CurrentUnitedHealthcarePolicy N/A

Mytesi (crofelemer) prior authorization

Defines UnitedHealthcare prior authorization requirements for Mytesi (crofelemer) for treatment of non-infectious diarrhea in adults with HIV/AIDS receiving antiretroviral therapy; applies to clinicians prescribing and pharmacists processing benefits under UnitedHealthcare plans.

Policy Summary

PayerUnitedHealthcare

PolicyMytesi (crofelemer) prior authorization

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical changes

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

Key ActionObtain prior authorization by documenting diagnosis of HIV/AIDS-associated non-infectious diarrhea and that the patient is on antiretroviral therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

adult patientspopulation

prior authprogram type

Coverage Criteria

inv-01: Initial Authorization — Covered when ALL of the following are met

Covered when ALL of the following are met

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Initial Authorization: Diagnosis of HIV/AIDS-associated diarrhea

Initial Authorization: Patient is on antiretroviral therapy

Authorization will be issued for 12 months.

inv-02: Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Reauthorization: Documentation of positive clinical response to Mytesi therapy

Authorization will be issued for 12 months.

Mytesi is indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS who are receiving antiretroviral therapy. Prior to using Mytesi, infectious causes of diarrhea must be ruled out to ensure the diarrhea is non‑infectious and appropriate for this therapy.

Initial Therapy

inv-10: Initial Therapy — Initial approval criteria

Initial approval criteria

Initial Therapy: Diagnosis of HIV/AIDS-associated diarrhea AND patient is on antiretroviral therapy

Approval for 12 months

Reauthorization / Continuation Criteria

inv-11: Reauthorization — Reauthorization rules

Reauthorization rules

Reauthorization: Documentation of positive clinical response

12-month reauthorization

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Mytesi. Initial authorization is granted when ALL clinical criteria are met, including a documented diagnosis of HIV/AIDS-associated diarrhea and evidence the patient is on antiretroviral therapy. Initial approvals and reauthorizations are issued for 12 months.

Initial approval: must have diagnosis of HIV/AIDS-associated diarrhea
Initial approval: patient must be on antiretroviral therapy
Authorization duration: 12 months

Denial Risk

Denial Risk / Missing Documentation

Absence of the required diagnosis of HIV/AIDS-associated diarrhea or lack of documentation that the patient is on antiretroviral therapy creates a risk for claim denial. Ruling out infectious causes of diarrhea is required for appropriate use and may be requested.

Missing ICD-10 diagnosis for HIV/AIDS-associated diarrhea may lead to denial
No documentation of current antiretroviral therapy may lead to denial
Providers should document evaluation for infectious etiologies of diarrhea

Documentation Required

Documentation Required for Reauthorization

For reauthorization, documentation of a positive clinical response to Mytesi therapy is required. UnitedHealthcare may use prior claim/medication history, diagnosis codes, and/or automated claim logic to approve initial or reauthorization requests. Supply limits may apply.

Reauthorization requires documented positive clinical response
Claims/medication history and ICD-10 codes may be used to authorize without additional documentation
Authorization duration: 12 months

Step Therapy

No step therapy requirements are specified for Mytesi in this policy.

There are no step therapy or prerequisite medication trials listed in the criteria

Definitions

HIV/AIDS-associated diarrhea (definition and key points)

DefinitionNon-infectious diarrhea in adult patients with HIV/AIDS receiving antiretroviral therapy.

Indicated useSymptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.

Requirement before useInfectious etiologies of diarrhea must be ruled out prior to use.

PopulationAdults with HIV/AIDS who are receiving antiretroviral therapy.

Background

Mytesi (crofelemer) is an anti‑diarrheal medication indicated for the symptomatic relief of non‑infectious diarrhea in adult patients with HIV/AIDS who are on antiretroviral therapy. Ruling out infectious etiologies of diarrhea is required for appropriate use; members must meet the policy coverage criteria for authorization.