CurrentEmblemHealthPolicy MG.MM.PH.220

Evomela (melphalan)

Covers medical necessity criteria, dosing, codes, and authorization requirements for Evomela (melphalan) when used as high-dose conditioning prior to autologous stem cell transplant or for palliative treatment in adults with multiple myeloma.

Policy Summary

PayerEmblemHealth

PolicyEvomela (melphalan)

Policy CodePolicy MG.MM.PH.220

Change TypeNo material changes

Effective Date

Next Review DateApr 9, 2025

Key ActionPrior authorization is required with documentation that the adult patient meets indication-specific criteria and that Evomela is prescribed by or in consultation with an oncologist or hematologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2indications covered

30d / 6moauth lengths

J9246,J9249HCPCS/J-codes

C90.00,C90.02ICD-10

Coverage Criteria for Evomela (melphalan)

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inv-02: Initial Approval — Palliative

Covered when ALL of the following are met:

Multiple Myeloma - Palliative Treatment: A. Patient is 18 years of age or older; AND B. Evomela is prescribed by, or in consultation with, an Oncologist or Hematologist; AND C. Evomela is used for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

inv-03: Renewal Criteria

Renewal/Continuation criteria — Coverage can be renewed when ALL of the following are met:

Renewal Criteria: 1. Patient continues to meet the indication-specific criteria; AND 2. There is evidence of response to therapy and stabilization of disease; AND 3. Absence of unacceptable toxicity from the drug.

Indications that are not supported by CMS-recognized compendia or by acceptable peer-reviewed medical literature will generally be considered not approvable and not reimbursable. Providers should ensure the proposed use of Evomela (melphalan) is supported by referenced compendia or literature when submitting for authorization.

Dosing Regimens and Administration

Regimen	Details
Conditioning prior to autologous stem cell transplantation
100 mg/m2/day IV administered over 30 minutes for 2 consecutive days (Day -3 and Day -2) prior to ASCT. Calculate body surface area using adjusted ideal body weight for patients who weigh >130% of ideal body weight. Administer prophylactic antiemetics. No dose adjustment necessary for conditioning treatment.

Regimen	Details
Palliative treatment for multiple myeloma
16 mg/m2 IV infusion over 15–20 minutes every 2 weeks for 4 doses, then after adequate recovery every 4 weeks. Administer prophylactic antiemetics. Consider dosage reduction of up to 50% in patients with renal impairment (BUN ≥30 mg/dL).

Procedure, Drug, and Diagnosis Codes

Applicable Procedure CodesHCPCSCovered

J9246	Injection, melphalan (evomela), 1 mg.
J9249	Injection, melphalan (apotex), 1 mg

Applicable NDCsNDC

68152-0109-00	Evomela Intravenous Powder for Solution: 50 mg.
72893-0001-01	Evomela Intravenous Powder for Solution: 50 mg single dose vial

ICD-10 DiagnosesICD-10Covered

C90.00	Multiple myeloma not having achieved remission.
C90.02	Multiple myeloma in relapse

Renal impairment threshold for dose reduction (palliative regimen)

BUN threshold for dose reduction considerationBUN ≥30 mg/dL

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for covered indications. Prior authorization must include documentation that the adult patient meets the indication-specific criteria (e.g., conditioning or palliative treatment for multiple myeloma as specified in the policy).

Documentation Required

Clinical Evidence Submission

Treating physician or primary care provider must submit clinical evidence that the member meets the criteria for the requested treatment or procedure. This documentation is required for preauthorization and may also be requested for post-service review. Without sufficient clinical documentation, EmblemHealth cannot properly review the request and the request may be denied.

Submit relevant clinical records, treatment history, diagnostic test results, and rationale demonstrating the member meets policy criteria
Preauthorization and post-payment reviews both require supporting clinical evidence from the treating physician or PCP

Denial Risk

Documentation Requirement / Denial Risk

Failure to submit clinical documentation showing the member meets the policy criteria will prevent proper review and may result in denial. Providers should ensure all requested medical records and supporting literature are included with the authorization request.

Note

Compendia and Literature Support Required

Indications not supported by CMS-recognized compendia or acceptable peer-reviewed literature may be deemed not approvable and not reimbursable. Providers should include citations to applicable compendia or peer-reviewed literature when seeking coverage for less well-established indications.

Line of Therapy Notes

inv-17: salvage

Conditioning prior to ASCT: Used as high-dose conditioning prior to autologous stem cell transplantation (ASCT)

typically Day -3 and Day -2 dosing per dosing section

inv-18: salvage

Palliative therapy: Used for palliative treatment when oral therapy is not appropriate

Background and Drug Information

Melphalan is a bifunctional alkylating agent that exerts cytotoxic effects primarily by cross-linking DNA strands and is cell cycle–phase nonspecific. It is used as high‑dose conditioning prior to autologous hematopoietic stem cell transplantation and for palliative treatment in patients with multiple myeloma; this policy applies to adult patients and requires prescribing by or in consultation with an oncologist or hematologist.

Definitions

Melphalan — definition and drug class details

Drug classAlkylating agent, bischloroethylamine type

Mechanism of actionBifunctional alkylating agent that is cell cycle–phase nonspecific and exerts cytotoxicity primarily by cross-linking DNA strands

Common uses (per policy)High‑dose conditioning prior to autologous stem cell transplantation and palliative treatment in multiple myeloma

Administration noteIV infusion per dosing guidelines; prophylactic antiemetics recommended