting) of inoperable bowel obstruction in members with cancer using injectable octreotide.

Injectable products only.

Cancer-Related Diarrhea

Authorization of 12 months may be granted for:

Cancer-related diarrhea: Treatment of cancer-related diarrhea when the member has grade 3 or greater diarrhea according to NCI CTCAE.grade 3+

Documentation must indicate grade 3 or greater per NCI CTCAE.

Enterocutaneous Fistula

Authorization of 12 months may be granted for:

Enterocutaneous fistula: Management of volume depletion from enterocutaneous fistula with injectable octreotide.

Injectable products only.

Gastroesophageal Varices

Authorization of 6 months may be granted for:

Gastroesophageal varices: Treatment of acute bleeding of gastroesophageal varices associated with cirrhosis using injectable octreotide.

Duration limited to 6 months per policy.

Pancreatic Fistulas

Authorization of 6 months may be granted for:

Pancreatic fistulas: Prevention and treatment of pancreatic fistulas following pancreatic surgery with injectable octreotide.

Duration limited to 6 months per policy.

Indication-specific Authorization Criteria and Continuation Conditions

Covered when indication-specific authorization and continuation criteria are met

Gastroesophageal Varices (injectable products only): Authorization of 6 months may be granted for treatment of acute bleeding of gastroesophageal varices associated with cirrhosis.

See documentation and duration limits.

Pancreatic Fistulas (injectable products only): Authorization of 6 months may be granted for prevention and treatment of pancreatic fistulas following pancreatic surgery.

See documentation and duration limits.

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

Injectable products only.

Short Bowel Syndrome (injectable products only):

Coverage for octreotide and related products is limited to the FDA‑approved indications and the compendial uses listed in this policy. All other indications are considered experimental/investigational and are not medically necessary and therefore are not covered.

Requests to continue or renew therapy are subject to prior authorization and must satisfy the applicable coverage criteria for the indication under which treatment was originally authorized. Continuation approvals are not automatic; the member must continue to meet the specified criteria in this policy.

Use of octreotide products for indications that are not listed among the FDA‑approved indications or the compendial uses in this policy is not medically necessary and may be denied.

When submitting a continuation request, providers must document that the member continues to meet the coverage criteria for the covered indication. Failure to meet the criteria for continuation may result in denial of the request.

Key Coding & Definition Items

Daily intravenous fluid requirement — threshold for authorization

Daily IV fluid requirement threshold> 3 liters per day

ContextUsed to determine 12-month authorization for short bowel syndrome when met

Product scopeApplies to injectable octreotide products for short bowel syndrome

Short bowel syndrome — authorization condition

Authorization duration12 months may be granted

CriterionMember's daily intravenous fluid requirement > 3 liters

Applies to

Prior Authorization & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all indications described in this policy. All uses not listed in the FDA‑approved indications or compendial uses are considered experimental/investigational and are not medically necessary.

All indications not explicitly listed in FDA‑approved or compendial sections are experimental/investigational and will be denied.
Prior authorization required for initial and continuation requests.

Documentation Required

Required Documentation for Prior Authorization

Submission of specified documentation is necessary to initiate prior authorization review. Insufficient documentation may result in denial or delay.

Acromegaly — Initial: 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 why surgery/radiotherapy was not performed.

Background and Drug Information

Octreotide is a synthetic somatostatin analogue that suppresses secretion of several hormones and neuropeptides. It is used clinically to reduce growth hormone and insulin‑like growth factor‑1 in acromegaly and to control the flushing and secretory diarrhea associated with carcinoid and vasoactive intestinal peptide‑secreting tumors. Long‑acting injectable formulations are commonly used for maintenance therapy after an initial response to short‑acting injections; an oral delayed‑release octreotide capsule (Mycapssa) is indicated for long‑term maintenance in patients who previously responded to and tolerated octreotide or lanreotide.

Definitions & Product Notes

Mycapssa — definition

ProductMycapssa (delayed‑release oral octreotide capsule)

Primary indicationLong‑term maintenance treatment in acromegaly patients who responded to and tolerated octreotide or lanreotide

Role in therapyOral maintenance option following response to short‑acting or long‑acting somatostatin analogs

Acromegaly — continuation criterion (IGF‑1)

Required biomarker changeIGF‑1 level decreased or normalized compared to pre‑treatment

Use caseCondition for 12‑month continuation authorization in acromegaly

Documentation

Policy Revision History

2025policy_release_referenceLatest

Policy reference number assigned as 1734-A; references list updated to include package inserts and guideline sources through 2025.

2024-11-11references_update

NCCN guideline and compendium references and other literature citations were accessed/updated as of November 11, 2024 and are cited in the references list.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOctreotide products (injectable and oral) — Coverage and Prior Authorization Criteria

Policy CodePolicy 1734-A

Change TypeNo material changes noted

Effective Date

Next Review Date

Key ActionObtain prior authorization with required clinical documentation (e.g., pretreatment IGF-1 for acromegaly, evidence of clinical benefit for NETs) to support approval.

SourceLink

On This Page

Authorization of 12 months may be granted for treatment when the daily intravenous fluid requirement is greater than 3 liters.

Documentation of IV fluid requirement required.

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

Injectable products only.

Meningiomas (injectable products only): Authorization of 12 months may be granted for treatment of meningiomas when used in combination with everolimus for surgically inaccessible recurrent or progressive disease.

Combination therapy with everolimus required per policy.

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

Laboratory documentation required for continuation.

NETs and other listed syndromes - 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 therapy.clinical benefit (improvement or stabilization)

Clinical documentation required for reauthorization.

All Other Indications: All members requesting authorization for continuation of therapy must meet all requirements in the coverage criteria.

Failure to meet coverage criteria may result in denial.

Short bowel syndrome (injectable products only)

Mycapssa — definition / indication

Drug descriptionDelayed‑release oral octreotide capsule (Mycapssa)

IndicationIndicated for long‑term maintenance treatment in acromegaly patients

PrerequisiteRequires prior response to and toleration of octreotide or lanreotide

Acromegaly — continuation criterion

Continuation requirementMember's IGF‑1 level has decreased or normalized since initiation of therapy

Authorization duration12 months may be granted for continuation when requirement met

Applies toAcromegaly continuation of octreotide therapy

Acromegaly — Continuation: laboratory report showing current normalized IGF‑1 or chart notes documenting that IGF‑1 has decreased or normalized since therapy initiation.

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

Documentation Required

Documentation Required for Continuation / Reauthorization

Continuation (reauthorization) approvals require documentation of ongoing benefit or meeting indication‑specific continuation criteria. Requests that do not meet continuation criteria or lack required documentation may be denied.

Acromegaly continuation — provide laboratory report with normalized or improved IGF‑1 or chart notes documenting IGF‑1 reduction/normalization.
Other indications — provide clinical documentation demonstrating improvement or stabilization in signs/symptoms since therapy initiation to support clinical benefit.
All continuation requests (including new members requesting ongoing therapy) must meet all coverage criteria; failure to meet criteria may result in denial.

Denial Risk

Continuation Requirements & Experimental/Investigational Exclusions

All members (including new members) requesting authorization for continuation of therapy must satisfy all applicable coverage criteria for the requested indication. Uses not meeting the coverage criteria are not covered.

Continuation requests will be reviewed against the full coverage criteria for the specific indication; missing elements may lead to denial.
Indications designated experimental/investigational will be denied as not medically necessary.
Ensure submission includes the same documentation required for initial approval plus evidence of continued clinical benefit when applicable.

Continuation requests must include lab report showing decreased or normalized IGF‑1