CurrentCignaPolicy N/A

Oncology - Xermelo Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for Xermelo (telotristat ethyl) for treatment of carcinoid syndrome diarrhea in adults, and identifies noncovered uses.

Policy Summary

PayerCigna

PolicyOncology - Xermelo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document ≥3 months of stable long-acting somatostatin analog therapy and ≥4 daily bowel movements while on that therapy for initial approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearapproval duration for Xermelo

≥3 morequired duration on somatostatin analog prior to Xermelo

≥4/daysymptom threshold for initial approval

NCCN v1.2025guideline cited

Coverage Criteria for Xermelo (telotristat ethyl)

FDA-Approved Indication

Covered when ONE of the following is met; approvals provided for 1 year.

Carcinoid Syndrome Diarrhea - Approval Pathways: Approve for 1 year if the patient meets ONE of the following (A or B).1 of 2

A) Initial Therapy

i: Patient has been on a long-acting somatostatin analog therapy for at least 3 consecutive months>=3 months
Examples: Somatuline Depot (lanreotide) and Sandostatin LAR (octreotide)
ii:

Policy Summary

PayerCigna

PolicyOncology - Xermelo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document ≥3 months of stable long-acting somatostatin analog therapy and ≥4 daily bowel movements while on that therapy for initial approval.

SourceLink

On This Page

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Regimen	Indication / Context	Coverage status
Xermelo (telotristat ethyl) in combination with a long-acting somatostatin analog (examples: Somatuline Depot [lanreotide], Sandostatin LAR [octreotide])
Persistent carcinoid syndrome diarrhea inadequately controlled by somatostatin analog therapy — patient has had ≥3 consecutive months on a long-acting somatostatin analog and continues to have ≥4 bowel movements/day while on that therapy; Xermelo will be used concomitantly with the somatostatin analog (initial therapy)
covered

Coding and Clinical Thresholds

Coding guidancemixed

No codes listed

Daily bowel movements — clinical threshold while on long-acting somatostatin analog therapy

Clinical thresholdPatient continues to have at least 4 bowel movements per day while on a long-acting somatostatin analog (prior to starting Xermelo)

Context from trialsEfficacy evaluated in patients with 4–12 daily bowel movements despite stable somatostatin analog therapy

Documentation requirementClinical documentation should record number of daily bowel movements while on somatostatin analog therapy

Duration on somatostatin analog therapy — at least 3 consecutive months

Required durationPatient has been on a long-acting somatostatin analog therapy for at least 3 consecutive months

Trial populationClinical trials required a stable somatostatin analog dose for at least 3 months before enrollment

Documentation requirementProvide records supporting ≥3 months of stable long-acting somatostatin analog therapy prior to Xermelo initiation

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior authorization required (1 year approvals)

Prior authorization is recommended for prescription benefit coverage of Xermelo; approvals are provided for the duration noted (1 year) when criteria are met.

Step Therapy

Step requirement — concomitant long-acting somatostatin analog

Xermelo is indicated only in combination with a long-acting somatostatin analog; initial approval requires inadequate control on somatostatin analog alone (persistent ≥4 bowel movements/day despite ≥3 months of stable long-acting somatostatin analog therapy).

Documentation Required

Required clinical documentation for initial approval

For initial therapy, documentation must show the patient has been on a long-acting somatostatin analog for at least 3 consecutive months and continued to have at least four bowel movements per day while on that therapy prior to starting Xermelo.

≥3 consecutive months on a long-acting somatostatin analog
Record showing ≥4 bowel movements per day while on that therapy prior to Xermelo

Documentation Required

Continuation therapy documentation

For continuation approvals, documentation should show the patient is currently receiving Xermelo concomitantly with a long-acting somatostatin analog for carcinoid syndrome diarrhea.

Denial Risk

Not covered uses — other indications

Requests for Xermelo for any indication other than carcinoid syndrome diarrhea are considered not medically necessary and will be denied.

Billing Rule

Coding/claims denial risk

Claims submitted without covered diagnosis or appropriate procedure/billing codes per the policy will be denied as not covered; providers must use the most appropriate codes at time of submission.

Line of Therapy and Special Use Cases

salvage

Salvage (Initial therapy context): Patient has persistent carcinoid syndrome diarrhea despite at least 3 months of stable long-acting somatostatin analog therapy, with ≥4 bowel movements/day while on that therapy, and will use Xermelo concomitantly with the somatostatin analog.see children

Examples of long-acting somatostatin analogs: Somatuline Depot, Sandostatin LAR

other

Continuation: Patient is currently receiving Xermelo concomitantly with a long-acting somatostatin analog for carcinoid syndrome diarrhea.current use

Approve for 1 year

OpenPayer

Oncology - Xermelo Prior Authorization Policy

Coverage Criteria for Xermelo (telotristat ethyl)

Coding and Clinical Thresholds

Provider Actions, Authorization, and Documentation

Definitions and Examples

Line of Therapy and Special Use Cases

Background