CommercialPrior AuthMedium impact
Pegzilarginase-nbln (Loargys)
BCBS Tennessee·TN · Genetics, Pediatrics, Internal Medicine·Medical Policy
Effective date
Jul 31, 2026
We identified it
Jul 17, 2026
Summary
BlueCross BlueShield of Tennessee has issued a new medical policy for Pegzilarginase-nbln (Loargys), a treatment for Arginase 1 Deficiency in patients ages 2-31. The policy establishes coverage criteria, prior authorization requirements, and mandatory documentation including genetic testing, enzyme assays, and functional assessments. Coverage is limited to 12-month authorizations with specific plasma arginine level targets and dose restrictions.
Action Required
By July 31, 2026: Billing team must implement prior authorization workflow for Pegzilarginase-nbln (Loargys) claims. Create authorization templates requiring: (1) lab results showing plasma arginine ≥250 micromol/L, (2) genetic confirmation (ARG1 pathogenic variant OR enzyme assay <1% normal), (3) baseline functional status documentation, and (4) confirmation of dietary protein restriction concurrent use. Providers must be in consultation with metabolic/enzyme disorder specialist. Update prior auth system to flag claims for non-qualifying patients (age <2 or ≥32 years, active infections within 3 weeks, HIV/Hepatitis B or C, prior transplant, PEG hypersensitivity, or dose exceeding 0.2 mg/kg weekly). For continuation requests, require pre-dose plasma arginine levels and functional assessment scores (2MWT, GMFM-E/D results). Configure system to deny claims without proper documentation and to auto-deny if patient falls outside approved age range. Failure to implement prior auth will result in claim denials.