Pharmacy Prior Authorization Criteria

Vimizim (elosulfase alfa)

Indications for Prior Authorization

Vimizim (elosulfase alfa)

• For diagnosis of Mucopolysaccharidosis type IVA
  Indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).

Criteria

Vimizim

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) confirmed by both of the following: [1-3]
• Documented clinical signs and symptoms of the disease (e.g., kyphoscoliosis, genu valgum, pectus carinatum, gait disturbance, growth deficiency, etc.)
AND
• Documented reduced fibroblast or leukocyte GALNS enzyme activity or molecular genetic testing for mutations in the GALNS gene.

Vimizim

Prior Authorization (Reauthorization)

Length of Approval: 24 Month(s)

• Patient demonstrates a positive clinical response to therapy

P & T Revisions

2024-07-31, 2023-07-06, 2022-08-18, 2021-07-07, 2021-05-25, 2020-06-16

References

1. Vimizim prescribing information. BioMarin Pharmaceutical Inc. Novato, CA. December 2019.
2. UptoDate. Mucopolysaccharidoses: Clinical features and diagnosis. Available at https://www.uptodate.com/contents/mucopolysaccharidoses-clinical-features-and-diagnosis?search=Mucopolysaccharidoses:%20clinical%20features%20and%20diagnosis.%20&source=search_result&selectedTitle=1~66&usage_type=default&display_rank=1. Accessed July 6, 2022.
3. Mucopolysaccharidosis IV. Available at https://rarediseases.org/rare-diseases/morquio-syndrome/#:~:text=Excessive%20amounts%20of%20keratan%20sulfate,to%20identify%20GALNS%20gene%20mutations. Accessed July 6, 2022.

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Revision History

• 2024-07-31: 2024 Annual Review. Updated verbiage in criterion 1.2 for clarity.
• 2023-07-06: Updated guideline
• 2022-08-18: 2022 Annual Review.
• 2021-07-07: Annual review
• 2021-05-25: Addition of EHB formulary. No changes to criteria
• 2020-06-16: Annual Review - Updated References

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