CurrentHealth NetPolicy CP PHAR.337

Telotristat Ethyl (Xermelo) coverage

Defines medical necessity and authorization criteria for telotristat ethyl (Xermelo) for treatment of carcinoid syndrome diarrhea for Health Net lines of business (Commercial, HIM, Medicaid). Applies to providers requesting coverage and prior authorization.

Policy Summary

PayerHealth Net

PolicyTelotristat Ethyl (Xermelo) coverage

Policy CodePolicy CP PHAR.337

Change TypeStep therapy bypass (IL HIM)generic redirectionPA notes

Effective Date06.01.17

Next Review Date

Key ActionPrior authorization required; submit documentation showing SSA trial and concurrent SSA use when applicable.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Added redirection to generic telotristat for brand Xermelo requests.

Added note that prior authorization may be required for concurrent SSA therapy.

Added step therapy bypass for IL HIM per IL HB 5395.

750 mg/dayMaximum recommended daily dose

3Maximum tablets per day

250 mgProduct strength

Commercial,HIM,MedicaidLines of business

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1IL HIM step therapy bypass

Coverage Criteria for Telotristat ethyl (Xermelo)

Initial Therapy — Covered when ALL of the following are met for Initial Approval

Covered when ALL of the following are met for Initial Approval:

Initial Approval Criteria: 1. Diagnosis of carcinoid syndrome diarrhea;

Initial Approval Criteria: 2. Failure of a one-month trial of a somatostatin analog (SSA) (e.g., octreotide, lanreotide) at up to maximally indicated doses unless clinically significant adverse effects are experienced or SSA is contraindicated;

Providers must document SSA trial or rationale if SSA cannot be used.

Initial Approval Criteria: 3. Xermelo (telotristat ethyl) is prescribed in combination with an SSA unless clinically significant adverse effects are experienced or all SSAs are contraindicated;

Prior authorization may be required for concurrent SSA therapy.

Initial Approval Criteria: 4. Dose does not exceed both: (a) 750 mg per day; and (b) 3 tablets per day (250 mg tablets);<= 750 mg/day; <= 3 tablets/day

Maximum daily dose per policy.

Initial Approval Criteria: 5. Member will use generic telotristat ethyl if available unless contraindicated or clinically significant adverse effects are experienced;

Continuation Therapy — Covered when ALL of the following are met for Continued Therapy

Covered when ALL of the following are met for Continued Therapy:

Continued Therapy Criteria: 1. Member is currently receiving medication via the Centene benefit or previously met initial approval criteria;

Includes members enrolled in programs with continuity of care where applicable.

Continued Therapy Criteria: 2. Member is responding positively to therapy (see Appendix D for examples, e.g., reduction in bowel movement frequency or reduction in urinary 5‑HIAA);

Document clinical response.

Continued Therapy Criteria: 3. Member continues to have diarrhea warranting therapy;

Continued Therapy Criteria: 4. Xermelo (telotristat ethyl) is prescribed in combination with an SSA unless clinically significant adverse effects are experienced or all SSAs are contraindicated;

Non‑FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of safety and efficacy in accordance with the applicable off‑label use policies (see related policies: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid). Other carcinoid syndrome manifestations such as flushing, abdominal pain, venous telangiectasia, bronchospasm, and cardiac valvular lesions are specifically listed as diagnoses/indications not authorized for Xermelo under this policy.

State Medicaid coverage provisions take precedence where they conflict with this clinical policy. Providers and reviewers should refer to the applicable state Medicaid manual and the member’s evidence of coverage for specific coverage provisions, limits, and administrative requirements.

Use of Xermelo (telotristat ethyl) for carcinoid syndrome symptoms other than diarrhea (for example, flushing or abdominal pain) is considered not authorized under this policy and requests for those indications are subject to denial unless coverage is supported by applicable off‑label use policies.

Coding and Dose Information

Codesmixed

N/A	No explicit CPT/HCPCS/ICD-10/NDC codes listed in this section of the document.

