CurrentEmblemHealthPolicy N/A

Hepzato (melphalan) via percutaneous hepatic perfusion — Coverage Criteria

Defines indications, contraindications, coding, and utilization management requirements for Hepzato (melphalan) used via percutaneous hepatic perfusion in members; applies to network providers submitting medication requests to Evolent/EmblemHealth.

Policy Summary

PayerEmblemHealth

PolicyHepzato (melphalan) via percutaneous hepatic perfusion — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionRequests for Hepzato (melphalan) require prior authorization by Evolent; continuation requests may be exempt if continuity conditions are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9248HCPCS code for Hepzato (melphalan) 1 mg

220 mgsingle-dose maximum excluded if exceeded

<50%maximum hepatic involvement for covered indication

REMS requiredREMS status

Commercial/Exchange/Medicaidapplicable lines of business

Coverage Criteria for Hepzato (melphalan) via PHP

Initial therapy — Uveal melanoma with hepatic metastases

Covered when ALL of the following are met

Uveal melanoma hepatic metastases coverage: Adult member has uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver AND no extrahepatic disease OR extrahepatic disease limited to bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.<50% liver involvement

From policy uveal melanoma indication.

Requests for Hepzato (melphalan) will be excluded (denied) when any of the following conditions are present: disease progression while taking Hepzato; concurrent use with other anticancer therapies; or dosing that exceeds the single-dose limit of 220 mg. These exclusion conditions are mandatory review considerations and will result in denial when documented in the medical record.

Hepzato (melphalan) is considered investigational/not medically necessary for off-label indications when the available evidence is insufficient or not generally accepted by the medical community. Insufficient evidence includes, but is not limited to: inadequate representation of the patient or cancer characteristics in published studies; lack of representation of the specific regimen under consideration; outcomes that are not clinically meaningful (for example, per ASCO guidance, hazard ratio ≥ 0.80 or survival benefits < 3 months for OS/PFS); poor experimental design relative to the question being addressed; reliance solely on uncontrolled case reports or abstracts without full peer-reviewed publication. Requests for off-label use must be supported by CMS-recognized compendia or acceptable peer-reviewed literature to be considered otherwise.

Policy Summary

PayerEmblemHealth

PolicyHepzato (melphalan) via percutaneous hepatic perfusion — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionRequests for Hepzato (melphalan) require prior authorization by Evolent; continuation requests may be exempt if continuity conditions are met.

SourceLink

On This Page

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Regimen	Indication / Coverage Conditions	Contraindications / REMS	Coverage Status
Hepzato (melphalan) via percutaneous hepatic perfusion (PHP)
Treatment of adult members with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease OR extrahepatic disease limited to bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
Contraindications include: allergy or hypersensitivity to melphalan or any Hepzato Kit component; hypersensitivity/allergy to heparin or presence of heparin‑induced thrombocytopenia; severe allergic reaction to iodinated contrast not controlled by premedication; active intracranial metastases or brain lesions with propensity to bleed; liver failure, portal hypertension, or known varices at risk for bleeding; surgery or medical treatment of the liver in the previous 4 weeks; active cardiac conditions (e.g., unstable coronary syndromes, worsening/new congestive heart failure, significant arrhythmias, severe valvular disease). Hepzato (melphalan) for PHP is available only through a restricted REMS program (Hepzato Kit REMS).
covered

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Requests for Hepzato (melphalan) require prior authorization by Evolent. Continuation requests may be exempt if the criteria for continuation are met (see Continuation request conditions).

All medication requests from network ordering providers must be processed by Evolent.
Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Prior Authorization

Continuation Request Conditions

Continuation authorization can be granted when ALL of the following are true: the member has not experienced disease progression while receiving Hepzato (melphalan); the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request.

Documentation Required

Supporting Documentation Required

Use of Hepzato (melphalan) must be supported by one of the following sources: FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature that meets CMS standards (see exclusions for insufficient evidence).

Denial Risk

Exclusion Criteria That Trigger Denial

Requests will be denied for the following exclusion criteria: disease progression while taking Hepzato (melphalan); concurrent use with other anticancer therapies; dosing that exceeds the single-dose limit of 220 mg; investigational use or off-label indications lacking sufficient evidence or not generally accepted by the medical community (including reliance on case reports, meeting abstracts without full peer-reviewed articles, or evidence that does not adequately represent the patient/cancer characteristics, regimen, or clinically meaningful outcomes).

Single-dose limit: Hepzato (melphalan) 220 mg.

Definitions

PHP (percutaneous hepatic perfusion) with melphalan — key facts

Procedure namePercutaneous hepatic perfusion (PHP) with melphalan (Hepzato)

Indication (covered)Adult members with uveal melanoma and unresectable hepatic metastases affecting less than 50% of the liver; no extrahepatic disease or extrahepatic disease limited to resectable/irradiable sites (bone, lymph nodes, subcutaneous, or lung)

Major risks/warningsMyelosuppression, severe infection, bleeding, symptomatic anemia, hemorrhage, hepatocellular injury, and thromboembolic events; monitor during and at least 72 hours after administration

REMS statusAvailable only through a restricted program under the Hepzato Kit REMS

Key contraindicationsHypersensitivity to melphalan or Hepzato Kit components; heparin allergy/heparin-induced thrombocytopenia; severe allergy to iodinated contrast not controlled by premedication; active intracranial metastases or bleeding-risk brain lesions; liver failure, portal hypertension, varices at risk for bleeding; recent (within 4 weeks) liver surgery or treatment; active significant cardiac conditions

Covered Regimens and Contraindications

Regimen Specifics	Single‑Dose Limit	Prior Authorization / Continuation	REMS / Safety Monitoring
Percutaneous hepatic perfusion (PHP) with Hepzato (melphalan) administered intra‑arterially per procedural protocol for hepatic metastases from uveal melanoma.
Single dose limit: ≤ 220 mg (dosing exceeding single dose limit is an exclusion).
Requests require prior authorization (HCPCS J9248). Continuation requests may be approved if no disease progression, prior use within the last year without a >30‑day lapse, and no addition of other anticancer agents.
Hepzato is distributed only through a restricted program under a REMS (Hepzato Kit REMS). Monitor for myelosuppression and severe periprocedural complications (including hemorrhage, hepatocellular injury, thromboembolic events) during and for at least 72 hours following administration; boxed warning for myelosuppression.

OpenPayer

Hepzato (melphalan) via percutaneous hepatic perfusion — Coverage Criteria

Coverage Criteria for Hepzato (melphalan) via PHP

Billing and Coding

Provider Requirements and Prior Authorization

Definitions

Applicable Line(s) of Therapy

Background

Covered Regimens and Contraindications