Description
Melphalan is a bifunctional alkylating agent which causes interference with DNA replication, transcription of RNA which ultimately results in cell death. Intra-arterial melphalan (Hepzato) is a liver directed treatment for uveal melanoma with unresectable hepatic metastases. Liver directed chemotherapy is a minimally invasive procedure known as percutaneous hepatic perfusion (PHP). During PHP, catheters are placed percutaneously, and an infusion of chemotherapy is administered directly to the liver.
Policy Application
All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.
Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Intra-arterial melphalan (Hepzato) may be considered medically necessary when
ALL
of the following criteria are met:
-
Individual is 18 years of age or older;
and
-
Individual has been diagnosed with uveal melanoma with unresectable hepatic liver metastases;
and
-
The liver metastases affect less than 50% of the liver;
and
-
Individual does not have any extra hepatic disease;
or
-
Individual has extra hepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation;
and
-
Healthcare setting is certified by and individual will be enrolled in the Hepzato Risk Evaluation and Mitigation Strategy (REMS) program, providing the appropriate monitoring to include assessment for complications during and for 72 hours by a healthcare provider after administration of intra-arterial melphalan (Hepzato);
or
Compendia Sources
Intra-arterial melphalan (Hepzato) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
Intra-arterial melphalan (Hepzato) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