Covered CPT Codesmixed

No codes listed

Maximum daily dose

Maximum daily dose750 mg per day (3 x 250 mg tablets)

Maximum tablets per day3 tablets per day (250 mg each)

Per-dose strength250 mg tablet

Document noteCoverage decisions are subject to terms, conditions, exclusions, and limitations of coverage documents and applicable state and federal requirements.

Policy effective date06.01.17 (refer to policy header)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Approval is granted only when initial or continued therapy criteria are met and supporting documentation is submitted.

Prior authorization required for Xermelo (telotristat ethyl).
Providers must submit documentation (office/chart notes, lab results, other clinical information) demonstrating the member meets all approval criteria.
Requests that do not meet the criteria may be denied.

Documentation Required

Required Documentation

Providers must submit clinical documentation to support that the member meets all approval criteria. This includes, but is not limited to, office notes, pertinent lab results, and prior treatment records.

Initial Therapy Criteria

inv-22: Initial therapy — detailed initial approval criteria

Initial therapy — detailed initial approval criteria:

Step 1: Diagnosis: Diagnosis of carcinoid syndrome diarrhea;

Step 2: Step therapy requirement (except IL HIM per IL HB 5395): Failure of a one-month trial of an SSA (e.g., octreotide, lanreotide) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all SSAs are contraindicated;duration = 1 month

For Illinois HIM requests the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395.

Step 3: Concomitant SSA use: Xermelo is prescribed in combination with an SSA, unless clinically significant adverse effects are experienced or all SSAs are contraindicated;

Prior authorization may be required for SSA therapy.

Continuation (Maintenance) Therapy Criteria

inv-23: Continued therapy — criteria for continuation of therapy

Continued therapy — criteria for continuation of therapy:

Continued therapy — eligibility: Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria;

Includes members in continuity of care programs per state-specific addendums.

Continued therapy — clinical response: Member is responding positively to therapy (see Appendix D for examples such as reduced bowel movement frequency or reduced urinary 5‑HIAA);

Documentation of response required.

Continued therapy — ongoing need: Member continues to have diarrhea indicating ongoing need for therapy;

Step Therapy Requirements and Exceptions

Step	Requirement	Duration / Notes
1	Failure of a one-month trial of a somatostatin analog (SSA) (e.g., octreotide, lanreotide) at up to maximally indicated doses is required prior to initiation of telotristat ethyl (Xermelo)	One month; SSA must be used at maximally indicated doses unless clinically significant adverse effects or contraindications exist. For Xermelo requests, member must use telotristat ethyl (generic if available) unless contraindicated. Dose limits: 750 mg/day and 3 tablets/day.

State / Line of Business	Policy Action	Effective Date / Reference
Illinois — Health Insurance Marketplace (HIM)	Step therapy requirement is bypassed for HIM members per Illinois HB 5395; the SSA trial requirement does not apply for Illinois HIM requests.	Applies as of 1/1/2026 per IL HB 5395; reflected in policy update (P&T Approval Date = 05.25).

Quantity Limits and Product Strength

Telotristat ethyl (Xermelo) — quantity limits

Quantity limit (daily)3 tablets per day

Tablet strength250 mg tablet

Preferred productTelotristat ethyl (generic) when available unless contraindicated

Definitions

SSA — definition

SSA (abbreviation)Somatostatin analog

Related termUsed as standard of care for carcinoid syndrome management

Example agentsOctreotide, lanreotide (as referenced in criteria)

Positive response to therapy — examples

Examples of positive responseReduction in bowel movement frequency

Biomarker responseReduction in urinary 5-HIAA levels

Timing of responseReduction in bowel movements observed as early as 1–3 weeks in TELESTAR trial

Background

Carcinoid syndrome results from hormone‑secreting neuroendocrine tumors and commonly presents with diarrhea, flushing, and other systemic symptoms. Management is centered on somatostatin analogs (SSAs), which are the primary therapy to control hormone‑related symptoms. Telotristat ethyl (Xermelo) is a tryptophan hydroxylase inhibitor approved as adjunct therapy to SSAs for adults with carcinoid syndrome who continue to have diarrhea despite SSA therapy. Clinical trial data demonstrated that telotristat can reduce bowel movement frequency within weeks when added to SSA therapy. Per dosing guidance, the product is available as a 250 mg tablet and the maximum recommended daily dose is 750 mg/day (3 × 250 mg tablets).

