Last Review Date: 07/01/2021

Date of Origin: 01/05/2021

Dates Reviewed:  01/2021, 07/2021

1. Length of Authorization

Coverage is provided for six months and may be renewed.

2. Dosing Limits

A.  Quantity Limit (max daily dose) [NDC Unit]:

• Danyelza 40 mg/10 mL single-dose vial: 12 vials every 28 days for 6 cycles total followed by 12 vials every 56 days thereafter

B.  Max Units (per dose and over time) [HCPCS Unit]:

• 150 billable units (150 mg) on days 1, 3, 5 of each 28-day treatment cycle for 6-cycles total followed by subsequent infusions every 8 weeks thereafter

3. Initial Approval Criteria ^1,2

Coverage is provided in the following conditions:

• Patient is at least 1 year or older; AND

Universal Criteria

• Will not be used in combination with other GD2-binding monoclonal antibodies (i.e., dinutuximab, etc.); AND
• Patient does not have uncontrolled hypertension; AND

High-Risk Neuroblastoma † Ф

• Used in combination with granulocyte-macrophage colony-stimulating factor [GM-CSF] (e.g., sargramostim); AND
• Patient has relapsed or refractory disease in the bone or bone marrow; AND
• Patient had at least a partial or minor response or stable disease to at least one prior systemic therapy

† FDA-labeled indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include severe neurotoxicity (peripheral neuropathy, transverse myelitis, reversible posterior leukoencephalopathy syndrome, neurological disorders of the eye, and severe urinary retention), severe hypertension, etc.

5. Dosage/Administration

6. Billing Code/Availability Information

HCPCS Code:

• J9999 – not otherwise classified, antineoplastic drugs (Discontinue on 07/01/21)
• J9348 – Injection, naxitamab-gqgk, 1 mg: 1 billable unit = 1 mg (Effective 07/01/21)

NDC:

• Danyelza 40 mg/10 mL single use vial: 73042-0201-xx

7. References

1. Danyelza [package insert]. New York, NY; Y-mAbs Therapeutics, Inc. ; November 2020.  Accessed December 2020.
2. Mora J,  Chan GCF,  Morgenstern DA, et al. Naxitamab, a new generation anti-GD2 monoclonal antibody (mAb) for treatment of relapsed/refractory high-risk neuroblastoma (HR-NB).  Journal of Clinical Oncology 2020 38:15_suppl, 10543-10543.
3. Kushner BH, Modak S, Ellen M. Basu EM,et al.  High-dose naxitamab plus stepped-up dosing of GM-CSF for high-risk neuroblastoma (HR-NB): Efficacy against histologically-evident primary refractory metastases in bone marrow (BM).  Journal of Clinical Oncology 2019 37:15_suppl, 10024-10024.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Articles (LCAs) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A