Coverage Policy Manual
Policy #: 2021005
Category: Pharmacy
Initiated: May 2021
Last Review: January 2025
  Tafasitamab-cxix (e.g., Monjuvi)
Description:
Tafasitamab-cxix is an Fc-modified monoclonal antibody that binds to CD19 antigens expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL). Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). (Monjuvi, 2020)
 
Regulatory Status
 
Tafasitamab-cxix (e.g., Monjuvi) was approved by the U.S. Food and Drug Administration (FDA) on July 31, 2020, in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
 
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
 
Coding
 
See CPT/HCPCS Code section below.
 
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.
 
Effective June 1, 2023, Prior Approval is required for Tafasitamib-crix (e.g., Monjuvi).
 
The Step Therapy Medication Act is applicable to fully insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.
 
Effective January 15, 2025
 
Meets Primary Coverage Criteria or Is Covered for Contracts Without Primary Coverage Criteria
 
FDA Labeled Indications:
 
For FDA labeled indications, all products must be dosed in accordance with the FDA label unless otherwise specified.
 
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
Tafasitamab-cxix (e.g., Monjuvi) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when the following criteria are met:
 
    1. Individual has a diagnosis of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma (Monjuvi, 2021); AND
    2. Individual is 18 years of age or older (Monjuvi, 2021); AND
    3. Individual is not eligible for autologous stem cell transplant (ASCT);
 
CONTINUED APPROVAL for up to 1 year:
    1. Individual has met initial criteria above; AND
    2. Documentation indicating disease response to treatment, such as stabilization of disease, decrease in size of tumor(s) or tumor spread; AND
    3. Absence of unacceptable toxicity from the drug, including myelosuppression, infections, and anaphylactic reactions.
 
Off-label Indications:
 
For off-label indications, authorizations will not exceed 12 mg/kg unless medical literature supports a higher dose.
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
1. Second line and subsequent therapy in combination with lenalidomide (NCCN 2A):
a. Relapsed or refractory disease < 12 months after completion of first-line therapy in non-candidates for CAR- T cell therapy; OR
b. Relapsed disease > 12 months after completion of first-line therapy is no intention to proceed to transplant; OR
c. Alternative systemic therapy (if not previously used) for relapsed/refractory disease; OR
2. In combination with lenalidomide if previously treated with an anthracycline-based regimen and no intention to proceed to transplant (NCCN 2A):
a.  As additional therapy for partial response, no response, progressive, or relapsed disease following chemoimmunotherapy for histologic transformation after minimal or no prior therapy; OR
b. For histologic transformation after multiple lines of prior therapies including ≥ 2 chemoimmunotherapy regimens for indolent disease prior to histologic transformation; OR
3. Second line and subsequent therapy in combination with lenalidomide (NCCN 2A):
a. Relapsed disease < 12 months after completion of first-line therapy (excluding primary refractory disease) in non-candidates for CAR-T cell therapy; OR
b. Relapsed disease > 12 months after completion of first-line therapy if no intention to proceed to transplant; OR
c. As alternative systemic therapy (if not previously used) for relapsed/refractory disease; OR
4. Second line and subsequent therapy in combination with lenalidomide for HIV-related diffuse large B-cell lymphoma, primary effusion lymphoma, and HHV8+ diffuse large B-cell lymphoma, not otherwise specified, or for HIV-related plasmablastic lymphoma (NCCN 2A):
a. Relapsed disease < 12 months after completion of first-line therapy (excluding primary refractory disease) in non-candidates for CAR T-cell therapy; OR
b. Relapsed disease > 12 months after completion of first-line therapy if no intention to proceed to transplant; OR
c. Alternative systemic therapy (if not previously used) for relapsed/refractory disease; OR
5. Second line and subsequent in combination with lenalidomide for monomorphic PTLD (B-cell type) (NCCN 2A):
a. Relapsed disease < 12 months after completion of initial treatment with chemoimmunotherapy (excluding primary refractory disease) in non-candidates for CAR T-cell therapy; OR
b. Relapsed disease > 12 months after completion of initial treatment with chemoimmunotherapy if no intention to proceed to transplant; OR
c. Alternative systemic therapy (if not previously used) for relapsed/refractory disease.
 
