CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medicaid_Octreotide_20250709 1

Defines Medicaid coverage and authorization durations for octreotide (Sandostatin) for FDA-approved indication acromegaly and compendial use congenital hyperinsulinism (CHI)/persistent hyperinsulinemic hypoglycemia of infancy, including documentation and continuation requirements.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedicaid_Octreotide_20250709 1

Policy CodePolicy N/A

Change TypeClarified (references updated through 2024 package inserts)

Effective Date06/01/2020

Next Review Date

Key ActionProviders must obtain prior authorization: 12-month authorization for acromegaly (initial and continuation when IGF-1 decreased/normalized); 6-month authorization for CHI initial; continuation requests must meet initial criteria.

SourceLink

POLICY UPDATE CHANGES

Reviewed dates listed: 3/2020, 7/2021, 5/2022; references updated through 2024 package insert citations.

2Covered Indications (listed)

12 moAuth length - acromegaly

6 moAuth length - CHI initial

0.86Confidence

Coverage stance: covered_with_criteria for octreotide (Sandostatin) for acromegaly (FDA-approved) and for congenital hyperinsulinism (CHI) as a compendial use. Scope: Defines Medicaid coverage and authorization durations for octreotide (Sandostatin) for FDA-approved acromegaly and compendial CHI/persistent hyperinsulinemic hypoglycemia of infancy, including documentation and continuation requirements. Authorization lengths: 12 months for acromegaly and 6 months for CHI initial authorization. Authorization for acromegaly requires documentation of a high pretreatment IGF-1 level for age and/or gender per laboratory reference range.

Policy Quick Facts

Covered Indications2

Standard authorization length for acromegaly12 months

Initial authorization length for CHI (infants)6 months

IGF-1 threshold noteHigh pretreatment for age and/or gender per laboratory reference range

Initial Therapy Criteria

Acromegaly - Initial Authorization

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

ALL of the following

IGF-1 pretreatment: Documentation that the member has a high pretreatment insulin-like growth factor-1 (IGF-1) level for age and/or gender based on the laboratory reference rangeHigh pretreatment for age and/or gender based on laboratory reference range
Surgery or radiotherapy response
- Inadequate or partial response to surgery or radiotherapy
- Clinical reason not to perform surgery or radiotherapy: Clinical reason why the member has not had surgery or radiotherapy

Congenital hyperinsulinism (CHI) / Persistent hyperinsulinemic hypoglycemia of infancy - Initial Authorization

Authorization of 6 months may be granted with documentation when ALL of the following are met:

ALL of the following

CHI / PHHI documentation: Documentation of CHI and persistent hyperinsulinemic hypoglycemia in an infant

All other indications (including new members requesting continuation)

Members requesting authorization with documentation for continuation of therapy must meet ALL initial authorization criteria:

Must meet initial criteria: Must meet the applicable initial authorization criteria for the indication requested

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Continuation Therapy Criteria

Acromegaly - Continuation Authorization

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

ALL of the following

IGF-1 response: Documentation that the member's IGF-1 level has decreased or normalized since initiation of therapyDecreased or normalized since initiation of therapy

Continuation requests for CHI must meet the same initial authorization criteria. Members requesting authorization with documentation for continuation of therapy must meet ALL initial authorization criteria (see 'All other indications').

Provider Actions

Prior Authorization

Authorization required

Providers must obtain prior authorization before initiating or continuing therapy. For acromegaly, authorization of 12 months may be granted for initial treatment and for continuation when the member's IGF-1 level has decreased or normalized since initiation. For congenital hyperinsulinism (CHI)/persistent hyperinsulinemic hypoglycemia of infancy, authorization of 6 months may be granted for initial treatment. Continuation requests for CHI or other indications must meet the applicable initial criteria.

Acromegaly — 12-month authorization (initial; continuation when IGF‑1 decreased/normalized)
Congenital hyperinsulinism (CHI)/PHHI — 6-month initial authorization

Documentation Required

Required clinical documentation

Submit clinical documentation that includes a pretreatment IGF-1 level reported as high for the patient’s age and/or gender based on the laboratory reference range. For acromegaly, document an inadequate or partial response to surgery or radiotherapy OR provide a clinical reason why surgery or radiotherapy was not performed. For CHI, submit documentation confirming congenital hyperinsulinism and persistent hyperinsulinemic hypoglycemia in an infant.

Clinical Evidence & Guidelines

Evidence includes package inserts: Octreotide acetate (Mylan, July 2024), Sandostatin (Novartis, November 2023), and Sandostatin LAR Depot (Novartis, July 2023). Guidelines cited include the Endocrine Society and AACE acromegaly guidelines. CHI is listed as a compendial use.

Background

Background: Octreotide (Sandostatin) is indicated by the FDA for the treatment of acromegaly to reduce growth hormone and IGF-1 in patients who have had inadequate response to or cannot undergo surgery, pituitary irradiation, or bromocriptine. It also has compendial use for congenital hyperinsulinism/persistent hyperinsulinemic hypoglycemia of infancy (CHI/PHHI). Coverage is conditional on meeting laboratory thresholds (e.g., documentation of high pretreatment IGF-1 for age and/or gender per lab reference range), prior therapy criteria (inadequate/partial response to or contraindication to surgery or radiotherapy), and appropriate documentation as required for authorization.

Definitions

IGF-1 (definition)Insulin-like growth factor-1; lab requirement: high pretreatment for age and/or gender based on laboratory reference range

CHI (term mapping)Congenital hyperinsulinism / persistent hyperinsulinemic hypoglycemia of infancy

Revision History

2024-07references_updatedLatest

Document includes package insert references through July 2024 (Octreotide acetate Mylan, July 2024) and Sandostatin insert Nov 2023; references list updated through 2024.

2022-05-01reviewed

Reviewed dates listed: 3/2020, 7/2021, 5/2022.

2021-07reviewed

Reviewed dates listed: 3/2020, 7/2021, 5/2022.

2020-03reviewed

Reviewed dates listed: 3/2020, 7/2021, 5/2022.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedicaid_Octreotide_20250709 1

Policy CodePolicy N/A

Change TypeClarified (references updated through 2024 package inserts)

Effective Date06/01/2020

Next Review Date

SourceLink

On This Page

OpenPayer

Medicaid_Octreotide_20250709 1

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Provider Actions

Applicable Codes

Clinical Evidence & Guidelines

Background

Revision History