Medical Drug Criteria (MDC)

Policy Num:       P1.001.007
Policy Name:     MONJUVI^® (tafasitamab-cxix)
Policy ID:          [P1.001.007] [Ac /L / M+ / P+ ]

Last Review:      September 22, 2025
Next Review:      September 20, 2026

Related MDC: NONE

MONJUVI^® (tafasitamab-cxix)

Summary

Monjuvi (tafasitamab-cxix) is a CD19-directed cytolytic antibody indicated, in combination with lenalidomide, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
 
Tafasitamab binds to the CD19 antigen on pre-B and mature B lymphocytes, inducing B-cell lysis via apoptosis and immune effector mechanisms including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis.

OBJECTIVE

To provide coverage guidance for the appropriate use of Monjuvi in adult patients with relapsed or refractory DLBCL not eligible for autologous stem cell transplant, ensuring compliance with FDA labeling and NCCN guidelines. 

POLICY STATEMENT

Monjuvi may be considered medically necessary in patients 18 years of age or older for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT), and if the conditions indicated below are met. 
 

POLICY GUIDELINES

Coverage eligibility will be considered when:
 
Patient has relapsed or refractory DLBCL, including DLBCL arising from low-grade lymphoma.
 
Patient is not a candidate for autologous HSCT.
 
Prior therapy included an anti-CD20 antibody (e.g., rituximab).
 
Authorization is for up to 12 months.

DOSAGE/ADMINISTRATION

Administer premedications prior to starting Monjuvi.
 
Recommended dose: 12 mg/kg IV infusion according to schedule:
 
Cycle 1: Days 1, 4, 8, 15, 22 (28-day cycle)
 
Cycles 2–3: Days 1, 8, 15, 22 (28-day cycle)
 
Cycle 4+: Days 1 and 15 (28-day cycle)
 
 
Administer with lenalidomide for a maximum of 12 cycles, then continue Monjuvi monotherapy until disease progression or unacceptable toxicity.

REQUIRED MEDICAL INFORMATION

Initial Therapy

a) Diagnosis of relapsed/refractory DLBCL, including arising from low-grade lymphoma; AND

b) Prescribed by hematologist/oncologist; AND

c) Relapsed or refractory disease confirmed; AND

d) Prior anti-CD20 antibody therapy; AND

e) Use in combination with lenalidomide; AND

f) Not eligible for autologous HSCT; AND

g) No prior allogeneic HSCT.

Renewal Criteria

Patient continues to meet initial criteria, AND

Demonstrated clinical benefit (tumor response or disease stabilization) with acceptable safety profile.

EXCLUSION CRITERIA

None specified.

BENEFIT APPLICATION

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

BACKGOUND

Monjuvi is an Fc-engineered anti-CD19 monoclonal antibody designed to enhance ADCC. FDA approval was based on the L-MIND trial, a multicenter, single-arm phase II study showing durable responses in combination with lenalidomide for relapsed/refractory DLBCL patients not eligible for ASCT.

REGULATORY STATUS

FDA approval: July 31, 2020, under accelerated approval.
 
NCCN Guidelines: Monjuvi + lenalidomide listed as a Category 2A option for relapsed/refractory DLBCL patients ineligible for transplant.

OTHER CRITERIA

1.    Validate that the treatment regimen is following the most up to date NCCN guidelines recommendations

PRACTICE GUIDELINES AND POSITION STATEMENTS

NCCN B-Cell Lymphoma Guidelines (v.2024–2025): Monjuvi + lenalidomide is a recommended option for transplant-ineligible relapsed/refractory DLBCL.

REFERENCES

1. Tafasitamab-cxix. DRUGDEX, IBM Micromedex. Greenwood Village, CO; 2022.
 
 
2. Monjuvi (tafasitamab-cxix) Prescribing Information. MorphoSys US Inc. Boston, MA; 2020.
 
 
3. Salles G, et al. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): Lancet Oncol. 2020;21(7):978-988.
 
 
4. NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. Version 2024.

Codes

Applicable Modifiers

N/A

Policy History