CONTINUED APPROVAL for up to 1 year:
    1. Met initial criteria for the medication; AND
    2. Documentation indicating disease response to treatment, such as stabilization of disease, decrease in size of tumor(s) or tumor spread; AND
    3. Absence of unacceptable toxicity from the drug, including myelosuppression, infections, and anaphylactic reactions.
 
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
Dosing per FDA Guidelines where applicable. For off-label indications, authorizations will not exceed 12 mg/kg unless medical literature supports a higher dose.
 
The recommended dosage of tafasitamab-cxix 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.
 
Tafasitamab-cxix is recommended to be administered in combination with lenalidomide 25 mg for a maximum of 12 cycles, then continued as monotherapy until disease progression or unacceptable toxicity.
 
Tafasitamab-cxix is available as lyophilized powder in single dose 200mg vial for reconstitution.
 
Tafasitamab-cxix should be administered as an intravenous infusion by a healthcare professional immediate access to emergency equipment and appropriate medical support to manage infusion-related 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
 
Tafasitamab-cxix, for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, tafasitamab-cxix for any indication or circumstance not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective November 2023 through January 14, 2025
 
Meets Primary Coverage Criteria or Is Covered for Contracts Without Primary Coverage Criteria
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
The use of tafasitamab-cxix meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of adults 18 years of age or older (FDA, Monjuvi, 2020) with B-cell lymphoma:
 
1. Preferred in combination with lenalidomide if previously treated with an anthracycline-based regimen and no intention to proceed to transplant (NCCN 2A)
a. As second-line therapy for partial response, no response, or progressive disease following chemoimmunotherapy if histologic transformation to diffuse large B-cell lymphoma after minimal or no prior treatment.
b. After multiple lines of chemoimmunotherapy for indolent or transformed disease.
 
2. Second line and subsequent in combination with lenalidomide for monomorphic PTLD (B-cell type) if no intention to proceed to transplant (NCCN 2A)
a. For relapsed or refractory disease >12 months after completion of initial treatment with chemoimmunotherapy
b. For primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of initial treatment with chemoimmunotherapy if no intention to proceed to CAR T-cell therapy.
c. As alternative systemic therapy (if not previously used) for relapsed/refractory disease if no intention to proceed to CAR T-cell therapy.
 
3. Second line and subsequent therapy in combination with lenalidomide if no intention to proceed to transplant for (NCCN 2A)
a. Relapsed or refractory disease >12 months after completion of first-line therapy
b. Primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of first-line therapy if no intention to proceed to CAR T-cell therapy.
c. Alternative systemic therapy (if not previously used) for relapsed/refractory disease if no intention to proceed to CAR T-cell therapy.
 
4. Second line and subsequent therapy in combination with lenalidomide for HIV-related diffuse large B-cell lymphoma, primary effusion lymphoma, and HHV8+ diffuse large B-cell lymphoma, not otherwise specified, or for HIV-related plasmablastic lymphoma if no intention to proceed to transplant for NCCN 2A)
a. Relapsed or refractory disease >12 months after completion of first-line therapy
b. Primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of first-line therapy if no intention to proceed to CAR T-cell therapy.
c. Alternative systemic therapy (if not previously used) for relapsed/refractory disease if no intention to proceed to CAR T-cell therapy.
 
5. Preferred second line and subsequent therapy in combination with lenalidomide if no intention to proceed to transplant for (NCCN 2A)
a. Relapsed or refractory disease >12 months after completion of first-line therapy
b. Primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of first-line therapy if no intention to proceed to CAR T-cell therapy.
c. Alternative systemic therapy (if not previously used) for relapsed/refractory disease if no intention to proceed to CAR T-cell therapy.
 
6. Used in combination with lenalidomide as second line and subsequent therapy (if not previously given) for no response, relapsed, or progressive disease in patients with indications for treatment (NCCN 2A)
 
7. Must be dosed in accordance with the FDA label.
 
CONTINUED APPROVAL for up to 1 year:
 
1. Met initial criteria for the medication; AND
2. Documentation indicating disease response to treatment, such as stabilization of disease, decrease in size of tumor(s) or tumor spread; AND
3. Absence of unacceptable toxicity from the drug, including myelosuppression, infections, and anaphylactic reactions.
 
