Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Zolbetuximab-clzb (Vyloy) may be considered medically necessary in individuals 18 years and older when ALL of the following criteria are met:
- Individual has a diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; and
- The tumor is human epidermal growth factor receptor 2 (HER2)-negative; and
- The tumor is CLDN18.2 positive as determined by an FDA-approved test; and
- Zolbetuximab-clzb (Vyloy) is being used in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment.
Compendia Sources
Zolbetuximab-clzb (Vyloy) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of zolbetuximab-clzb (Vyloy) 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.
Procedure codes
