ModifiedmedimpactPolicy N/A

Somatostatin analog prior authorization criteria updates

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Updates to prior authorization (PA) criteria for somatostatin analog agents affecting Kentucky Medicaid prescribers and pharmacy providers (Fee-for-Service and MCO members). Effective September 1, 2026.

Policy Summary

Payermedimpact

PolicySomatostatin analog prior authorization criteria updates

Policy CodePolicy N/A

Change TypePrior authorization criteria update

Effective DateSep 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with diagnosis documentation per FDA Indications and provide progress notes, labs, or imaging to support renewals.

SourceLink

POLICY UPDATE CHANGES

Effective September 1, 2026, the Commonwealth of Kentucky DMS is making changes to the prior authorization criteria for listed somatostatin analog agents.

Renewal criteria require documentation of positive clinical response or disease stabilization demonstrated by clinical signs/symptoms, biochemical markers, imaging, or absence of clinically significant progression.

Initial approval requires a diagnosis supported by the FDA package insert Indications and Usage or a nationally recognized compendium and dosing within current FDA requirements.

Administration/site rules: medication must be administered by a home infusion provider or be self-administered with physician attestation per FDA prescribing information for initial approval in some situations.

2026-09-01Effective date of changes

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Somatostatin analog prior authorization criteria updates

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Policy Summary

Payermedimpact

PolicySomatostatin analog prior authorization criteria updates

Policy CodePolicy N/A

Change TypePrior authorization criteria update

Effective DateSep 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with diagnosis documentation per FDA Indications and provide progress notes, labs, or imaging to support renewals.

SourceLink

POLICY UPDATE CHANGES

Effective September 1, 2026, the Commonwealth of Kentucky DMS is making changes to the prior authorization criteria for listed somatostatin analog agents.

Initial approval requires a diagnosis supported by the FDA package insert Indications and Usage or a nationally recognized compendium and dosing within current FDA requirements.

2026-09-01Effective date of changes

Coverage Criteria for Somatostatin Analogs

Initial Therapy

Covered when ALL of the following are met for initial approval:

Initial Approval: Patient has a diagnosis supported by the INDICATIONS AND USAGE section of the FDA package insert or listed in a nationally recognized compendium; AND the requested dosage is within current FDA requirements; AND when applicable, the medication is being administered by a home infusion provider OR the physician attests that self-administration is appropriate per FDA-approved prescribing information.

Applies to listed somatostatin analog agents (e.g., octreotide acetate, lanreotide acetate, pasireotide, BYNFEZIA, SOMATULINE DEPOT, SIGNIFOR/SIGNIFOR LAR).

Continuation Therapy

Covered when ALL of the following are met for renewal:

Renewal: Documentation (e.g., progress note, laboratory results, or imaging report) of positive clinical response or stabilization of disease as evidenced by one or more of the following: improvement or stabilization of disease-related signs and symptoms; OR improvement, normalization, or stabilization of disease-specific biochemical markers; OR stable disease or improvement on imaging (if applicable); OR no evidence of clinically significant disease progression; AND the requested dosage is within current FDA requirements.

Clinical evidence required to continue therapy.

No specific exclusions are listed in this policy. The document states "None explicitly listed in document." and the coverage stance is covered with criteria, meaning coverage is allowed when the stated initial or renewal criteria are met (diagnosis per FDA Indications and Usage or a nationally recognized compendium, dosing within current FDA requirements, and applicable administration/site rules).

If required documentation showing clinical benefit or evidence that dosing conforms to current FDA requirements is not provided, the request may not be approved. Renewal denials are specifically tied to a lack of documentation of positive clinical response or disease stabilization (for example, absence of progress notes, laboratory results, or imaging demonstrating improvement, stabilization, or no clinically significant progression).

Initial Therapy Requirements

Initial therapy

Initial approval requirements for the listed agents:

Initial approval: Diagnosis supported by the INDICATIONS AND USAGE section of the FDA package insert or listed in a nationally recognized compendium; AND the requested dosage is within current FDA requirements; AND when applicable, medication is being administered by a home infusion provider OR the physician attests that self-administration is appropriate per FDA-approved prescribing information.

