Tafasitamab-cxix (Monjuvi) (ARCHIVED)

Policy ID: I-226-006

Section: Injections

Effective Date: September 15, 2020

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-226-006

Section: Injections

Effective Date: September 15, 2020

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Tafasitamab-cxix (Monjuvi ^® ) is a humanized CD19-directed cytolytic monoclonal antibody that contains an IgG 1/2 hybrid Fc domain with two (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.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

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.

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

Compendia Sources

Tafasitamab-cxix (Monjuvi) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of tafasitamab-cxix (Monjuvi) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9349

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C82.00

C82.01

C82.02

C82.03

C82.04

C82.05

C82.06

C82.07

C82.08

C82.09

C82.10

C82.11

C82.12

C82.13

C82.14

C82.15

C82.16

C82.17

C82.18

C82.19

C82.20

C82.21

C82.22

C82.23

C82.24

C82.25

C82.26

C82.27

C82.28

C82.29

C82.30

C82.31

C82.32

C82.33

C82.34

C82.35

C82.36

C82.37

C82.38

C82.39

C82.40

C82.41

C82.42

C82.43

C82.44

C82.45

C82.46

C82.47

C82.48

C82.49

C82.50

C82.51

C82.52

C82.53

C82.54

C82.55

C82.56

C82.57

C82.58

C82.59

C82.60

C82.61

C82.62

C82.63

C82.64

C82.65

C82.66

C82.67

C82.68

C82.69

C82.80

C82.81

C82.82

C82.83

C82.84

C82.85

C82.86

C82.87

C82.88

C82.89

C82.90

C82.91

C82.92

C82.93

C82.94

C82.95

C82.96

C82.97

C82.98

C82.99

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 3-17-2021

Adopted policy was previously policy number I-171 (same title)

Internal Medical Policy Committee 3-23-2022 Annual Review, no changes in criteria

Internal Medical Policy Committee 3-23-2023 Annual review, no clinical content change

Internal Medical Policy Committee 7-26-2023 - Effective September 01, 2023

Removed NCCN Recommendations
Added Compendia sources statement 'Drug may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'
Added additional diagnosis codes
Updated experimental/investigational statement

Internal Medical Policy Committee 7-16-2024 Effective September 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

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.

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