CurrentUnitedHealthcarePolicy N/A

Voxzogo (vosoritide) prior authorization and medical necessity

Prior authorization and medical necessity criteria for coverage of Voxzogo (vosoritide) for pediatric patients with achondroplasia; applies to UnitedHealthcare pharmacy clinical programs and affected members/providers.

Policy Summary

PayerUnitedHealthcare

PolicyVoxzogo (vosoritide) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation confirming patient is <18 years with achondroplasia (clinical/radiographic or FGFR3 genetic confirmation), open epiphyses, no recent or planned limb-lengthening surgery, and prescription by an eligible specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

age <18initial age requirement

open epiphysesskeletal maturity requirement

no limb-lengthening w/in 18msurgery exclusion/requirement

12 monthsauthorization period

specialist requiredprescriber specialty

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Coverage Criteria for Voxzogo (vosoritide)

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Therapy: Patient is less than 18 years of age; diagnosis of achondroplasia confirmed by either (A) medical records documenting clinical manifestations characteristic of achondroplasia AND radiographic findings characteristic of achondroplasia OR (B) molecular genetic testing confirming the FGFR3 c.1138G>A or c.1138G>C (p.Gly380Arg) variant; 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, endocrinologist, or a practitioner with specialized expertise in the management of achondroplasia.

Authorization issued for 12 months.

inv-02: Continuation Therapy

Reauthorization covered when ALL of the following are met:

Reauthorization: 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, endocrinologist, or a practitioner with specialized expertise in the management of achondroplasia.

Authorization issued for 12 months.

Patients who have undergone limb-lengthening surgery within the prior 18 months or who plan to have limb-lengthening surgery while on Voxzogo are excluded from coverage. Documentation of recent or planned limb-lengthening may result in denial of authorization unless the exclusion criteria are resolved.

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial authorization is approved only when ALL listed criteria are met; authorization issued for 12 months.

Patient is <18 years of age
Diagnosis of achondroplasia confirmed by either: (a) medical records documenting clinical manifestations and radiographic findings characteristic of achondroplasia, OR (b) molecular genetic testing documenting FGFR3 c.1138G>A or c.1138G>C (p.Gly380Arg) variant
Patient has open epiphyses
No limb‑lengthening surgery in the prior 18 months and no planned limb‑lengthening while on therapy
Prescribed by a clinical geneticist, endocrinologist, or practitioner with specialized expertise in achondroplasia

Denial Risk

Documentation Insufficiency — Denial Risk

Initial Authorization Criteria

inv-13: Initial Authorization

Covered when ALL of the following are met:

Initial Authorization

Diagnosis of achondroplasia (one of the following):: (1) Medical records documenting BOTH: (a) clinical manifestations characteristic of achondroplasia (e.g., macrocephaly, frontal bossing, midface retrusion, disproportionate short stature with rhizomelic shortening, brachydactyly, trident hands, thoracolumbar kyphosis, accentuated lumbar lordosis) AND (b) radiographic findings characteristic of achondroplasia (e.g., large calvaria, narrowing of the foramen magnum, undertubulated shortened long bones with metaphyseal abnormalities, narrowing of interpedicular distance of the caudal spine, square ilia, horizontal acetabula, small sacrosciatic notches, proximal scooping of femoral metaphyses, short narrow chest).
OR: (2) Molecular genetic testing confirming the c.1138G>A or c.1138G>C (p.Gly380Arg) variant in FGFR3.
Epiphyses and surgical history:

Reauthorization / Continuation Criteria

inv-14: Reauthorization

Reauthorization covered when ALL of the following are met:

Authorization issued for 12 months.

Step Therapy and Prior Authorization Automation

Step	Requirement / Description	Coverage action
0	Not specified in this policy; automated approval based on previous claim/medication history, diagnosis codes (ICD‑10), and/or claim logic may be used. Use of automated approval and re‑approval processes varies by program and/or therapeutic class.	neutral

Quantity Limits and Supply Constraints

Voxzogo (vosoritide) — Supply limits may be in place

Policy statementSupply limits may be in place for Voxzogo (vosoritide).

ApplicabilityApplies to initial and reauthorization approvals per UnitedHealthcare clinical programs.

