CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Octreotide Products 1734 A Sgm P2023

Defines covered indications, required documentation, initial and continuation authorization criteria, and authorization durations for octreotide products (including octreotide acetate, Sandostatin, Sandostatin LAR, Bynfezia Pen, and Mycapssa). Applies to injectable products and Mycapssa as specified; other uses are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOctreotide Products 1734 A Sgm P2023

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation (IGF-1 lab reports and chart notes showing prior surgery/radiotherapy response or clinical reason for not having surgery/radiotherapy; for cancer-related diarrhea submit chart notes documenting grade 3 or 4 diarrhea).

SourceLink

POLICY UPDATE CHANGES

No material changes

ManyCovered Indications (FDA or compendial)

Other usesConsidered experimental/investigational

12 monthsTypical authorization duration

6 monthsShorter authorizations (selected)

This policy applies to multiple octreotide products including injectable formulations (octreotide acetate, Sandostatin, Sandostatin LAR, Bynfezia Pen) and the oral formulation Mycapssa as specified. Coverage is mixed: FDA-approved indications and specified compendial uses are considered covered when the policy’s approval criteria and required documentation are met, while all other uses are considered experimental/investigational and not medically necessary.

Covered Indications (general)

The FDA-approved indications and compendial uses below are considered covered provided all approval criteria are met and the member has no exclusions to the prescribed therapy.

ALL of the following

FDA-Approved Indications (selected products)
- Octreotide acetate / Sandostatin / Bynfezia Pen: acromegaly for reduction of GH and IGF-1 when inadequate response to or cannot be treated with surgery, pituitary irradiation, and bromocriptine at maximally tolerated doses.
- Octreotide acetate / Sandostatin / Bynfezia Pen: symptomatic treatment of metastatic carcinoid tumors to suppress severe diarrhea and flushing.
- Octreotide acetate / Sandostatin / Bynfezia Pen: treatment of profuse watery diarrhea associated with VIP-secreting tumors.
- Sandostatin LAR: long-term maintenance therapy in acromegalic patients who have responded to and tolerated Sandostatin subcutaneous injection.
- Sandostatin LAR: long-term treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
- Sandostatin LAR: long-term treatment of profuse watery diarrhea associated with VIP-secreting tumors.
- Mycapssa: long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
- Octreotide and Sandostatin: congenital hyperinsulinism (CHI)/persistent hyperinsulinemic hypoglycemia of infancy (PHHI).
- Octreotide products (injectable): AIDS-associated diarrhea.
- Octreotide products (injectable): inoperable bowel obstruction.
- Octreotide products (injectable): cancer-related diarrhea.
- Octreotide products (injectable): enterocutaneous fistula.
- Octreotide products (injectable): gastroesophageal varices (acute bleeding associated with cirrhosis).
- Octreotide products (injectable): pancreatic fistulas.
- Octreotide products (injectable): pituitary adenoma.
- Octreotide products (injectable): short bowel syndrome.
- Octreotide products (injectable): Zollinger-Ellison syndrome.
Compendial Uses (injectable products only)
- Neuroendocrine tumors (NETs): GI tract, lung, thymus (carcinoid tumors).
- Neuroendocrine tumors (NETs): tumors of the pancreas (islet cell tumors).
- Well-differentiated grade 3 NETs with favorable biology.
- Gastroenteropancreatic NETs (GEP-NETs).
- Pheochromocytoma and paraganglioma.
- Thymomas and thymic carcinomas.

Prior Authorization & Documentation Requirements

Documentation required to initiate prior authorization

Submission of the following information is necessary to initiate prior authorization review:

ALL of the following

Acromegaly initial vs continuation
- Initial approval: Laboratory report indicating high pretreatment IGF-1 for age/gender and chart notes indicating inadequate or partial response to surgery or radiotherapy OR clinical reason member has not had surgery or radiotherapy.
- Continuation: Laboratory report indicating normal current IGF-1 levels OR chart notes indicating IGF-1 has decreased or normalized since therapy initiation.
Cancer-related diarrhea: chart notes indicating grade 3 or 4 diarrhea.

Prior Authorization

Submit prior authorization with documentation

Prior authorization required with submission of laboratory reports (IGF-1) and chart notes demonstrating prior surgery/radiotherapy response or a clinical reason for not having surgery/radiotherapy for acromegaly. For cancer-related diarrhea initial requests, submit chart notes documenting grade 3 or 4 diarrhea.

Documentation Required

Demonstrate clinical benefit for reauthorization

For reauthorization of NETs, carcinoid syndrome, VIPomas, pheochromocytoma/paraganglioma, thymomas/thymic carcinomas, AIDS-associated diarrhea, bowel obstruction, cancer-related diarrhea, and Zollinger-Ellison syndrome provide documentation that the member is experiencing clinical benefit as evidenced by improvement or stabilization in clinical signs and symptoms since initiation of therapy.

