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Asset Publisher
Monjuvi™ (tafasitamab-cxix) (Intravenous)
Policy Number: VP-0559
(Intravenous)
Document Number: IC-0559
Last Review Date: 10/30/2023
Date of Origin: 09/01/2020
Dates Reviewed: 09/2020, 11/2020, 01/2021, 04/2021, 11/2021, 11/2022, 11/2023
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization 1
Coverage will be provided for 6 months and may be renewed (unless otherwise specified).
- Combination therapy with lenalidomide may not exceed a maximum of twelve (12) 28-day cycles (continued treatment as a single-agent may be renewed until disease progression or unacceptable toxicity).
- Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
- Monjuvi 200 mg single-dose vial: 7 vials per dose
- Cycle 1: 35 vials per 28-day cycle
- Cycle 2 and 3: 28 vials per 28-day cycle
- Cycle 4 and beyond: 14 vials per each 28-day cycle
- Max Units (per dose and over time) [HCPCS Unit]:
B-Cell Lymphomas
- 700 billable units (1400 mg) per dose on the following 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.
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
- Patient is at least 18 years of age; AND
Universal Criteria 1-3
- Patient has not received prior therapy with immunomodulatory imide (IMiD-class) agents (e.g., lenalidomide, etc.); AND
- Patient has not received prior therapy with CD19-directed therapy (e.g., axicabtagene, tisagenlecleucel, etc.) OR patient previously received anti-CD19 therapy and re-biopsy indicates CD-19 positive disease; AND
B-Cell Lymphomas † ‡ Ф 1-4
- Patient has follicular lymphoma (grade 1-2); AND
- Used as subsequent therapy (if not previously given) in combination with lenalidomide for no response, relapsed, or progressive disease; OR
- Patient has histologic transformation of indolent lymphomas (follicular lymphoma or marginal zone lymphoma) to diffuse large B-cell lymphoma (DLBCL); AND
- Used in combination with lenalidomide if previously treated with an anthracycline-based regimen and no intention to proceed to transplant; AND
- Used as additional therapy for partial response, no response, or progressive disease following chemoimmunotherapy; OR
- Used for patients who have received multiple lines of chemoimmunotherapy for indolent or transformed disease; OR
- Patient has HIV-related B-cell lymphomas (e.g., diffuse large B-cell lymphoma [DLBCL], primary effusion lymphoma, HHV8-positive diffuse large B-cell lymphoma [not otherwise specified], or plasmablastic lymphoma), DLBCL, high-grade B-cell lymphomas, or monomorphic post-transplant lymphoproliferative disorder (PTLD) (B-cell type); AND
- Used as subsequent therapy in combination with lenalidomide and no intention to proceed to transplant; AND
- Used for relapsed or refractory disease >12 months after completion of first-line therapy; OR
- Used for primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of first-line therapy AND no intention to proceed to CAR T-cell therapy; OR
- Used as alternative systemic therapy (if not previously used) for relapsed/refractory disease and no intention to proceed to CAR T-cell therapy
† FDA Approved Indication(s); ‡ Compendium Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1
Coverage may be renewed based on the following criteria:
- Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion-related reactions, severe myelosuppression (e.g., thrombocytopenia, neutropenia, anemia), severe infection, etc.; AND
- Disease response with treatment defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
- Combination therapy with lenalidomide may not exceed a maximum of twelve (12) 28-day cycles (continued treatment as a single-agent may be renewed until disease progression or unacceptable toxicity)
- Dosage/Administration 1
Indication |
Dose |
B-Cell Lymphomas |
Administer 12 mg/kg intravenously according to the following dosing schedule:
Administer tafasitamab in combination with lenalidomide for a maximum of twelve (12) 28-day cycles and then continue tafasitamab as a single-agent until disease progression or unacceptable toxicity. |
- Billing Code/Availability Information
HCPCS Code:
- J9349 – Injection, tafasitamab-cxix, 2 mg; 1 billable unit = 2 mg
NDC:
- Monjuvi 200 mg lyophilized powder in single-dose vial for injection: 73535-0208-xx
- References
- Monjuvi [package insert]. Boston, MA; Morphosys US, Inc., June 2021. Accessed October 2023.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) tafasitamab-cxix. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed October 2023.
