Medical Drug Criteria (MDC)

Policy Num:       P1.001.004
Policy Name:     DANYELZA® (naxitamab-gqgk)
Policy ID:          [P1.001.004]  [Ac / B / M+ / P+]  [0.00.00]

Last Review:       September 17, 2024
Next Review:      September 20, 2025
 

Related MDC:None

DANYELZA^®
 (naxitamab-gqgk)

Summary

Danyelza (naxitamab-gqgk) is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GMCSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Danyelza has a boxed warning for serious infusion-related reactions and neurotoxicity.

Policy Statements

Initiation of Danyelza meets the definition of medical necessity when used to treat the following indication and the specific criteria below are met.

Policy Guidelines

Coverage eligibility for Danyelza will be considered when the following criteria is met:

• Authorization of 12 months may be granted for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy; and the the specific criteria below is met.

DOSAGE/ADMINISTRATION

The recommended dosage is:

•    3 mg/kg/day (up to 150 mg/day), administered as an intravenous infusion on day 1, 3, and 5 of each treatment cycle.
•    Treatment cycles are repeated every 4 weeks until complete response or partial response, followed by 5 additional cycles every 4 weeks. 
•    Subsequent cycles may be repeated every 8 weeks.
 

REQUIRED MEDICAL INFORMATION

Initiation of naxitamab-gqgk (Danyelza) injection meets the definition of medical necessity with ANY of the following conditions when ALL associated criteria are met:

1. Relapsed or refractory high-risk neuroblastoma in the bone or bone marrow

      a. Member is diagnosed with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow

      b. Member demonstrated a partial response, minor response, or stable disease to one prior systemic therapy

      c. Naxitamab-gqgk is use is in combination with a granulocyte-macrophage colonystimulating factor (i.e., sargramostim)

      d. Naxitamab-gqgk is used in combination with premedications to mitigate the risk of infusion reactions (e.g., corticosteroids) and neurotoxicity (e.g., gabapentin)

      e. Naxitamab-gqgk is not used in combination with dinutuximab (Unituxin)

      f. The dose does not exceed 3 mg/kg/day on Day 1, 3, and 5 every 4 weeks of each treatment cycle until complete or partial response. Five additional treatment cycles are given every 4 weeks following a complete or partial response and then subsequent cycles every 8 weeks

2. Other FDA-approved or NCCN supported diagnosis (not previously listed above)

    a. Member meets one of the following:

         i. Member is diagnosed with a condition that is consistent with an indication listed in the product’s FDA-approved prescribing information (or package insert) AND member meets any additional requirements  listed in the “Indications and Usage” section of the FDA-approved prescribing information (or package insert)

          ii. Indication AND usage is recognized in NCCN Drugs and Biologics Compendium as a Category 1 or 2A recommendation

   b. The dose does not exceed 3 mg/kg/day on Day 1, 3, and 5 every 4 weeks of each treatment cycle until complete or partial response. Five additional treatment cycles are given every 4 weeks following a complete or partial response and then subsequent cycles every 8 weeks

Continuation of naxitamab-gqgk (Danyelza) injection meets the definition of medical necessity when ALL of the following criteria are met:

1. An authorization or reauthorization for naxitamab-gqgk (Danyelza) injection has been previously approved by Triple-S or another health plan in the past 2 years for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow or other FDA-approved or NCCN supported diagnosis; OR the member has previously met ALL indication-specific criteria.

2. The member has a beneficial response to treatment (i.e., no disease progression or toxicity)

3. Naxitamab-gqgk is not used in combination with dinutuximab (Unituxin) 4. The dose does not exceed 3 mg/kg/day on Day 1, 3, and 5 every 4 weeks of each treatment cycle until complete or partial response. Five additional treatment cycles are given every 4 weeks following a complete or partial response and then subsequent cycles every 8 weeks

EXCLUSION CRITERIA

N/A

BENEFIT APPLICATION

BlueCard/National Account Issues:  Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

OTHER CRITERIA

Validate that the treatment regimen is following the most up to date NCCN guidelines recommendations.

References

1.     Danyelza (naxitamab) [prescribing information]. New York, NY: Y-mAbs Therapeutics Inc;  03/2024
2.     Florida Blue Medical Coverage Guidelines. http://mcgs.bcbsfl.com/MCG

Codes

Applicable Modifiers

As per correct coding guidelines

Policy History