Asset Publisher
Evomela® (melphalan)
Policy Number: VP-0547
(Intravenous)
Last Review Date: 09/05/2024
Date of Origin: 07/01/2020
Dates Reviewed: 07/2020, 07/2021, 09/2021, 07/2022, 07/2023, 09/2024
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization
Conditioning Treatment: Coverage is provided for 6 months and may NOT be renewed.
All Other Indications: Coverage is provided for 6 months and may be renewed.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
- Evomela 50 mg single-dose vial for reconstitution: 10 vials
- Max Units (per dose and over time) [HCPCS Unit]:
- Conditioning Treatment: 250 billable units for 2 doses only prior to ASCT
- All Other Indications: 50 billable units every 14 days for 4 doses, then 50 billable units every 28 days thereafter
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
- Patient is at least 18 years of age; AND
Universal Criteria 1
- Patient does not have a history of serious allergic reactions to melphalan; AND
- Patient must have had an intolerance to melphalan (Alkeran®) IV prior to consideration of Evomela®; AND
Multiple Myeloma (MM) † 1,2,7
- Used as high-dose myeloablative conditioning treatment † Ф; AND
- Patient will receive an autologous stem cell transplant (ASCT); OR
- Used as primary therapy for symptomatic disease in non-transplant candidates ‡; AND
- Used in combination with daratumumab, bortezomib, and prednisone; AND
- Patient is unable to tolerate oral melphalan therapy; OR
- Used for the management of POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome ‡; AND
- Used in combination with dexamethasone; AND
- Patient is unable to tolerate oral melphalan therapy; AND
- Patient is transplant ineligible; OR
- Patient is transplant eligible and used as induction therapy
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1
Coverage can be renewed based upon the following criteria:
- Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe gastrointestinal toxicity (e.g., nausea, vomiting, diarrhea, mucositis), severe hepatotoxicity, severe bone marrow suppression, hypersensitivity reactions, secondary malignancies (e.g., myeloproliferative syndrome, acute leukemia), etc.; AND
Conditioning Treatment
- Coverage cannot be renewed.
All Other Indications
- Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread
- Dosage/Administration 1
Indication |
Dose |
MM – Conditioning Treatment |
Administer 100 mg/m2/day over 30 minutes by intravenous infusion for 2 consecutive days (Day -3 and Day -2) prior to autologous stem cell transplantation (ASCT, Day 0). Note: For patients who weigh more than 130% of their ideal body weight, body surface area should be calculated based on adjusted ideal body weight. |
All Other Indications |
Administer 16 mg/m2 over 15-20 minutes at 2-week intervals for 4 doses, then, after adequate recovery from toxicity, at 4-week intervals.
|
- Billing Code/Availability Information
HCPCS Code:
- J9246 - Injection, melphalan (evomela), 1 mg; 1 billable unit = 1 mg
NDC:
- Evomela 50 mg lyophilized powder in single-dose vial for reconstitution: 72893-0001-xx
- References
- Evomela [package insert]. East Windsor, NJ; Acrotech Biopharma, LLC.; April 2022. Accessed August 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Evomela®. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2024.
- Aljitawi OS, Ganguly S, Abhyankar SH, et al. Phase IIa cross-over study of propylene glycol-free melphalan (LGD-353) and Alkeran in multiple myeloma autologous transplantation. Bone Marrow Transplant. 2014;49(8):1042-1045
- Hari P, Aljitawi OS, Arce-Lara C, et al. A phase IIb, multicenter, open-label, safety, and efficacy study of high-dose, propylene glycol-free melphalan hydrochloride for injection (EVOMELA) for myeloablative conditioning in multiple myeloma patients undergoing autologous transplantation. Biol Blood Marrow Transplant. 2015;21(12):2100-2105.
- Mai EK, Benner A, Bertsch U, et al. Single Versus Tandem High-Dose Melphalan Followed by Autologous Blood Stem Cell Transplantation in Multiple Myeloma: Long-Term Results From the Phase III GMMG-HD2 Trial. Br J Haematol. 2016 Jun;173(5):731-41. doi: 10.1111/bjh.13994.
- Moreau P, Facon T, Attal M, et al. Comparison of 200 mg/m(2) Melphalan and 8 Gy Total Body Irradiation Plus 140 mg/m(2) Melphalan as Conditioning Regimens for Peripheral Blood Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma: Final Analysis of the Intergroupe Francophone Du Myélome 9502 Randomized Trial. Blood. 2002 Feb 1;99(3):731-5. doi: 10.1182/blood.v99.3.731.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Multiple Myeloma Version 4.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2024.
- Li J, Zhang W, Jiao L, Duan MH, Guan HZ, Zhu WG, Tian Z, Zhou DB. Combination of melphalan and dexamethasone for patients with newly diagnosed POEMS syndrome. Blood. 2011 Jun 16;117(24):6445-9. doi: 10.1182/blood-2010-12-328112.
- Dispenzieri A. POEMS Syndrome: 2019 Update on diagnosis, risk-stratification, and management. Am J Hematol 2019;94:812-827. Doi: 10.1002/ajh.25495.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Melphalan: Multiple Myeloma Order Template, MUM76. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed August 2024.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
C90.00 |
Multiple myeloma not having achieved remission |
C90.02 |
Multiple myeloma in relapse |
C90.10 |
Plasma cell leukemia not having achieved remission |
C90.12 |
Plasma cell leukemia in relapse |
C90.20 |
Extramedullary plasmacytoma not having achieved remission |
C90.22 |
Extramedullary plasmacytoma in relapse |
C90.30 |
Solitary plasmacytoma not having achieved remission |
C90.32 |
Solitary plasmacytoma in relapse |
D47.9 |
Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified |
E31.9 |
Polyglandular dysfunction, unspecified |
G62.9 |
Polyneuropathy, unspecified |
G90.9 |
Disorder of the autonomic nervous system, unspecified |
L98.9 |
Disorder of the skin and subcutaneous tissue, unspecified |
Z52.011 |
Autologous donor, stem cells |
Z85.79 |
Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues |
Z94.84 |
Stem cells transplant status |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
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Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |