CurrentConnectiCarePolicy C16325-A

Xermelo (telotristat ethyl) Coverage for Carcinoid Syndrome Diarrhea

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This policy governs pharmacy benefit coverage and prior authorization for Xermelo (telotristat ethyl) used to treat carcinoid syndrome diarrhea in adults. Coverage requires documented disease, inadequate response to antidiarrheals, ongoing somatostatin analog therapy, and fulfillment of clinical and prescriber requirements.

Policy Summary

PayerConnectiCare

PolicyXermelo (telotristat ethyl) Coverage for Carcinoid Syndrome Diarrhea

Policy CodePolicy C16325-A

Change TypeNo material change

Effective DateMar 4, 2026

Next Review DateJan 1, 2027

Key ActionSubmit documentation of the diagnosis, two-week antidiarrheal trial, at least three months of maximum or highest tolerated SSA therapy, and baseline bowel movements of at least four per day.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum member age

250 mg TIDPolicy dosage

≥ 4/dayBaseline bowel movements

3 months

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CurrentConnectiCarePolicy C16325-A

Xermelo (telotristat ethyl) Coverage for Carcinoid Syndrome Diarrhea

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Policy Summary

PayerConnectiCare

PolicyXermelo (telotristat ethyl) Coverage for Carcinoid Syndrome Diarrhea

Policy CodePolicy C16325-A

Change TypeNo material change

Effective DateMar 4, 2026

Next Review DateJan 1, 2027

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum member age

250 mg TIDPolicy dosage

≥ 4/dayBaseline bowel movements

3 months

12 monthsAuthorization duration

85%Continuation adherence

Coverage Criteria

Initial Therapy Criteria

Covered when ALL of the following initial therapy criteria are met:

Initial therapy

Diagnosis: The member has a carcinoid or neuroendocrine tumor and a diagnosis of carcinoid syndrome diarrhea.
Prior antidiarrheal treatment: The member has had a two-week trial and failure or inadequate response to an antidiarrheal such as loperamide.2-week trial
Prior SSA therapy: The member has received FDA-approved maximum or highest tolerated dose somatostatin analog therapy, such as octreotide solution or depot or lanreotide depot.at least 3 months
Combination treatment: The prescriber attests that the member will continue SSA therapy in combination with Xermelo.
Baseline severity: The member's baseline bowel movements are documented.≥ 4 per day
Age and prescriber: The member is 18 years of age or older, and Xermelo is prescribed by or in consultation with an oncologist or gastroenterologist.age ≥ 18 years
If prescribed in consultation, consultation notes must be submitted with the initial request and reauthorization requests.

Continuation Therapy Criteria

Continuation therapy is covered when ALL of the following criteria are met:

Continuation therapy

Adherence is at least 85% of the time as verified by the prescriber or member medication fill history, or adherence is less than 85% because surgery or treatment of an infection caused temporary discontinuation.≥ 85% unless temporary interruption is due to surgery or infection
Safety: The prescriber attests to, or the clinical reviewer finds, no evidence of intolerable adverse effects or drug toxicity.
Clinical response: The member demonstrates a positive clinical response, shown by decreased bowel movements and/or improvement in the condition's signs and symptoms.

All other uses of Xermelo (telotristat ethyl) are considered experimental or investigational and are subject to the applicable off-label policy.

Coverage is excluded for members with a history of hypersensitivity to telotristat.

Coding and Key Thresholds

HCPCS CodeHCPCS

N/A

Baseline bowel movements

Required baselineAt least 4 bowel movements per day

Applies toInitial Xermelo therapy authorization

DocumentationThe member’s baseline bowel movements per day must be documented

Prior somatostatin analog therapy

Minimum durationAt least 3 months

Required doseFDA-approved maximum or highest tolerated dose

ExamplesOctreotide solution or depot, or lanreotide depot

Authorization and Documentation Requirements

Prior Authorization

Specialist Prescribing Requirement

Prior authorization requires prescribing by, or consultation with, an oncologist or gastroenterologist.

Prior Authorization

Initial Authorization Criteria

Initial authorization requires documentation that all required clinical criteria are met for Xermelo in carcinoid syndrome diarrhea.

Member has a carcinoid or neuroendocrine tumor with a diagnosis of carcinoid syndrome diarrhea.
Member has had a 2-week trial and failure or inadequate response to an antidiarrheal, such as loperamide.
Member has received an FDA-approved maximum or highest tolerated dose of somatostatin analog therapy for at least 3 months.
Prescriber attests that somatostatin analog therapy will continue in combination with Xermelo.
Baseline bowel movements are ≥ 4 per day.

Clinical Background

Carcinoid syndrome diarrhea is associated with carcinoid or neuroendocrine tumors and is mediated in part by excess peripheral serotonin. Xermelo (telotristat ethyl) inhibits tryptophan hydroxylase, reducing peripheral serotonin production and the frequency of diarrhea. It is used in adults whose symptoms remain inadequately controlled despite somatostatin analog therapy.

