CurrentMass General Brigham Health PlanPolicy N/A

Xermelo Effective 07/01/2023

Defines prior authorization, eligibility, quantity limits, specialty dispensing, initial and continuation criteria for Xermelo (telotristat ethyl) under the pharmacy benefit for Mass General Brigham Health Plan (MassHealth UPPL/Commercial/Exchange).

Policy Summary

PayerMass General Brigham Health Plan

PolicyXermelo Effective 07/01/2023

Policy CodePolicy N/A

Change TypeClarified continuation criteria

Effective DateJul 1, 2023

Next Review Date

Key ActionPrior authorization is required; submit documentation of age, carcinoid syndrome diarrhea diagnosis, inadequate response to SSA, and confirmation Xermelo will be used with SSA; for reauthorization provide provider attestation of clinical improvement.

SourceLink

POLICY UPDATE CHANGES

Added continuation of therapy criteria requiring provider attestation of improvement in member's condition.

12 monthsApproval Duration

90/30 daysQuantity Limit (Xermelo 250 mg)

>=18Minimum Age (years)

Coverage Summary

coverage_stance: covered_with_criteria; scope: Defines prior authorization, eligibility, quantity limits, specialty dispensing, initial and continuation criteria for Xermelo (telotristat ethyl) under the pharmacy benefit for Mass General Brigham Health Plan (MassHealth UPPL/Commercial/Exchange). Indication: Telotristat ethyl (Xermelo) used with somatostatin analogs (SSA) to treat diarrhea associated with carcinoid syndrome in adults when SSA therapy alone is inadequate. Effective date: 07/01/2023; Last review: 05/10/2023.

Initial Authorization (Medical Necessity) - Criteria

Initial Authorization (Medical Necessity)

Authorization may be granted if ALL of the following are met and documentation submitted:

Age: Member is at least 18 years of age>= 18 years
Diagnosis: Member has a diagnosis of carcinoid syndrome diarrhea
Prior therapy: Member has had an inadequate response to somatostatin analog (SSA) therapy
Concomitant therapy: Xermelo will be used in combination with SSA therapy
Access limitation: Medication was not obtained solely through physician samples or manufacturer's assistance program
Authorization may be granted for members currently being treated with Xermelo, except when medication obtained through samples or manufacturer’s assistance program

Continuation / Reauthorization Criteria

Continuation / Reauthorization

Reauthorization will be granted when ALL of the following are met:

Ongoing criteria: All initial authorization criteria continue to be met
Provider attestation: Provider attests to improvement in member's condition

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required for Xermelo. Initial authorization requires documentation of age (≥18 years), diagnosis of carcinoid syndrome diarrhea, inadequate response to somatostatin analog (SSA) therapy, and that Xermelo will be used in combination with SSA therapy. Authorization may be granted for members currently being treated with Xermelo except when the medication was obtained solely through physician samples or a manufacturer's assistance program.

Exception: does not apply when medication obtained solely via samples or manufacturer's assistance program

Documentation Required

Clinical documentation for initial and renewal requests

Submit clinical documentation showing inadequate response to somatostatin analog (SSA) therapy, the diagnosis of carcinoid syndrome diarrhea, and confirmation that Xermelo will be used in combination with SSA for initial requests. For reauthorization, submit documentation that all initial criteria continue to be met and a provider attestation that the member has experienced improvement in their condition.

Billing Rule

Specialty pharmacy dispensing

Xermelo is designated a specialty medication and must be dispensed at a contracted specialty pharmacy under the plan's pharmacy benefit.

Background

Telotristat ethyl is a prodrug of telotristat and acts as a tryptophan hydroxylase inhibitor. It is indicated for the treatment of diarrhea associated with carcinoid syndrome in adults and is used in combination with somatostatin analog (SSA) therapy when SSA alone is inadequate. Initial authorization requires age ≥18, diagnosis of carcinoid syndrome diarrhea, inadequate response to SSA, and that Xermelo will be used with an SSA; reauthorization requires that initial criteria continue to be met and the provider attests to improvement in the member's condition.

Revision History

2019-02-20approval

Approved by the Pharmacy & Therapeutics (P&T) committee.

2021-01-20review

Reviewed by P&T; effective 2021-09-01.

2023-05-10reviewLatest

Added continuation of therapy criteria requiring provider attestation of improvement in member's condition. Marked as material; effective 2023-07-01.

2023-07-01effective_date

Policy effective date for the May 10, 2023 updates.