VOXZOGO (vosoritide)
Self-Administration – injectable
Diagnosis considered for coverage:
Indicated to increase linear growth in pediatric patients with achondroplasia who are 5 years of age and older with open epiphyses.
Coverage Criteria:
For diagnosis of achondroplasia:
- Dose does not exceed weight-based dosing as approved by the FDA; AND
- Patient is 5 years of age and older; AND
- Prescribed by or in consultation with a specialist (e.g., skeletal dysplasia specialist, orthopedics, clinical geneticist, endocrinologist, or a physician who has specialized expertise in the management of achondroplasia); AND
- Radiographic evidence indicating open epiphyses (growth plates); AND
- Documentation of member’s current weight; AND
- Documentation of baseline annualized growth velocity, calculated based on standing height measured over the course of 6 months prior to request; AND
- Diagnosis of achondroplasia is confirmed by one of the following (a or b):
- A) Both of the following:
- Patient has clinical characteristics of achondroplasia (e.g., macrocephaly, frontal bossing, midface retrusion, disproportionate short stature with rhizomelic shortening of arms and legs, brachydactyly, trident configuration of the hands, thoracolumbar kyphosis, and accentuated lumbar lordosis)
- Patient has radiographic findings of achondroplasia (e.g., large calvaria and narrowing of the foramen magnum region, undertubulated, shortened long bones with metaphyseal abnormalities, narrowing of the interpedicular distance of the caudal spine, square ilia and horizontal acetabula, small sacrosciatic notches, proximal scooping of the femoral metaphyses, and short and narrow chest); OR
- B) Molecular genetic testing confirmed c. 1138G>A or c.1138G>C variant (i.e., p.Gly380Arg mutation) in the fibroblast growth factor receptor-3 (FGFR3) gene; AND
- A) Both of the following:
- Patient did not have limb-lengthening surgery in the previous 18 months and does not plan on having limb-lengthening surgery while on Voxzogo therapy; AND
- Voxzogo is not prescribed concurrently with any human growth hormone products (e.g., Genotropin®, Humatrope®, Norditropin®, Nutropin AQ®, Omnitrope®, Saizen®, Zomacton®)
Reauthorization Criteria:
For diagnosis of achondroplasia:
- Dose does not exceed weight-based dosing as approved by the FDA, AND
- Documentation of a positive clinical response to therapy (e.g., improvement in annualized growth velocity [AGV] compared to baseline)
- Radiographic evidence within last 4 months indicating continued open epiphyses (growth plates), AND
- Voxzogo is not prescribed concurrently with any human growth hormone products (e.g., Genotropin®, Humatrope®, Norditropin®, Nutropin AQ®, Omnitrope®, Saizen®, Zomacton®)
Coverage Duration:
- Initial: 1 year
- Reauthorization: 1 year
Dosing:
|
Actual Body Weight Dose Injection Volume |
Vial Strength for Reconstitution* |
Dose |
Injection Volume |
|
10-11 kg |
0.4 mg |
0.24 mg |
0.3 mL |
|
12-16 kg |
0.56 mg |
0.28 mg |
0.35 mL |
|
17-21 kg |
0.56 mg |
0.32 mg |
0.4 mL |
|
22-32 kg |
0.56 mg |
0.4 mg |
0.5 mL |
|
33-43 kg |
1.2 mg |
0.5 mg |
0.25 mL |
|
44-59 kg |
1.2 mg |
0.6 mg |
0.3 mL |
|
60-89 kg |
1.2 mg |
0.7 mg |
0.35 mL |
|
≥ 90 kg |
1.2 mg |
0.8 mg |
0.4 mL |
*Vial strength used to prepare dose is determined by patient weight as follows: 10 to <12 kg: use 0.4 mg vial, 12 to <33 kg: use 0.56 mg vial, ≥33 kg: use 1.2 mg vial. Concentration will vary based on vial used.
*The concentration of vosoritide in reconstituted 0.4 mg vial and 0.56 mg vial is 0.8 mg/mL. The concentration of vosoritide in reconstituted 1.2 mg vial is 2 mg/mL.
Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Additional Information:
- Administration:
- Reconstitute prior to use. The injection volume is based on both patient’s weight and concentration of reconstituted Voxzogo.
- Monitor growth and adjust dosage according to actual body weight every 3-6 months.
- Permanently discontinue upon confirmation of no further growth potential, indicated by closure of epiphyses.
- Recommend to eat a meal and drink about 8 to 10 ounces of fluid within 1 hour before injection.
- Use in specific populations:
- Not recommended in patients with eGFR < 60 mL/min/1.73m2.
Policy Updates:
- 5/17/2022 – New policy approved by P&T
References:
- Voxzogo Prescribing Information. BioMarin Pharmaceutical Inc., Novato, CA. November 2021.
- Pauli RM. Achondroplasia: a comprehensive clinical review. Orphanet J Rare Dis 2019;14(1):1-49.
- Bacino CA. Achondroplasia. UpToDate. Available by subscription at: http://www.uptodate.com/. Accessed December 16, 2021.
Last review date: May 17, 2022