Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Stage II B with unfavorable classical Hodgkin Lymphoma

Treatment: Procedure J9130 - Dacarbazine, J9000 - Doxorubicin HCL; J9299 - Nivolumab; J9360 - Vinblastine Sulfate

The insurer denied coverage for procedure J9130 - Dacarbazine, J9000 - Doxorubicin HCL; J9299 - Nivolumab; J9360 - Vinblastine Sulfate.

The denial is upheld.

 
This is a patient who has a diagnosis of Stage II B with unfavorable classical Hodgkin Lymphoma (HL). The Nivo-AVD (Nivolumab plus doxorubicin, vinblastine, and dacarbazine) regimen was prescribed and denied. The appeal is based on a phase II CheckMate 205 study.

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient.      

The procedure J9130 - Dacarbazine, J9000 - Doxorubicin HCL; J9299 - Nivolumab; J9360 - Vinblastine Sulfate is not considered medically necessary for this patient and is denied. 

The patient has a diagnosis of Stage II B with unfavorable classical Hodgkin Lymphoma (HL).

The denial was appealed based on Cohort D of the CheckMate 205 trial, which assessed nivolumab monotherapy followed by nivolumab plus doxorubicin, vinblastine, and dacarbazine (N-AVD) for newly diagnosed classical Hodgkin's Lymphoma (cHL). A total of 51 patients were enrolled and treated. At diagnosis, 49% (percent) of patients had an International Prognostic Score of 3 or greater. Overall, 59% (percent) experienced a grade 3 to 4 treatment-related adverse event. Treatment-related febrile neutropenia was reported in 10% (percent) of patients. Endocrine immune-mediated adverse events were all grade 1 to 2 and did not require high-dose corticosteroids; all nonendocrine immune-mediated adverse events resolved (most commonly, rash; 5.9% [percent]). At the end of therapy, the objective response rate (95% [percent] Confidence Interval [CI]) per independent radiology review committee was 84% (percent]) (71% [percent] to 93% [percent]), with 67% (percent) (52% [percent] to 79% [percent]), achieving complete remission (five patients [10% (percent)] were nonevaluable and counted as nonresponders). With a minimum follow-up of 9.4 months, 9-month modified progression-free survival was 92% (percent). Patients with higher-level Hodgkin Reed-Sternberg programmed death-ligand 1 expression had more favorable responses to N-AVD (P = .041). Median overall survival (OS) was not reached; OS at 5 years was 71.4% (percent) (95% [percent] CI, 64.8-77.1).

This is a single phase II study, which is not sufficient to support medical necessity. This is a phase II study, and not a comparative study, and although it indicates superiority over standard National Comprehensive Cancer Network (NCCN) supported therapies, a single phase II study is not enough to support medical necessity.

"A total of 51 patients were enrolled and treated. At diagnosis, 49% (percent) of patients had an International Prognostic Score of 3 or greater. Overall, 59% (percent) experienced a grade 3 to 4 treatment-related adverse event. Treatment-related febrile neutropenia was reported in 10% (percent) of patients. Endocrine immune-mediated adverse events were all grade 1 to 2 and did not require high-dose corticosteroids; all nonendocrine immune-mediated adverse events resolved (most commonly, rash; 5.9% [percent]). At the end of therapy, the objective response rate (95% [percent] CI) per independent radiology review committee was 84% (percent) (71% to 93% [percent]), with 67% (percent) (52% to 79% [percent]), achieving complete remission (five patients [10% (percent)] were nonevaluable and counted as nonresponders). With a minimum follow-up of 9.4 months, 9-month modified progression-free survival was 92% (percent). Patients with higher-level Hodgkin Reed-Sternberg programmed death-ligand 1 expression had more favorable responses to N-AVD (P = .041)" (Ramchandren R., et al 2019).

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for procedure J9130 - Dacarbazine, J9000 - Doxorubicin HCL; J9299 - Nivolumab; J9360 - Vinblastine Sulfate is not substantiated.