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
Dosing per FDA Guidelines
 
The recommended dosage of tafasitamab-cxix 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.
 
Tafasitamab-cxix is recommended to be administered in combination with lenalidomide 25 mg for a maximum of 12 cycles, then continued as monotherapy until disease progression or unacceptable toxicity.
 
Tafasitamab-cxix is available as lyophilized powder in single dose 200mg vial for reconstitution.
 
Tafasitamab-cxix should be administered as an intravenous infusion by a healthcare professional immediate access to emergency equipment and appropriate medical support to manage infusion-related 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
 
Tafasitamab-cxix, for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, the use of tafasitamab-cxix for any indication or circumstance not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective February 15, 2023 - October 31, 2023
 
Meets Primary Coverage Criteria or Is Covered for Contracts Without Primary Coverage Criteria
 
The use of tafasitamab-cxix meets member benefit certificate primary coverage criteria for the treatment of adults 18 years of age or older (FDA, Monjuvi, 2020) with B-cell lymphoma:
 
    1. Preferred in combination with lenalidomide if previously treated with an anthracycline-based regimen and no intention to proceed to transplant (NCCN 2A)
a. As second-line therapy for partial response, no response, or progressive disease following chemoimmunotherapy if histologic transformation to diffuse large B-cell lymphoma after minimal or no prior treatment.
b. After multiple lines of chemoimmunotherapy for indolent or transformed disease.
2. Second-line and subsequent in combination with lenalidomide for monomorphic PTLD (B-cell type) if no intention to proceed to transplant (NCCN 2A)
a. For relapsed or refractory disease >12 months after completion of initial treatment with chemoimmunotherapy
b. For primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of initial treatment with chemoimmunotherapy if no intention to proceed to CAR T-cell therapy
c. As alternative systemic therapy (if not previously used) for relapsed/refractory disease if no intention to proceed to CAR T-cell therapy
3. Second-line and subsequent therapy in combination with lenalidomide if no intention to proceed to transplant for (NCCN 2A)
a. Relapsed or refractory disease >12 months after completion of first-line therapy
b. Primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of first-line therapy if no intention to proceed to CAR T-cell therapy
c. Alternative systemic therapy (if not previously used) for relapsed/refractory disease if no intention to proceed to CAR T-cell therapy
4. Second-line and subsequent therapy in combination with lenalidomide for HIV-related diffuse large B-cell lymphoma, primary effusion lymphoma, and HHV8+ diffuse large B-cell lymphoma, not otherwise specified, or for HIV-related plasmablastic lymphoma if no intention to proceed to transplant for NCCN 2A)
a. Relapsed or refractory disease >12 months after completion of first-line therapy
b. Primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of first-line therapy if no intention to proceed to CAR T-cell therapy
c. Alternative systemic therapy (if not previously used) for relapsed/refractory disease if no intention to proceed to CAR T-cell therapy
5. Preferred second line and subsequent therapy in combination with lenalidomide if no intention to proceed to transplant for (NCCN 2A)
a. Relapsed or refractory disease >12 months after completion of first-line therapy
b. Primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of first-line therapy if no intention to proceed to CAR T-cell therapy
c. Alternative systemic therapy (if not previously used) for relapsed/refractory disease if no intention to proceed to CAR T-cell therapy
6. Used in combination with lenalidomide as second line and subsequent therapy (if not previously given) for no response, relapsed, or progressive disease in patients with indications for treatment (NCCN 2A)
7. Must be dosed in accordance with the FDA label.
 
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
Dosing per FDA Guidelines
 
The recommended dosage of Tasasitamab-cxix 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.
 
Tafasitamab-cxix is recommended to be administered in combination with lenalidomide 25 mg for a maximum of 12 cycles, then continued as monotherapy until disease progression or unacceptable toxicity.
 
Tafasitamab-cxix is available as lyophilized powder in single dose 200mg vial for reconstitution.
 
