Last Review Date: 09/01/2020

Date of Origin: 09/01/2020

Dates Reviewed: 09/2020

I. Length of Authorization

Coverage will be provided for six months and may be renewed.

• Combined use with lenalidomide must not exceed a maximum of 12 cycles; however, continued maintenance tafasitamab monotherapy may be renewed until disease progression or unacceptable toxicity.

II. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Monjuvi 200 mg SDV: 7 vials per dose
  • Cycle 1: 35 vials per 28-day cycle
  • Cycle 2 & 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]:

Diffuse Large B-Cell Lymphoma (DLBCL)

• 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.

III. Initial Approval Criteria 

Coverage is provided in the following conditions:

• Patient is 18 years or older; AND

Universal Criteria 

• Patient does not have an active infection, including clinically important localized infections; AND
• Patient does not have CNS lymphoma involvement; AND
• Patient has not received an allogeneic stem cell transplant OR autologous-SCT within the prior 3 months of therapy; AND
• Patient has not received prior therapy with immunomodulatory imide (IMiD-class) agents (e.g., lenalidomide); 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

Diffuse Large B-Cell Lymphoma (DLBCL) †  Ф 

• Patient has a diagnosis of diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma (excluding primary refractory AND ‘double or triple hit’ disease); AND
• Patient has at least one measurable lesion; AND
• Patient’s disease is relapsed or refractory; AND
• Therapy will be initiated in combination with lenalidomide (Note: use is for up to 12 cycles only); AND
• Patient is NOT eligible for autologous stem cell transplant; AND
• Patient is ineligible for intensive therapy (i.e., high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT))

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

IV. Renewal Criteria 

Coverage can be renewed based on the following criteria:

• Patient continues to meet 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 the following: severe infusion type reactions, severe thrombocytopenia, severe neutropenia, severe infection, etc.; AND
• Disease response with treatment defined as stabilization of disease or decrease in size of tumor or tumor spread; AND
• Combination therapy with lenalidomide may not exceed a maximum of 12 cycles (continued tafasitamab single-agent maintenance therapy may be continued until disease progression or unacceptable toxicity)

V. Dosage/Administration  

VI. Billing Code/Availability Information

HCPCS code:

• J9999 - Not otherwise classified, antineoplastic drugs

NDC:

• Monjuvi 200 mg lyophilized powder in single-dose vial for injection: 73535-0208-xx

VII. References

1. Monjuvi [package insert]. Boston, MA; Morphosys, Inc., August 2020. Accessed August 2020.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) tafasitamab. National Comprehensive Cancer Network, 2020. 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 September 2020.
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.

Appendix 1 – Covered Diagnosis Codes

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: http://www.cms.gov/medicare-coverage-database/search/advanced-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