Reviewer # 3

This patient is a male diagnosed with anterior uveal melanoma of the left eye. He initially had brachytherapy to the left eye. He developed a lesion in the liver. He subsequently received Y-90 radiation. There was an increase in the size and number of the liver lesions on the MRI. In early 2019 ipilimumab and nivolumab treatment was started.

The scientific evidence in peer-reviewed literature supports improvement in health outcomes.
The development of checkpoint inhibitors, such as ipilimumab and nivolumab, which modulate the effects of the cytotoxic T-lymphocyte associated protein 4 [CTLA-4] and programmed cell death protein 1 [PD-1], respectively, has revolutionized outcomes for these patients. Monotherapy improves metastatic disease survival, but dual therapy provides greater benefit with 58% of patients alive at 3 years." (Carreau, NA., Pavlick, AC. 2019)"Ipilimumab was the first checkpoint inhibitor to gain FDA approval by demonstrating a survival benefit in metastatic melanoma patients in a prospectively randomized Phase III clinical trial. Pembrolizumab was initially approved for ipilimumab-refractory metastatic melanoma patients; however, the indication was expanded to the first-line setting based on KEYNOTE-006 results" (Force, J., & Salama, A. K. 2017) "Newly emerging treatments include the anti-programmed cell death 1 receptor agents (nivolumab and pembrolizumab), anti-programmed death-ligand 1 agents, and oncolytic vaccines (talimogene laherparepevec) Available treatments for select sites include adoptive T cell therapies and dendritic cell vaccines"(Maverakis, E. et al. 2015).

Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299) does have approval from the regulatory bodies, as it is approved for metastatic melanoma.

The patient has metastatic melanoma with primary uveal melanoma. He has metastasis to the liver. It is an appropriate indication for this combination. This is appropriate treatment for this patient. It is recommended per National Comprehensive Cancer Network (NCCN) guidelines and Immunotherapy.
The requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient.The carrier's denial of coverage for Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299) should be reversed.