CurrentHealth NetPolicy CP CPA.32

Crofelemer (Mytesi)

Policy governs medical necessity criteria and prior authorization requirements for crofelemer (Mytesi) for treatment of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy for Health Net/Centene lines of business.

Policy Summary

PayerHealth Net

PolicyCrofelemer (Mytesi)

Policy CodePolicy CP CPA.32

Change TypeNo material changes

Effective DateNov 16, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis of HIV/AIDS, age >18, current antiretroviral therapy, failure of alternative antidiarrheals unless contraindicated, and dose ≤250 mg/day.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

250 mg/daymaximum approved daily dose

Age > 18minimum age for coverage

6 moinitial approval length

12 mocontinuation approval length

HIV adults on ARTFDA-indicated population

Coverage Criteria for Crofelemer (Mytesi)

inv-01: Initial Approval Criteria

Covered when ALL of the following are met:

Initial Approval

Diagnosis of HIV/AIDS.
Non-infectious diarrhea in a patient with HIV/AIDS.
Age > 18 years.
Member is currently receiving antiretroviral therapy as evidenced by claims history.
Failure of an antidiarrheal medication (e.g., loperamide, diphenoxylate/atropine, bismuth subsalicylate) unless clinically significant adverse effects or contraindications to these agents exist.

Policy Summary

PayerHealth Net

PolicyCrofelemer (Mytesi)

Policy CodePolicy CP CPA.32

Change TypeNo material changes

Effective DateNov 16, 2016

Next Review Date

SourceLink

On This Page

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Requested dose does not exceed 250 mg (2 tablets) per day.

inv-02: Continuation / Renewals

Covered when ALL of the following are met:

Continuation Therapy

Member status
- Member currently receiving medication via Centene benefit or member has previously met initial approval criteria.
- Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.
Member is responding positively to therapy.
If request is for a dose increase, the new dose does not exceed 250 mg (2 tablets) per day.

inv-03: Not Authorized / Exclusions

Excluded Indications: Irritable bowel syndrome with diarrhea and other non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided per off-label use policy (see CP.CPA.09) or applicable evidence of coverage documents.

Refer to CP.CPA.09 for off-label uses and CP.CPA.190 for non-formulary/no coverage situations.

Irritable bowel syndrome with diarrhea and other non‑FDA approved indications addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the plans off‑label use requirements (see CP.CPA.09) or applicable evidence of coverage documents.

Use of crofelemer (Mytesi) for indications that are not FDA‑approved and are not specifically supported by this policy is not authorized / not medically necessary unless adequate supporting documentation is provided per the off‑label use policy (CP.CPA.09) or evidence of coverage criteria.

Coding and Dosage

Covered CPT CodesCPT

No codes listed

inv-07: Maximum daily dose

Maximum daily dose250 mg/day (do not exceed 250 mg per day)

Equivalent tablet count2 tablets per day (125 mg each) maximum

Policy threshold typeDose threshold for coverage/authorization

Provider Requirements and Submission

Prior Authorization

Prior Authorization Required

Prior authorization required — submission of documentation that the member meets all approval criteria including diagnosis, age, etc.

Clinical documentation (office chart notes, lab results, other clinical information) must be submitted to support that the member has met all applicable approval criteria.
Requests lacking sufficient documentation for FDA-unlisted or off-label indications will be reviewed per off-label / non-covered criteria (see CP.CPA.09 and applicable evidence of coverage documents).
Provider must document that the member is currently receiving antiretroviral therapy (when applicable) as evidenced by claims history or chart documentation.

Documentation Required

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

Include diagnosis confirming HIV/AIDS and non-infectious diarrhea when applicable.
Include member age to confirm > 18 years when applicable.
Include documentation of current antiretroviral therapy when relevant.

Step Therapy

Trial of Antidiarrheal Medication Required

Provider must document trial and failure of an antidiarrheal medication unless clinically justified (e.g., significant adverse effects or all agents contraindicated).

Examples of antidiarrheal medications: loperamide, diphenoxylate/atropine (Lomotil), bismuth subsalicylate (Pepto-Bismol).
If not trialed, include clinical rationale why antidiarrheal therapy is contraindicated or not tolerated.

Denial Risk

Off-label / Non-covered Indications

Requests for indications not listed in this policy or for non‑FDA indications without sufficient supporting documentation will be reviewed per off-label / non-covered criteria.

Off-label requests should include evidence of efficacy and safety consistent with CP.CPA.09 and applicable evidence of coverage documents.

Background

Crofelemer (Mytesi) is a delayed‑release 125 mg tablet indicated for the symptomatic relief of non‑infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. The policy limits use to adults (>18 years) within that FDA‑indicated population and specifies a maximum recommended dose of 250 mg per day.

Drug Definition

inv-13: Mytesi (crofelemer) — product description and formulation (delayed-release 125 mg tablet)

Active ingredient and brandCrofelemer (Mytesi)

FormulationDelayed-release 125 mg tablet

FDA-indicated use (per label)Symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy

Dosage presentation noteTablets are delayed-release; maximum daily dose per policy is 250 mg/day