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
 
Tafasitamab-cxix, for any indication not listed above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, the use of tafasitamab-cxix for any indication not listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective February 7, 2022 to February 14, 2023
 
Meets Primary Coverage Criteria or Is Covered for Contracts Without Primary Coverage Criteria
 
The use of tafasitamab-cxix meets member benefit certificate primary coverage criteria for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma when ALL of the following criteria are met:
        1. Member is diagnosed with relapsed or refractory diffuse large B-cell lymphoma (FDA, Monjuvi, 2020; NCCN 2A) AND  ⬚  
        2. Member is 18 years of age or older (FDA, Monjuvi, 2020) AND
        3. Member is not eligible for high dose chemotherapy with autologous stem-cell transplantation (NCCN 2A) AND
        4. Member has received at least 1 previous systemic therapy for the treatment of DLBCL (NCCN 2A) AND
            1. One therapy must have included a CD20-targeted therapy (Salles, 2020) AND
            2. One therapy must have included an anthracycline (NCCN 2A) AND
        5. Member has declined or is not a candidate for CAR-T treatment.
 
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
    • 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.
 
Tafasitamab-cxix is recommended to be administered in combination with lenalidomide 25 mg for a maximum of 12 cycles, then continued as monotherapy until disease progression or unacceptable toxicity.
 
Tafasitamab-cxix is available as lyophilized powder in single dose 200mg vial for reconstitution.
 
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
 
Tafasitamab-cxix, for any indication not listed above, does not meet member benefit certificate primary coverage criteria.
 
For members with contracts without primary coverage criteria, the use of tafasitamab-cxix for any indication not listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective January 01, 2022 to February 6, 2022
 
Meets Primary Coverage Criteria or Is Covered for Contracts Without Primary Coverage Criteria
 
The use of tafasitamab-cxix meets member benefit certificate primary coverage criteria for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma when ALL of the following criteria are met:
        1. Member is diagnosed with relapsed or refractory diffuse large B-cell lymphoma (FDA, Monjuvi, 2020; NCCN 2A) AND  ⬚  
        2. Member is 18 years of age or older (FDA, Monjuvi, 2020) AND
        3. Member is not eligible for high dose chemotherapy with autologous stem-cell transplantation (NCCN 2A) AND
        4. Member has received at least 1 previous systemic therapies for the treatment of DLBCL (NCCN 2A) AND
            1. One therapy must have included a CD20-targeted therapy (Salles, 2020) AND
            2. One therapy must have included an anthracycline (NCCN 2A) AND
        5. Member has declined or is not a candidate for CAR-T treatment.
 
NCCN 1 and 2A recommendations in accordance with Coverage Policy #2000030.
 
Dosage and Administration
    • 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.
 
Tafasitamab-cxix is recommended to be administered in combination with lenalidomide 25 mg for a maximum of 12 cycles, then continued as monotherapy until disease progression or unacceptable toxicity.
 
Tafasitamab-cxix is available as lyophilized powder in single dose 200mg vial for reconstitution.
 
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
 
Tafasitamab-cxix, for any indication not listed above, does not meet member benefit certificate primary coverage criteria.
 
For members with contracts without primary coverage criteria, the use of tafasitamab-cxix for any indication not listed above is considered investigational.
 
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 
Effective Prior to January 01, 2022
 
Meets Primary Coverage Criteria or Is Covered for Contracts Without Primary Coverage Criteria
 
The use of tafasitamab-cxix meets member benefit certificate primary coverage criteria for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma when ALL of the following criteria are met:
 
    1. Member is diagnosed with relapsed or refractory diffuse large B-cell lymphoma AND
    2. Member is 18 years of age or older AND
    3. Member has received at least one, but no more than three previous systemic therapies for the treatment of DLBCL AND
        1. One therapy must have included a CD20-targeted therapy AND
        2. One therapy must have included an anthracycline AND
    4. Member has declined or is not a candidate for CAR-T treatment AND
    5. Member is not eligible for high dose chemotherapy with autologous stem-cell transplantation AND
    6. Member will be using in combination with lenalidomide for a maximum of 12 cycles AND
    7. Member has a current ECOG performance status of 2 or lower
 
The ECOG or Eastern Cooperative Oncology Group Performance Status is based on the following scale:
    • 0 = Fully active, able to carry on all pre-disease performance without restriction
    • 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light house work, office work
    • 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
    • 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
    • 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
    • 5 = Dead
 
NCCN 1 and 2A recommendations in accordance with Coverage Policy #2000030.
 
