ModifiedCentenePolicy CP.PHAR.668

Toripalimab-tpzi (Loqtorzi) coverage

Defines medical necessity criteria, dosing, and authorization requirements for toripalimab-tpzi (Loqtorzi) for Centene-affiliated health plans, affecting providers requesting coverage for adult members in Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyToripalimab-tpzi (Loqtorzi) coverage

Policy CodePolicy CP.PHAR.668

Change TypeMaterial updates — off-label indications addedapproval duration and coding revised

Effective DateMar 1, 2024

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation showing diagnosis, oncologist involvement, age ≥18, disease status, prior PD-(L)1 exposure, and dosing that matches an approved or guideline-supported regimen.

SourceLink

POLICY UPDATE CHANGES

Added NCCN recommended off-label indications for anal carcinoma, small bowel adenocarcinoma, appendiceal neoplasms and cancers, colon cancer and rectal cancer.

Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition.

Added HCPCS code J3263 (injection, toripalimab-tpzi, 1 mg) and removed miscellaneous J3590/C9399 entries.

2FDA approved indications

240 mg q3w / 3 mg/kg q2wPrimary dosing regimens

J3263HCPCS code

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Coverage Criteria

Initial Therapy — Advanced Nasopharyngeal Carcinoma

Covered when ALL of the following are met

Initial Approval - NPC: 1. Diagnosis of nasopharyngeal carcinoma (NPC); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Disease is unresectable, recurrent, or metastatic; 5. Loqtorzi is prescribed in one of the following ways: (a) in combination with cisplatin and gemcitabine, or (b) as a single agent for disease that has progressed on or after platinum-containing chemotherapy; 6. Member has not received prior treatment with an anti-PD-(L)1 antibody; 7. Requested dose matches one of the following: (a) combination with cisplatin and gemcitabine: 240 mg every three weeks; (b) single-agent after platinum progression: 3 mg/kg IV every two weeks; or (c) a dose supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN; approval duration varies by line of business (Medicaid/HIM 12 months; Commercial 6 months or to renewal).

Operational: Prescriber must submit documentation (e.g., office notes, labs) supporting diagnosis, prior therapy history, and that member meets the criteria above.

Prior authorization is required and governed by plan medical necessity processes.

Initial Therapy — NCCN Recommended Off-Label Indications

Covered when ALL of the following are met for NCCN-recommended off-label indications

Initial Approval - NCCN Off-label: 1. Diagnosis of one of the following: (a) anal carcinoma; OR (b) a cancer with dMMR/MSI-H or POLE/POLD1 ultra-hypermutated phenotype (examples: small bowel adenocarcinoma, appendiceal neoplasms/cancers, colon cancer, rectal cancer); 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age ≥ 18 years; 4. Prescribed as a single agent; 5. For anal carcinoma: disease is metastatic, recurrent, or progressive and therapy is either (i) prior to proceeding to abdominoperineal resection, or (ii) second-line or subsequent therapy; 6. Dose is within the FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).TMB > 50 mut/Mb noted as an example of ultra-hypermutated phenotype

Prescribed regimen must be FDA-approved or recommended by NCCN; provider must submit evidence when relying on guideline or literature support.

Operational: Prescriber must provide documentation (e.g., pathology, biomarker testing, clinical notes) to support the off-label indication and any guideline/literature justification for dosing when applicable.

Prior authorization required; coverage subject to plan medical necessity rules.

Continuation Therapy

Covered for continuation when ALL of the following are met

Continued Therapy: 1. Member is currently receiving Loqtorzi via the Centene benefit, or documentation shows the member has received Loqtorzi for at least 30 days for a covered indication; 2. Member is responding positively to therapy as documented by the prescriber; 3. If the request is for a dose increase, the new dose meets one of the following: (a) for combination with cisplatin and gemcitabine: does not exceed 240 mg every 3 weeks and total duration for the combination does not exceed 24 months; (b) as a single agent: does not exceed 3 mg/kg every 2 weeks; (c) new dose is within the FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Maximum duration for combination noted: up to 24 months

Prescribed regimen must be FDA-approved or recommended by NCCN; documentation supporting continued benefit is required for reauthorization.

Requests for uses of toripalimab-tpzi (Loqtorzi) that are non‑FDA approved and not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or unless an evidence of coverage document permits coverage.

Coverage of toripalimab-tpzi is governed by the terms of the member’s benefit plan. All authorization and payment decisions are subject to the terms, conditions, exclusions, and limitations contained in the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance), applicable state and federal requirements, and Health Plan administrative policies and procedures. This clinical policy provides guidance on medical necessity but does not guarantee payment.

