Last Review Date: 04/07/2025

Date of Origin: 12/07/2023

Dates Reviewed: 12/2023, 03/2024, 07/2024, 10/2024, 01/2025, 04/2025

1. Length of Authorization ^{Δ 1,4,5,9-13}

Coverage will be provided for 6 months and may be renewed (unless otherwise specified).

• Head and Neck Cancers in combination with chemotherapy can be authorized up to a maximum of 24 months (35 total doses).

2. Dosing Limits

Max Units (per dose and over time) [HCPCS Unit]:

• 480 billable units every 2 weeks

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ^1,2

• Patient has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy ^Δ; AND

Head and Neck Cancers † ‡ Ф ^1-5,9

• Patient has Cancer of the Nasopharynx; AND
  • Used as first-line therapy; AND
    • Patient has metastatic OR recurrent, locally advanced disease; AND
    • Used in combination with cisplatin and gemcitabine; OR
  • Used as subsequent therapy; AND
    • Patient has recurrent unresectable or metastatic disease; AND
      • Used as single-agent therapy; AND
        • Patient experienced disease progression on or after a platinum-containing chemotherapy regimen; OR
      • Used in combination with cisplatin and gemcitabine (Note: Only applies to metastatic disease); OR

• Patient has Very Advanced Head and Neck Cancer*; AND
  • • Patient has nasopharyngeal cancer; AND

• • • Used for one of the following:

• Unresectable locoregional recurrence with prior radiation therapy (RT)
• Unresectable second primary with prior RT
• Unresectable persistent disease with prior RT
• Recurrent/persistent disease with distant metastases; AND

• Used as one of the following:
  • • Single agent; AND

• Used as an alternate subsequent-line option if patient experienced disease progression on or after platinum-containing therapy; OR
  • • • In combination with cisplatin and gemcitabine; AND
        • Patient has a performance status 0-1

* Very Advanced Head and Neck Cancer includes: Newly diagnosed locally advanced T4b (M0) disease; newly diagnosed unresectable regional nodal disease (typically N3); metastatic disease at initial presentation (M1); or recurrent or persistent disease.

Small Bowel Adenocarcinoma ‡ ^2,10

• Used as single agent treatment; AND
• Patient has microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) disease OR polymerase epsilon/delta (POLE/POLD1) mutation with ultra-hypermutated phenotype [e.g., tumor mutational burden (TMB) > 50 mut/Mb] as determined by an FDA-approved or CLIA-compliant testv; AND
  • Patient has advanced or metastatic disease; OR
  • Patient has locally unresectable or medically inoperable disease; AND
    • Used as primary treatment

Anal Carcinoma ‡ ^2,11

• Patient has metastatic squamous cell carcinoma; AND
• Used as a single agent as subsequent therapy

Colon Cancer ‡ ^2,12

• Used as single agent treatment; AND
• Patient has MSI-H/dMMR disease OR POLE/POLD1 mutation with ultra-hypermutated phenotype (e.g., TMB >50 mut/Mb) as determined by an FDA-approved or CLIA-compliant testv; AND
• Used for locally unresectable, medically inoperable, advanced, or metastatic disease

Appendiceal Adenocarcinoma – Colon Cancer ‡ ^2,12

• Used as single agent treatment; AND
• Patient has MSI-H/dMMR disease OR POLE/POLD1 mutation with ultra-hypermutated phenotype (e.g., TMB >50 mut/Mb) as determined by an FDA-approved or CLIA-compliant testv; AND
• Used for advanced or metastatic disease

Rectal Cancer ‡ ^2,13

• Used as single agent treatment; AND
• Patient has MSI-H/dMMR disease OR POLE/POLD1 mutation with ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb) as determined by an FDA-approved or CLIA-compliant testv; AND
• Used for advanced or metastatic disease

v If confirmed using an FDA approved assay – http://www.fda.gov/CompanionDiagnostics

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

4. Renewal Criteria ^{Δ 1,4,5,9}

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Duration of authorization has not been exceeded (refer to Section I); AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion-related reactions, severe immune-mediated adverse reactions (e.g., pneumonitis, hepatotoxicity and hepatitis, colitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions/rash, etc.), complications of allogeneic hematopoietic stem cell transplantation (HSCT), etc.

5. Dosage/Administration ^{Δ 1,9-13}

6. Billing Code/Availability Information

HCPCS Code:

• J3263 – Injection, toripalimab-tpzi, 1 mg; 1 billable unit = 1 mg

NDC:

• Loqtorzi 240 mg/6 mL solution in a single-dose vial: 70114-0340-xx

7. References

1. Loqtorzi [package insert]. Redwood City, CA; Coherus BioSciences, Inc.; October 2024. Accessed March 2025.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) toripalimab-tpzi. National Comprehensive Cancer Network, 2025. 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 March 2025.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Head and Neck Cancers. Version 2.2025. National Comprehensive Cancer Network, 2025. 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 March 2025.
4. Mai HQ, Chen QY, Chen D, et al. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial [published correction appears in Nat Med. 2022 Jan;28(1):214]. Nat Med. 2021;27(9):1536-1543. doi:10.1038/s41591-021-01444-0
5. Wang FH, Wei XL, Feng J, et al. Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02). J Clin Oncol. 2021;39(7):704-712. doi:10.1200/JCO.20.02712
6. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
7. Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from https://www.hoparx.org/documents/65/HOPA_Drug_Waste_Issue_Brief_-_Updated_01.19.22_FINAL.pdf
8. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
9. Hai-Qiang Mai et al., Final overall survival analysis of JUPITER-02: A phase 3 study of toripalimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC). JCO 41, 6009-6009(2023). DOI:10.1200/JCO.2023.41.16_suppl.6009.
10. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Small Bowel Adenocarcinoma. Version 2.2025. National Comprehensive Cancer Network, 2025. 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 March 2025.
11. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Anal Carcinoma. Version 2.2025. National Comprehensive Cancer Network, 2025. 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 March 2025.
12. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Colon Cancer. Version 1.2025. National Comprehensive Cancer Network, 2025. 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 March 2025.
13. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Rectal Cancer. Version 1.2025. National Comprehensive Cancer Network, 2025. 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 March 2025.

Appendix 1 – Covered Diagnosis Codes

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