CurrentAvMedPolicy N/A

Voxzogo (vosoritide) prior authorization and step-edit request

Form and clinical criteria governing prior authorization and step-edit requests for vosoritide (Voxzogo) for AvMed members; applies to prescribers and specialty pharmacy processing requests.

Policy Summary

PayerAvMed

PolicyVoxzogo (vosoritide) prior authorization and step-edit request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign and complete the prior authorization/step-edit request form and fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

12 moReauthorization duration

1 vial/dayQuantity limit

1.2 mgMax daily dose

Coverage Criteria

Initial Therapy — Covered when ALL of the following are met for initial authorization:

Covered when ALL of the following are met for initial authorization:

Initial Authorization Criteria: 1) Provider is an endocrinologist or metabolic geneticist specializing in treatment of achondroplasia; 2) Member is < 18 years of age; 3) Member has a diagnosis of achondroplasia confirmed by BOTH clinical/radiographic features AND identification of a heterozygous pathogenic FGFR3 variant by molecular genetic testing (submit test results); 4) Member has NOT had nor will receive limb-lengthening surgery within the previous 18 months; 5) Other causes of achondroplasia or short stature have been ruled out (examples listed, excludes homozygous achondroplasia); 6) Requested medication will NOT be used in combination with growth hormone, growth hormone analogs, or IGF-1; 7) Member's epiphyses are still open (submit current bone x-ray confirming open epiphyses); 8) Member's estimated glomerular filtration rate (eGFR) is >= 60 mL/min/1.73 m2; 9) Member's current height and weight must be provided; 10) Member does NOT have a history of significant cardiac or vascular disease and is not currently taking antihypertensive medications; 11) Member will be regularly monitored for transient hypotensive events while using the requested medication.

All criteria must be met; documentation required for each.

Continuation / Reauthorization — Reauthorization criteria — all must be met:

Reauthorization criteria — all must be met:

Policy Summary

PayerAvMed

PolicyVoxzogo (vosoritide) prior authorization and step-edit request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign and complete the prior authorization/step-edit request form and fax to 1-305-671-0200.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Reauthorization Criteria: 1) Member continues to meet the initial diagnostic criteria for achondroplasia; 2) Absence of unacceptable toxicity from the drug (e.g., severe hypotension, severe injection site reactions); 3) Member did NOT have closure of epiphyses or decreased growth velocity (< 1.5 cm per year) since last approval (submit current bone x-ray documentation); 4) Member has shown beneficial response to treatment as evidenced by BOTH annualized growth velocity >= 1.5 cm/year AND improvement in height compared to last measurement (within the past 6 months); 5) Member's current height and weight must be provided.

All criteria must be checked for approval.

Use of vosoritide in homozygous achondroplasia is excluded. The policy specifies that other causes of achondroplasia or short stature must be ruled out and explicitly lists homozygous achondroplasia as an exclusion (see "Other causes... excludes approved labeled indication").

Initial Therapy Details

Initial dosing and authorization

Weight-based dosing, vial strength guidance, and initial authorization limits:

Dosing and quantity limits: Weight-based dosing per manufacturer table (examples include: 10–11 kg dose 0.24 mg using 0.4 mg vial; 12–16 kg dose 0.28 mg using 0.56 mg vial; 17–21 kg dose 0.32 mg using 0.56 mg vial; 22–32 kg dose 0.4 mg using 0.56 mg vial; 33–43 kg dose 0.5 mg using 1.2 mg vial; 44–59 kg dose 0.6 mg using 1.2 mg vial; 60–89 kg dose 0.7 mg using 1.2 mg vial; ≥90 kg dose 0.8 mg using 1.2 mg vial); maximum approval of 1 vial per day and maximum dose of 1.2 mg daily; initial authorization duration: 6 months.Max: 1 vial/day; Max dose: 1.2 mg/day

Quantity limits and dosing table must be followed; submit weight to determine vial strength and dose.

Reauthorization / Continuation

Reauthorization — requires demonstration of continued benefit and safety

Reauthorization requires demonstration of continued benefit and safety.

Reauthorization: See reauthorization criteria: continued diagnostic criteria, absence of unacceptable toxicity, no closure of epiphyses or decreased growth velocity, and documented benefit (annualized growth velocity >= 1.5 cm/year and improvement in height).