Uses of toripalimab-tpzi that are non‑FDA approved and not addressed in this policy are considered not authorized (not medically necessary) under this policy unless the provider supplies sufficient supporting documentation per the Health Plan’s off‑label use policies referenced above. Providers should follow plan-level PA processes and exercise professional medical judgment when requesting coverage for off‑label indications.

Covered Regimens and Dosing

Regimen	Indication	Dose / Schedule	Maximum Duration	Coverage
{"text":"Toripalimab in combination with cisplatin and gemcitabine","status":"","}
{"text":"First-line treatment for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC)","status":"","}
{"text":"240 mg IV every 3 weeks","status":"","}
{"text":"Up to 24 months","status":"","}
{"text":"Covered with criteria","status":"covered","}

Regimen	Indication	Dose / Schedule	Maximum Duration	Coverage
{"text":"Toripalimab as a single agent","status":"","}
{"text":"Previously treated recurrent unresectable or metastatic NPC after progression on platinum-containing chemotherapy","status":"","}
{"text":"3 mg/kg IV every 2 weeks","status":"","}
{"text":"Not specified (continuation criteria apply)","status":"","}
{"text":"Covered with criteria","status":"covered","}

Coding

Referenced HCPCS CodesHCPCS

J3263

Injection, toripalimab-tpzi, 1 mg

Tumor mutational burden — key biomarker threshold (inv-08)

TMB thresholdTumor mutational burden (TMB) greater than 50 mutations per megabase (TMB > 50 mut/Mb)

Context of useExample threshold used to define ultra-hypermutated phenotype in dMMR/MSI-H or POLE/POLD1 mutated tumors

Relevant tumor types (examples)Small bowel adenocarcinoma; appendiceal neoplasms/cancers; colon cancer; rectal cancer (listed as examples of ultra-hypermutated tumors)

Line of Therapy

first-line

First-line NPC: Loqtorzi in combination with cisplatin and gemcitabine for first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC).

Dose: 240 mg every 3 weeks; combination duration noted up to 24 months.

second-line

Second-line/Subsequent-line NPC: Loqtorzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

Dose: 3 mg/kg IV every 2 weeks.

Biomarker Requirements

dMMR/MSI-H; POLE/POLD1; TMB — biomarker requirements and examples (inv-22)

Required biomarkersDeficient mismatch repair/microsatellite instability‑high (dMMR/MSI‑H) OR POLE/POLD1 mutation with ultra‑hypermutated phenotype

Example quantitative thresholdTumor mutational burden (TMB) > 50 mut/Mb cited as an example for the ultra‑hypermutated phenotype

Tumor examples where this appliesSmall bowel adenocarcinoma; appendiceal neoplasms and cancers; colon cancer; rectal cancer

Prescribing requirementsPrescribed by or in consultation with an oncologist or hematologist; age ≥ 18 years; prescribed as a single agent for these off‑label uses

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must demonstrate the diagnosis, that the prescription was made by or in consultation with an oncologist, the member meets age and disease-status criteria, and that prior anti‑PD-(L)1 therapy rules are met (member has not received prior anti‑PD-(L)1 antibody for initial approval).

Prior authorization governed by the Health Plan's medical necessity guidelines and coverage documents.
Member must not have received prior anti‑PD-(L)1 therapy for initial approval (see Initial Approval Criteria I.A.6).

Documentation Required

Required Supporting Documentation

Providers must submit supporting clinical documentation such as office chart notes, laboratory results, and other relevant clinical information to show the member meets all approval criteria.

Acceptable documentation includes office notes, labs, and other clinical information demonstrating criteria are met.

Definitions

Nasopharyngeal Carcinoma (NPC) — definition / label (inv-18)

AbbreviationNPC

TermNasopharyngeal Carcinoma

Appendix locationDefined in Appendix A: Abbreviation/Acronym Key

Health Plan — definition / label (inv-19)

TermHealth Plan

Definition summaryA health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

Policy role

Background

Toripalimab-tpzi (Loqtorzi) is a programmed cell death protein‑1 (PD‑1) blocking monoclonal antibody. It is indicated for adults as: (1) first‑line therapy in combination with cisplatin and gemcitabine for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and (2) single‑agent therapy for recurrent unresectable or metastatic NPC after progression on platinum‑containing chemotherapy. The Health Plan’s clinical policy incorporates these FDA‑approved indications and also recognizes certain NCCN‑recommended off‑label uses (including examples of ultra‑hypermutated tumors) when criteria and required supporting evidence are met.