CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1486

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).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1486 Hepzato Melphalan_10252024

Policy CodePolicy UM ONC_1486

Change Typerevised

Effective DateOct 25, 2024

Next Review Date

Key ActionAll medication requests must be processed by Evolent and uses not authorized by Evolent may be deemed not approvable and not reimbursable.

SourceLink

POLICY UPDATE CHANGES

Document shows committee review dates 10/11/23 and 10/09/24 with approval date October 9, 2024 and effective date October 25, 2024.

1Primary Covered Indication (uveal melanoma hepatic metastases)

4Explicit Exclusion Criteria Items

3Continuation criteria elements

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.

Unproven / Exclusions (Not Covered)

Denial Risk

Exclusion triggers claim denial

Claims will be excluded or denied when any of the following apply: disease progression while taking Hepzato (melphalan); concurrent use with other anticancer therapies; single dose exceeding 220 mg; or investigational/off‑label use lacking sufficient supporting evidence as defined by the policy (e.g., inadequate representation of patient/cancer characteristics or regimen in published evidence, outcomes not clinically meaningful, poor study design, reliance on case reports or abstracts without full peer‑reviewed articles).

Provider Actions & Requirements

Prior Authorization

Medication requests processed by Evolent

All medication requests must be processed by Evolent and uses not authorized by Evolent may be deemed not approvable and not reimbursable.

Documentation Required

Support for use required

Use must be supported by FDA labeling, CMS‑recognized compendia, NCCN, ASCO guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Note

Review and final approval

Utilization Management Department conducts review; final approval by the Utilization Management Committee.

Clinical Evidence & References

Key evidence sources include the Hepzato prescribing information (Delcath Systems, Inc., 2023) and the pivotal FOCUS phase 3 trial (PHP‑OCM‑301/301A) reporting percutaneous hepatic perfusion with melphalan for ocular melanoma liver metastases (J Clin Oncol. 2022;40;16S).

Supportive compendia and reference resources listed for policy use are NCCN and ASCO guidelines, AHFS Drug Information, Micromedex, and Clinical Pharmacology.

Background

This policy defines accepted indications for Hepzato (melphalan) and references FDA labeling, CMS‑recognized compendia, and professional guidelines to support use. It cites key literature including the Hepzato prescribing information and the FOCUS phase 3 trial, and notes that Evolent is responsible for processing all medication requests for the payer.

The policy requires that use be supported by FDA approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements, and outlines review and final approval roles within Utilization Management.

Continuation request exemption: an allowance for continuation of a not‑approvable medication when the member has not experienced disease progression on the medication, 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 to the continuation request.

Revision History

2023-10-11committee_review

Document shows committee review dates 10/11/23 and 10/09/24 with approval date October 9, 2024 and effective date October 25, 2024.

2024-10-09committee_review_and_approvalLatest

Document shows committee review dates 10/11/23 and 10/09/24 with approval date October 9, 2024 and effective date October 25, 2024.

2024-10-25effective_dateLatest

Document shows committee review dates 10/11/23 and 10/09/24 with approval date October 9, 2024 and effective date October 25, 2024.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1486 Hepzato Melphalan_10252024

Policy CodePolicy UM ONC_1486

Change Typerevised

Effective DateOct 25, 2024

Next Review Date

Key ActionAll medication requests must be processed by Evolent and uses not authorized by Evolent may be deemed not approvable and not reimbursable.

SourceLink

On This Page

OpenPayer

Um Onc_1486 Hepzato Melphalan_10252024

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions (Not Covered)

Applicable Codes

Provider Actions & Requirements

Clinical Evidence & References

Background

Revision History