CurrentUnitedHealthcarePolicy 2025 P 1221-9

Xermelo (telotristat ethyl) prior authorization

Defines UnitedHealthcare prior authorization and reauthorization criteria for Xermelo (telotristat ethyl) for treatment of carcinoid syndrome diarrhea in adults, and notes program operational rules affecting coverage.

Policy Summary

PayerUnitedHealthcare

PolicyXermelo (telotristat ethyl) prior authorization

Policy CodePolicy 2025 P 1221-9

Change TypeNo material change

Effective Date9/1/2025

Next Review Date

Key ActionObtain prior authorization documenting diagnosis of carcinoid syndrome diarrhea and that diarrhea is inadequately controlled on somatostatin analog therapy, with Xermelo used in combination with SSA.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2025 P 1221-9policy identifier

Xermelomedication

Carcinoid diarrheaindication

12 moauth duration

Coverage Criteria

inv-01: Initial Authorization

Policy Summary

PayerUnitedHealthcare

PolicyXermelo (telotristat ethyl) prior authorization

Policy CodePolicy 2025 P 1221-9

Change TypeNo material change

Effective Date9/1/2025

Next Review Date

SourceLink

On This Page

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Initial Authorization: Diagnosis of carcinoid syndrome diarrhea

Authorization will be issued for 12 months.

Initial Authorization: Diarrhea is inadequately controlled with somatostatin analog (SSA) therapy (e.g., octreotide, Sandostatin LAR, Somatuline Depot, lanreotide)

Authorization will be issued for 12 months.

Initial Authorization: Used in combination with somatostatin analog therapy (e.g., octreotide, Sandostatin LAR, Somatuline Depot, lanreotide)

Authorization will be issued for 12 months.

UnitedHealthcare may apply program-level operational rules that affect coverage decisions. Supply limits may be in place for Xermelo and related claims. In addition, the program may use automated approval logic that evaluates prior claim and medication history, diagnosis codes (ICD-10), and other claim-level logic; such automated processing can approve or deny requests independent of the written clinical criteria when the program rules indicate. Providers should be aware that approvals issued by automated review may differ from manual medical-necessity determinations.

Xermelo is not supported when the clinical presentation does not meet the coverage criteria. Specifically, requests will be subject to denial if the submitted diagnosis is not carcinoid syndrome diarrhea, or if documentation shows the member’s diarrhea is adequately controlled on somatostatin analog (SSA) therapy. These unsupported uses include use for non-indicated diagnoses or continuation when symptoms are controlled on SSA therapy.

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required — Initial Therapy

Initial authorization: Xermelo (telotristat ethyl) will be authorized only when all initial criteria are met: documented diagnosis of carcinoid syndrome diarrhea AND diarrhea is inadequately controlled while on somatostatin analog (SSA) therapy (e.g., octreotide, Sandostatin LAR, Somatuline Depot, lanreotide). Xermelo must be used in combination with concurrent somatostatin analog therapy. Authorization (initial) will be issued for up to 12 months.

Diagnosis: carcinoid syndrome diarrhea
Required prior therapy: inadequate control on an SSA (examples: octreotide, Sandostatin LAR, Somatuline Depot, lanreotide)
Combination therapy: Xermelo must be prescribed and administered in combination with a somatostatin analog
Initial approval length: up to 12 months

Documentation Required

Reauthorization Documentation

Reauthorization requires documentation of a positive clinical response to Xermelo. Examples of acceptable documentation include clinician progress notes describing reduction in bowel movement frequency, improvement in stool consistency, decreased urgency, or other objective clinical measures compared with baseline while on Xermelo plus SSA. Reauthorization will be issued for up to 12 months.

Documented positive clinical response to Xermelo (clinical notes, symptom logs, or objective measures)
Authorization length: up to 12 months

Denial Risk

Automated Approval Limitations — Denial Risk

Automated approval limitations: UnitedHealthcare may use claims-, medication-, and diagnosis-based automated approval logic for some programs, but automated processes will only approve when the claims/diagnosis logic supports medical necessity. If automated review cannot verify required criteria (diagnosis, evidence of inadequate control on an SSA, or concurrent SSA use), the request may be denied or routed for manual review. Providers should submit explicit supporting documentation when initial or reauthorization requests may not be evident in claims data.

Automated approvals may be granted only when claims/medication history and diagnosis codes support all required criteria
If claims logic does not demonstrate diagnosis, inadequate control on an SSA, or concurrent SSA therapy, provide clinical documentation to avoid denial
Use of automated approval processes varies by program and therapeutic class

Definitions

Somatostatin analog (SSA) — examples and definition entries

DefinitionSomatostatin analog (SSA) — class of medications used to control symptoms of carcinoid syndrome; examples include octreotide (Sandostatin LAR), Somatuline Depot, and lanreotide.

Common SSA examplesOctreotide (e.g., Sandostatin LAR)

Common SSA examplesSomatuline Depot

Common SSA examplesLanreotide

Relevance to Xermelo therapyXermelo is indicated only in combination with SSA therapy for adults whose diarrhea is inadequately controlled on SSA therapy.

Background

Xermelo (telotristat ethyl) is a tryptophan hydroxylase inhibitor indicated for the treatment of carcinoid syndrome diarrhea in adults as adjunctive therapy to somatostatin analogs when diarrhea is inadequately controlled with SSA therapy. The policy specifies that initial authorization requires a diagnosis of carcinoid syndrome diarrhea and that diarrhea be inadequately controlled with SSAs (for example, octreotide, Sandostatin LAR, Somatuline Depot, or lanreotide). When these criteria are met, authorization is issued for 12 months.

OpenPayer

Xermelo (telotristat ethyl) prior authorization

Coverage Criteria

Initial Therapy

Continuation / Reauthorization

Provider Actions & Documentation Requirements

Definitions

Background