CurrentUnitedHealthcarePolicy N/A

Ravicti (glycerol phenylbutyrate) prior authorization

Defines UnitedHealthcare prior authorization and reauthorization criteria for Ravicti (glycerol phenylbutyrate oral liquid) for treatment of urea cycle disorders, and notes plan/State-specific coverage variations.

Policy Summary

PayerUnitedHealthcare

PolicyRavicti (glycerol phenylbutyrate) prior authorization

Policy CodePolicy N/A

Change TypeEffective date addedclarified brand exclusion

Effective Date5/1/2026

Next Review DateFeb 1, 2026

Key ActionSubmit prior authorization documenting UCD diagnosis and inadequate response to dietary protein restriction or amino acid supplementation; authorization issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Effective date 5/1/2026 recorded for the program.

Updated program to note that brand Ravicti is typically excluded from coverage.

UCDsIndicated diagnosis

12 moAuthorization duration

Acute hyperammonemiaNot indicated for

Brand excludedBrand coverage note

Coverage Criteria for Ravicti (glycerol phenylbutyrate)

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Initial Therapy

Covered when ALL of the following are met

Initial Authorization for Ravicti: Patient has a diagnosis of a urea cycle disorder (UCD).

Initial Authorization for Ravicti: Inadequate response to one of the following: (1) dietary protein restriction OR (2) amino acid supplementation.

Initial Authorization for Ravicti: Ravicti will be used concomitantly with dietary protein restriction and, when applicable, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

Authorization will be issued for 12 months.

Continuation Therapy / Reauthorization

Reauthorization covered when BOTH criteria are met

Reauthorization for Ravicti: Documentation of positive clinical response to Ravicti therapy.

Reauthorization for Ravicti: Patient is actively on dietary protein restriction and, when applicable, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

Authorization will be issued for 12 months.

Ravicti (glycerol phenylbutyrate) is not indicated for the treatment of acute hyperammonemia. The agent is intended for chronic management of urea cycle disorders and must be used in conjunction with dietary protein restriction and, when appropriate, dietary supplements. Additionally, the safety and efficacy of Ravicti for treatment of N‑acetylglutamate synthase (NAGS) deficiency have not been established.

Brand Ravicti is typically excluded from coverage. Individual benefit plans may apply tried/failed or step-therapy requirements in order to provide coverage for Ravicti; providers should consult plan-specific policies to determine whether alternative agents must be tried and failed prior to approval.

Initial Therapy Authorization Requirements

Initial Therapy

Covered when ALL of the following are met

Initial Authorization for Ravicti: Diagnosis of urea cycle disorders (UCDs).

Initial Authorization for Ravicti: Inadequate response to one of: (1) dietary protein restriction; or (2) amino acid supplementation.

Initial Authorization for Ravicti: Therapy will be used concomitantly with dietary protein restriction and, when applicable, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

Authorization will be issued for 12 months.

Reauthorization / Continuation Requirements

Reauthorization

Reauthorization covered when BOTH criteria are met

Reauthorization for Ravicti: Documentation of positive clinical response to Ravicti therapy.

Reauthorization for Ravicti: Patient remains on dietary protein restriction and, when applicable, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

Authorization will be issued for 12 months.

Provider Actions, Documentation, and Denial Risk

Prior Authorization

Prior Authorization Required

Prior authorization is required. Ravicti will be approved for initial authorization only when there is a diagnosis of a urea cycle disorder (UCD) and documentation that the member had an inadequate response to dietary protein restriction or amino acid supplementation. Therapy must be used concomitantly with dietary protein restriction and, when applicable, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein‑free calorie supplements). Initial approvals are issued for 12 months.

Required: diagnosis of a urea cycle disorder (UCD).
Required: inadequate response to one of: dietary protein restriction OR amino acid supplementation.
Required: documentation that Ravicti will be used with dietary protein restriction and, if applicable, supplements (essential amino acids, arginine, citrulline, protein‑free calorie supplements).
Initial authorization duration: 12 months.

Documentation Required

Reauthorization Documentation

Reauthorization will be approved only when documentation shows a positive clinical response to Ravicti and the member remains on active dietary protein restriction and, when applicable, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein‑free calorie supplements). Reauthorizations are issued for 12 months.

