CurrentUnitedHealthcarePolicy N/A

Ravicti (glycerol phenylbutyrate) — Step therapy coverage criteria

This document defines UnitedHealthcare's step therapy requirement requiring trial of sodium phenylbutyrate before coverage of Ravicti for members with urea cycle disorders; it affects prescribers and pharmacists managing these medications under UnitedHealthcare pharmacy benefits.

Policy Summary

PayerUnitedHealthcare

PolicyRavicti (glycerol phenylbutyrate) — Step therapy coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

Key ActionMembers new to therapy must try sodium phenylbutyrate before Ravicti unless there is documented failure, contraindication, or intolerance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12authorization duration

sodium PBrequired prior therapy

grandfatheredgrandfathering provision

P3098-9program number

Coverage Criteria

Initial Authorization Criteria

Covered when ONE of the following is met:

Approval pathway: History of failure or contraindication to sodium phenylbutyrate

Approval pathway: History of intolerance to sodium phenylbutyrate oral tablets

Current therapy pathway: Patient is currently on Ravicti therapy (documented in claims history)

Patients who were established on Ravicti therapy solely through manufacturer‑supplied free samples or through assistance from the Horizon Therapeutics TranscendRare program are not considered current users for the purposes of this program. Such patients must meet the same initial authorization requirements as members who are new to therapy.

Documentation that a member’s ongoing Ravicti use was based on a sample or TranscendRare assistance will result in the member being processed under the initial authorization pathway, which requires evidence of a prior trial and failure or contraindication to sodium phenylbutyrate, or documented intolerance to sodium phenylbutyrate oral tablets.

Policy Summary

PayerUnitedHealthcare

PolicyRavicti (glycerol phenylbutyrate) — Step therapy coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

Key ActionMembers new to therapy must try sodium phenylbutyrate before Ravicti unless there is documented failure, contraindication, or intolerance.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Therapy Criteria

Initial coverage requirements — members new to therapy must meet ONE of the following:

Initial authorization: Trial and documented failure or contraindication to sodium phenylbutyrate

Documentation should support trial and failure/contraindication.

Initial authorization: History of intolerance to sodium phenylbutyrate oral tablets

Documentation should support intolerance to oral tablets.

Initial authorization: Current Ravicti use documented in claims history without reliance on manufacturer samples or TranscendRare assistance

If current use was established via manufacturer samples or TranscendRare assistance, patient must meet initial authorization criteria as new to therapy.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ravicti (glycerol phenylbutyrate). When coverage criteria are met, approvals are granted for 12 months. State mandates, federal requirements, and member-specific benefit plans may affect coverage duration.

Approval duration: 12 months (when criteria met)
Prior authorization required before coverage

Step Therapy

Step Therapy Requirement

A step-therapy trial of sodium phenylbutyrate is required prior to approval of Ravicti for members new to therapy. Members currently documented on Ravicti in claims history may continue therapy without meeting the step requirement. Exceptions (see documentation and denial-risk callouts) apply.

Required prior trial: sodium phenylbutyrate (oral)
Existing Ravicti users documented in claims are exempt from step trial

Documentation Required

Required Documentation

Documentation must be submitted to support exceptions or to demonstrate failure/intolerance to sodium phenylbutyrate. Acceptable documentation includes clinical notes describing trial duration, reason for discontinuation (e.g., lack of efficacy, adverse effects), intolerance or contraindication details, and pharmacy/claims history showing prior Ravicti use. If therapy was initiated via a manufacturer-provided sample or assistance program, documentation must show whether the patient received subsequent paid fills.

Clinical notes with trial duration and reason for failure/intolerance
Evidence of contraindication (medical record)
Pharmacy/claims history showing prior Ravicti fills to establish current use
Documentation of manufacturer sample/assistance program receipt and subsequent paid fills

Denial Risk

Denial Triggers if Step Therapy Exceptions Not Met

Requests that do not document a trial of sodium phenylbutyrate, or that fail to provide documentation of intolerance/contraindication or prior Ravicti use (when claimed), will be denied. Initiations established solely by a one-time manufacturer sample or assistance program without subsequent paid fills will not be accepted as proof of current therapy and may result in denial unless initial authorization criteria for new therapy are met.

Denial triggers: no documented sodium phenylbutyrate trial or documented failure/intolerance
Denial triggers: claimed current Ravicti use only supported by manufacturer sample/assistance without paid fills

Reauthorization and Continuation

Continuation and reauthorization requirements:

Reauthorization: Authorization will be granted for 12 months when criteria are met12 months

State mandates, federal requirements, and the member specific benefit plan may impact coverage.

Continuation for current users: Members currently on Ravicti therapy as documented in claims history will be allowed to continue therapy

Continuation is permitted provided use was not established solely via manufacturer samples or TranscendRare assistance.

Step Therapy Table

Step	Requirement	Exceptions / Documentation
1	Member must have trial of sodium phenylbutyrate (Buphenyl) prior to initiation of Ravicti (glycerol phenylbutyrate)	Documented history of failure or contraindication to sodium phenylbutyrate
2	If member has history of intolerance to sodium phenylbutyrate oral tablets, Ravicti may be considered without trial	Documentation of intolerance to oral sodium phenylbutyrate tablets required
3	Members currently on Ravicti may continue therapy without prior trial of sodium phenylbutyrate	Patient must be documented in claims history as current Ravicti user and must NOT have been established on therapy solely via manufacturer free samples or TranscendRare program assistance

Definitions

Step Therapy definition

TermStep Therapy

DefinitionRequirement that members new to Ravicti (glycerol phenylbutyrate) must first try sodium phenylbutyrate prior to coverage of Ravicti, unless a documented failure, contraindication, or intolerance to sodium phenylbutyrate oral tablets exists, or the member is already established on Ravicti as documented in claims history.

PurposeEncourage use of a lower-cost alternative (sodium phenylbutyrate) within urea cycle disorder adjunctive therapy prior to coverage of Ravicti.

ExceptionsDocumented history of failure or contraindication to sodium phenylbutyrate, documented intolerance to sodium phenylbutyrate oral tablets, or current Ravicti users documented in claims history (not established solely via manufacturer samples/assistance).

Background

Ravicti (glycerol phenylbutyrate) and sodium phenylbutyrate are adjunctive therapies used in the chronic management of urea cycle disorders (UCDs) alongside dietary protein restriction and amino acid supplementation when indicated. This program promotes use of the lower‑cost alternative, sodium phenylbutyrate, as the preferred initial therapy before coverage of Ravicti is approved unless a listed exception applies.

When authorization is considered, coverage for Ravicti is based on meeting one of the program pathways: history of failure or contraindication to sodium phenylbutyrate, history of intolerance to sodium phenylbutyrate oral tablets, or documented current Ravicti use that was not established via manufacturer samples or the TranscendRare assistance program.