WHA
 

Naglazyme (galsulfase injection)

Indications for Prior Authorization

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

Criteria

Naglazyme

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Submission of medical records (e.g., chart notes) confirming diagnosis of Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy Syndrome)
    • AND
  • Diagnosis is confirmed by one of the following:
    • Submission of medical records (e.g., chart notes) confirming absence or deficiency of arylsulfatase B (ARSB) enzyme activity in fibroblasts or leukocytes
      • OR
    • Both of the following:
      • Submission of medical records (e.g., chart notes) confirming presence of mutation in ARSB gene
        • AND
      • Provider attests mutation was detected by a FDA-approved test or a test performed at a facility approved by CLIA.
Naglazyme

Prior Authorization (Reauthorization)

Length of Approval: 24 Month(s)

  • Patient demonstrates positive clinical response to therapy

  • Guideline ID
    GL-641235

  • Formulary
    premium

  • Effective date
    Aug 1, 2026

  • P&T approval date
    Aug 1, 2006

P & T Revisions

2026-07-06, 2026-06-02, 2025-07-02, 2024-06-05, 2023-10-03, 2023-06-06, 2022-06-01, 2021-08-02, 2021-05-10, 2020-05-14

  1. Naglazyme Prescribing Information. BioMarin Pharmaceuticals Inc. Accessed May 2026.
  2. Mucopolysaccharidoses: Clinical features and diagnosis, Sheldon L Kaplan, MD. UpToDate, September 2024, Accessed June 2026.
  3. Mucopolysacchardidosis type 6, Genetic and Rare Diseases Information Center, National Center for Advancing Translational Sciences, National Institutes of Health. Accessed June 2026.
  • 2026-07-06: Guideline update to require confirmation of disease.
  • 2026-06-02: 2026 Annual Review. No criteria changes.
  • 2025-07-02: 2025 Annual Review. No criteria changes. Updated references.
  • 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