CurrentCignaPolicy IP0520

Paromomycin (Humatin) — Coverage Criteria

Defines medical necessity criteria, authorization duration, and coverage limitations for paromomycin (Humatin) for Cigna-administered health plans; applies to providers requesting coverage for treatment of specified infectious indications.

Policy Summary

PayerCigna

PolicyParomomycin (Humatin) — Coverage Criteria

Policy CodePolicy IP0520

Change TypeNo material change

Effective DateJan 15, 2023

Next Review DateJan 1, 2024

Key ActionObtain prior authorization and document the diagnosis corresponding to an approved indication to support coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4listed medically necessary indications

up to 12 moinitial authorization duration

up to 12 moreauthorization duration

1guideline references cited

Coverage Criteria for Paromomycin (Humatin)

Initial Therapy

Policy Summary

PayerCigna

PolicyParomomycin (Humatin) — Coverage Criteria

Policy CodePolicy IP0520

Change TypeNo material change

Effective DateJan 15, 2023

Next Review DateJan 1, 2024

Key ActionObtain prior authorization and document the diagnosis corresponding to an approved indication to support coverage.

SourceLink

On This Page

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Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for paromomycin (Humatin). Initial approvals may be granted for up to 12 months. Reauthorization (continuation) approvals may be granted for up to 12 months.

Initial approval: up to 12 months
Reauthorization approval: up to 12 months

Documentation Required

Documentation Required to Support Medical Necessity

Provider must document the patient's diagnosis and supporting clinical information demonstrating that the request is for one of the medically accepted indications listed in this policy (e.g., intestinal amebiasis; hepatic coma; cryptosporidiosis-associated diarrhea in patients with HIV; Dientamoeba fragilis infection). Include relevant prior treatments, laboratory or diagnostic findings, HIV status and antiretroviral therapy optimization when applicable, and any other information needed to establish medical necessity.

Document diagnosis corresponding to one of the approved indications
When applicable, document HIV status and ART optimization
Include prior therapies, diagnostic/laboratory data, and clinical rationale

Step Therapy

Step Therapy / Sequencing

No formal step therapy requirements are specified in this policy. Clinicians should follow applicable clinical guidelines (for example, HHS and CDC guidance) and consider alternative therapies as clinically indicated prior to or in conjunction with paromomycin when appropriate.

No step therapy mandated by this policy
Follow clinical guidelines (HHS, CDC) and consider alternatives as clinically appropriate

Background

Humatin (paromomycin) is an oral broad‑spectrum aminoglycoside antibiotic indicated for treatment of intestinal amebiasis (acute and chronic) and as adjunctive therapy in the management of hepatic coma. The policy also recognizes paromomycin’s use for certain parasitic diarrheas per guideline recommendations, including management of Cryptosporidium‑associated diarrhea in patients with HIV and treatment of Dientamoeba fragilis, when those indications meet the medical necessity criteria outlined in this policy. Prior authorization is required, with initial and reauthorization approvals available for up to 12 months when criteria are met and benefit is demonstrated.

Definitions

Humatin (paromomycin) — key definition and usage notes

Generic nameParomomycin

Brand nameHumatin

Drug class and routeOral broad‑spectrum aminoglycoside antibiotic

Primary FDA‑listed indications (common usage)Treatment of intestinal amebiasis (acute and chronic); adjunctive therapy for management of hepatic coma

Guideline‑recommended usesRecommended by HHS for Cryptosporidium‑associated diarrhea in adolescents and adults with HIV (used with optimized ART, rehydration and supportive care); recommended by CDC for Dientamoeba fragilis management

Clinical note on supportive careWhen used for Cryptosporidium in patients with HIV, paromomycin should be combined with optimized antiretroviral therapy, electrolyte replacement, symptomatic treatment, and rehydration