CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1381-5

Voxzogo (vosoritide) prior authorization

Defines prior authorization criteria for pharmacy coverage of Voxzogo (vosoritide) for pediatric patients with achondroplasia; applies to payers' formulary/prior authorization processes and prescribers seeking coverage.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVoxzogo (vosoritide) prior authorization

Policy CodePolicy 2025 P 1381-5

Change TypeAdded reauthorization open epiphyses requirementbackground updates

Effective DateMar 1, 2026

Next Review Date

Key ActionObtain prior authorization and document positive clinical response and open epiphyses for reauthorization; approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Added requirement that patient has open epiphyses to reauthorization criteria.

Updated background and coverage criteria with expanded indication in pediatric patients of all ages (historical note).

Annual reviews with updates to references documented for multiple years.

2026-03-01policy effective date

12 moauthorization duration

3/2022–12/2025P&T history

increase linear growthapproved indication

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Coverage Criteria for Voxzogo (vosoritide)

Initial Authorization

Covered when ALL of the following are met:

Initial Authorization criteria: a) Diagnosis of achondroplasia; b) Patient is less than 18 years of age; c) Patient has open epiphyses

Authorization will be issued for 12 months

Reauthorization

Covered when ALL of the following are met:

Reauthorization criteria: a) Documentation of positive clinical response to vosoritide therapy; b) Patient has open epiphyses

Authorization will be issued for 12 months

No explicit clinical exclusions are listed in this policy document. However, the policy notes that supply limits and medical necessity rules may apply and could affect approvals under program-specific processes.

The policy does not enumerate specific conditions classified as not medically necessary. The document states that approvals (initial or reauthorization) may be based solely on claims, medication history, diagnosis codes, or automated processes, and that non-approval may occur if medical necessity or supply limits are not met or documentation is insufficient.

Provider Actions, Documentation, and Risk

Prior Authorization

Prior Authorization Required

Prior authorization is required; initial approvals are granted when all specified criteria are met and are issued for 12 months. Reauthorizations are granted when documentation supports positive clinical response and epiphyses remain open, and are issued for 12 months. State mandates and member-specific benefit plan coverage may affect authorization and coverage determinations.

Initial authorization criteria: diagnosis of achondroplasia; patient < 18 years; patient has open epiphyses. Authorization duration: 12 months.
Reauthorization criteria: documentation of positive clinical response to therapy; patient has open epiphyses. Authorization duration: 12 months.

Step Therapy

No step therapy requirements are specified in this policy.

Documentation Required

Documentation Requirements

Claims, medication history, and diagnosis codes (ICD-10) may be used alone to approve or deny initial and reauthorization requests; UnitedHealthcare (program rules) may use automated approval and re-approval processes. Supply limits and medical necessity determinations may also affect approval.

Automated approval may be based solely on prior claims, pharmacy history, and ICD-10 diagnosis codes.
Supply limits and medical necessity checks may trigger denial or modification of approval.
State mandates, federal requirements, and member-specific benefit plan terms may alter documentation or approval requirements.

Denial Risk

Denial / Non-Approval Risks

Potential denial triggers include lack of documented medical necessity, failure to meet initial or reauthorization clinical criteria, exceeding supply limits, or result of automated program rules that do not find supporting claim/medication history.

Step	Requirement
1	No step therapy requirements are specified in this document.

Definitions

inv-12: open epiphyses

DefinitionDocumented presence of growth plates allowing potential for linear growth; required for both initial authorization and reauthorization

Role in initial authorizationPatient must have open epiphyses as one of the three required initial criteria (diagnosis of achondroplasia; <18 years; open epiphyses)

Role in reauthorizationPatient must have open epiphyses for reauthorization in addition to documented positive clinical response

inv-13: achondroplasia

IndicationAchondroplasia — indicated diagnosis for use of vosoritide in pediatric patients to increase linear growth

Label contextIndication applies to pediatric patients with achondroplasia who have open epiphyses (accelerated approval)

Use in authorization criteriaDiagnosis of achondroplasia is a required initial authorization criterion

Background

Voxzogo (vosoritide) background and regulatory context are reflected in the policy’s clinical rules: the document permits that some approvals can be processed using prior claims, medication history, or diagnosis codes alone, and that automated approval processes vary by program. Additionally, the policy highlights that supply limits and medical necessity requirements may be enforced and influence coverage decisions.

Revision History and Policy Changes

2026-03-01policy_effectiveLatest

Policy effective date set to 2026-03-01.

2025-12revision

Annual review; added requirement that patient has open epiphyses to reauthorization criteria.

2024-12revision

Updated background and coverage criteria with expanded indication in pediatric patients of all ages and updated references.

2023-12revision

Annual review; added state mandate footnote (no change to coverage criteria).

2023-03creation

New prior authorization program established for Voxzogo (vosoritide).

2022-03creation

Change control history begins: initial program creation recorded (Prior Authorization/Notification - Voxzogo).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVoxzogo (vosoritide) prior authorization

Policy CodePolicy 2025 P 1381-5

Change TypeAdded reauthorization open epiphyses requirementbackground updates

Effective DateMar 1, 2026

Next Review Date

Key ActionObtain prior authorization and document positive clinical response and open epiphyses for reauthorization; approvals issued for 12 months.

SourceLink

On This Page

OpenPayer

Voxzogo (vosoritide) prior authorization

Coverage Criteria for Voxzogo (vosoritide)

Initial Therapy Requirements

Reauthorization / Continuation Criteria

Coding and Authorization Duration

Provider Actions, Documentation, and Risk

Step Therapy Requirements

Site-of-Care

Definitions

Background

Revision History and Policy Changes