CurrentMass General Brigham Health PlanPolicy N/A

Ravicti (glycerol phenylbutyrate) prior authorization and coverage

Defines prior authorization, specialty pharmacy, quantity/step limits, and medical necessity criteria for Ravicti for Mass General Brigham Health Plan members with urea cycle disorders.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRavicti (glycerol phenylbutyrate) prior authorization and coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with genetic test or enzyme assay results, specialist documentation, and documentation of prior inadequate response or contraindication to sodium phenylbutyrate.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsInitial approval duration

6 monthsReauthorization duration

Prior Authorization requiredAccess control

Specialty pharmacyDispensing requirement

Coverage Criteria — Ravicti

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inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Authorization Requirements: Member has a diagnosis of urea cycle disorder.

Initial Authorization Requirements: Provider has submitted results from a genetic test or an enzyme assay supporting the diagnosis.

Initial Authorization Requirements: Provider is a specialist in genetic or metabolic diseases or consultation notes from a specialist are provided.

Initial Authorization Requirements: Member has paid claims or physician-documented inadequate response, adverse reaction, or contraindication to sodium phenylbutyrate.

Additional pathway: Authorization may be granted for members new to the plan who are currently receiving treatment with Ravicti.

Initial Therapy

inv-10: Initial Therapy — Initial authorization criteria (duplicate/alternate grouping of initial therapy rules)

Initial authorization

Initial Authorization: Authorization may be granted for members new to the plan already receiving Ravicti, or when member has a diagnosis of urea cycle disorder; diagnostic genetic or enzyme testing supports the diagnosis; specialist involvement is documented; and there is physician-documented inadequate response, adverse reaction, or contraindication to sodium phenylbutyrate.

Initial approvals will be for 3 months.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ravicti (glycerol phenylbutyrate). Requests for members new to the plan who are currently receiving Ravicti may be authorized with supporting documentation. Pharmacy and medical benefit specialty rules apply; this product is designated specialty and must be filled at a contracted specialty pharmacy when applicable.

All plans: Specialty medications contact Phone: 877-519-1908, Fax: 855-540-3693
Non-specialty meds contact Phone: 800-711-4555, Fax: 844-403-1029

Step Therapy

Step Therapy / Prior Agent Requirement

Step therapy/prior-agent documentation required. Authorization may be granted when the member has a documented inadequate response, adverse reaction, or contraindication to sodium phenylbutyrate, or for members already receiving Ravicti at the time of plan enrollment.

Step therapy requirement: documentation of inadequate response, adverse reaction, or contraindication to sodium phenylbutyrate
Exception: members currently receiving Ravicti at plan enrollment may be authorized with supporting records

Documentation Required

Required Documentation

Submit documentation supporting the diagnosis and specialist involvement. Required documentation includes genetic testing or enzyme assay results confirming a urea cycle disorder, specialist consultation or that the prescriber is a genetic/metabolic disease specialist, and prior treatment history.

Genetic test or enzyme assay results supporting diagnosis of urea cycle disorder
Documentation that prescriber is a specialist in genetic/metabolic diseases OR consultation notes from such a specialist
Evidence of prior claims or physician documentation showing inadequate response, adverse reaction, or contraindication to sodium phenylbutyrate

Denial Risk

Denial Triggers and Continuation Requirements

Requests lacking required documentation, failure to meet diagnostic criteria (no genetic test/enzyme assay confirming urea cycle disorder), absence of specialist involvement or missing evidence of prior-agent trial (or exception for existing Ravicti users) may be denied.

Denial triggers: missing genetic/enzyme test results
Denial triggers: no specialist documentation or consultation notes
Denial triggers: no documentation of prior sodium phenylbutyrate trial or documented exception for members already receiving Ravicti
For continuation: reauthorization requires physician documentation of decreased ammonia levels

Requirement	Details
Documentation of prior inadequate response, adverse reaction, or contraindication to sodium phenylbutyrate
Member has paid claims or physician-documented evidence showing inadequate response, an adverse reaction, or a clinical contraindication to sodium phenylbutyrate; this documentation must be submitted with the authorization request.

Background

Ravicti (glycerol phenylbutyrate) is an ammonia-scavenging agent used in the management of chronic urea cycle disorders (UCDs). The drug is indicated for patients whose UCDs cannot be adequately controlled with dietary protein restriction and/or amino acid supplementation alone and who require alternative ammonia-scavenging therapy. As a specialty medication under this plan, Ravicti dispensing and utilization are managed through the specialty pharmacy program and prior authorization requirements to ensure appropriate use.

Definitions

Urea cycle disorder (UCD) definition — clinical context

DefinitionA group of inherited metabolic disorders that result in impaired removal of ammonia via the urea cycle, sometimes requiring pharmaceutical ammonia‑scavenging agents such as Ravicti (glycerol phenylbutyrate).

Clinical consequenceImpaired urea cycle function leads to accumulation of ammonia, which may require pharmacologic ammonia‑scavenging therapy when dietary protein restriction and/or amino acid supplementation are insufficient.

Typical management contextRavicti is FDA‑indicated for chronic UCDs not controlled by dietary measures alone and is used as alternative ammonia‑scavenging therapy.

Relevant specialistsCare is typically managed by geneticists or metabolic disease specialists (specialist involvement or consultation documentation is required for authorization).