Medical Drug Criteria (MDC)

Policy Num:       P1.001.007
Policy Name:     MONJUVI^® (tafasitamab-cxix)
Policy ID:          [P1.001.007][Ac /L / M+ / P+ ][0.00.00]

Last Review:      September 17, 2024
Next Review:      September 20, 2025

Related MDC: NONE

MONJUVI^® (tafasitamab-cxix)

Summary

Monjuvi 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 works by binding to the CD19 antigen expressed on the surface of pre-B and mature B lymphocytes causing B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis

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 for tafasitamab-cxix (Monjuvi) will be considered when the following criteria are met:

• Authorization of 12 months may be granted for treatment 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), including at least failure to the following category
  • Anti-CD20 antibody (e.g., rituximab)

DOSAGE/ADMINISTRATION

• Administer premedications prior to starting MONJUVI. 

• The recommended dosage of MONJUVI is 12 mg/kg as an intravenous infusion according to the following dosing schedule: 

• Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle.

• Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle.

• Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle.

• Administer MONJUVI in combination with lenalidomide for a maximum of 12 cycles and then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity.

REQUIRED MEDICAL INFORMATION

Initial Therapy

a)   The patient has a diagnosis of DLBCL, including DLBCL arising from low grade lymphoma; AND
b)   Prescribed by an oncologist or hematologist; AND 
c)   The patient has relapsed or refractory disease; AND
d)   Previous therapy included an anti-CD20 antibody; AND 
e)   Tafasitamab is administered in combination with lenalidomide; AND 
f)    The patient is not a candidate for autologous hematopoietic stem cell transplantation (HSCT); AND  
g)   The patient has not previously undergone allogeneic HSCT 

Renewal Approval Criteria 

a)   The patient is currently receiving tafasitamab-cxix and continues to meet initial criteria; AND  
b)    The patient has continued clinical benefit on tafasitamab-cxix therapy as demonstrated by tumor response or lack of disease progression, and an acceptable toxicity profile.

EXCLUSION CRITERIA

None

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.

OTHER CRITERIA

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

Population Reference No. 1 Policy Statement

REFERENCES

1.    Tafasitamab-cxix. In: DRUGDEX [database on the Internet]. Greenwood Village (CO): IBM Corporation; 2022 [cited 2023 August 7]. Available from: www.micromedexsolutions.com. Subscription required to view.
2.    MONJUVI(R) intravenous injection, tafasitamab-cxix intravenous injection. MorphoSys US Inc (per FDA), Boston, MA, 2020.
 

Codes

Applicable Modifiers

N/A

Policy History

Payment Policy Guidelines

Economic Impact

Interqual Criteria

Policy Categorization