Pharmacy Prior Authorization Criteria

Voxzogo (vosoritide)

For diagnosis of Increase linear growth in pediatric patients with achondroplasia
Indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

Patient has clinical manifestations characteristic of achondroplasia (e.g., macrocephaly, frontal bossing, midface retrusion, disproportionate short stature with rhizomelic shortening of the arms and the legs, brachydactyly, trident configuration of the hands, thoracolumbar kyphosis, and accentuated lumbar lordosis)

AND

Patient has radiographic findings characteristic of achondroplasia (e.g., large calvaria and narrowing of the foramen magnum region, undertubulated, shortened long bones with metaphyseal abnormalities, narrowing of the interpedicular distance of the caudal spine, square ilia and horizontal acetabula, small sacrosciatic notches, proximal scooping of the femoral metaphyses, and short and narrow chest)

Molecular genetic testing confirmed c.1138G>A or c.1138G>C variant (i.e., p.Gly380Arg mutation) in the fibroblast growth factor receptor-3 (FGFR3) gene

AND

Patient did not have limb-lengthening surgery in the previous 18 months and does not plan on having limb-lengthening surgery while on Voxzogo therapy

AND

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

AND

Patient demonstrates positive clinical response to therapy as evidenced by one of the following:

AND

2024-02-20, 2023-11-20, 2023-11-06, 2023-01-19, 2022-02-18, 2022-01-21

Voxzogo Prescribing Information. BioMarin Pharmaceutical Inc., Novato, CA. October 2023.
Pauli RM. Achondroplasia: a comprehensive clinical review. Orphanet J Rare Dis 2019;14(1):1-49.
Bacino CA. Achondroplasia. UpToDate. Available by subscription at: http://www.uptodate.com/. Accessed January 5, 2024.

2024-02-20: 2024 annual review: no criteria changes.
2023-11-20: Removed age criteria based on updated labeling
2023-11-06: Program update to standard reauthorization language. No changes to clinical intent.
2023-01-19: Annual review - no criteria changes.
2022-02-18: Updated reauth criterion #2 to require specific positive clinical response
2022-01-21: New program