Telotristat Ethyl (Xermelo) Coverage
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Defines medical necessity and prior authorization criteria for telotristat ethyl (Xermelo) for treatment of carcinoid syndrome diarrhea for Peach State Health Plan members across covered lines of business.
Added failure of an SSA requirement for Illinois HIM requests per prescribing information.
Extended initial approval duration from 6 months to 12 months for this maintenance medication.
Redirected brand Xermelo requests to generic telotristat when available.
Clarified examples of a positive response to therapy (e.g., reduction in bowel movement frequency, reduction in urinary 5-HIAA levels).
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met for initial therapy:
Approval duration: 12 months
Continuation Therapy
Covered when ALL of the following are met for continued therapy:
Approval duration: 12 months
Other diagnoses/indications
Other/Off-label uses handling:
See referenced policies CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53
Non‑FDA approved indications for telotristat ethyl that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of safety and efficacy in accordance with the applicable off‑label use policy for the member's line of business (see policies CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, and CP.PMN.53 for Medicaid) or other applicable evidence‑of‑coverage documents.
Use of Xermelo (telotristat ethyl) for carcinoid syndrome manifestations other than diarrhea — for example flushing, cardiac valvular lesions, abdominal pain, venous telangiectasia, or bronchospasm — is considered not authorized under this policy absent convincing evidence and documentation per the referenced off‑label policies.
Initial Authorization Criteria
Initial Therapy
Initial authorization criteria for carcinoid syndrome diarrhea:
Approval duration: 12 months
Continued Therapy Requirements
Continued Therapy
Continued therapy requirements for carcinoid syndrome diarrhea:
Approval duration: 12 months
Provider Actions & Documentation
Prior authorization required for Xermelo
Prior authorization is required for telotristat ethyl (Xermelo). Approval will be granted only when the listed initial or continued therapy criteria in this policy are met (including diagnosis, required concomitant SSA use unless contraindicated, generic substitution when available, and dosing limits).
- Prior authorization may also be required for somatostatin analog (SSA) therapy.
- Approval duration for authorized requests is 12 months.
SSA trial required; IL HIM bypass per IL HB 5395
A trial (and failure) of a somatostatin analog (SSA) is required before initiating Xermelo for most requests; for Illinois HIM requests the policy includes an SSA failure requirement but also incorporates an IL HIM step therapy bypass per IL HB 5395 where applicable.
- For Illinois HIM requests: Failure of an SSA (e.g., octreotide, lanreotide) is required unless clinically significant adverse effects or contraindications exist; IL HB 5395 step therapy bypass provisions are reflected in the policy.
- For all other requests: Failure of a one-month trial of an SSA at up to maximally indicated doses is required unless adverse effects or contraindications exist.
Submit supporting clinical documentation
The provider must submit supporting clinical documentation with the prior authorization request demonstrating that the member meets all approval criteria.
- Acceptable documentation includes office chart notes, laboratory results, or other clinical information showing diagnosis and prior SSA treatment/response, concomitant SSA use (unless contraindicated), and dosing.
- Include documentation of generic telotristat availability or contraindication to generic if applicable.
Documentation or criteria failure may lead to denial
Lack of documentation that the required approval criteria were met may result in denial of the request.
- Examples of missing documentation that can lead to denial: no documented diagnosis of carcinoid syndrome diarrhea, no evidence of required SSA trial or contraindication, no evidence of concomitant SSA use when required, or dosing that exceeds policy limits.
- Non‑FDA uses not addressed in the policy require sufficient evidence per off-label policies; absence of such documentation may also lead to denial.
Coding & Dosing
Step Therapy Requirements
| Step | Requirement | Notes |
|---|---|---|
| 1 | ||
| Failure of a somatostatin analog (SSA) prior to initiation of telotristat ethyl (Xermelo) | ||
| For most requests: failure of a one-month trial of an SSA (e.g., octreotide, lanreotide) at up to maximally indicated doses unless clinically significant adverse effects or contraindications; Illinois HIM requests: failure of an SSA required except where IL HIM bypass under IL HB 5395 applies |
Quantity Limits
Definitions
Background
Telotristat ethyl is a tryptophan hydroxylase inhibitor indicated as adjunctive therapy with somatostatin analogs for adults with carcinoid syndrome diarrhea that is inadequately controlled by SSA therapy. Clinical evidence demonstrates that when added to an SSA, telotristat can reduce bowel movement frequency; it is intended for use as a complement to SSA treatment rather than as monotherapy.
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