Reauthorization period: 12 months; provide supporting documentation (labs, diagnostics, chart notes).

Quantity Limits and Dosing Caps

Quantity limit — Voxzogo (vosoritide)

Quantity limitMaximum approval of 1 vial per day

Perper day

DrugVoxzogo (vosoritide)

Maximum daily dose — Voxzogo (vosoritide)

Maximum daily doseMaximum dose of 1.2 mg daily

ContextListed as the maximum daily dose for Voxzogo on dosing/quantity limits

DrugVoxzogo (vosoritide)

eGFR threshold

eGFR threshold>= 60 mL/min/1.73 m2

Where statedRequired for initial authorization (member's estimated glomerular filtration rate)

DocumentationSubmit current eGFR as supporting documentation

Coding

Coding — Key clinical threshold

Key clinical threshold>= 60 mL/min/1.73 m2

Applies toMember's estimated glomerular filtration rate for initial authorization

RequirementDocument eGFR in authorization request

Provider Actions and Documentation

Prior Authorization

Form submission and authorization durations

The prescribing physician must sign and clearly print their name on the prior authorization/step-edit request form (preprinted stamps are not valid). Office staff may complete remaining fields. Fax the completed form to 1-305-671-0200. If information is incomplete, incorrect, or illegible, the authorization process may be delayed.

Fax: 1-305-671-0200

Documentation Required

Required supporting documentation

To support each checked clinical criterion, submit all relevant documentation (lab results, diagnostics, and/or chart notes). For molecular genetic testing requirements, include the test report showing identification of a heterozygous pathogenic FGFR3 variant. Initial authorizations are for 6 months; reauthorizations are for 12 months.

Initial authorization: 6 months
Reauthorization: 12 months
Include molecular genetic testing results confirming heterozygous pathogenic FGFR3 variant

Step Therapy

Samples and prior therapy verification

Samples do not meet step-edit or prior authorization criteria. Previous therapies will be verified via pharmacy paid claims or submitted chart notes.

Samples do not satisfy step edit/PA requirements
Previous therapies verified through claims or chart notes

Denial Risk

Incomplete or missing documentation

If requested information is incomplete, incorrect, or illegible, or if required supporting documentation is missing, the authorization process may be delayed or the request may be denied. Ensure current bone x-ray confirming open epiphyses (initial) or demonstrating no epiphyseal closure/decreased growth velocity (reauthorization), current height and weight, eGFR results, and documentation of monitoring plans for hypotension and cardiac/vascular status are provided.

Provide current bone x-ray (initial and reauthorization requirements)
Provide current height and weight
Provide eGFR results (≥ 60 mL/min/1.73 m2)
Document monitoring plan for transient hypotension and absence of significant cardiac/vascular disease

Step Therapy

Step	Requirement / Notes
1	Use of samples to initiate therapy does not meet step edit/prior authorization criteria; previous therapies will be verified through pharmacy paid claims or submitted chart notes.

Background

Achondroplasia is characterized by disproportionate short stature with distinctive clinical and radiographic features such as proximal shortening of the arms, macrocephaly, narrow chest, short fingers, and specific pelvic and femoral radiographic changes. The policy requires diagnosis confirmation by both clinical/radiographic features and identification of a heterozygous pathogenic FGFR3 variant (molecular genetic testing results must be submitted). Treatment with vosoritide applies to pediatric patients with open epiphyses and includes monitoring considerations such as regular surveillance for transient hypotensive events.

Definitions

Confirmed achondroplasia — diagnostic criteria

Diagnostic confirmationDiagnosis confirmed by BOTH clinical and radiographic features consistent with achondroplasia AND identification of a heterozygous pathogenic FGFR3 variant by molecular genetic testing

Clinical/radiographic examplesProximal shortening of arms, large head, narrow chest, short fingers; ilia and horizontal acetabula, narrow sacrosciatic notch, proximal radiolucency of the femurs, generalized metaphyseal abnormality, decreasing interpedicular distance caudally

Genetic testing specificsIdentify heterozygous pathogenic FGFR3 variants (examples: 1138G>A and 1138G>C); submit molecular genetic test results