CurrentUnitedHealthcarePolicy N/A

Ravicti (glycerol phenylbutyrate) — Prior Authorization Coverage Criteria

Defines UnitedHealthcare pharmacy prior authorization criteria for Ravicti (glycerol phenylbutyrate oral liquid) for management of urea cycle disorders; applies to members whose benefit plans require prior authorization.

Policy Summary

PayerUnitedHealthcare

PolicyRavicti (glycerol phenylbutyrate) — Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 1, 2026

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization by documenting diagnosis of a urea cycle disorder and inadequate response to dietary protein restriction or amino acid supplementation; initial approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Ravictidrug covered by policy

12 monthsapproval period

Acute hyperammonemiaindication exclusion

Brand typically excludedbrand coverage note

Coverage Criteria for Ravicti

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Initial Therapy

Covered when ALL of the following are met:

Initial Authorization: Diagnosis of urea cycle disorders (UCDs)

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

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

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Continuation Therapy

Reauthorization is approved when BOTH criteria are met:

Reauthorization: Documentation of positive clinical response to Ravicti therapy

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

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Ravicti is not indicated for treatment of acute hyperammonemia in patients with urea cycle disorders (UCDs). Its use is intended for chronic management in patients who cannot be controlled with dietary protein restriction and/or amino acid supplementation alone, and it must be used concomitantly with dietary protein restriction and, when applicable, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein‑free calorie supplements). 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 under many UnitedHealthcare plan designs; tried/failed requirements or other plan‑specific restrictions may apply. Providers should consult the member’s benefit plan to determine whether a brand exclusion or step/try‑fail criteria are in effect before submitting a prior authorization request.

Initial Authorization Criteria

Initial Authorization

Initial Authorization: (a) Diagnosis of urea cycle disorders (UCDs)

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Initial Authorization: (b) Inadequate response to one of the following: (1) Dietary protein restriction (2) Amino acid supplementation

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Initial Authorization: (c) Will be used concomitantly with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements)

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Initial Authorization: Initial authorization duration: 12 months

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Reauthorization / Continuation Criteria

Reauthorization

Reauthorization: Documentation of positive clinical response to Ravicti therapy

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

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Reauthorization duration: 12 months (state mandates and member benefit plan specifics may apply)

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Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization and Duration

Prior Authorization Required: Ravicti requires prior authorization for initial and continued therapy. Approvals are typically issued for 12 months when criteria are met. Note that brand Ravicti may be excluded by some plans; check member-specific benefits for exclusion or tried/failed rules.

Initial and reauthorization approvals are commonly valid for 12 months
Check plan-level exclusions for brand Ravicti and any tried/failed requirements

Denial Risk

Denial Triggers for Missing Criteria

Denial triggers — items likely to cause denial or delay include missing or incomplete documentation of diagnosis, lack of documentation that dietary protein restriction and/or amino acid supplementation were tried or are being used concomitantly, absence of documentation of clinical benefit on reauthorization, or lack of supporting claim/medication history when automated review is used.

Missing or unspecified diagnosis of a urea cycle disorder (UCD)
No documentation that dietary protein restriction was tried or is currently being followed
No evidence of prior amino acid supplementation or other dietary management when required
On reauthorization: no documentation of positive clinical response to Ravicti
Incomplete medication or claim history when the program relies on prior-claim automated decisions

Documentation Required

Reauthorization Documentation Requirements

Reauthorization documentation — providers must submit documentation of ongoing clinical benefit and confirm continued use of dietary management. Reauthorization will be approved when both of the following are documented.

Documentation of positive clinical response to Ravicti therapy (e.g., reduction in hyperammonemic events, laboratory/improvement notes, clinical assessments)
Evidence patient is actively maintaining dietary protein restriction and, when applicable, continued use of dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements)

Note

Additional Program Rules

Additional program rules — UnitedHealthcare may use previous claim/medication history, diagnosis codes, and automated claim logic to approve initial or reauthorization requests. Medical necessity and/or step therapy requirements may also apply and can affect approval decisions.

Approvals may be granted based on prior claim/medication history and ICD-10 diagnosis codes without full clinical documentation in some programs
Medical necessity and step therapy rules may apply; verify member-specific program rules

Step Therapy / Program Rules

Step	Requirement / Rule	Notes
1	Medical necessity and/or step therapy may be in place	UnitedHealthcare may apply medical necessity or step therapy program rules for Ravicti coverage; requirements depend on the member's benefit plan
2	Automated approvals may be based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic	Use of automated approval and re-approval processes varies by program and therapeutic class
[{"text":"3","status":""},{"text":"Clinical documentation may still be required for some programs","status":""},{"text":"Even when automated approvals are used, plan-specific rules or documentation requests may apply","status":""}

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 controlled with dietary protein restriction and/or amino acid supplementation alone. It is administered as an oral liquid and is intended to be used in conjunction with ongoing dietary protein restriction and, where clinically appropriate, dietary supplements such as essential amino acids, arginine, citrulline, or protein‑free calorie supplements.

Definitions

Urea cycle disorders (UCDs) — definition and short description

DefinitionInherited metabolic disorders causing impaired conversion of ammonia to urea, resulting in hyperammonemia and requiring management with dietary protein restriction, amino acid supplementation, and when necessary, nitrogen-scavenging therapy.

Clinical role of RavictiRavicti (glycerol phenylbutyrate) is a nitrogen‑scavenging agent indicated for chronic management of patients with UCDs who cannot be controlled with dietary protein restriction and/or amino acid supplementation alone.

Use with other therapiesMust be used concomitantly with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein‑free calorie supplements).

Not for acute treatmentNot indicated for treatment of acute hyperammonemia in patients with UCDs.

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

Policy Summary

PayerUnitedHealthcare

PolicyRavicti (glycerol phenylbutyrate) — Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 1, 2026

Next Review DateFeb 1, 2025

SourceLink

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