vp-0559
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Monjuvi™ (tafasitamab-cxix) (Intravenous)

Policy Number: VP-0559

Last Review Date: 10/22/2021

Date of Origin: 09/01/2020

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

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.

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
  1. 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

Indication

Dose

Diffuse Large

B-Cell Lymphoma

The recommended dosage of Monjuvi is 12 mg/kg as an intravenous infusion according to the following dosing schedule:

  • Cycle 1: Days 1, 4, 8, 15 and 22 of a 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.

Administer Monjuvi in combination with lenalidomide for a maximum of 12 cycles and then continue Monjuvi as monotherapy until disease progression or unacceptable toxicity.

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

ICD-10

ICD-10 Description

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

C83.90

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

C85.20

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

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