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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.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Authorization Criteria
Covered when ONE of the following is met:
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.
Initial Therapy Criteria
Initial Therapy Criteria
Initial coverage requirements — members new to therapy must meet ONE of the following:
Documentation should support trial and failure/contraindication.
Documentation should support intolerance to oral tablets.
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 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 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
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 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
Reauthorization and Continuation
Continuation and reauthorization requirements:
State mandates, federal requirements, and the member specific benefit plan may impact coverage.
Continuation is permitted provided use was not established solely via manufacturer samples or TranscendRare assistance.
Step Therapy Table
| Step | Requirement | Exceptions / Documentation | Coverage |
|---|---|---|---|
| 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
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.
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