Voxzogo (vosoritide) — United Healthcare
Achondroplasia with open epiphyses
Initial criteria
- Patient is less than 18 years of age
- Diagnosis of achondroplasia confirmed by one of the following: (1) Submission of medical records documenting both of the following: (a) Patient has clinical manifestations characteristic of achondroplasia (e.g., macrocephaly, frontal bossing, midface retrusion, disproportionate short stature with rhizomelic shortening of the arms and legs, brachydactyly, trident configuration of the hands, thoracolumbar kyphosis, and accentuated lumbar lordosis) AND (b) 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, horizontal acetabula, small sacrosciatic notches, proximal scooping of the femoral metaphyses, short and narrow chest) OR (2) Submission of medical records documenting molecular genetic testing confirmed c.1138G>A or c.1138G>C variant (p.Gly380Arg mutation) in the FGFR3 gene
- Patient has open epiphyses
- Patient has not had limb-lengthening surgery in the previous 18 months AND does not plan to have limb-lengthening surgery while on Voxzogo
- Prescribed by a clinical geneticist OR endocrinologist OR a practitioner with specialized expertise in the management of achondroplasia
Reauthorization criteria
- Documentation of positive clinical response to Voxzogo therapy (e.g., improvement in annualized growth velocity compared to baseline)
- Patient has open epiphyses
- Patient does not plan to have limb-lengthening surgery while on Voxzogo
- Prescribed by or in consultation with a clinical geneticist OR endocrinologist OR a practitioner with specialized expertise in the management of achondroplasia
Approval duration
12 months