Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Metastatic melanoma. 
Treatment: J9144 injection, Daratumumab, 10 milligram (mg) And hyaluronidase - FIHJ, 6 units. 
The insurer denied coverage for J9144 injection, Daratumumab, 10 mg And hyaluronidase - FIHJ, 6 units. 
The denial is overturned. 

This is an adult male with stage four (IV) metastatic melanoma, chronic lymphocytic lymphoma (CLL), monoclonal gammopathy of undetermined significance (MGUS), and immune thrombocytopenia (ITP) (confirmed with bone marrow biopsy). There was a recent decline in platelet counts. Prior treatment included intravenous immunoglobulin (IVIG). The treating provider recommended treatment with J9144 injection, Daratumumab, 10 mg And hyaluronidase - FIHJ, six units, which is under review. 

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. 

Several studies confirm the utility of this treatment. 

Daratumumab, an anti-CD38 (cluster of differentiation 38) antibody, targets plasma cells and is indicated for the treatment of multiple myeloma (MM). Daratumumab has been successfully used to treat refractory autoimmune cytopenias in children, a few cases of post-transplant autoimmune cytopenias, and refractory systemic lupus erythematosus (SLE) in adults. 

Per Tsykunova, G., et al., (2022), "Daratumumab is an anti-CD38 antibody approved for the treatment of multiple myeloma and has been successfully used to treat autoimmune hemolytic anemia and ITP in children." 

Per Raedler L. A. (2016), "Daratumumab is the first Food and Drug Administration (FDA)-approved monoclonal antibody that targets CD38 that has demonstrated single-agent efficacy in patients with multiple myeloma who have received several previous treatments, including those whose disease is double-refractory to a proteasome inhibitor and an immunomodulatory drug (IMiD) agent." 

Per Phipps, C., Chen, Y., Gopalakrishnan, S., & Tan, D. (2015), "Despite the recent major advancement in therapy for multiple myeloma, it remains an incurable disease. There remains an unmet need for novel therapies that target different mechanisms of action. Immunotherapy with monoclonal antibodies is a promising area of development and will expand our therapeutic armamentarium in the fight against myeloma. Daratumumab is a novel, high-affinity, therapeutic human monoclonal antibody against unique CD38 epitope with broad-spectrum killing activity. It has a favorable safety profile as monotherapy in patients with relapsed/refractory myeloma and also demonstrates significant single-agent activity." 

The requested service does not have final approval from the appropriate regulatory bodies for this diagnosis. 

However, it is appropriate, off-label. Hyaluronidase is a vehicle that makes it possible to give it subcutaneously (SQ). 

This patient a good candidate for the requested service. 

Daratumumab, an anti-CD38 antibody, targets plasma cells and is indicated for the treatment of MM. Daratumumab has been successfully used to treat refractory autoimmune cytopenias in children, a few cases of post-transplant autoimmune cytopenias, and refractory SLE in adults and makes it possible to give it SQ.  It is an appropriate treatment off-label for this patient. 

The adverse risks are not increased over standard treatment/services. 

The side effect profile is not of greater risk than the alternatives. 

There are no comparative studies. However, Daratumumab is immunotherapy and other established immunotherapies have proven effective, and Darzalex (daratumumab) does have literature support.                                    

In summary, the denial of J9144 injection, Daratumumab, 10 milligrams (mg) And hyaluronidase - FIHJ, 6 units should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are not substantially increased over standard treatments.