Loading...

UnitedHealthcare Bylvay Prior Auth Coverage Update | OpenPayer

v1.0.11

OpenPayerPolicy UpdatesPharmacy & Specialty DrugsUnitedHealthcare Bylvay Prior Auth Coverage Update…

CurrentUnitedHealthcarePolicy N/A

Bylvay (odevixibat) prior authorization

Prior authorization and notification requirements for Bylvay (odevixibat) for treatment of pruritus in patients with PFIC and Alagille syndrome (ALGS); applies to pharmacy benefit requests under UnitedHealthcare.

Policy Summary

PayerUnitedHealthcare

PolicyBylvay (odevixibat) prior authorization

Policy CodePolicy N/A

Change TypeCoverage criteria addedauthorization duration revised

Effective DateNov 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization request; initial approvals issued for 12 months when criteria for PFIC or ALGS are met.

SourceLink

POLICY UPDATE CHANGES

Updated initial authorization durations to 12 months.

Added coverage criteria for new ALGS indication.

Updated background and reference information.

12 monthsauthorization duration (initial & reauthorization)

>=3 mominimum age for PFIC

>=12 mominimum age for ALGS

1Program number

Coverage Criteria for Bylvay (odevixibat)

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.

inv-01: Initial Therapy - PFIC

Covered when ALL of the following are met

PFIC initial: Diagnosis of progressive familial intrahepatic cholestasis (PFIC)

PFIC symptom: Patient is experiencing pruritus associated with PFIC

Authorization will be issued for 12 months

inv-02: Reauthorization - PFIC

Covered when ALL of the following are met

PFIC reauth: Documentation of positive clinical response to Bylvay therapy

Authorization will be issued for 12 months

inv-03: Initial Therapy - ALGS

Covered when ALL of the following are met

ALGS initial: Diagnosis of Alagille syndrome (ALGS)

ALGS symptom: Patient is experiencing pruritus associated with ALGS

Authorization will be issued for 12 months

inv-04: Reauthorization - ALGS

Covered when ALL of the following are met

ALGS reauth: Documentation of positive clinical response to Bylvay therapy

Authorization will be issued for 12 months

Patients with genetic variants that result in a non-functional or completely absent bile salt export pump (BSEP) protein may not respond to Bylvay (odevixibat). Consider genetic or molecular evidence of BSEP deficiency when evaluating expected treatment benefit.

Initial Therapy

inv-12: Initial therapy — Initial authorization criteria

Initial authorization criteria

Initial PFIC or ALGS: Diagnosis of PFIC or ALGS AND patient experiencing pruritus associated with that diagnosis

Authorization will be issued for 12 months

Reauthorization / Continuation Criteria

inv-13: Reauthorization/Continuation — Reauthorization requirement and criteria (document required evidence of clinical response).

Reauthorization requirement

Continuation: Documentation of positive clinical response to Bylvay therapy required for reauthorization

Authorization will be issued for 12 months

Provider Actions and Authorization Details

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval is issued for 12 months when criteria are met for PFIC or ALGS indications.

Initial Authorization: Diagnosis of progressive familial intrahepatic cholestasis (PFIC) and pruritus associated with PFIC.
Initial Authorization: Diagnosis of Alagille syndrome (ALGS) and pruritus associated with ALGS.
Authorization duration: 12 months for initial approvals.

Step Therapy

No Step Therapy

No specific step therapy requirements are listed in this document.

Documentation Required

Reauthorization Documentation

For reauthorization, submit documentation of positive clinical response to Bylvay therapy.

Reauthorization requirement: Documentation of positive clinical response to Bylvay.
Reauthorization duration: 12 months.

Denial Risk

Denial Risk / Claim Logic

Requests may be denied if evidence of diagnosis, claim/medication history, or claim logic do not support approval per program rules.

Denial risk: Requests may be denied if documentation does not support the requested indication (diagnosis/pruritus).
Operational note: UnitedHealthcare may rely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic; automated approval processes vary by program.
Supply limits may be in place.

Site of Care and Supply Limits

Note

Supply limits may apply; site‑of‑care not specified

Supply limits may be applied per plan or program; the policy does not specify site‑of‑care or infusion center requirements.

Plans or programs may enforce supply limits.
No site‑of‑care or infusion center requirement is specified in the document.

Background

Bylvay (odevixibat) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) aged 3 months and older and in patients with Alagille syndrome (ALGS) aged 12 months and older.

Efficacy of Bylvay may be limited in patients with genetic variants that produce a non-functional or absent bile salt export pump (BSEP) protein; such patients may not experience therapeutic benefit from treatment.

Definitions and Key Terms

BSEP-related nonresponse

Limitation of useBylvay may not be effective in genetic variants resulting in non-functional or complete absence of bile salt export pump (BSEP) protein.

Clinical implicationPatients with BSEP-negative or non-functional BSEP variants are unlikely to respond to Bylvay therapy; consider alternative management or genetic counseling.

Related indicationsBylvay is indicated for pruritus in PFIC (patients >= 3 months) and in ALGS (patients >= 12 months); limitation applies regardless of indication if BSEP is non-functional or absent.

Documentation / testingConsider reviewing genetic testing results for BSEP (ABCB11) variants when available to inform likelihood of response.

Policy Summary

PayerUnitedHealthcare

PolicyBylvay (odevixibat) prior authorization

Policy CodePolicy N/A

Change TypeCoverage criteria addedauthorization duration revised

Effective DateNov 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization request; initial approvals issued for 12 months when criteria for PFIC or ALGS are met.

SourceLink

On This Page

Coverage Criteria for Bylvay (odevixibat)Initial Therapy Reauthorization / Continuation Criteria Provider Actions and Authorization Details Site of Care and Supply Limits Background Definitions and Key Terms