Documentation of positive clinical response to Ravicti required.
Evidence patient remains on active dietary protein restriction and any indicated supplements.
Reauthorization duration: 12 months.

Denial Risk

Denial Risk Overview

Coverage may be impacted by plan‑specific exclusions and step therapy. Brand Ravicti is typically excluded by some plans and may require tried/failed alternatives before approval. UnitedHealthcare may use prior claim/medication history, diagnosis codes (ICD‑10), and automated claim logic to approve or deny requests. Lack of required documentation, failure to meet medical necessity, or not meeting step therapy/tried‑and‑failed requirements increases risk of denial.

Plan-specific exclusions may apply; check member benefit for Ravicti exclusion status.
If Ravicti is excluded, documentation of tried/failed alternatives may be required.
Automated approvals may occur based on prior claims/medication history and diagnosis codes.
Denial risks: missing documentation, not meeting medical necessity, not meeting step therapy/tried/failed rules.

Requirement	Details	Coverage status
Step therapy / medical necessity
Medical necessity and/or step therapy may be in place; plans may require tried/failed alternatives before approval.

Brand exclusion
Brand Ravicti is typically excluded from coverage; refer to plan-specific tried/failed criteria to determine exclusion status.

Automated approval processes
UnitedHealthcare may approve based on prior claim/medication history, diagnosis codes, and/or claim logic; use of automated approval/re-approval varies by program.

Site-of-Care and Program Automation

Note

Site-of-care/program variations: automated approval may apply; no site directives

Use of automated approval and re-approval processes varies by program; this document does not specify site-of-care mandates. Program variations may apply for approvals processed based on claims/medication history or diagnosis codes.

Automated approval/re-approval may be used in some programs based on previous claims, medication history, or diagnosis codes
No explicit site-of-care directives (e.g., infusion center) specified in this policy

Background on Ravicti and Urea Cycle Disorders

Ravicti (glycerol phenylbutyrate) is a nitrogen‑scavenging agent indicated for the chronic management of patients with urea cycle disorders (UCDs) who cannot be adequately managed by dietary protein restriction and/or amino acid supplementation alone. Therapy with Ravicti must be administered in combination with dietary protein restriction and, when applicable, appropriate dietary supplements such as essential amino acids, arginine, or citrulline. Ravicti is not intended for acute hyperammonemic episodes and has not been shown to be safe or effective for NAGS deficiency.

Key Definitions

Urea cycle disorders (UCDs) — Definition and brief management summary

DefinitionInherited metabolic disorders causing impaired nitrogen elimination leading to hyperammonemia; management may include dietary protein restriction, amino acid supplementation, and nitrogen‑scavenging agents.

Typical chronic managementUse of nitrogen‑scavenging agents (e.g., glycerol phenylbutyrate/Ravicti) for patients who cannot be controlled with dietary protein restriction and/or amino acid supplementation alone.

Concomitant care requirementsRavicti must be used with dietary protein restriction and, when applicable, dietary supplements such as essential amino acids, arginine, citrulline, or protein‑free calorie supplements.

Not for acute episodesRavicti is not indicated for treatment of acute hyperammonemia in patients with UCDs.

Unestablished useSafety and efficacy of Ravicti for N‑acetylglutamate synthase (NAGS) deficiency have not been established.

Policy Summary

PayerUnitedHealthcare

PolicyRavicti (glycerol phenylbutyrate) prior authorization

Policy CodePolicy N/A

Change TypeEffective date addedclarified brand exclusion

Effective Date5/1/2026

Next Review DateFeb 1, 2026

Key ActionSubmit prior authorization documenting UCD diagnosis and inadequate response to dietary protein restriction or amino acid supplementation; authorization issued for 12 months.

SourceLink

On This Page

OpenPayer

Ravicti (glycerol phenylbutyrate) prior authorization

Coverage Criteria for Ravicti (glycerol phenylbutyrate)

Initial Therapy Authorization Requirements

Reauthorization / Continuation Requirements

Provider Actions, Documentation, and Denial Risk

Step Therapy and Plan Exclusions

Site-of-Care and Program Automation

Background on Ravicti and Urea Cycle Disorders

Key Definitions