Description
Tafasitamab-cxix (Monjuvi®) is a humanized CD19-directed cytolytic monoclonal antibody that contains an IgG1/2 hybrid Fc domain with 2 amino acid substitutions to modify the Fc-mediated functions of the antibody. Tafasitamab-cxix (Monjuvi) binds to CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies. Upon binding to CD19, tafasitamab-cxix (Monjuvi) mediates B-cell lysis through apoptosis and immune effect or mechanisms, including antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Food and Drug Administration Indications
Tafasitamab-cxix (Monjuvi) may be considered medically necessary when the following criteria are met:
- Individual is 18 years of age or older; and
- Treatment of individuals with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma; and
- Given in combination with lenalidomide; or
National Comprehensive Cancer Network Recommendations
- Used in combination with lenalidomide for treatment of histologic transformation to diffuse large B-cell lymphoma (DLBCL) without translocations of MYC and BCL2 and/or BCL6 in individuals who are not candidates for transplant and have received:
- Minimal or no chemoimmunotherapy prior to histologic transformation to DLBCL and have no response or progressive disease after chemoimmunotherapy (anthracycline- or anthracenedione-based regimens preferred unless contraindicated); or
- Multiple prior therapies including greater than or equal to 2 lines of chemoimmunotherapy for indolent or transformed disease; or
- Second-line and subsequent therapy in combination with lenalidomide for partial response, no response, relapsed, progressive, or refractory diffuse large B-cell lymphoma in non-candidates for transplant; or
- Used in combination with lenalidomide in individuals with histologic transformation of nodal marginal zone lymphoma to DLBCL who are not candidates for transplant and have received:
- Minimal or no chemoimmunotherapy prior to histologic transformation to diffuse large B-cell lymphoma and have no response or progressive disease after chemoimmunotherapy (anthracycline- or anthracenedione-based regimens preferred unless contraindicated); or
- Multiple prior therapies including greater than or equal to 2 lines of chemoimmunotherapy for indolent or transformed disease.
Tafasitamab-cxix (Monjuvi) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence does not support its use for any other indication.
Procedure Codes
Outpatient HCPCS (C Codes)
Diagnosis Codes
C83.30
|
C83.31
|
C83.32
|
C83.33
|
C83.34
|
C83.35
|
C83.36
|
C83.37
|
C83.38
|
C83.39
|
C85.20
|
C85.21
|
C85.22
|
C85.23
|
C85.24
|
C85.25
|
C85.26
|
C85.27
|
C85.28
|
C85.29
|
|
Professional Statements and Societal Positions Guidelines
Not Applicable
ND Committee Review
Internal Medical Policy Committee 9-21-2020 Adopted policy effective 9-15-2020
Links
References (PDF)
Disclaimer
Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.