CurrentAnthemPolicy CC-0213

Medical Drug Clinical Criteria - Voxzogo (vosoritide)

Defines clinical criteria for medical-benefit coverage (initial and continuation) of Voxzogo (vosoritide) for pediatric individuals with achondroplasia, lists approval durations, quantity limit, and relevant billing codes.

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria - Voxzogo (vosoritide)

Policy CodePolicy CC-0213

Change TypeNo material change (2025 annual review)prior material updates include age criteria and initial criteria/quantity limit

Effective DateApr 1, 2025

Next Review Date

Key ActionProvide documentation confirming age <18, genetic confirmation of FGFR3 mutation, diagnosis of achondroplasia, and evidence of open epiphyses for initial approval.

SourceLink

POLICY UPDATE CHANGES

2/21/2025 Annual Review: No changes. Coding Reviewed: Removed all diagnosis pend. Added ICD-10-CM Q77.4.

12/11/2023 Select Review: Update age criteria in clinical criteria.

2/25/2022 Annual Review: Add new clinical criteria and quantity limit for Voxzogo.

1Covered Indications

1ICD-10 Covered Diagnosis

1Daily Quantity Limit (vial/day)

3Major Exclusion Criteria

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Coverage Summary

Scope: Defines clinical criteria for medical-benefit coverage of Voxzogo (vosoritide) for pediatric individuals with achondroplasia, including initial and continuation criteria, and lists approval durations and billing codes. Coverage stance: covered_with_criteria — Voxzogo is covered when clinical criteria are met (pediatric achondroplasia with open epiphyses). Quantity limit: 1 vial per day for single-dose vials (0.4 mg, 0.56 mg, 1.2 mg). This policy is effective 04/01/2025 and was last reviewed on 02/21/2025. The policy type is medical-benefit coverage under document CC-0213.

Key thresholds and quick facts

Age< 18 years

Renal function exclusioneGFR < 60 mL/min/1.73 m2

Quantity limit1 vial/day

Effective date2025-04-01

Last review2025-02-21

Initial Therapy Criteria

Initial requests

Initial requests for Voxzogo (vosoritide) may be approved if the following criteria are met:

ALL of the following

Individual is less than 18 years of age< 18 years
Individual has a diagnosis of achondroplasia
ICD-10-CM Q77.4
Documentation is provided that diagnosis has been verified via genetic mutation in fibroblast growth factor receptor 3 (FGFR3)
Documentation is provided that individual has epiphyses that have not yet closed

Continuation Therapy Criteria

Continuation requests

Continuation requests for Voxzogo (vosoritide) may be approved if the following criteria are met:

ALL of the following

There is clinically significant improvement in growth velocity
Required for continuation approval
Documentation is provided that individual has epiphyses that have not yet closedOpen epiphyses
Therapy should be discontinued upon epiphyseal closure

Exclusions and Contraindications

Not approved (Exclusions/Contraindications)

Requests for Voxzogo (vosoritide) may not be approved for the following:

ANY of the following

Individual with an eGFR <60 mL/min/1.73 m2eGFR < 60 mL/min/1.73 m2
Renal function exclusion
Individual using in combination with growth stimulants (growth hormone therapy, insulin-like growth factor 1 or anabolic steroids) (NCT 03197766)
Combination therapy exclusion
Individual undergoing limb-lengthening surgery (NCT 03197766)
Surgical exclusion

Applicable Codes

ICD-10 Diagnosis (covered indication)ICD-10Covered

Q77.4

Achondroplasia

Provider Actions & Billing

Prior Authorization

Clinical documentation required for initial approval

Provide documentation confirming age <18, diagnosis of achondroplasia, genetic confirmation of FGFR3 mutation, and evidence that epiphyses have not yet closed.

Age < 18 years
Diagnosis: achondroplasia (ICD-10 Q77.4)
Genetic confirmation of FGFR3 mutation
Evidence of open (unclosed) epiphyses

Prior Authorization

Clinical documentation required for continuation

Provide documentation of clinically significant improvement in growth velocity and evidence that epiphyses remain open.

Documentation of clinically significant improvement in growth velocity
Evidence of open (unclosed) epiphyses

Clinical Evidence

121Phase 3 trial (n): 121 pediatric individuals; 52-week randomized, double-blind, placebo-controlled

1.57Efficacy outcome: Annualized growth velocity improvement (cm/year) vs placebo

Voxzogo (vosoritide) is FDA-approved under an accelerated pathway; continued approval may be contingent on verification of clinical benefit from confirmatory outcomes such as pubertal growth velocity, body segment proportionality, final adult height, and achondroplasia-associated complications.

Background

Drug class: Voxzogo (vosoritide) is a C-type natriuretic peptide (CNP) analog administered once daily by subcutaneous injection, dosed by actual body weight.

Indication: Approved to increase linear growth in pediatric patients with achondroplasia who have open epiphyses.

Regulatory context: Approval was based on a phase 3 randomized, double-blind, placebo-controlled trial demonstrating a 1.57 cm/year improvement in annualized growth velocity versus placebo; approval was granted via an accelerated pathway and may require confirmatory trials to verify clinical benefit.

Definitions:

• Open epiphyses: Growth plates have not yet closed; therapy should be discontinued upon epiphyseal closure.

• Clinically significant improvement in growth velocity: Not specifically quantified in this policy; required for continuation approval and based on clinical assessment.

Revision History

2/25/2022added

Annual Review: Add new clinical criteria and quantity limit for Voxzogo; added HCPCS codes J3490 and C9399; established 1 vial per day quantity limit.

12/11/2023revised

Select Review: Update age criteria in clinical criteria (age criteria modified to <18 years).

2/21/2025clarifiedLatest

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria - Voxzogo (vosoritide)

Policy CodePolicy CC-0213

Change TypeNo material change (2025 annual review)prior material updates include age criteria and initial criteria/quantity limit

Effective DateApr 1, 2025

Next Review Date

Key ActionProvide documentation confirming age <18, genetic confirmation of FGFR3 mutation, diagnosis of achondroplasia, and evidence of open epiphyses for initial approval.

SourceLink

On This Page

Therapy should be discontinued upon epiphyseal closure

May not be approved when the above criteria are not met and for all other indications

General exclusion for other indications

Open epiphyses: Growth plates have not yet closed; therapy should be discontinued upon epiphyseal closure.

Monitoring: Growth and physical development should be monitored regularly every 3 to 6 months; permanently discontinue Voxzogo when epiphyses are closed.

Billing Rule

Quantity limit

Limit = 1 vial per day for Voxzogo single-dose vials (0.4 mg, 0.56 mg, 1.2 mg).

J3490
C9399

Denial Risk

Contraindications and exclusions

Claims may be denied for individuals with eGFR <60 mL/min/1.73 m2; those receiving specified combination growth stimulants (growth hormone therapy, IGF-1, or anabolic steroids); individuals undergoing limb-lengthening surgery; or when the stated clinical criteria (age, diagnosis, genetic confirmation, open epiphyses, or continued growth response) are not met.

eGFR <60 mL/min/1.73 m2
Use in combination with growth stimulants (growth hormone, IGF-1, anabolic steroids)
Undergoing limb-lengthening surgery
Failure to meet required clinical criteria

Documentation Required

Monitoring requirement

Growth and physical development should be monitored every 3 to 6 months; discontinue Voxzogo upon epiphyseal closure.

Monitor growth and physical development every 3 to 6 months
Permanently discontinue therapy when epiphyses have closed

Annual Review: No clinical policy statement changes. Coding reviewed: removed all diagnosis pend and added ICD-10-CM Q77.4.