Commercial

Belantamab mafodotin-blmf (Blenrep)
08.01.70b

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

Belantamab mafodotin-blmf (Blenrep)​ is considered medically necessary and, therefore, covered for the treatment of adults with progressive, relapsed, or refractory multiple myeloma when all of the following criteria are met: 
  • ​The individual has received at least 4 prior therapies, including an anti-CD38 monoclonal antibody1, a proteasome inhibitor2, and an immunomodulatory agent3
  • ​The individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
​1 Examples of anti-CD38 monoclonal antibodies include daratumumab (Darzalex®), daratumumab-hyaluronidase-fihj (Darzalex Faspro™) and isatuximab-irfc (Sarclisa®)
2 Examples of proteasome inhibitors (PI) include bortezomib (Velcade®), carfilzomib (Kyprolis®), and ixazomib (Ninlaro®)
3 Examples of immunomodulary agents include lenalidomide (Revlimid®), pomalidomide (Pomalyst®), and thalidomide (Thalomid®)

​EXPERIMENTAL/INVESTIGATIONA
L

All other uses for belantamab mafodotin-blmf (Blenrep)​ are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.


REQUIRED DOCUMENTATION


The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home ​health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.


Guidelines

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS
 
The ECOG has developed the ECOG Performance Status; it was originally published in 1982 in the American Journal of Clinical Oncology*. ECOG states, "These scales and criteria are used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. They are included here for health care professionals to access."
G​RADE
​ECOG 
​0​
Fully active, able to carry on all pre-disease performance without restriction
​1
​Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
​2
Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
​3
Capable of only limited self care, confined to bed or chair more than 50 percent of waking hours
​4
Completely disabled. Cannot carry on any self care: Totally confined to bed or chair
​5
​​Dead
*Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655. ​

BENEFIT APPLICATION


Subject to the terms and conditions of the applicable benefit contract, belantamab mafodotin-blmf (Blenrep) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.


US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Belantamab mafodotin-blmf (Blenrep)​ was approved by the US Food and Drug Administration (FDA) on August 5, 2020 for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

The safety and effectiveness in pediatric individuals have not been established.​


Description

Multiple myeloma is a cancer that is created from plasma cells with abnormal genetic variations. Normally, plasma cells grow and divide to make new cells; once cells grown old or get managed, they die. In contrast, myeloma cells replicate throughout the bone marrow, destroy the bone tissue, and crowd-out normal blood cells in the bone marrow as they grow. The antibodies synthesized by myeloma cells do not fight infections like normal antibodies do. Common signs and symptoms include anemia, bone pain, kidney damage due to elevated creatinine or serum protein, infection, fatigue, and hypercalcemia.

Like many types of malignancies, further treatment of multiple myeloma after relapsed, progressive, or refractory disease usually yields a shorter duration and lower quality of response compared to the initial response. There is a high demand for agents that treat multiple myeloma that does not respond or that progresses after first- or subsequent-line therapy.

Belantamab mafodotin-blmf (Blenrep)​ was approved by the US Food and Drug Administration (FDA) on August 5, 2020 for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

Belantamab mafodotin-blmf (Blenrep)​ is an anti-BCMA antibody-drug conjugate (ADC) and microtubule inhibitor conjugate that targets B-cell maturation antigen (BCMA), a protein expressed on normal B lymphocytes and multiple myeloma cells.​​ Upon binding to BCMA, belantamab mafodotin-blmf (Blenrep)​​ is internalized and monomethyl auristatin F (MMAF) is released via proteolytic cleavage which causes disruption in the microtubule network and eventually cell cycle arrest and apoptosis. In addition to MMAF-induced apoptosis, belantamab mafodotin-blmf (Blenrep)​​ causes tumor cell lysis through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellula phagocytosis (ADCP).​ The recommended dosage of belantamab mafodotin-blmf (Blenrep) is 2.5 mg/kg of actual body weight given as an intravenous infusion over approximately 30 minutes once every 3 weeks until disease progression or unacceptable toxicity. 

RISK EVALUATION AND MITIGATION STRATEGY (REMS) PROG​​​​RAM


The FDA initiated a Risk Evaluation and Mitigation Strategy (REMS) program due to the risk of ocular toxicity associated with the use of belantamab mafodotin-blmf (Blenrep)​​. This program informs professional providers, individuals receiving this drug, healthcare settings, and wholesalers-distributors about the potential risk and outlines processes to ensure the safety of the individuals receiving this drug. Measures include enrollment/certification into the program, counseling, baseline and follow-up ophthalmic examinations, preservative-free lubricant eye drop use, etc.


