Um Onc_1486 Hepzato Melphalan_10252024
Defines accepted indications, inclusion and exclusion criteria, continuation criteria, medication management and approval authority for Hepzato (melphalan) for cancer treatment, including FDA-approved and select off-label use (uveal melanoma with hepatic metastases).
Document shows committee review dates 10/11/23 and 10/09/24 with approval date October 9, 2024 and effective date October 25, 2024.
Coverage Summary
Hepzato (melphalan) is covered with criteria for treatment of adult members with uveal melanoma who have unresectable hepatic metastases involving 50% of the liver, and either no extrahepatic disease or extrahepatic disease limited to bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Continuation requests may be exempt when the member has not experienced disease progression on therapy, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added. Claims are excluded for disease progression on Hepzato, concurrent anticancer therapies, single doses exceeding 220 mg, or investigational/off‑label uses lacking sufficient supporting evidence.
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