CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Hepzato (melphalan) percutaneous hepatic perfusion — Coverage Criteria

Defines accepted indications, contraindications, exclusions, coding, and prior authorization expectations for Hepzato (melphalan) delivered via percutaneous hepatic perfusion for members of Neighborhood Health Plan of Rhode Island (processed by Evolent). Affects ordering providers requesting authorization for this therapy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHepzato (melphalan) percutaneous hepatic perfusion — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization from Evolent before administering Hepzato; continuation requests allowed only if prior authorization was active within the last year without >30 day lapse and there is no disease progression.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9248HCPCS code

220 mgSingle dose max

<50% liverIndication limit

RequiredREMS

Coverage Criteria for Hepzato (melphalan) Percutaneous Hepatic Perfusion

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Indication — Uveal melanoma with hepatic metastases

Covered when ALL of the following are met

Uveal melanoma hepatic metastases criteria: Adult member 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.<50% liver involvement

From policy indication specifics

Exclusions for Hepzato (melphalan) percutaneous hepatic perfusion include situations where the treatment is no longer appropriate or lacks supporting evidence. Specifically, requests will be excluded if there is disease progression while taking Hepzato, if Hepzato is used concurrently with other anticancer therapies, or if the ordered dose exceeds the single dose limit of 220 mg.

Use of Hepzato for investigational or off‑label indications that are not supported by sufficient evidence is considered not medically necessary under this policy. The policy defines sufficient evidence as clinical data that adequately represents the patient population and regimen, demonstrates clinically meaningful outcomes (for example as recommended by ASCO), and is reported in appropriate study designs; uncontrolled case reports or abstracts without full peer‑reviewed publication are explicitly insufficient. Uses not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature are excluded.

Covered Regimens and Clinical Constraints

Regimen	Indication	Coverage status	Notes / Requirements
Hepzato (melphalan) percutaneous hepatic perfusion	Local hepatic-directed melphalan perfusion for unresectable hepatic metastases from uveal melanoma in adults with hepatic involvement <50% and no extrahepatic disease or extrahepatic disease limited to bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.	Covered	Prior authorization required (J9248). Single dose must not exceed 220 mg. Use limited to patients meeting contraindication and safety requirements (REMS enrollment required; monitor for hypersensitivity, heparin allergy/HIT, severe iodinated contrast allergy, active intracranial metastases at risk for bleed, liver failure/portal hypertension/varices, recent liver surgery/treatment within 4 weeks, and unstable cardiac conditions). Continuation requests allowed if prior authorization was active within the last year without >30-day lapse and no disease progression or addition of other anticancer therapies.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Authorization required

Prior authorization by Evolent is required for Hepzato (melphalan) requests. Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Evolent processes all medication requests from network ordering providers.
Medications not authorized by Evolent may be non-approvable / non-reimbursable.

Prior Authorization

Continuation exemption

Continuation requests for a previously authorized medication may be exempt from reauthorization when continuity criteria are met.

Member has not experienced disease progression on the requested medication.
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No additional medication(s) are being added to the continuation request.

Documentation Required

Required supporting evidence and safety documentation

Support for medical necessity must be provided with each request. Include FDA labeling, CMS‑recognized compendia, professional society guidelines, or peer‑reviewed literature that meets CMS standards. Document monitoring and safety measures required by the Hepzato REMS.

Use FDA approved product labeling, CMS‑approved compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.
Document adherence to REMS requirements for Hepzato (melphalan) and monitoring for myelosuppression and severe periprocedural complications during and for at least 72 hours post‑administration.
Provide dosing documentation — requests exceeding the single dose limit of 220 mg will be excluded.

Denial Risk

Common exclusion triggers

Requests meeting any exclusion criteria are likely to be denied. Review and document current disease status, concurrent therapies, and supporting evidence before submission.

Disease progression while receiving Hepzato (melphalan) is an exclusion trigger.
Concurrent use with other anticancer therapies is excluded.
Dosing that exceeds the single dose limit of 220 mg is excluded.
Investigational or off‑label indications lacking sufficient evidence (not supported by CMS compendia, appropriate peer‑reviewed literature, or widely accepted clinical practice) are excluded — ensure published evidence adequately represents the patient population, regimen, and clinically meaningful outcomes.

Definitions and Procedure Description

inv-12: Percutaneous hepatic perfusion (PHP) with Hepzato — procedure definition, infusion route, systemic risk notes

DefinitionPercutaneous hepatic perfusion (PHP) with Hepzato is intra-arterial infusion of melphalan for isolated hepatic perfusion to treat unresectable hepatic metastases

Infusion route and procedure notesDelivered via hepatic intra-arterial administration (percutaneous hepatic perfusion) during a periprocedural intervention; monitor for severe periprocedural complications including hemorrhage and hepatocellular injury

Systemic risk and REMSAssociated systemic risks include myelosuppression (boxed warning) and severe complications; Hepzato for PHP is available only through the Hepzato Kit REMS program

Contraindications/safety considerationsConsider hypersensitivity to melphalan or kit components, heparin allergy/HIT, severe iodinated contrast allergy, active intracranial metastases at risk for bleed, liver failure/portal hypertension/varices, recent liver surgery/treatment within 4 weeks, and unstable cardiac conditions

Background

Hepzato (melphalan) is administered via percutaneous hepatic perfusion (PHP) as a liver‑directed chemotherapy approach for patients with hepatic metastases. The policy highlights its application for adult members with uveal melanoma who have unresectable hepatic metastases (typically limited to less than 50% liver involvement) and notes significant treatment risks including myelosuppression and other procedure‑related complications. Hepzato is available only through the appropriate REMS program and clinicians must consider contraindications and safety monitoring prior to use.