| Coverage Policy Manual | |
| Policy #: | 2020024 |
| Category: | Pharmacy |
| Initiated: | October 2020 |
| Last Review: | October 2023 |
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| Belantamab mafodotin-blmf (e.g., Blenrep™) | |
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| Description: |
Belantamab mafodotin-blmf is an anti-B cell maturation antigen (BCMA) antibody, conjugated to a microtubule disrupting agent- monomethyl auristatin- via a stable, protease resistant linker. It is first in its class. Belantamabmafodotin is indicated for the treatment of adult patients with relapsed or refractory MM who have received at least 4 prior lines of therapy.
Belantamab mafodotin has a black-box warning regarding ocular toxicity. It states that belantamab mafodotin has caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms, such as blurred vision and dry eyes. Ophthalmic exams are to be performed prior to each dose, and promptly for worsening symptoms.
Due to the risks of ocular toxicity, belantamab mafodotin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the BLENREP REMS.
Regulatory Status
On August 5, 2020 the FDA granted accelerated approval to belantamab mafodotin-blmf for 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.
On November 22, 2022, GSK announced the market withdrawal of Belantamab mafodotin-blmf (e.g., Blenrep) following the request of the FDA. The request was based on the previously announced outcome of the DREAMM-3 phase III confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulation. As part of GSK’s efforts to ensure physicians and patients are supported during this important time, patients already enrolled in the Blenrep Risk Evaluation and Mitigation Strategy (REMS) program will have the option to enroll in a compassionate use program to continue to access treatment.
Coding
See CPT/HCPCS Code section below.
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Policy/ Coverage: |
Effective August 1, 2021, for members of plans that utilize an oncology benefits management program, Prior Approval is required for this service and is managed through the oncology benefits management program.
The initial use of this drug requires documentation of direct physician involvement and signature in the ordering and evaluation as documented in the medical records. Concurrent review will require continued evidence of appropriate physician involvement.
Effective January 1, 2023
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Belantamab mafodotin-blmf does not meet member benefit certificate primary coverage criteria that there be scientific evidence in improving health outcomes.
For members with contracts without primary coverage criteria, belantamab-mafodotin-blmf is considered investigational.
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective October 2022 to December 31, 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of belantamab mafodotin -blmf meets primary coverage criteria in adults with relapsed or refractory multiple myeloma who meet ALL the following criteria (NCCN 2A):
The use of this drug is covered if a FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Dosage and Administration
The recommended dosage of belantamab-mafodotin-blmf is 2.5 mg/kg of actual body weight IV over approximately 30 minutes once every 3 weeks until disease progression or unacceptable toxicity.
See FDA labeling for dosage modifications for corneal adverse reactions and other adverse reactions.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Belantamab mafodotin-blmf does not meet member benefit certificate primary coverage criteria for any other indication.
For members with contracts without primary coverage criteria, belantamab-mafodotin-blmf is considered investigational for any other indication.
Investigational services are specific contract exclusions in most member benefit certificates of coverage
Effective November 1, 2021 to September 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of belantamab mafodotin -blmf (Blenrep™), meets primary coverage criteria in adults with relapsed or refractory multiple myeloma who meet all the following criteria (NCCN 2A):
4. Must perform an ophthalmic exam prior to initiation of belantamab and prior to each dose of belantamab
5. Have an ECOG status of 0-2.
The use of this drug is covered if a FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Dosage and Administration
The recommended dosage of belantamab-mafodotin-blmf (Blenrep™) is 2.5 mg/kg of actual body weight IV over approximately 30 minutes once every 3 weeks until disease progression or unacceptable toxicity.
See FDA labeling for dosage modifications for corneal adverse reactions and other adverse reactions.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Belantamab mafodotin-blmf (Blenrep) does not meet member benefit certificate primary coverage criteria for any other indication.
For members with contracts without primary coverage criteria, belantamab-mafodotin-blmf (Blenrep™) is considered investigational for any other indication.
Investigational services are specific contract exclusions in most member benefit certificates of coverage
Effective October 2020 to October 31, 2021
Policy/Coverage
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of belantamab mafodotin -blmf (Blenrep™), meets primary coverage criteria in adults with relapsed or refractory multiple myeloma who have received at least 4 lines of therapy who meet all the following criteria:
4. Must perform an ophthalmic exam prior to initiation of belantamab and prior to each dose of belantamab
5. Have an ECOG status of 0-2.
NCCN 1, 2A and 2B recommendations are covered in accordance with Coverage Policy #2000030
Dosage and Administration
The recommended dosage of belantamab-mafodotin-blmf (Blenrep™) is 2.5 mg/kg of actual body weight IV over approximately 30 minutes once every 3 weeks until disease progression or unacceptable toxicity.
See FDA labeling for dosage modifications for corneal adverse reactions and other adverse reactions.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Belantamab mafodotin-blmf (Blenrep) does not meet member benefit certificate primary coverage criteria for any other indication.