PEER-REVIEWED LITERATURE

SUMMARY 
The safety and effectiveness of belantamab mafodotin-blmf (Blenrep) was evaluated in DREAMM-2, a Phase 2, open-label, randomized, multicenter, two-arm study. Adult participants had relapsed or refractory multiple myeloma with disease progression after three or more prior therapies, including an anti-CD38 monoclonal antibody, an immunomodulatory agent, and a proteasome inhibitor (median number of prior lines of therapy was 7, range: 3 to 21). Additionally, they had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.​ Participants ​received either belantamab mafodotin-blmf (Blenrep) 2.5 mg/kg or 3.4 mg/kg intravenously once every 3 weeks until disease progression or unacceptable toxicity (median 3 doses, range 1 to 11). With the focus of this summary on those who re​ceived the FDA-approved dose of 2.5 mg/kg, the major efficacy outcome measure of overall response rate was 31% (30 of 97 participants). ​Ocular adverse reactions occurred in 77% of participants, resulting in a Black Box Warning in the prescrbing information and the development of a Risk Evaluation and Mitigation Strategy (REMS) program to ensure appropriate and safe use.​ 

OFF-LABEL INDICATION

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.​

References

Belantamab mafodotin-blmf (Blenrep). [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline​; 08/2020Available at: https://www.blenrep.com/​. Accessed August 18, 2020. 

Eastern Cooperative Oncology Group (ECOG). ECOG performance status. 2020. Available at: http://ecog-acrin.org/resources/ecog-performance-status. Accessed August 21, 2020. 

Elsevier’s Clinical Pharmacology Compendium. belantamab mafodotin-blmf (Blenrep)​. 08/11/2020. [Clinical Key Web site]. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed August 19, 2020.

Laubach JP. Multiple myeloma: Clinical features, laboratory manifestations, and diagnosis. [UpToDate Web Site]. Updated 08/13/2020. Available at: http://www.uptodate.com/home [via subscription only]. Accessed August 21, 2020. ​

Lexi-Drugs Compendium. belantamab mafodotin-blmf (Blenrep)​. 08/18/2020.​ [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed August 19, 2020.

Lonial S, Lee HC, Badros A, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomized, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221.​

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. belantamab mafodotin-blmf (Blenrep)​. [NCCN Web site]. 2020. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed August 27, 2020.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Multiple Myeloma. V.1.2021. 08/24/2020. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf [via free subscription]. Accessed August 27, 2020.

National Comprehensive Cancer Network (NCCN). NCCN Guidelines for Patients - Multiple Myeloma. 2019. [NCCN Web site]. Available at: https://www.nccn.org/patients/guidelines/content/PDF/myeloma-patient.pdf [via free subscription]. Accessed August 19, 2020.

Rajkumar SV. Multiple myeloma: Treatment of relapsed or refractory disease. [UpToDate Web site]. 08/10/2020. Available at: http://www.uptodate.com/contents/treatment-of-relapsed-or-refractory-multiple-myeloma?source=search_result&search=daratumumab&selectedTitle=4~10. Accessed August 21, 2020. ​

Risk Evaluation and Mitigation Strategy (REMS) Program. Blenrep REMS. 08/05/2020. Available at: https://www.accessdata.fda.gov/Scripts/Cder/Rems/index.cfm​ . Accessed August 21, 2020. 

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. belantamab mafodotin-blmf (Blenrep)​ prescribing information and approval letter [FDA Web site]. 08/05/2020. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed August 6, 2020.


Coding

CPT Procedure Code Number(s)
N/A

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)
C90.00 Multiple myeloma not having achieved remission

C90.01 Multiple myeloma in remission

C90.02 Multiple myeloma in relapse

HCPCS Level II Code Number(s)
            
J9037 Injection, belantamab mafodontin-blmf, 0.5 mg

Revenue Code Number(s)
N/A




Coding and Billing Requirements



Policy History

4/1/2021
4/5/2021
5/5/2021
08.01.70
Medical Policy Bulletin
Commercial
No