Dosage and Administration
 
The recommended dose of tafasitamab-cxix is 12mg/kg based on actual body weight administered 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.
 
Tafasitamab-cxix is recommended to be administered in combination with lenalidomide 25 mg for a maximum of 12 cycles, then continued as monotherapy until disease progression or unacceptable toxicity.
 
Tafasitamab-cxix is available as lyophilized powder in single dose 200mg vial for reconstitution.
 
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
 
Tafasitamab-cxix does not meet member benefit certificate primary coverage criteria for any other indication.
 
For members with contracts without primary coverage criteria, the use of tafasitamab-cxix in any other condition than listed above is considered investigational.
 
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
The efficacy of tafasitamab-cxix for DLBCL was studied in an open-label, multicenter, single arm trial. Patients who had relapsed or refractory DLBCL after one to three prior systemic therapies, including a CD20-directed cytolytic antibody, and were not candidates for high dose chemotherapy and ASCT were eligible for the trial. Patients were given tafasitamab-cxix 12mg/kg intravenously in combination with lenalidomide for a maximum of 12 28-Day cycles followed by tafasitamab-cxix monotherapy until disease progression or unacceptable toxicity. Tafasitamab-cxix was given as follows: 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; Cycles 4 and beyond: Days 1 and 15 of each 28-day cycle. Oral lenalidomide 25mg was given on Days 1 to 21 of each 28-day cycle. 71 patients were enrolled in the study. All had received a prior CD20-containing therapy and 9 patients (13%) had received prior ASCT. 26 patients (37%) had a complete response and 13 patients (18%) had a partial response. The median duration of response was 21.7 months. Response duration ranged from 0 to 24 months. Serious adverse events reported included pneumonia, febrile neutropenia, pulmonary embolism, bronchitis, atrial fibrillation, and congestive cardiac failure.
 
2022 Update
Tafasitamab (MOR208), an Fc-modified, humanized, anti-CD19 monoclonal antibody, combined with the immunomodulatory drug lenalidomide was clinically active with a good tolerability profile in the open-label, single-arm, phase II L-MIND study of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) ineligible for autologous stem-cell transplantation. To assess long-term outcomes, the study reported an updated analysis with ≥35 months' follow-up. Patients were aged >18 years, had received one to three prior systemic therapies (including ≥1 CD20-targeting regimen) and Eastern Cooperative Oncology Group performance status 0-2. Patients received 28-day cycles of tafasitamab (12 mg/kg intravenously), once weekly during cycles 1-3, then every 2 weeks during cycles 4-12. Lenalidomide (25 mg orally) was administered on days 1-21 of cycles 1-12. After cycle 12, progression-free patients received tafasitamab every 2 weeks until disease progression. The primary endpoint was best objective response rate. After ≥35 months' follow-up (data cut-off: October 30, 2020), the objective response rate was 57.5% (n=46/80), including a complete response in 40.0% of patients (n=32/80) and a partial response in 17.5% of patients (n=14/80). The median duration of response was 43.9 months (95% confidence interval [95% CI]: 26.1-not reached), the median overall survival was 33.5 months (95% CI: 18.3-not reached) and the median progression-free survival was 11.6 months (95% CI: 6.3-45.7). There were no unexpected toxicities. Subgroup analyses revealed consistent long-term efficacy results across most subgroups of patients. This extended follow-up of L-MIND confirms the long duration of response, meaningful overall survival, and well-defined safety profile of tafasitamab plus lenalidomide followed by tafasitamab monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma ineligible for autologous stem cell transplantation. (Duell J, Maddocks KJ, González-Barca E, et.al., 2021)
 
2023 Update
Information about the long-term tolerability of tafasitamab is still limited. 5 of 92 patients treated within a phase IIa study of single agent tafasitamab in relapsed or refractory B NHL were followed for up to five years or longer for long-term tolerability. Treatment was very well tolerated in an outpatient setting with no hospitalizations needed and mild and tolerable adverse events that occurred mostly within the first two years of treatment. Given the excellent tolerability and efficacy of tafasitamab this agent can be used to induce remission in relapsed or refractory lymphoma either alone or in combination with chemotherapy. (Tilch MK, Robak T, Ghiggi C, et.al., 2022)
 
