Pharmacy Prior Authorization Criteria

Loargys (pegzilarginase-nbln) - PA, NF

Indications for Prior Authorization

Loargys (pegzilarginase-nbln)

• For diagnosis of Hyperargininemia
  Indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. This indication is approved under accelerated approval based on reduction of plasma arginine. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Criteria

Loargys

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of hyperargininemia
AND
• Both of the following:
• Submission of medical records (e.g., chart notes) confirming the presence of arginase 1 deficiency (ARG1-D)
AND
• Provider attests ARG1-D was detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Used in conjunction with dietary protein restriction
AND
• Patient is 2 years of age or older
AND
• Prescribed by or in consultation with a specialist with expertise in the treatment of metabolic disorders

Loargys

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive response to therapy, as evidenced by a reduction in plasma arginine concentration [A]
AND
• Used in conjunction with dietary protein restriction

Loargys

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming diagnosis of hyperargininemia
AND
• Both of the following:
• Submission of medical records (e.g., chart notes) confirming the presence of arginase 1 deficiency (ARG1-D)
AND
• Provider attests ARG1-D was detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Used in conjunction with dietary protein restriction
AND
• Patient is 2 years of age or older
AND
• Prescribed by or in consultation with a specialist with expertise in the treatment of metabolic disorders

P & T Revisions

2026-07-03, 2026-05-19

References

1. Loargys Prescribing Information. Immedica Pharma US Inc., Chicago, IL. February 2026.

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End Notes

1. As per clinical consult, 27th April 2026, plasma arginine concentration should be used to demonstrate a positive clinical response to therapy. Additionally, P&T feedback to remove the word clinical from this criterion as the outcome measure listed is a surrogate outcome in the clinical trial.

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Revision History

• 2026-07-03: Addition of NF criteria.
• 2026-05-19: New Program

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