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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.

  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).
  1. 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
  1. 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.
  1. 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

  1. 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)
  1. Dosage/Administration 1

Indication

Dose

B-Cell Lymphomas

Administer 12 mg/kg intravenously 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 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.

  1. 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
  1. References
  1. Monjuvi [package insert]. Boston, MA; Morphosys US, Inc., June 2021. Accessed October 2023.
  2. 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.
  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 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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