- Salles G, Duell J, González Barca E, et al. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. Epub 2020 Jun 5.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas Version 5.2023. National Comprehensive Cancer Network, 2023. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed October 2023.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
C82.00 |
Follicular lymphoma grade I, unspecified site |
C82.01 |
Follicular lymphoma grade I, lymph nodes of head, face, and neck |
C82.02 |
Follicular lymphoma grade I, intrathoracic lymph nodes |
C82.03 |
Follicular lymphoma grade I, intra-abdominal lymph nodes |
C82.04 |
Follicular lymphoma grade I, lymph nodes of axilla and upper limb |
C82.05 |
Follicular lymphoma grade I, lymph nodes of inguinal region and lower limb |
C82.06 |
Follicular lymphoma grade I, intrapelvic lymph nodes |
C82.07 |
Follicular lymphoma grade I, spleen |
C82.08 |
Follicular lymphoma grade I, lymph nodes of multiple sites |
C82.09 |
Follicular lymphoma grade I, extranodal and solid organ sites |
C82.10 |
Follicular lymphoma grade II, unspecified site |
C82.11 |
Follicular lymphoma grade II, lymph nodes of head, face, and neck |
C82.12 |
Follicular lymphoma grade II, intrathoracic lymph nodes |
C82.13 |
Follicular lymphoma grade II, intra-abdominal lymph nodes |
C82.14 |
Follicular lymphoma grade II, lymph nodes of axilla and upper limb |
C82.15 |
Follicular lymphoma grade II, lymph nodes of inguinal region and lower limb |
C82.16 |
Follicular lymphoma grade II, intrapelvic lymph nodes |
C82.17 |
Follicular lymphoma grade II, spleen |
C82.18 |
Follicular lymphoma grade II, lymph nodes of multiple sites |
C82.19 |
Follicular lymphoma grade II, extranodal and solid organ sites |
C82.20 |
Follicular lymphoma grade III, unspecified, unspecified site |
C82.21 |
Follicular lymphoma grade III, unspecified, lymph nodes of head, face, and neck |
C82.22 |
Follicular lymphoma grade III, unspecified, intrathoracic lymph nodes |
C82.23 |
Follicular lymphoma grade III, unspecified, intra-abdominal lymph nodes |
C82.24 |
Follicular lymphoma grade III, unspecified, lymph nodes of axilla and upper limb |
C82.25 |
Follicular lymphoma grade III, unspecified, lymph nodes of inguinal region and lower limb |
C82.26 |
Follicular lymphoma grade III, unspecified, intrapelvic lymph nodes |
C82.27 |
Follicular lymphoma grade III, unspecified, spleen |
C82.28 |
Follicular lymphoma grade III, unspecified, lymph nodes of multiple sites |
C82.29 |
Follicular lymphoma grade III, unspecified, extranodal and solid organ sites |
C82.30 |
Follicular lymphoma grade IIIa, unspecified site |
C82.31 |
Follicular lymphoma grade IIIa, lymph nodes of head, face, and neck |
C82.32 |
Follicular lymphoma grade IIIa, intrathoracic lymph nodes |
C82.33 |
Follicular lymphoma grade IIIa, intra-abdominal lymph nodes |
C82.34 |
Follicular lymphoma grade IIIa, lymph nodes of axilla and upper limb |
C82.35 |
Follicular lymphoma grade IIIa, lymph nodes of inguinal region and lower limb |
C82.36 |
Follicular lymphoma grade IIIa, intrapelvic lymph nodes |
C82.37 |
Follicular lymphoma grade IIIa, spleen |
C82.38 |
Follicular lymphoma grade IIIa, lymph nodes of multiple sites |
C82.39 |
Follicular lymphoma grade IIIa, extranodal and solid organ sites |
C82.40 |
Follicular lymphoma grade IIIb, unspecified site |
C82.41 |
Follicular lymphoma grade IIIb, lymph nodes of head, face, and neck |
C82.42 |
Follicular lymphoma grade IIIb, intrathoracic lymph nodes |
C82.43 |
Follicular lymphoma grade IIIb, intra-abdominal lymph nodes |
C82.44 |
Follicular lymphoma grade IIIb, lymph nodes of axilla and upper limb |
C82.45 |
Follicular lymphoma grade IIIb, lymph nodes of inguinal region and lower limb |
C82.46 |
Follicular lymphoma grade IIIb, intrapelvic lymph nodes |
C82.47 |
Follicular lymphoma grade IIIb, spleen |
C82.48 |
Follicular lymphoma grade IIIb, lymph nodes of multiple sites |
C82.49 |
Follicular lymphoma grade IIIb, extranodal and solid organ sites |
C82.50 |