Program variabilityUse of automated approval and re-approval processes and any quantity/supply limits varies by program and therapeutic class.

Action for providersVerify member-specific quantity limits and program rules prior to dispensing or administering therapy.

Site of Care

Note

Site of care: not specified

Site of care is not specified in this policy.

Background

Vosoritide (Voxzogo) is a C-type natriuretic peptide analog indicated to increase linear growth in pediatric patients with achondroplasia who have open epiphyses. Approval was granted under accelerated approval based on improved annualized growth velocity; continued approval may depend on confirmatory trials.

Definitions

Definition of Achondroplasia — clinical and radiographic features

Definition — AchondroplasiaA genetic skeletal dysplasia characterized by disproportionate short stature and specific clinical and radiographic features (e.g., macrocephaly, frontal bossing, rhizomelic shortening).

Diagnostic evidence — clinical/radiographicMedical records may document clinical manifestations characteristic of achondroplasia plus radiographic findings characteristic of achondroplasia to confirm diagnosis.

Diagnostic evidence — molecularMolecular genetic testing confirming FGFR3 p.Gly380Arg (c.1138G>A or c.1138G>C) variant establishes the molecular diagnosis of achondroplasia.

Relevant clinical feature examplesExamples include macrocephaly, frontal bossing, and rhizomelic shortening noted on clinical exam and imaging.

FGFR3 p.Gly380Arg mutation — molecular diagnostic variant c.1138G>A or c.1138G>C

Policy Summary

PayerUnitedHealthcare

PolicyVoxzogo (vosoritide) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2026

Next Review DateN/A

SourceLink

On This Page

Failure to provide required documentation may result in denial of the request.

Missing documentation of age <18
Absence of confirmed achondroplasia (clinical + radiographic OR genetic test)
No evidence of open epiphyses
No documentation that limb‑lengthening surgery has not occurred within the prior 18 months or is not planned while on therapy

Documentation Required

Diagnostic Documentation Required

Medical records must document the clinical and diagnostic evidence supporting the achondroplasia diagnosis.

Clinical manifestations: e.g., macrocephaly, frontal bossing, midface retrusion, disproportionate short stature with rhizomelic shortening, brachydactyly, trident hands, thoracolumbar kyphosis, accentuated lumbar lordosis
Radiographic findings: e.g., large calvaria, narrowed foramen magnum, undertubulated shortened long bones with metaphyseal abnormalities, narrowing interpedicular distance caudally, square ilia, horizontal acetabula, small sacrosciatic notches, proximal scooping of femoral metaphyses, short narrow chest
OR molecular genetic test confirming FGFR3 c.1138G>A or c.1138G>C (p.Gly380Arg)

Documentation Required

Response and Reauthorization Documentation

Reauthorization requires documentation of clinical benefit and continued eligibility.

Documentation of positive clinical response (e.g., improvement in annualized growth velocity compared to baseline)
Evidence patient continues to have open epiphyses
Documentation that limb‑lengthening surgery is not planned while on Voxzogo
Prescribed by or in consultation with a clinical geneticist, endocrinologist, or practitioner with specialized expertise in achondroplasia

Step Therapy

Automated Approval / Program Rules

Automated approval processes may be used in some UnitedHealthcare programs; supply limits may apply.

UnitedHealthcare may approve initial or reauthorization based on prior claims/medication history, diagnosis codes (ICD‑10), and claim logic in certain programs

Patient has open epiphyses; patient has not had limb-lengthening surgery in the previous 18 months; patient does not plan to have limb-lengthening surgery while on Voxzogo.

Prescriber: Prescribed by a clinical geneticist, endocrinologist, or a practitioner with specialized expertise in the management of achondroplasia.

Authorization issued for 12 months.

Molecular variant (HGVS)

FGFR3 c.1138G>A or c.1138G>C (p.Gly380Arg).

GeneFGFR3 (fibroblast growth factor receptor 3).

Clinical useConfirmation of achondroplasia for coverage determination when molecular testing is submitted.

Documentation requirementSubmission of medical records documenting molecular genetic testing confirming the c.1138G>A or c.1138G>C variant satisfies diagnostic documentation per policy.