Naglazyme (galsulfase injection)
Indications for Prior Authorization
Naglazyme (galsulfase injection)
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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
- Naglazyme Prescribing Information. BioMarin Pharmaceuticals Inc. April 2020.
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