Apply per agent labeling for octreotide acetate, lanreotide acetate, pasireotide, BYNFEZIA, SOMATULINE DEPOT, SIGNIFOR/SIGNIFOR LAR.

Renewal / Continuation Requirements

Renewal criteria

Renewal requires documentation of continued benefit or stabilization.

Renewal: Documentation of positive clinical response or stabilization (progress notes, laboratory results, or imaging) demonstrating improvement or stability in disease-related signs and symptoms, disease-specific biochemical markers, or imaging; AND dosing remains within current FDA requirements.

Examples include improvement or stabilization of signs/symptoms; improvement, normalization, or stabilization of biochemical markers; stable disease or improvement on imaging; or no evidence of clinically significant progression.

Administrative Routing and Dosage Coding

Administrative routing identifiersmixed

BIN: 023880	Pharmacy BIN number for KY MCO
PCN: KYPROD1	Pharmacy PCN for KY MCO/FFS
GROUP: KYM01	Group for KY MCO
BIN: 026309	Pharmacy BIN number for KY FFS
GROUP: KYF01	Group for KY FFS

inv-06: Dosage

Dosage requirementRequested dosage must be within current FDA requirements (apply agent-specific labeling)

ScopeApplies to listed somatostatin analog agents (e.g., octreotide acetate, lanreotide acetate, pasireotide, BYNFEZIA)

Initial & RenewalDosage requirement applies to both initial approval and renewal requests

Administration noteWhen applicable, dosing and administration should follow FDA-approved prescribing information (including self-administration criteria)

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required for somatostatin analogs (initial approval prerequisites)

Prior authorization is required for the listed somatostatin analog agents. For initial approval, the prescriber must document a diagnosis supported by the INDICATIONS AND USAGE section of the FDA package insert or listed in a nationally recognized compendium, and the requested dosage must be within current FDA requirements. When applicable for initial requests, the medication must be administered by a home infusion provider or the physician must attest that self-administration is appropriate per FDA‑approved prescribing information.

PA applies to the listed somatostatin analogs (e.g., octreotide acetate, lanreotide acetate, pasireotide, BYNFEZIA).
Initial approval requires: (1) diagnosis per FDA Indications and Usage or compendium; (2) dosing within current FDA requirements; (3) when applicable, administration by home infusion or physician attestation of appropriate self-administration.

Note

Provider notice: PA criteria change and contact info (high importance)

Effective September 1, 2026, MedImpact notifies Kentucky Medicaid prescribers and pharmacy providers of PA criteria changes and encourages providers to obtain necessary PA information or identify alternatives; contact information is provided for KY FFS and MCO questions.

Administration / Site of Care Rules

Step Therapy

Site‑of‑care: home infusion or physician‑attested self‑administration

The medication may be approved when it is administered by a home infusion provider or when the physician attests that self‑administration is being used and is appropriate per the FDA‑approved prescribing information.

Definitions and Documentation Standards

inv-12: Documentation of clinical response

Accepted documentation typesProgress note, laboratory results, or imaging report demonstrating improvement or stabilization of disease

Clinical response examplesImprovement or stabilization of disease‑related signs and symptoms; improvement, normalization, or stabilization of disease‑specific biochemical markers

Imaging evidenceStable disease or improvement on imaging (if applicable)

Progression criterionNo evidence of clinically significant disease progression may support renewal

Background

Somatostatin analogs (for example, octreotide acetate, lanreotide acetate, pasireotide, and related formulations) are used for conditions described in the FDA "Indications and Usage" or in nationally recognized compendia. Typical clinical assessment of response includes improvement or stabilization of disease-related signs and symptoms, changes in disease-specific biochemical markers (improvement, normalization, or stabilization), and stable disease or improvement on imaging when applicable. Administration and site-of-care considerations can include use via a home infusion provider or physician-attested self-administration when appropriate per FDA-approved prescribing information.