Diffuse follicle center lymphoma, unspecified site |
C82.51 |
Diffuse follicle center lymphoma, lymph nodes of head, face, and neck |
C82.52 |
Diffuse follicle center lymphoma, intrathoracic lymph nodes |
C82.53 |
Diffuse follicle center lymphoma, intra-abdominal lymph nodes |
C82.54 |
Diffuse follicle center lymphoma, lymph nodes of axilla and upper limb |
C82.55 |
Diffuse follicle center lymphoma, lymph nodes of inguinal region and lower limb |
C82.56 |
Diffuse follicle center lymphoma, intrapelvic lymph nodes |
C82.57 |
Diffuse follicle center lymphoma, spleen |
C82.58 |
Diffuse follicle center lymphoma, lymph nodes of multiple sites |
C82.59 |
Diffuse follicle center lymphoma, extranodal and solid organ sites |
C82.60 |
Cutaneous follicle center lymphoma, unspecified site |
C82.61 |
Cutaneous follicle center lymphoma, lymph nodes of head, face, and neck |
C82.62 |
Cutaneous follicle center lymphoma, intrathoracic lymph nodes |
C82.63 |
Cutaneous follicle center lymphoma, intra-abdominal lymph nodes |
C82.64 |
Cutaneous follicle center lymphoma, lymph nodes of axilla and upper limb |
C82.65 |
Cutaneous follicle center lymphoma, lymph nodes of inguinal region and lower limb |
C82.66 |
Cutaneous follicle center lymphoma, intrapelvic lymph nodes |
C82.67 |
Cutaneous follicle center lymphoma, spleen |
C82.68 |
Cutaneous follicle center lymphoma, lymph nodes of multiple sites |
C82.69 |
Cutaneous follicle center lymphoma, extranodal and solid organ sites |
C82.80 |
Other types of follicular lymphoma, unspecified site |
C82.81 |
Other types of follicular lymphoma, lymph nodes of head, face, and neck |
C82.82 |
Other types of follicular lymphoma, intrathoracic lymph nodes |
C82.83 |
Other types of follicular lymphoma, intra-abdominal lymph nodes |
C82.84 |
Other types of follicular lymphoma, lymph nodes of axilla and upper limb |
C82.85 |
Other types of follicular lymphoma, lymph nodes of inguinal region and lower limb |
C82.86 |
Other types of follicular lymphoma, intrapelvic lymph nodes |
C82.87 |
Other types of follicular lymphoma, spleen |
C82.88 |
Other types of follicular lymphoma, lymph nodes of multiple sites |
C82.89 |
Other types of follicular lymphoma, extranodal and solid organ sites |
C82.90 |
Follicular lymphoma, unspecified, unspecified site |
C82.91 |
Follicular lymphoma, unspecified, lymph nodes of head, face, and neck |
C82.92 |
Follicular lymphoma, unspecified, intrathoracic lymph nodes |
C82.93 |
Follicular lymphoma, unspecified, intra-abdominal lymph nodes |
C82.94 |
Follicular lymphoma, unspecified, lymph nodes of axilla and upper limb |
C82.95 |
Follicular lymphoma, unspecified, lymph nodes of inguinal region and lower limb |
C82.96 |
Follicular lymphoma, unspecified, intrapelvic lymph nodes |
C82.97 |
Follicular lymphoma, unspecified, spleen |
C82.98 |
Follicular lymphoma, unspecified, lymph nodes of multiple sites |
C82.99 |
Follicular lymphoma, unspecified, extranodal and solid organ sites |
C83.30 |
Diffuse large B-cell lymphoma unspecified site |
C83.31 |
Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck |
C83.32 |
Diffuse large B-cell lymphoma intrathoracic lymph nodes |
C83.33 |
Diffuse large B-cell lymphoma intra-abdominal lymph nodes |
C83.34 |
Diffuse large B-cell lymphoma lymph nodes of axilla and upper limb |
C83.35 |
Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb |
C83.36 |
Diffuse large B-cell lymphoma intrapelvic lymph nodes |
C83.37 |
Diffuse large B-cell lymphoma, spleen |
C83.38 |
Diffuse large B-cell lymphoma lymph nodes of multiple sites |
C83.39 |
Diffuse large B-cell lymphoma extranodal and solid organ sites |
C83.80 |
Other types of follicular lymphoma, unspecified site |
C83.81 |
Other types of follicular lymphoma, lymph nodes of head, face, and neck |
C83.82 |
Other types of follicular lymphoma, intrathoracic lymph nodes |
C83.83 |
Other types of follicular lymphoma, intra-abdominal lymph nodes |
C83.84 |
Other types of follicular lymphoma, lymph nodes of axilla and upper limb |
