CurrentCareSourcePolicy N/A

Ravicti (glycerol phenylbutyrate) - Pharmacy Coverage Criteria

This policy governs pharmacy benefit coverage and prior authorization requirements for Ravicti (glycerol phenylbutyrate) for members in the stated jurisdiction, including initial and reauthorization criteria and quantity limits.

Policy Summary

PayerCareSource

PolicyRavicti (glycerol phenylbutyrate) - Pharmacy Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative revision

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and document trial and failure, intolerance, or contraindication to Buphenyl when requesting Ravicti.

SourceLink

POLICY UPDATE CHANGES

Removed prescriber specialty requirement and documented history of hyperammonemia associated with diagnosis of a UCD requirement.

12 monthsInitial approval duration

12 monthsReauthorization duration

112 mL/dayQuantity limit

Non-preferredFormulary status

Coverage Criteria for Ravicti (glycerol phenylbutyrate)

Initial Therapy

Covered when ALL of the following are met for initial authorization

Initial Authorization: 1) Member has a clinical diagnosis of an appropriate disease state (urea cycle disorder) and meets individual criteria; 2) Dietary treatment has been insufficient to maintain plasma ammonia below the upper limit of normal (ULN) of 35 µmol/L despite adherence; 3) Member is currently treated with and adherent to dietary protein restriction and, when appropriate, dietary supplements (e.g., essential amino acids, arginine except ARGID, citrulline for OTCD and CPSID, protein‑free calorie supplements); 4) Member tried and failed Buphenyl (sodium phenylbutyrate) unless one of the following applies: a) not tolerated due to severe adverse effects; b) contraindication to Buphenyl (e.g., hypersensitivity, pregnancy, breastfeeding); or c) failed to maintain ammonia below ULN despite optimized Buphenyl dosing (13 g/day, max 20 g/day) and adherence; 5) Member does NOT have N‑acetylglutamate synthase (NAGS) deficiency; 6) Ravicti is NOT being used to treat acute hyperammonemia; 7) Treatment is not complicated by conditions causing sodium retention and edema (e.g., congestive heart failure, severe renal insufficiency).see text

If all met, approve for 12 months

Continuation Therapy / Reauthorization

Covered for reauthorization when ALL of the following are met

Policy Summary

PayerCareSource

PolicyRavicti (glycerol phenylbutyrate) - Pharmacy Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative revision

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and document trial and failure, intolerance, or contraindication to Buphenyl when requesting Ravicti.

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.

Reauthorization: 1) Member continues to meet all initial authorization requirements; 2) Chart notes document clinical improvement of signs and symptoms (e.g., normalized plasma ammonia levels).see text

If all met, approve for additional 12 months

CareSource considers Ravicti (glycerol phenylbutyrate) not medically necessary for treatment of the following disease states due to lack of robust controlled trial evidence demonstrating superior efficacy compared with available therapies: Byler disease (progressive familial intrahepatic cholestasis 1 / PFIC-1), cirrhosis with hepatic encephalopathy, cystic fibrosis, and medium-chain acyl-CoA dehydrogenase (MCAD) deficiency.

The rationale for these exclusions is that there are insufficient robust clinical controlled trials demonstrating that Ravicti provides superior efficacy in these disease states compared with currently available treatments. As a result, use of Ravicti for these indications is considered not medically necessary and is excluded from coverage under this policy.

Initial Therapy Criteria

Initial therapy

Initial authorization criteria for Ravicti

Initial therapy node: See coverage initial therapy criteria: Dietary treatment insufficient to maintain plasma ammonia < ULN (35 µmol/L) despite adherence; current adherence to dietary protein restriction and appropriate supplements; trial and failure of Buphenyl or documented intolerance/contraindication or failure despite optimized Buphenyl dosing (13 g/day, max 20 g/day); absence of NAGS deficiency; not for acute hyperammonemia; not complicated by sodium‑retaining conditions causing edema.see text

Approve 12 months if met

Continuation / Reauthorization Criteria

Reauthorization

Reauthorization requirements

Reauthorization node: Member meets all initial authorization requirements and has chart documentation showing clinical improvement (e.g., normalized plasma ammonia).see text

Approve for additional 12 months if met

Provider Actions, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior Authorization Required for Ravicti (non-preferred product). Ravicti is covered under the pharmacy benefit only when prior authorization is obtained.