Policy Summary

PayerHealth Net

PolicyTelotristat Ethyl (Xermelo) coverage

Policy CodePolicy CP PHAR.337

Change TypeStep therapy bypass (IL HIM)generic redirectionPA notes

Effective Date06.01.17

Next Review Date

Key ActionPrior authorization required; submit documentation showing SSA trial and concurrent SSA use when applicable.

SourceLink

On This Page

Continued Therapy Criteria: 5. Dose does not exceed both: (a) 750 mg per day; and (b) 3 tablets per day (250 mg tablets).<= 750 mg/day; <= 3 tablets/day

If request is for a dose increase, the new dose must not exceed these maximums.

Step Therapy

Step Therapy Requirement

A trial of a somatostatin analog (SSA) is required prior to approval of Xermelo except where noted for Illinois HIM requests. Specifically, a one-month trial of an SSA (e.g., octreotide, lanreotide) at up to maximally indicated doses must have failed, unless clinically significant adverse effects occurred or SSAs are contraindicated. For Xermelo therapy, Xermelo must be prescribed in combination with an SSA unless adverse effects or contraindications preclude SSA use.

Step therapy requirement: one-month trial of an SSA at maximally indicated doses unless intolerant or contraindicated.
Xermelo must be used in combination with an SSA unless clinically significant adverse effects or contraindications exist.

Step Therapy

Illinois Step Therapy Bypass (IL HB 5395)

Illinois (HIM) requests: per IL HB 5395, step therapy requirements do not apply for Illinois HIM requests as of 01/01/2026. Providers submitting HIM requests in Illinois should note the step therapy bypass for telotristat ethyl.

IL step therapy bypass effective 01/01/2026 per IL HB 5395.

Note

Administrative and Coverage Notes

Coverage decisions are subject to the terms, exclusions, and limitations of the member's benefit plan and applicable state and federal rules. Providers must follow Health Plan-level administrative policies and procedures when submitting prior authorization and billing requests.

Coverage subject to plan terms, exclusions, and limitations.
Providers must follow Health Plan-level administrative policies and procedures for prior authorization and billing.

Denial Risk

Denial Triggers

Requests that do not meet the approval criteria, lack required documentation, exceed dosing limits, or are for non‑covered indications may be denied.

Denial triggers include: inadequate supporting documentation, failure to meet step therapy or clinical criteria (unless IL HIM bypass applies), requests for non‑covered indications, and dose requests exceeding policy limits.

Step 4: Product selection: Member must use telotristat ethyl (generic) if available unless contraindicated or clinically significant adverse effects are experienced;

Step 5: Dosing limits: Dose does not exceed both: (a) 750 mg per day; and (b) 3 tablets per day (250 mg tablets).<= 750 mg/day; <= 3 tablets/day

Continued therapy — concomitant SSA: Xermelo is prescribed in combination with an SSA unless clinically significant adverse effects are experienced or all SSAs are contraindicated;

Continued therapy — dosing limits: Dose does not exceed both: (a) 750 mg per day; and (b) 3 tablets per day (250 mg tablets).<= 750 mg/day; <= 3 tablets/day

If request is for a dose increase, the new dose must not exceed these maximums.

ReminderThis clinical policy is a guide to medical necessity and does not constitute a contract or guarantee of payment.

Review responsibilityDeveloped by licensed health care professionals based on review of available evidence and standards of practice.