Melphalan Hepatic Delivery System (Hepzato Kit™)

Restricted Product(s):

• melphalan hepatic delivery system (Hepzato Kit™) for intra-arterial administration by a healthcare professional

FDA Approved Use:

• For liver-directed treatment of adults with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The patient has a diagnosis of uveal melanoma; AND 
   1. The patient is 18 years of age or older; AND 
   2. The patient has unresectable hepatic metastases affecting less than 50% of the liver; AND 
   3. ONE of the following: 
      1. The patient does NOT have extrahepatic disease; OR 
      2. The patient has extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation; AND 
   4. The patient weighs 35 kg or greater; OR 
2. The patient has an indication that is supported by ALL requirements in NCCN 1 or 2A recommended use for the requested agent [i.e., the indication must be supported by ALL requirements in the NCCN “Recommended Use” box (e.g., performance status, disease severity, previous failures, monotherapy vs combination therapy)]; AND 
   1. ONE of the following: 
      1. The patient’s age is within FDA labeling for the requested indication or NCCN 1 or 2A compendia supported recommendation for the requested agent; OR 
      2. The prescriber has provided information in support of using the requested agent for the patient’s age; AND 
3. The requested quantity (dose) and treatment duration (and maximum units) is within FDA labeled dosing for the requested indication or NCCN 1 or 2A compendia supported dosing for the requested indication; AND 
4. The patient will NOT receive more than 6 infusions total; AND 
5. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).

Duration of Approval: 365 days (maximum of up to 6 total infusions per lifetime)

References:

all information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

April 2024: Coding change: Added HCPCS code J9248 to dosing reference table effective 4/1/2024; deleted C9399, J3490, J3590, and J9999 termed 3/31/2024.

November 2023: Original medical policy criteria issued.