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)

• Submission of medical records (e.g., chart notes) confirming diagnosis of Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome)
AND
• Diagnosis is confirmed by one of the following:
• Submission of medical records (e.g., chart notes) confirming absence or deficiency of galactosamine-6-sulfatase (GALNS) enzyme activity in fibroblasts or leukocytes
OR
• Both of the following:
• Submission of medical records (e.g., chart notes) confirming presence of mutation in GALNS gene
AND
• Provider attests mutation was detected by a FDA-approved test or a test performed at a facility approved by CLIA

Vimizim

Prior Authorization (Reauthorization)

Length of Approval: 24 Month(s)

• Patient demonstrates a positive clinical response to therapy

P & T Revisions

2026-07-06, 2025-08-25, 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. June 2026.
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 June 2026.
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.
4. Akyol, M.U., Alden, T.D., Amartino, H. et al. Recommendations for the management of MPS IVA: systematic evidence- and consensus-based guidance. Orphanet J Rare Dis 14, 137 (2019). https://doi.org/10.1186/s13023-019-1074-9

---

Revision History

• 2026-07-06: 2026 Annual review. EHB formulary removed from guideline. Confirmation of disease verbiage updated.
• 2025-08-25: 2025 Annual Review. No criteria changes. Updated references.
• 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

---