Pharmacy Prior Authorization Criteria

Naglazyme (galsulfase injection)

Indications for Prior Authorization

Naglazyme (galsulfase injection)

• For diagnosis of Mucopolysaccharidosis (MPS VI)
  Indicated for patients with Mucopolysaccharidosis VI (MPS VI). Naglazyme has been shown to improve walking and stair-climbing capacity.

Criteria

Naglazyme

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy Syndrome)

Naglazyme

Prior Authorization (Reauthorization)

Length of Approval: 24 Month(s)

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2024-06-05, 2023-10-03, 2023-06-06, 2022-06-01, 2021-08-02, 2021-05-10, 2020-05-14

References

1. Naglazyme Prescribing Information. BioMarin Pharmaceuticals Inc. April 2020.

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Revision History

• 2024-06-05: 2024 Annual Review. No criteria changes.
• 2023-10-03: Program update to standard reauthorization language. No changes to clinical intent
• 2023-06-06: Initial auth shortened to 12 months. Reauth criteria created with 24 month approval.
• 2022-06-01: Annual Review, no criteria changes.
• 2021-08-02: 2021 UM Annual Review.
• 2021-05-10: 2021 UM Annual Review.
• 2020-05-14: Annual Review - Updated References

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