B-precursor cell acute lymphoblastic leukemia (B-ALL) in adults is an aggressive and challenging condition, and patients with relapsed/refractory (R/R) disease after allogeneic stem cell transplantation (SCT), or noncandidates for SCT, have a particularly poor prognosis. The authors investigated the activity of the Fc-modified anti-CD19 antibody tafasitamab in adults with R/R B-ALL (NCT01685021).
 
Adults with R/R B-ALL received single-agent tafasitamab 12 mg/kg weekly for up to four 28-day cycles. Patients with complete remission (with or without neutrophil/platelet recovery; complete remission [CR] or complete remission with incomplete count recovery [CRi]) after cycles 2, 3, or 4 could continue tafasitamab every 2 weeks for up to 3 further months. The primary end point was overall response rate (ORR).
 
Twenty-two patients were treated (median, 2 prior lines of therapy; range, 1-8). Six patients completed 2 cycles, and 2 of these patients responded for an ORR of 9%; 16 patients (73%) progressed before their first response assessment. Responses lasted 8 and 4 weeks in the 2 patients with CR and minimal residual disease (MRD)-negative CRi, respectively. Tafasitamab produced rapid B-cell/blast depletion in 21 of 22 patients within 1 to 2 weeks of first administration. Tafasitamab was well tolerated, with the most frequent adverse events being infusion-related reactions (59.1%) and fatigue (40.9%). Grade 3 to 4 febrile neutropenia (22.7%) was the most common hematologic adverse event.
 
Tafasitamab monotherapy was associated with clinical activity in a subset of patients with R/R B-ALL, including short-lasting CR and MRD-negative CRi. Given its favorable tolerability profile, further development of tafasitamab in chemoimmunotherapy combinations and MRD settings should be explored. (Klisovic RB, Leung WH, Brugger W, et.al., 2021)
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement.
 
2025 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2025. No new literature was identified that would prompt a change in the coverage statement.
 
CPT/HCPCS:
C9070Injection, tafasitamab-cxix, 2 mg
J9349Injection, tafasitamab-cxix, 2 mg
References: Duell J, Maddocks KJ, González-Barca E, et.al.,(2021) Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958. PMID: 34196165; PMCID: PMC8409029.

Klisovic RB, Leung WH, Brugger W, Dirnberger-Hertweck M, Winderlich M, Ambarkhane SV, Jabbour EJ.(2021) A phase 2a, single-arm, open-label study of tafasitamab, a humanized, Fc-modified, anti-CD19 antibody, in patients with relapsed/refractory B-precursor cell acute lymphoblastic leukemia. Cancer. 2021 Nov 15;127(22):4190-4197. doi: 10.1002/cncr.33796. Epub 2021 Aug 3. PMID: 34343354; PMCID: PMC9292493.

Monjuvi [package insert]. Boston, MA; Morphosys US Inc. 2020

National Comprehensive Cancer Network (NCCNA)(2023) National Comprehensive Cancer Network, Inc. 2023 Practice Guidelines in Oncology—B-Cell Lymphomas v.1.2023. Monjuvi. Available at https://www.nccn.org. Accessed February 1, 2023.

NCCN Clinical Practice Guidelines in Oncology™. © 2020 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on Janurary 25, 2021. B-Cell Lymphomas. V1.2021. Revised January 20, 2021.

Salles G, Duell J, González Barca E, et al.(2020) Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncology. 2020 Jul;21(7):978-988.

Tilch MK, Robak T, Ghiggi C, Wuff E, Herold S, Theobald M, Hess G.(2022) Safety of the Anti-CD19 antibody Tafasitamab in Long Term Responders from A Phase II Trial for Relapsed Lymphoma. Clin Lymphoma Myeloma Leuk. 2022 Apr;22(4):270-275. doi: 10.1016/j.clml.2021.10.005. Epub 2021 Oct 16. PMID: 34776401.
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