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.
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.
Coverage Criteria for Somatostatin Analogs
Initial Therapy
Covered when ALL of the following are met for initial approval:
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:
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:
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.
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
| 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 |
Provider Actions and Authorization Requirements
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.
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.
- MedImpact asks pharmacy providers to work with prescribers and patients to obtain prior authorization information or find alternatives.
- Program contact emails: KYMFFS@medimpact.com (Fee-for-Service) and KYMCOPBM@medimpact.com (MCO).
Required documentation for renewal (acceptable types)
For renewal, provide documentation demonstrating a positive clinical response or stabilization of disease. Acceptable documentation includes progress notes, laboratory results, or imaging reports showing improvement or stabilization of signs/symptoms, disease‑specific biochemical markers, or imaging findings.
- Progress notes documenting clinical improvement or stability.
- Laboratory results showing improvement, normalization, or stabilization of disease‑specific biochemical markers.
- Imaging reports demonstrating stable disease or improvement (if applicable).
Denial triggers for renewal — missing documentation
Renewal requests may be denied if documentation of positive clinical response or disease stabilization is not provided. Absence of progress notes, relevant laboratory results, or imaging showing improvement/stability constitutes a denial risk.
- Lack of any progress note demonstrating benefit is a denial trigger.
- Missing laboratory evidence of improved/normalized/stable disease‑specific markers may lead to denial.
- Absence of imaging showing stable disease or improvement (when applicable) increases denial risk.
Administration / Site of Care Rules
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
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.
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