CurrentMass General Brigham Health PlanPolicy N/A

Hepzato (melphalan hepatic delivery system) — coverage criteria

Policy governs prior authorization and medical-benefit coverage for Hepzato (melphalan hepatic delivery system) for adults with hepatic-dominant metastatic uveal melanoma treated through Mass General Brigham Health Plan/MassHealth.

Policy Summary

PayerMass General Brigham Health Plan

PolicyHepzato (melphalan hepatic delivery system) — coverage criteria

Policy CodePolicy N/A

Change TypeAdded required data element

Effective DateAug 11, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with oncologist documentation, ideal body weight, extent of liver involvement, dosing, and requested duration (≤ six doses).

SourceLink

POLICY UPDATE CHANGES

Added criterion requiring the member's ideal body weight.

≤6maximum requested duration/reauthorization allowance

≥18age requirement

<50%limit on hepatic tumor burden

Medical PAbenefit and utilization management

Coverage Criteria for Hepzato (melphalan hepatic delivery system)

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inv-01: Initial Authorization

Authorization may be granted when ALL of the following are met:

Initial authorization criteria: 1. Diagnosis of uveal melanoma with unresectable hepatic metastases; 2. Member is ≥18 years of age; 3. Prescriber is an oncologist or consult notes from an oncologist are provided; 4. Member has liver metastases that affect < 50% of the liver; 5. ONE of the following: (a) Member does not have any extrahepatic disease OR (b) Extrahepatic disease is limited to the bone, lymph nodes, subcutaneous tissue, or lung and is amenable to resection or radiation; 6. Member's ideal body weight is provided; 7. Appropriate dosing per product labeling; 8. Requested duration is ≤ six doses.

Follow-up documentation required for continuation (positive response).

inv-02: Continuation of Therapy / Reauthorization

Continuation and reauthorization requirements:

Continuation criteria: Provider documents positive response to therapy for continuation of treatment.

Initial approvals may be granted for 6 months; reauthorizations may be granted for a total of 6 doses.

Authorization is limited to adult members (age ≥18) with a diagnosis of uveal melanoma and unresectable hepatic metastases affecting less than 50% of the liver. Requests are eligible only when the disease is hepatic-dominant: either no extrahepatic disease is present, or any extrahepatic disease is limited to bone, lymph nodes, subcutaneous tissue, or lung and is amenable to resection or radiation. The member's ideal body weight and documentation of appropriate dosing must be provided. Initial requests should specify a duration of therapy of ≤ six doses.

Requests that do not meet all of the listed criteria — including diagnosis, age, oncologist prescriber or consult, <50% hepatic involvement, permissible extrahepatic disease status, documentation of ideal body weight, appropriate dosing, and a requested duration of ≤ six doses — may be reviewed and denied. Additionally, prior authorization for members who are new to the plan but currently receiving treatment may be reviewed on a case‑by‑case basis; absence of required documentation may result in denial.

Regimen	Indication	Dosing / Administration	Coverage status
Hepzato (melphalan hepatic delivery system)	Liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases	Administered per product labeling and appropriate dosing; member's ideal body weight must be provided; requested duration ≤ six doses	Covered with criteria

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for medical benefit administration of Hepzato (melphalan hepatic delivery system). Approvals are determined by case-by-case review of submitted clinical documentation.

Medical benefit administration only
Contact for prior authorization: Phone: 833-895-2611; Fax: 888-656-6671

Step Therapy

No step therapy requirement is specified for this therapy.

Documentation Required

Required Supporting Documentation

Clinical documentation must be provided to support the request. Include oncologist prescriber or consult notes, documentation of extent of liver metastases, member's ideal body weight, dosing details, and documentation supporting requested duration (≤ six doses). For continuation requests, provide documentation of positive response to therapy.

Oncologist prescriber or consult notes
Extent of liver metastases (must be < 50% of liver)
Member's ideal body weight
Appropriate dosing details
Requested duration (≤ six doses)
For continuation: documentation of positive response to therapy

Denial Risk

Criteria-based Denial Risk

Requests that do not meet the clinical criteria may be denied. Key denial risks include: diagnosis not consistent with uveal melanoma with unresectable hepatic metastases; member age < 18 years; prescriber is not an oncologist and no oncologist consult notes provided; liver metastases affecting ≥ 50% of the liver; extrahepatic disease beyond allowed sites or not amenable to resection/radiation; missing required documentation (ideal body weight, dosing, duration); or requested duration > six doses.

Definitions

Unresectable hepatic metastases

DefinitionUnresectable hepatic metastases: liver metastases from uveal melanoma that cannot be surgically removed and affect less than 50% of the liver.

Quantitative thresholdLess than 50% of liver involvement (<50%).

Clinical implicationPatients with hepatic metastases affecting ≥50% of the liver are not eligible per policy.

Permissible extrahepatic disease

Allowed extrahepatic sitesBone, lymph nodes, subcutaneous tissue, or lung.

Resectability/radiation requirementExtrahepatic disease in allowed sites must be amenable to resection or radiation to qualify.

No extrahepatic disease optionPolicy also permits eligibility if there is no extrahepatic disease.

Exclusion statementExtrahepatic disease beyond the specified sites or not amenable to resection/radiation makes the patient ineligible.

Policy Summary

PayerMass General Brigham Health Plan

PolicyHepzato (melphalan hepatic delivery system) — coverage criteria

Policy CodePolicy N/A

Change TypeAdded required data element

Effective DateAug 11, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with oncologist documentation, ideal body weight, extent of liver involvement, dosing, and requested duration (≤ six doses).

SourceLink

On This Page

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Hepzato (melphalan hepatic delivery system) — coverage criteria

Coverage Criteria for Hepzato (melphalan hepatic delivery system)

Billing and Coding

Provider Actions and Requirements

Definitions

Line of Therapy / Salvage Use

Background

Revision History and Policy Changes