Prior Authorization

Mycapssa-specific requirement

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

Initial Authorization Criteria and Durations

Initial Authorization Criteria and Durations (by indication)

Authorization durations and specific initial criteria per indication.

ALL of the following

Acromegaly (initial)
- Authorization of 12 months may be granted when member has a high pretreatment IGF-1 level for age/gender.
- Member had inadequate or partial response to surgery or radiotherapy OR there is a clinical reason why the member has not had surgery or radiotherapy.
- For Mycapssa requests: member has previously responded to and tolerated treatment with octreotide or lanreotide.
Neuroendocrine tumors (NETs) - injectable products
- Authorization of 12 months may be granted for NETs of the GI tract (carcinoid tumor).
- Authorization of 12 months may be granted for NETs of the thymus (carcinoid tumor).
- Authorization of 12 months may be granted for NETs of the lung (carcinoid tumor).
- Authorization of 12 months may be granted for NETs of the pancreas, including gastrinomas, glucagonomas, and insulinomas.
- Authorization of 12 months may be granted for well-differentiated grade 3 NETs with favorable biology (e.g., relatively low Ki-67 <55%, SSR positive imaging).
- Authorization of 12 months may be granted for treatment of GEP-NETs.
Carcinoid syndrome (injectable products only): Authorization of 12 months may be granted for treatment.
VIPomas (injectable products only): Authorization of 12 months may be granted for management of symptoms related to hormone hypersecretion.
Pheochromocytoma and paraganglioma (injectable products only): Authorization of 12 months may be granted for treatment.
Thymomas and thymic carcinomas (injectable products only): Authorization of 12 months may be granted for treatment.
Congenital hyperinsulinism/PHHI (octreotide and Sandostatin only): Authorization of 6 months may be granted for treatment in an infant.
AIDS-associated diarrhea (injectable products only): Authorization of 12 months when anti-microbials or anti-motility agents have become ineffective.
Inoperable bowel obstruction in cancer (injectable products only): Authorization of 12 months for management of GI symptoms.
Cancer-related diarrhea (injectable products only): Authorization of 12 months when member has grade 3 or greater diarrhea per NCI CTCAE.
Enterocutaneous fistula (injectable products only): Authorization of 12 months for management of volume depletion.
Gastroesophageal varices (injectable products only): Authorization of 6 months for treatment of acute bleeding associated with cirrhosis.
Pancreatic fistulas (injectable products only): Authorization of 6 months for prevention and treatment following pancreatic surgery.
Pituitary adenoma (injectable products only): Authorization of 12 months for treatment.
Short bowel syndrome (injectable products only): Authorization of 12 months may be granted when daily IV fluid requirement is greater than 3 liters.
Zollinger-Ellison syndrome (injectable products only): Authorization of 12 months for treatment.

Key clinical thresholds for initial authorization

IGF-1 pretreatmentHigh for age and/or gender per laboratory reference range

Ki-67 (well-differentiated grade 3 NETs)< 55% (example threshold indicating favorable biology)

NCI CTCAE diarrhea grade>= grade 3

Short bowel syndrome IV fluids> 3 liters/day (daily IV fluid requirement)

Continuation / Reauthorization Criteria

Criteria for continued therapy and reauthorization.

ANY of the following

Acromegaly: Authorization of 12 months may be granted for continuation when member's IGF-1 level has decreased or normalized since initiation of therapy.
NETs, carcinoid syndrome, VIPomas, pheochromocytoma/paraganglioma, thymomas/thymic carcinomas, AIDS-associated diarrhea, bowel obstruction, cancer-related diarrhea, and Zollinger-Ellison syndrome: Authorization of 12 months may be granted for continued treatment when member is experiencing clinical benefit as evidenced by improvement or stabilization in clinical signs and symptoms since initiation of therapy.
All other indications: members requesting continuation must meet all initial authorization criteria (including new members).

Clinical Evidence and Background

Octreotide products are somatostatin analogues available in multiple brands and formulations with FDA indications that include acromegaly, symptomatic treatment of metastatic carcinoid tumors, VIPomas, and other conditions; Sandostatin LAR and Mycapssa have specific labeled maintenance indications. Injectable octreotide products also have compendial uses for various neuroendocrine tumors and other surgical/oncologic complications. The policy references product package inserts and clinical guidelines and cites evidence sources including package inserts, the NCCN compendia, clinical practice guidelines, and multiple clinical trials and systematic reviews (see evidence list).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOctreotide Products 1734 A Sgm P2023

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Octreotide Products 1734 A Sgm P2023

Coverage Summary and Covered Indications

Prior Authorization & Documentation Requirements

Initial Authorization Criteria and Durations

Continuation / Reauthorization Criteria

Exclusions / Not Medically Necessary

Applicable Codes

Clinical Evidence and Background

Definitions & Thresholds

Revision History