Last Review Date: 10/22/2021

Date of Origin: 09/01/2020

Dates Reviewed: 09/2020, 11/2020, 01/2021, 04/2021, 11/2021

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)

• 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.

III. 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

Diffuse Large B-Cell Lymphoma (DLBCL) † Ф ^1-3

• Therapy will be initiated in combination with lenalidomide (NOTE: combination therapy with lenalidomide is for up to 12 cycles only); AND
• Patient is ineligible for stem cell transplant; AND
  • Patient has diffuse large B-cell lymphoma (DLBCL); AND
    • Used as subsequent therapy for partial response, no response, relapsed, progressive, or refractory disease; OR
  • Patient has DLBCL without translocations of MYC and BCL2 and/or BCL6 transformed from grade 1-2 Follicular Lymphoma OR DLBCL transformed from Nodal Marginal Zone Lymphoma; AND
    • Patient received multiple lines of prior therapies, including two or more prior lines of chemoimmunotherapy for indolent or transformed disease; OR
    • Patient received minimal or no chemoimmunotherapy prior to histologic transformation with no response or progressive disease after chemoimmunotherapy which must have included an anthracycline or anthracenedione-based regimen, unless contraindicated

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

IV. Renewal Criteria ¹

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: severe infusion-related reactions, severe thrombocytopenia, severe neutropenia, 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 12 cycles (continued tafasitamab single-agent maintenance therapy may be continued until disease progression or unacceptable toxicity)

V. Dosage/Administration ¹

VI. 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

VII. References

1. Monjuvi [package insert]. Boston, MA; Morphosys, Inc., June 2021. Accessed October 2021.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) tafasitamab. National Comprehensive Cancer Network, 2021. 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 2021.
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: 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