CurrentUnitedHealthcarePolicy 2025 P 1381-5

Voxzogo (vosoritide) prior authorization

Policy Summary

PayerUnitedHealthcare

PolicyVoxzogo (vosoritide) prior authorization

Policy CodePolicy 2025 P 1381-5

Change TypeClarified (requirement added); Annual review (no changes)

Effective DateMar 1, 2026

Next Review Date

Key ActionSubmit prior authorization for Voxzogo and provide documentation of positive clinical response to support reauthorization; approvals are issued for 12 months when criteria are met.

POLICY UPDATE CHANGES

Added requirement that patient has open epiphyses to reauthorization criteria (12/2024 entry in change control).

Annual reviews listed with no changes to coverage criteria for 12/2025.

12 monthsAuthorization duration (initial and reauthorization)

<18Age limit for initial therapy

Open epiphysesSkeletal maturity requirement

Accelerated approvalRegulatory status

Coverage Summary

UnitedHealthcare prior authorization program for Voxzogo (vosoritide) covering initial authorization and reauthorization criteria for pediatric patients with achondroplasia, including duration of authorization and notes on automated approvals and state/federal mandates. Coverage stance: covered_with_criteria. Regulatory note: accelerated approval based on improvement in annualized growth velocity; continued approval may require confirmatory trial data.

Key policy facts

Authorization duration (initial)12 months

Authorization duration (reauthorization)12 months

Age limit for initial therapyPediatric <18

Skeletal maturity requirementOpen epiphyses required

Regulatory statusAccelerated approval

Effective date2026-03-01

Last review2025-12-01

Initial Authorization Criteria

Initial Authorization

Voxzogo will be approved based on all of the following criteria:

Initial Authorization criteria

Diagnosis of achondroplasia
Age: Patient is less than 18 years of age
Skeletal maturity: Patient has open epiphyses
Term definition: Open epiphyses = presence of unfused growth plates indicating ongoing linear growth; required for initiation and reauthorization per policy.

Reauthorization / Continuation Criteria

Reauthorization

Voxzogo will be approved based on the following criterion:

Reauthorization criteria

Clinical response: Documentation of positive clinical response to Voxzogo therapy
Providers must supply documentation of a positive clinical response to support reauthorization.
Skeletal maturity: Patient has open epiphyses
Term definition: Open epiphyses = presence of unfused growth plates indicating ongoing linear growth; required for initiation and reauthorization per policy.

Prior Authorization & Provider Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Voxzogo; initial approvals issued for 12 months when all initial criteria are met. Reauthorizations issued for 12 months when reauthorization criteria are met.

Documentation Required

Document positive clinical response for reauthorization

Providers must supply documentation of a positive clinical response to Voxzogo therapy to support reauthorization.

Denial Risk

Denial risk if criteria not met

Claims may be denied if the member does not have achondroplasia, is 18 years or older at initiation, or does not have open epiphyses as required by the policy.

Billing Rule

Automated approvals permitted

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic using automated approval processes.

Billing Rule

Supply limits and medical necessity

Supply limits and medical necessity reviews may be applied per program rules.

Definitions & Background

Voxzogo (vosoritide) is a C-type natriuretic peptide analog indicated to increase linear growth in pediatric patients with achondroplasia who have open epiphyses. This indication is approved under accelerated approval based on improvement in annualized growth velocity; continued approval may depend on confirmatory trial evidence.

Open epiphyses: Presence of unfused growth plates indicating ongoing linear growth; required for initiation and reauthorization per policy.

Revision History

12/2024material_change

Annual review: Added requirement that patient has open epiphyses to reauthorization criteria.

12/2025annual_reviewLatest

Annual review with no changes to coverage criteria; references updated.