Aldurazyme (laronidase)
Indications for Prior Authorization
Aldurazyme (laronidase)
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For diagnosis of Mucopolysaccharidosis I (MPS I)
Indicated for adult and pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms. The risks and benefits of treating mildly affected patients with the Scheie form have not been established. Aldurazyme has not been evaluated for effects of the central nervous system manifestations of the disorder.
Criteria
Aldurazyme
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
- One of the following:
- Diagnosis of Hurler or Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) OR
- Diagnosis of Scheie form of Mucopolysaccharidosis I (MPS I) in patients with moderate to severe symptoms
Aldurazyme
Prior Authorization (Reauthorization)
Length of Approval: 24 Month(s)
- Patient demonstrates positive clinical response to therapy
P & T Revisions
2024-06-05, 2023-08-22, 2023-06-06, 2022-06-08, 2021-09-27, 2021-05-11, 2020-05-14
References
- Aldurazyme Prescribing Information, BioMarin Pharmaceutical Inc. Novato, CA. December 2019.
Revision History
- 2024-06-05: Annual Review - no criteria changes
- 2023-08-22: Program update to standard reauthorization language. No changes to clinical intent
- 2023-06-06: Anual Review - Reauth criteria created with 24 month approval duration. Initial auth reduced to 12 month approval
- 2022-06-08: Annual Review
- 2021-09-27: Annual Review
- 2021-05-11: Annual Review
- 2020-05-14: Annual Review