Definitions

Carcinoid syndrome

DefinitionSymptoms mediated by some carcinoid tumors

Common symptomFlushing

Common symptomDiarrhea

Somatostatin analog

DefinitionA therapy class used with Xermelo for carcinoid syndrome diarrhea

ExamplesOctreotide and lanreotide

Policy requirementSSA therapy must continue in combination with Xermelo

Xermelo Initial Therapy

Initial therapy requires ALL of the following:

Xermelo initial therapy: The member has documented carcinoid syndrome diarrhea associated with a carcinoid or neuroendocrine tumor; has failed or had an inadequate response to a two-week antidiarrheal trial; has received FDA-approved maximum or highest tolerated dose somatostatin analog therapy for at least three months; will continue SSA therapy with Xermelo; and has at least four baseline bowel movements per day.

The member must be at least 18 years old, and therapy must be prescribed by or in consultation with an oncologist or gastroenterologist. If prescribed in consultation, consultation notes must be submitted with the initial request and reauthorization requests.

Xermelo Continuation Therapy

Continuation therapy requires ALL of the following:

Xermelo continuation therapy

Adherence is at least 85% of the time as verified by the prescriber or member medication fill history, or adherence is less than 85% because surgery or treatment of an infection caused temporary discontinuation.≥ 85% unless temporary interruption is due to surgery or infection
Safety: There is no evidence of intolerable adverse effects or drug toxicity, as attested to by the prescriber or determined by the clinical reviewer.
Clinical response: The member has a positive clinical response demonstrated by decreased bowel movements and/or improved signs and symptoms.

Required Treatment Sequence

Step	Required therapy	Duration	Coverage requirement
1	Antidiarrheal, such as loperamide	2 weeks	Trial and failure or inadequate response before Xermelo

Step	Required therapy	Duration	Coverage requirement
2	FDA-approved maximum or highest tolerated dose somatostatin analog (SSA) therapy, such as octreotide solution or depot or lanreotide depot	At least 3 months	Continue SSA therapy in combination with Xermelo

Dose and Quantity Limits

Xermelo dosage

Dose250 mg three times daily

RouteBy mouth as an oral tablet

AdministrationTake with food

Site of Care and Benefit

Billing Rule

Use the pharmacy benefit for home administration

Xermelo is an oral medication covered under the pharmacy benefit and is self-administered by the patient at home.

Policy Summary

PayerConnectiCare

PolicyXermelo (telotristat ethyl) Coverage for Carcinoid Syndrome Diarrhea

Policy CodePolicy C16325-A

Change TypeNo material change

Effective DateMar 4, 2026

Next Review DateJan 1, 2027

SourceLink

On This Page

Continuation adherence

Required adherenceAt least 85% of the time

VerificationPrescriber verification or member medication fill history

Temporary interruption exceptionAdherence below 85% may be accepted when surgery or treatment of an infection causes temporary discontinuation

Step Therapy

Antidiarrheal Trial Required

Document a 2-week trial and failure or inadequate response to an antidiarrheal before requesting Xermelo.

Examples include loperamide, diphenoxylate/atropine, or tincture of opium.
Nonspecific antidiarrheals may benefit refractory diarrhea regardless of cause.

Step Therapy

Somatostatin Analog Therapy

Document at least 3 months of treatment with an FDA-approved maximum or highest tolerated dose of a somatostatin analog before initial Xermelo authorization.

Acceptable SSA therapy includes octreotide solution or depot and lanreotide depot.
The prescriber must attest that SSA therapy will continue in combination with Xermelo.

Documentation Required

Complete Supporting Documentation

Submit complete medical records and the clinical rationale supporting medical necessity and the requested coverage determination.

Records may include patient records, test results, and ordering-provider credentials.
Additional documentation may be requested to verify that treatment is medically necessary, not experimental or investigational, and within the member’s benefits.

Documentation Required

Diagnosis and Antidiarrheal History

Document that the member has a carcinoid or neuroendocrine tumor and a diagnosis of carcinoid syndrome diarrhea, along with the required prior antidiarrheal trial.

Include the antidiarrheal agent, trial duration of at least 2 weeks, and failure or inadequate response.

Documentation Required

SSA Therapy and Baseline Severity

Document the member’s SSA treatment history and baseline disease severity before initial authorization.

SSA therapy: FDA-approved maximum or highest tolerated dose for at least 3 months.
SSA plan: prescriber attestation that therapy will continue with Xermelo.
Baseline severity: ≥ 4 bowel movements per day.

Documentation Required

Continuation Documentation

For continuation authorization, document adherence, tolerability, and a positive clinical response to Xermelo.

Adherence must be at least 85% based on prescriber verification or medication fill history, unless lower adherence resulted from surgery or infection requiring temporary discontinuation.
Prescriber attests, or clinical review confirms, no intolerable adverse effects or drug toxicity.
Document decreased bowel movements and/or improvement in signs and symptoms.

Documentation Required

Consultation Notes Required

When Xermelo is prescribed in consultation with an oncologist or gastroenterologist, submit the consultation notes with both the initial request and each reauthorization request.

Consultation documentation must accompany the applicable authorization submission.

Unsupported block type: denial_risk

Tryptophan hydroxylase inhibitor

DefinitionA drug class that inhibits the rate-limiting enzyme in serotonin biosynthesis

Policy drugTelotristat and telotristat ethyl are tryptophan hydroxylase inhibitors

MechanismInhibition reduces peripheral serotonin production and the frequency of carcinoid syndrome diarrhea