Must submit valid prior authorization request before dispensing
Ravicti is non-preferred; Buphenyl is the preferred alternative

Step Therapy

Step Requirement — Preferred Product (Buphenyl)

Step therapy requirement: member must have tried and failed Buphenyl prior to Ravicti unless there is documented intolerance or a contraindication. Buphenyl is the preferred product.

Documented trial of Buphenyl with evidence of failure to control ammonia OR
Documented intolerance (e.g., severe adverse effects) or contraindication (e.g., hypersensitivity, pregnancy, breastfeeding) to Buphenyl

Documentation Required

Required Documentation

Required documentation must be provided with the prior authorization request and retained in chart notes: diagnosis, evidence of dietary management and adherence, plasma ammonia levels, and documentation of trial/failure or intolerance to alternatives (Buphenyl).

Chart notes documenting clinical diagnosis of a urea cycle disorder (or other approved diagnosis)
Documentation of dietary protein restriction and adherence, and use of appropriate supplements (arginine, citrulline, etc.)
Plasma ammonia levels (baseline and subsequent) showing failure to maintain below ULN or improvement on therapy
Documentation of trial and failure of Buphenyl or documentation of intolerance/contraindication to Buphenyl
For reauthorization, chart notes showing clinical improvement (e.g., normalized plasma ammonia)

Denial Risk

Denial Triggers / Risk of Non-Coverage

Denial triggers include lack of prior authorization, failure to meet initial criteria (including inadequate dietary management or lack of documented trial/failure of preferred therapy), use for excluded indications, or use for acute hyperammonemia.

Lack of prior authorization request or incomplete PA documentation
Failure to document adequate dietary management and adherence
No documented trial of Buphenyl or lack of documented intolerance/contraindication to Buphenyl
Request for Ravicti to treat acute hyperammonemia (not covered)
Requests for diagnoses considered not medically necessary (e.g., PFIC-1/Byler disease, cirrhosis with hepatic encephalopathy, cystic fibrosis, MCAD deficiency)

Billing and Coding

Billing codesNDC

NDC	Must use valid NDC code

inv-06: Plasma ammonia ULN — 35 µmol/L

Plasma ammonia ULN35 µmol/L

ContextULN referenced as threshold for inadequate dietary control in initial authorization criteria

Use in reauthorizationNormalized plasma ammonia (below ULN) is required as evidence of clinical improvement for reauthorization

inv-07: Buphenyl optimized dosing — 13 g/day, max 20 g/day

Optimized Buphenyl dosing13 g/day (optimized), maximum 20 g/day

Role in step therapyFailure to maintain ammonia below ULN despite optimized dosing qualifies as reason to use Ravicti

DocumentationChart notes must document optimized dosing and adherence

Step Therapy / Preferred Alternatives

Step	Requirement	Notes
{"text":"1","status":""}\|{"text":"Must trial Buphenyl (sodium phenylbutyrate) unless contraindicated or not tolerated","status":""}\|{"text":"Alternative preferred product: Buphenyl; documentation of trial and failure, intolerance, or contraindication required","status":""}

Quantity Limits

inv-17: Ravicti (glycerol phenylbutyrate) — 112 mL

Quantity limit112 mL per day

Formulary statusNon-preferred product (prior authorization required)

Benefit typePharmacy benefit; must use valid NDC for billing

Site of Care

Note

Site of service allowed: Home

Administration or dispensation of Ravicti is permitted in the home setting; home is an allowed site of service under the policy.

Definitions

inv-13: ULN (plasma ammonia) — Upper limit of normal specified as 35 µmol/L

Upper limit of normal (ULN)35 µmol/L

PurposeUsed as the target threshold for ammonia control in initial and continuation criteria

Policy useFailure to maintain ammonia below 35 µmol/L despite dietary management triggers step requirement to try optimized Buphenyl

Background

Ravicti (glycerol phenylbutyrate) is an ammonia-scavenging agent used in the management of urea cycle disorders (UCDs) to reduce hyperammonemia. Standard management of UCDs includes dietary protein restriction and appropriate amino acid supplementation; an objective of therapy is control of plasma ammonia to below the policy-specified upper limit of normal (35 µmol/L). Reauthorization requires that the member continues to meet initial authorization criteria and that chart notes document clinical improvement (for example, normalized plasma ammonia), in which case treatment may be approved for an additional 12 months.