CurrentColorado Rocky Mountain Health PlansPolicy N/A

Ravicti (glycerol phenylbutyrate) prior authorization

Criteria and prior authorization rules for Ravicti (glycerol phenylbutyrate oral liquid) for management of urea cycle disorders; applies to members subject to UnitedHealthcare Pharmacy Clinical Pharmacy Programs administered by Colorado Rocky Mountain Health Plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyRavicti (glycerol phenylbutyrate) prior authorization

Policy CodePolicy N/A

Change TypeMinor/No material changes

Effective DateMay 1, 2026

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization and submit medical records documenting diagnosis, prior therapies, and ammonia levels or intolerance/contraindication to sodium phenylbutyrate as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization duration

RavictiMedication

Acute hyperammonemiaNot indicated for

NAGS deficiencyExcluded

Trial/failure to sodium phenylbutyrateStep requirement

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Coverage Criteria for Ravicti (glycerol phenylbutyrate)

Initial Authorization

Ravicti will be approved when ALL of the following are met:

(1) Patient has a diagnosis of a urea cycle disorder (UCD).
(2) Patient does not have N-acetylglutamate synthase (NAGS) deficiency.
(3) Patient has history of inadequate response to one of the following: (a) dietary protein restriction; (b) amino acid supplementation.
ALL of the following
- (a): Both of the following: (i) History of failure to sodium phenylbutyrate (Buphenyl®); (ii) Submission of medical records documenting one of the following while on sodium phenylbutyrate: fasting ammonia level > 0.5 × ULN OR any ammonia level (fasting or non‑fasting) above the ULN.
- (b): Both of the following: (i) History of intolerance to sodium phenylbutyrate oral tablets; (ii) Submission of medical records (e.g., chart notes, prescription claims history) documenting a trial of sodium phenylbutyrate oral tablets.
- (c): Submission of medical records documenting a contraindication to sodium phenylbutyrate.
- (d): Both of the following: (i) Patient is currently on Ravicti therapy; (ii) Patient has not been established on therapy solely via manufacturer‑supplied free samples or assistance from the Horizon Therapeutics TranscendRare™ program (e.g., sample redeemed via sample card).
(5) Ravicti will be used concomitantly with dietary protein restriction and, when appropriate, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein‑free calorie supplements).

Reauthorization

Reauthorization will be approved when ALL of the following are met:

Reauthorization: 1) Documentation of positive clinical response to Ravicti therapy; 2) Patient is actively on dietary protein restriction and, when appropriate, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein‑free calorie supplements); authorization will be issued for 12 months.

Ravicti is not indicated for the treatment of acute hyperammonemia; requests for use in that setting do not meet the chronic‑management indication. The policy also states that safety and efficacy have not been established for N‑acetylglutamate synthase (NAGS) deficiency, and NAGS deficiency is an exclusionary condition for approval.

Other high‑level limits include the requirement that Ravicti be used only as part of ongoing dietary management (concomitant dietary protein restriction and, when appropriate, dietary supplements) and that initial approvals require documentation of prior inadequate response to dietary protein restriction and/or amino acid supplementation and evidence of failure, intolerance, or contraindication to sodium phenylbutyrate when applicable. Requests lacking required documentation (for example, of prior dietary management, ammonia levels while on sodium phenylbutyrate, or trial/intolerance/contraindication to sodium phenylbutyrate) may be denied.

Initial Therapy Requirements

Initial therapy

Initial coverage requires:

Initial: Diagnosis of UCD; not NAGS deficiency; prior inadequate response to dietary protein restriction and/or amino acid supplementation; and evidence of failure, intolerance, or contraindication to sodium phenylbutyrate OR current Ravicti use not established solely via manufacturer free samples/program assistance; Ravicti will be used concomitantly with dietary protein restriction and, when appropriate, dietary supplements.

Continuation / Reauthorization Requirements

Continuation therapy

Reauthorization/continuation requirements

Continuation: Documentation of positive clinical response to Ravicti therapy and patient remains on dietary protein restriction and, when appropriate, dietary supplements; authorization duration is 12 months.

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals will be issued when the diagnostic and prior-treatment criteria are met. Authorization duration: 12 months. State mandates, federal requirements, and member-specific benefits may affect coverage.

Authorization duration: 12 months
Check plan-specific exclusions for brand Ravicti and tried/failed criteria
State mandates and member benefit plans may affect coverage

Step Therapy

Step Therapy / Failure Requirements

Requests must document prior inadequate response to dietary protein restriction and/or amino acid supplementation. A trial of sodium phenylbutyrate is required (trial, failure, or documented intolerance) unless there is a listed exception (contraindication or current Ravicti use meeting criteria).

Required prior therapies: dietary protein restriction and amino acid supplementation

Step Therapy Requirements

Step	Requirement / Exception
Step 1: Trial of sodium phenylbutyrate (Buphenyl)	Patient must have prior trial of sodium phenylbutyrate unless an exception below applies.
Failure while on sodium phenylbutyrate	History of failure to sodium phenylbutyrate plus submission of medical records documenting either: fasting ammonia > 0.5 x ULN or any ammonia level above the ULN.
Intolerance to sodium phenylbutyrate oral tablets	History of intolerance to sodium phenylbutyrate oral tablets with submission of medical records (e.g., chart notes, prescription claims) documenting the trial.
Contraindication to sodium phenylbutyrate	Submission of medical records documenting a contraindication to sodium phenylbutyrate.
Current Ravicti user established without manufacturer assistance	Patient is currently on Ravicti and was not established on therapy solely via manufacturer-supplied samples or Horizon Therapeutics TranscendRare program assistance; if established via manufacturer sample/assistance, initial authorization criteria must be met as if new to therapy.

Clinical Coding & Key Lab Thresholds

Ammonia level

Fasting ammonia thresholdFasting ammonia level > 0.5 x ULN

Any ammonia level thresholdAny ammonia level (fasting or non‑fasting) above the laboratory upper limit of normal (ULN)

Context for useThese ammonia thresholds are used to document biochemical failure while on sodium phenylbutyrate as part of step/failure criteria for Ravicti approval

Key Definitions

UCD (definition)

DefinitionUrea cycle disorder (UCD): an inherited metabolic condition causing impairment of the urea cycle resulting in hyperammonemia; Ravicti is indicated for chronic management of patients with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.

Concomitant careTherapy with Ravicti must be used with dietary protein restriction and, when appropriate, dietary supplements (e.g., essential amino acids, arginine, citrulline).

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

NAGS deficiency (coverage exclusion)

Coverage stanceN-acetylglutamate synthase (NAGS) deficiency: safety and efficacy of Ravicti have not been established; NAGS deficiency is excluded from coverage.

Implication for prior authorization

Background

Ravicti (glycerol phenylbutyrate) is a nitrogen‑binding agent indicated for the chronic management of urea cycle disorders (UCDs) in patients who cannot be adequately managed with dietary protein restriction and/or amino acid supplementation alone. It must be used together with dietary protein restriction and, where needed, dietary supplements such as essential amino acids, arginine, or citrulline.

Within the policy context, Ravicti is positioned as a maintenance therapy rather than an acute rescue agent. Authorization for initiation requires a diagnosis of UCD, exclusion of NAGS deficiency, and documentation that dietary measures were insufficient; in most cases the policy requires evidence of failure, intolerance, or contraindication to sodium phenylbutyrate (or that the patient is an existing Ravicti user not established solely via manufacturer free samples/program assistance) before Ravicti will be approved.