Yuviwel (navepegritide)
Indications for Prior Authorization
Yuviwel (navepegritide)
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For diagnosis of Increase linear growth in pediatric patients with achondroplasia
Indicated to increase linear growth in pediatric patients 2 years of age and older 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).
Criteria
Yuviwel
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
- Submission of medical records (e.g., chart notes) confirming diagnosis of achondroplasia by one of the following:
- Both of the following:
- 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)
- Disease is confirmed by the presence of c.1138G>A or c.1138G>C variant (i.e., p.Gly380Arg mutation) in the fibroblast growth factor receptor-3 (FGFR3) gene as detected by a FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
- Patient has open epiphyses AND
- Patient is 2 years of age or older AND
- Prescribed by or in consultation with one of the following:
- Clinical geneticist
- Endocrinologist
- A physician who has specialized expertise in the management of achondroplasia
Yuviwel
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
- Patient continues to have open epiphyses AND
- Patient demonstrates positive clinical response to therapy as evidenced by one of the following:
- Improvement in annualized growth velocity (AGV) compared to baseline
- Improvement in height Z-score compared to baseline
- Prescribed by or in consultation with one of the following:
- Clinical geneticist
- Endocrinologist
- A physician who has specialized expertise in the management of achondroplasia
P & T Revisions
2026-05-20
References
- Yuviwel Prescribing Information. Ascendis Pharma Endocrinology, Inc. Princeton, New Jersey. February 2026.
- Bacino CA. Achondroplasia: Clinical features, diagnosis, and management. UpToDate. Available by subscription at: http://www.uptodate.com/. Accessed April 14, 2026.
Revision History
- 2026-05-20: New Program
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