Vosoritide (Voxzogo) Form

Vosoritide (Voxzogo™) is an analog of C-type natriuretic peptide (CNP). FDA Approved Indication(s) Voxzogo is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses.
This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Voxzogo is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Achondroplasia (must meet all):

1. Diagnosis of achondroplasia with genetic testing confirming a mutation in the fibroblast growth factor receptor 3 (FGFR3) gene;
2. Prescribed by or in consultation with a pediatric endocrinologist;
   
   3. Age between 4.4 months (see Appendix D) and 18 years;
   4. At the time of request, radiographic evidence indicates open epiphyses (growth plates);
3. Documentation of baseline annualized growth velocity, calculated based on standing height measured over the course of 6 months prior to request;
4. Documentation of member’s current weight (in kg);
   7. Voxzogo is not prescribed concurrently with any human growth hormone products (e.g., Genotropin®, Humatrope®, Norditropin®, Nutropin AQ®, Omnitrope®, Saizen®, Zomacton®);

5. Dose does not exceed 1 vial per day and weight-based daily dosing (see Section V. Dosage and Administration). Approval duration: 6 months
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   CLINICAL POLICY Vosoritide B. Other diagnoses/indications (must meet 1 or 2):

6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Achondroplasia (must meet all):
8. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
9. Member is responding positively to therapy as evidenced by improvement in annualized growth velocity from baseline;
10. Radiographic evidence within the last four months indicates that the member continues to have open epiphyses (growth plates);
    
    4. Documentation of member’s current weight (in kg);
    5. If request is for a dose increase, new dose does not exceed 1 vial per day and weight- based daily (see Section V. Dosage and Administration). Approval duration: 6 months
       B. Other diagnoses/indications (must meet 1 or 2):

11. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: Page 2 of 6

    CLINICAL POLICY Vosoritide CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

12. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CNP: C-type natriuretic peptide
    FDA: Food and Drug Administration FGFR3: fibroblast growth factor receptor 3 Appendix B: Therapeutic Alternatives
    Not applicable Appendix C: Contraindications/Boxed Warnings
    None reported Appendix D: General Information • Use of Voxzogo in the pediatric population is supported by evidence from an adequate and well-controlled study in 121 pediatric patients aged 5 to 15 years with achondroplasia, pharmacokinetic data in pediatric patients aged 4.5 months to 15 years, and additional safety data in pediatric patients aged 4.4 months to < 5 years. o 4.4 months is equivalent to approximately 4 months and 12 days. V. Dosage and Administration Maximum Dose Varies per actual body weight Indication Achondroplasia Dosing Regimen Dose is a once-daily SC injection based on actual body weight: • 3 kg: 0.096 mg/day; • 4 kg: 0.12 mg/day; • 5 kg: 0.16 mg/day; • 6-7 kg: 0.2 mg/day • 8-11 kg: 0.24 mg/day; • 12-16 kg: 0.28 mg/day; • 17-21 kg: 0.32 mg/day; • 22-32 kg: 0.4 mg/day; • 33-43 kg: 0.5 mg/day; Page 3 of 6

    CLINICAL POLICY Vosoritide Indication Dosing Regimen • 44-59 kg: 0.6 mg/day; • 60-89 kg: 0.7 mg/day; • ≥ 90 kg: 0.8 mg/day. Maximum Dose VI. Product Availability Lyophilized powder in single-dose vials: 0.4 mg, 0.56 mg, 1.2 mg VII.