C83.85 |
Other types of follicular lymphoma, lymph nodes of inguinal region and lower limb |
C83.86 |
Other types of follicular lymphoma, intrapelvic lymph nodes |
C83.87 |
Other types of follicular lymphoma, spleen |
C83.88 |
Other types of follicular lymphoma, lymph nodes of multiple sites |
C83.89 |
Other types of follicular lymphoma, extranodal and solid organ sites |
C83.90 |
Non-follicular (diffuse) lymphoma, unspecified, unspecified site |
C83.91 |
Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of head, face, and neck |
C83.92 |
Non-follicular (diffuse) lymphoma, unspecified, intrathoracic lymph nodes |
C83.93 |
Non-follicular (diffuse) lymphoma, unspecified, intra-abdominal lymph nodes |
C83.94 |
Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of axilla and upper limb |
C83.95 |
Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of inguinal region and lower limb |
C83.96 |
Non-follicular (diffuse) lymphoma, unspecified, intrapelvic lymph nodes |
C83.97 |
Non-follicular (diffuse) lymphoma, unspecified, spleen |
C83.98 |
Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of multiple sites |
C83.99 |
Non-follicular (diffuse) lymphoma, unspecified, extranodal and solid organ sites |
C85.10 |
Unspecified B-cell lymphoma, unspecified site |
C85.11 |
Unspecified B-cell lymphoma, lymph nodes of head, face, and neck |
C85.12 |
Unspecified B-cell lymphoma, intrathoracic lymph nodes |
C85.13 |
Unspecified B-cell lymphoma, intra-abdominal lymph nodes |
C85.14 |
Unspecified B-cell lymphoma, lymph nodes of axilla and upper limb |
C85.15 |
Unspecified B-cell lymphoma, lymph nodes of inguinal region and lower limb |
C85.16 |
Unspecified B-cell lymphoma, intrapelvic lymph nodes |
C85.17 |
Unspecified B-cell lymphoma, spleen |
C85.18 |
Unspecified B-cell lymphoma, lymph nodes of multiple sites |
C85.19 |
Unspecified B-cell lymphoma, extranodal and solid organ sites |
C85.20 |
Mediastinal (thymic) large B-cell lymphoma unspecified site |
C85.21 |
Mediastinal (thymic) large B-cell lymphoma lymph nodes of head, face, and neck |
C85.22 |
Mediastinal (thymic) large B-cell lymphoma intrathoracic lymph nodes |
C85.23 |
Mediastinal (thymic) large B-cell lymphoma intra-abdominal lymph nodes |
C85.24 |
Mediastinal (thymic) large B-cell lymphoma lymph nodes of axilla and upper limb |
C85.25 |
Mediastinal (thymic) large B-cell lymphoma lymph nodes of inguinal region and lower limb |
C85.26 |
Mediastinal (thymic) large B-cell lymphoma intrapelvic lymph nodes |
C85.27 |
Mediastinal (thymic) large B-cell lymphoma spleen |
C85.28 |
Mediastinal (thymic) large B-cell lymphoma lymph nodes of multiple sites |
C85.29 |
Mediastinal (thymic) large B-cell lymphoma extranodal and solid organ sites |
C85.80 |
Other specified types of non-Hodgkin lymphoma, unspecified site |
C85.81 |
Other specified types of non-Hodgkin lymphoma, lymph nodes of head, face, and neck |
C85.82 |
Other specified types of non-Hodgkin lymphoma, intrathoracic lymph nodes |
C85.83 |
Other specified types of non-Hodgkin lymphoma, intra-abdominal lymph nodes |
C85.84 |
Other specified types of non-Hodgkin lymphoma, lymph nodes of axilla and upper limb |
C85.85 |
Other specified types of non-Hodgkin lymphoma, lymph nodes of inguinal region and lower limb |
C85.86 |
Other specified types of non-Hodgkin lymphoma, intrapelvic lymph nodes |
C85.87 |
Other specified types of non-Hodgkin lymphoma, spleen |
C85.88 |
Other specified types of non-Hodgkin lymphoma, lymph nodes of multiple sites |
C85.89 |
Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites |
D47.Z1 |
Post-transplant lymphoproliferative disorder (PTLD) |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Articles (LCAs), and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA, LLC |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA, LLC |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |
MONJUVI® (tafasitamab-cxix) Prior Auth Criteria |
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