For members with contracts without primary coverage criteria, belantamab-mafodotin-blmf (Blenrep™)
is considered investigational for any other indication.
Investigational services are specific contract exclusions in most member benefit certificates of coverage
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| Rationale: |
The efficacy and safety of belantamab mafodotin-blmf (Blenrep) was evaluated in a randomized, open-label, multicenter phase 2 clinical trial of 196 patients with relapsed and refractory multiple myeloma with disease progression after three or more lines of therapy and were refractory to immunomodulatory drugs and proteasome inhibitors, and refractory or intolerant (or both) to an anti-CD38 monoclonal antibody (DREAMM-2 trial; NCT03525678). Patients were excluded from the trial with corneal epithelial disease at baseline, except mild punctate keratopathy. They received either belantamab mafodotin 2.5 mg/kg (n=97) or 3.4 mg/kg (n=99) intravenously once every 3 weeks until disease progression or unacceptable toxicity. The primary outcome was overall response rate, which was 31% (30/97; 97.5% CI 20.8-42.6) in the 2.5 mg/kg cohort and 34% (34/99; CI 23.9-46.0) in the 3.4 mg/kg cohort. The most common grade 3-4 adverse events in the safety population were keratopathy in 26 (27%) of 95 patients in the 2.5 mg/kg cohort and 21 (21%) of 99 patients in the 3.4 mg/kg cohort. Two deaths were potentially related, one case of sepsis in the 2.5 mg/kg cohort and one case of hemophagocytic lymphohistiocytosis in the 3.4 mg/kg cohort.
In this study, single agent belantamab mafodotin resulted in clinically meaningful activity in patients with relapsed or refractory multiple myeloma. The median duration of response was not reached but duration of follow-up was short. The median progression-free survival was 2.9 months in the 2.5 mg/kg cohort and 4.9 months in the 3.4 mg/kg cohort. The most common reason for treatment discontinuation was keratopathy.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement.
October 2022 Update
On the basis of the DREAMM-2 study single-agent belantamab mafodotin (belamaf) was approved for patients with relapsed or refractory multiple myeloma (RRMM) who received ≥4 prior therapies, including anti-CD38 therapy. The authors investigated longer term efficacy and safety outcomes in DREAMM-2 after 13 months of follow-up among patients who received belamaf 2.5 mg/kg.
DREAMM-2 is an ongoing, phase 2, open-label, 2-arm study investigating belamaf (2.5 or 3.4 mg/kg) in patients with RRMM who had disease progression after ≥3 lines of therapy and were refractory to immunomodulatory drugs and proteasome inhibitors and refractory and/or intolerant to an anti-CD38 therapy. The primary outcome was the proportion of patients that achieved an overall response, assessed by an independent review committee.
As of January 31, 2020, 10% of patients still received belamaf 2.5 mg/kg. Thirty-one of 97 patients (32%; 97.5% confidence interval [CI], 21.7%-43.6%) achieved an overall response, and 18 responders achieved a very good partial response or better. Median estimated duration of response, overall survival, and progression-free survival were 11.0 months (95% CI, 4.2 months to not reached), 13.7 months (95% CI, 9.9 months to not reached), and 2.8 months (95% CI, 1.6-3.6 months), respectively. Response and survival outcomes in patients who had high-risk cytogenetics or renal impairment were consistent with outcomes in the overall population. Outcomes were poorer in patients with extramedullary disease. In patients who had a clinical response and prolonged dose delays (>63 days; mainly because of corneal events), 88% maintained or deepened responses during their first prolonged dose delay. Overall, there were no new safety signals during this follow-up.
Extended follow-up confirms sustained clinical activity without new safety signals with belamaf in this heavily pretreated patient population with RRMM. (Lonial S, Lee HC, Badros A, et.al., 2021)
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2023. No new literature was identified that would prompt a change in the coverage statement.
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| CPT/HCPCS: | |
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| References: |
Belantamab mafodotin. In Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.: 2020. URL: http://www.clinicalpharmacology.com. Updated periodically. Subscription required to view. BLENREP [package insert]. Brentford, Middlesex, UK: GlaxoSmithKline, 2020 Food and Drug Administration.(2020) FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-granted-accelerated-approval-belantamab-mafodotin-blmf-multiple-myeloma. Last accesses 10/20/2020. Lonial S, Lee HC, Badros A, et al.(2020) Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019 Dec 16. DOI: 10.1016/S1470-2045(19)30788-0 Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Sborov D, Suvannasankha A, Weisel K, Voorhees PM, Womersley L, Baron J, Piontek T, Lewis E, Opalinska J, Gupta I, Cohen AD.(2021) Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study. Cancer. 2021 Nov 15;127(22):4198-4212. doi: 10.1002/cncr.33809. Epub 2021 Jul 27. PMID: 34314018; PMCID: PMC8597112. |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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