vp-0600
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Zynlonta™ (loncastuximab tesirine-lpyl) (Intravenous)

Policy Number: VP-0600

Last Review Date: 05/03/2021

Date of Origin: 05/03/2021

Dates Reviewed: 05/2021

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 every six months thereafter.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Zynlonta 10 mg powder for injection: 2 vials every 21 days for the first two doses followed by 1 vial every 21 days thereafter
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • Relapsed or Refractory B-Cell Lymphoma

Cycle 1 – 2

  • 20 mg per each 21 day cycle

Subsequent Cycles

  • 10 mg per each 21 day cycle

III. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years old; AND
  • Patient advised to minimize or avoid exposure to direct natural or artificial sunlight including exposure through glass windows; AND

Universal Criteria 1

  • Used as single agent therapy; AND
  • Patient has not received prior anti-CD19 therapy, (e.g., tafasitamab, CAR-T) OR patient previously received anti-CD19 therapy and re-biopsy indicates CD-19 positive disease; AND
  • Patient does not have active graft-versus-host disease; AND
  • Patient has not had an autologous stem cell transplant (ASCT) within 30 days or allogeneic stem cell transplant (AlloSCT) with 60 days, prior to start of therapy; AND
  • Patient does not have active CNS lymphoma (includes leptomeningeal disease); AND
  • Patient does not have a clinically significant active infection (e.g., Grade 3 or 4 infections); AND
  • Patient does not have any clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath); AND

Large B-Cell Lymphoma † Ф 1,4

  • Patient has relapsed or refractory disease (includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma); AND
  • Patient has received at least two prior lines of therapy

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

IV. Renewal Criteria 1

Coverage can be renewed based upon 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 effusion and edema (e.g., pleural effusion, pericardial effusion, ascites, peripheral edema, and general edema), myelosuppression, infections, severe cutaneous reactions (e.g., photosensitivity, rash), etc.; AND
  • Disease response with treatment defined by stabilization of disease or decrease in size of tumor or tumor spread.

V. Dosage/Administration 1

Indication

Dose

R/R B-Cell Lymphoma

  • Administer 0.15 mg/kg every 3 weeks for 2 cycles, then 0.075 mg/kg every 3 weeks for subsequent cycles
    • Treat until disease progression or unacceptable toxicity

*For patients with a body mass index (BMI) ≥35 kg/m2, calculate the dose based on an

adjusted body weight (ABW) as follows: ABW in kg = 35 kg/m2× (height in meters)2.

VI. Billing Code/Availability Information

HCPCS Code:

  • J9999 – Not otherwise classified, antineoplastic drugs

NDC:

  • Zynlonta 10 mg single-use powder for injection: 79952-0110-xx

VII. References

  1. Zynlonta [package insert]. Murray Hill, NJ; ADC Therapeutics, Inc. April 2021. Accessed April 2021.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) loncastuximab tesirine. 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 April 2021.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for B-Cell Lymphomas v3.2021. 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 April 2021.
  4. ADC Therapeutics. A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-2). Available from: https://clinicaltrials.gov. NLM identifier: NCT03589469. Accessed April 26, 2021.

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 Determinations (LCDs), and Local Coverage Articles (LCAs) 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/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, 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