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 case involves an adult male diagnosed with stage four (IV) metastatic melanoma, chronic lymphocytic lymphoma, and monoclonal gammopathy of undetermined significance who was recommended for treatment with J9144 injection, Daratumumab, 10 mg and hyaluronidase - FIHJ, 6 units.  The proposed treatment was denied coverage with claims that it was experimental and investigational. The physician appealed the determination stating that the patient continues to have severe prolonged pancytopenia requiring transfusions, progressed him, romiplostim injections, to 5-day course of intravenous immunoglobulin (IVIG), and a 4-day course of oral dexamethasone 40 mg given evidence of transient hemolysis. Prior to this, the patient received treatment with tumor infiltrating lymphocyte (TIL) therapy on protocol.  The physician stated that the use of high-dose, long-term steroids are not a treatment option given the direct cytotoxic effect on TIL's, which the patient's melanoma continues to have a response to at this time. The physician went on to state that 2 bone marrow biopsies were performed post TIL showing hypocellular marrow with trilineage maturing hematopoiesis and focal decrease of megakaryocytes. Given the small improvement in cytopenia following IVIG, further treatment with immune mediated therapy is the next step in the patient's care.  The treating physician noted that based on available evidence provided, daratumumab, and anti-CD38 (cluster of differentiation 38) monoclonal antibody, is the next appropriate option to manage the patient's prolonged immune cytopenia and has the potential to improve quality of life and outcomes.  Based on the patient's oncologic history, complicated treatment course, and severe pancytopenia despite receipt of guideline endorsed treatment, it was the physician's medical opinion that daratumumab 16 mg/ kilogram (kg) subcutaneous weekly injections for 8 weeks followed by 2 every other week injections are safe and provides the best chance for response.  

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

The requested service has final approval from the appropriate regulatory bodies for this diagnosis.

This patient is a good candidate for the requested service, and it is one of the best available treatments for this patient at this time.

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

The information provided for review noted the patient was diagnosed with stage IV metastatic melanoma who continued to have severe pancytopenia despite guideline endorsed treatment. Current medical literature notes that CD38 as a target has been considered for some time, but clinically, daratumumab, a CD38 monoclonal antibody, was the first to be tested, and it has delivered the best clinical responses as a single agent to date. The patient had trialed multiple treatment measures and was being recommended for daratumumab. The treating physician noted that the long-term use of high-dose steroids is not a treatment option for this patient given the direct cytotoxic effect on tumor infiltrating lymphocytes.  In taking the extent of the patient's condition into consideration to include his treatment history, given the small improvement in cytopenia following IVIG, further treatment with immune mediated therapy is appropriate for this individual.  

In summary, the denial of J9144 injection, Daratumumab, 10 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.