Last Review Date: 03/05/2024

Date of Origin: 09/01/2020

Dates Reviewed: 09/2020, 11/2020, 01/2021, 04/2021, 11/2021, 11/2022, 11/2023, 03/2024

1. 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).

2. Dosing Limits

1. 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

2. Max Units (per dose and over time) [HCPCS Unit]:

• 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

3. 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, loncastuximab tesirine, 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 diffuse large B-cell lymphoma (DLBCL) (including DLBCL not otherwise specified and DLBCL arising from low grade lymphoma) †; AND

• Used for relapsed or refractory disease in patients who are not eligible for autologous stem cell transplant (ASCT); AND
• Used in combination with lenalidomide; OR

• Patient has histologic transformation of indolent lymphomas (follicular lymphoma or marginal zone lymphoma) to 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, progressive, or relapsed disease following chemoimmunotherapy for histologic transformation after minimal or no prior therapy; OR
• Used for patients who have received multiple lines of prior therapy including ≥2 chemoimmunotherapy regimens for indolent or transformed disease; OR

• Patient has HIV-related B-cell lymphomas (i.e., HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL [not otherwise specified], or plasmablastic lymphoma), high-grade B-cell lymphomas ‡; AND

• Used as subsequent therapy in combination with lenalidomide and no intention to proceed to transplant; AND

• Used for relapsed 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 patient is a non-candidate for CAR T-cell therapy; OR
• Used as alternative systemic therapy (if not previously used) for relapsed/refractory disease and patient is a non-candidate for CAR T-cell therapy; OR
  • • • Patient has 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 disease >12 months after completion of initial treatment with chemoimmunotherapy; OR
          • Used for primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of initial treatment with chemoimmunotherapy AND patient is a non-candidate for CAR T-cell therapy; OR
          • Used as alternative systemic therapy (if not previously used) for relapsed/refractory disease and patient is a non-candidate for CAR T-cell therapy

† FDA Approved Indication(s); ‡ Compendium Recommended Indication(s); Ф Orphan Drug

4. 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)

5. Dosage/Administration ¹

6. 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

7. References

1. Monjuvi [package insert]. Boston, MA; Morphosys US, Inc., June 2021. Accessed February 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) tafasitamab-cxix. National Comprehensive Cancer Network, 2024. 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 February 2024.
3. 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.
4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas Version 1.2024. National Comprehensive Cancer Network, 2024. 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 February 2024.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A