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Epkinly™ (epcoritamab-bysp)

Policy Number: VP-0710

(Subcutaneous)

 

Last Review Date: 08/01/2024

Date of Origin: 07/05/2023

Dates Reviewed: 07/2023, 03/2024, 08/2024

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

Coverage will be provided for 6 months and may be renewed.

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Epkinly 4 mg/0.8 mL single-dose vial: 1 vial on days 1, 8, and 15 of cycle 1
  • Epkinly 48 mg/0.8 mL single-dose vial: 1 vial on days 15 and 22 of cycle 1; days 1, 8, 15, 22 of cycles 2 and 3; days 1 and 15 of cycles 4 to 9; and day 1 of cycle 10 and beyond
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 1200 billable units per 28 days
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria 1

  • Prophylaxis for infection will be followed according to local guidelines (e.g., Pneumocystis jirovecii pneumonia (PJP), Herpes virus, etc.); AND
  • Patient does not have a clinically significant active systemic infection; AND
  • Patient does not have primary central nervous system (CNS) lymphoma or CNS involvement of disease; AND
  • Used as a single agent; AND

B-Cell Lymphomas † ‡ 1,3,4

  • Used after at least two prior lines of systemic therapy; AND
    • Patient has diffuse large B-cell Lymphoma (DLBCL) (including DLBCL, not otherwise specified), high-grade B-cell lymphoma, HIV-related B-cell lymphoma (i.e., HIV-related DLBCL, primary effusion lymphoma, or HHV8-positive large B-cell lymphoma, not otherwise specified), or monomorphic post-transplant lymphoproliferative disorder (PTLD) (B-cell type); AND
      • Used for partial response, progressive, relapsed, or refractory disease; OR
    • Patient has follicular lymphoma Ф OR histologic transformation of an indolent lymphoma (follicular lymphoma or marginal zone lymphoma) to DLBCL; AND
      • Used for partial response, no response, progressive, relapsed, or refractory disease

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

  1. Renewal Criteria 1

Coverage may be renewed based upon 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: serious infections, serious or life-threatening cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), severe cytopenias (including neutropenia, anemia, and thrombocytopenia), etc.; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread
  1. Dosage/Administration 1,7

Indication

Dose

Follicular Lymphoma

Administer subcutaneously in 28-day cycles, until disease progression or unacceptable toxicity.

  • Cycle 1: 
    • Step-up dose one: 0.16 mg on day 1
    • Step-up dose two: 0.8 mg on day 8
    • Step-up dose three: 3 mg on day 15
    • First full dose: 48 mg on day 22
  • Cycles 2 and 3:
    • 48 mg on days 1, 8, 15, 22
  • Cycles 4 to 9:
    • 48 mg on days 1 and 15
  • Cycles 10 and beyond:
  • 48 mg on day 1

All other B-Cell Lymphoma Subtypes

Administer subcutaneously in 28-day cycles, until disease progression or unacceptable toxicity.

  • Cycle 1: 
    • Step-up dose one: 0.16 mg on day 1
    • Step-up dose two: 0.8 mg on day 8
    • First full dose: 48 mg on day 15
  • Patients should be hospitalized for 24 hours after administration of the first full 48 mg dose due to the risks of CRS and ICANS
    • 48 mg on day 22
  • Cycles 2 and 3:
    • 48 mg on days 1, 8, 15, 22
  • Cycles 4 to 9:
    • 48 mg on days 1 and 15
  • Cycles 10 and beyond:
    • 48 mg on day 1

Note:

  • Must be administered by a healthcare professional with appropriate medical support to manage severe reactions such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
  • Ensure adequate hydration before administering therapy. Premedicate before each dose in Cycle 1.
  1. Billing Code/Availability Information

HCPCS Code:

  • J9321 – Injection, epcoritamab-bysp, 0.16 mg; 1 billable unit = 0.16 mg

NDC(s):

  • Epkinly 4 mg/0.8 mL single-dose vial: 82705-0002-xx
  • Epkinly 48 mg/0.8 mL single-dose vial: 82705-0010-xx
  1. References
  1. Epkinly [package insert]. Plainsboro, NJ; Genmab US, Inc.; June 2024. Accessed July 2024.
  2. Hutchings M, Mous R, Clausen MR, et al. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase ½ study. Lancet. 2021 Sep 25;398(10306):1157-1169. Doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) epcoritamab. 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 July 2024.
  4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas, Version 2.2024. 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 July 2024.
  5. Thieblemont C, Phillips T, Ghesquieres H, et al. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. doi: 10.1200/JCO.22.01725. Epub 2022 Dec 22. PMID: 36548927; PMCID: PMC10115554.
  6. Linton KM, Vitolo U, Jurczak W, et al. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study. Lancet Haematol. 2024 Jun 13:S2352-3026(24)00166-2. doi: 10.1016/S2352-3026(24)00166-2.
  7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Epcoritamab-bysp: Diffuse Large B-Cell Lymphoma Chemotherapy Order Template, DBL85. 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 July 2024.
  8. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Epcoritamab-bysp: Classic Follicular Lymphoma Chemotherapy Order Template, FOL35. 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 July 2024.

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 regional 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 non-follicular lymphoma, unspecified site

C83.81

Other non-follicular lymphoma, lymph nodes of head, face, and neck

C83.82

Other non-follicular lymphoma, intrathoracic lymph nodes

C83.83

Other non-follicular lymphoma, intra-abdominal lymph nodes

C83.84

Other non-follicular lymphoma, lymph nodes of axilla and upper limb

C83.85

Other non-follicular lymphoma, lymph nodes of inguinal region and lower limb

C83.86

Other non-follicular lymphoma, intrapelvic lymph nodes

C83.87

Other non-follicular lymphoma, spleen

C83.88

Other non-follicular lymphoma, lymph nodes of multiple sites

C83.89

Other non-follicular lymphoma, extranodal and solid organ sites

C83.90

Non-follicular (diffuse) lymphoma, 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)

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/LCD/LCA):  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

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA

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