Draftblue cross blue shield - tennesseePolicy N/A

Pegzilarginase-nbln (Loargys)

Defines coverage, prior authorization documentation, prescriber specialty, initial and continuation criteria, dosing limits, monitoring, and exclusions for pegzilarginase (Loargys) for treatment of hyperargininemia due to Arginase 1 Deficiency in members aged 2 to <32 years when criteria are met.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyPegzilarginase-nbln (Loargys)

Policy CodePolicy N/A

Change TypeDraft New Policy

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit chart notes, medical records, or lab results documenting elevated plasma arginine (>=250 micromol/L) and diagnostic confirmation, baseline functional status, and specialty prescriber documentation for prior authorization.

SourceLink

POLICY UPDATE CHANGES

New draft policy for pegzilarginase-nbln (Loargys) with coverage criteria for ARG1-D.

1Covered Indication (ARG1-D)

2 to <32Covered age range

>=250Baseline plasma arginine threshold (micromol/L)

50-150Therapeutic pre-dose arginine range (micromol/L)

Coverage Summary

Coverage stance: Covered with criteria for pegzilarginase-nbln (Loargys) for treatment of Arginase 1 Deficiency (ARG1-D) in patients aged 2 to <32 years. Authorization is contingent on meeting the policy's specified initial and continuation criteria, including baseline plasma arginine, diagnostic confirmation, dosing limits, monitoring, and functional assessments.

Key thresholds and coverage

Baseline plasma arginine threshold>= 250 micromol/L

Therapeutic pre-dose plasma arginine range50 - 150 micromol/L

Covered age range2 years to <32 years

Maximum dose<= 0.2 mg/kg once weekly