CurrentCentenePolicy CP PHAR.668

Toripalimab-tpzi (Loqtorzi) — Nasopharyngeal Carcinoma Coverage Criteria

Defines medical necessity and prior authorization requirements for coverage of toripalimab-tpzi (Loqtorzi) for treatment of nasopharyngeal carcinoma across Centene lines of business (Commercial, HIM, Medicaid). Applies to providers requesting coverage under Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyToripalimab-tpzi (Loqtorzi) — Nasopharyngeal Carcinoma Coverage Criteria

Policy CodePolicy CP PHAR.668

Change TypeNo material change

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionPrior authorization required; submit documentation demonstrating member meets initial or continued therapy criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J3263HCPCS code added for toripalimab-tpzi

240 mg q3wFirst-line dosing

3 mg/kg q2wSingle-agent dosing

24 moMax duration (1L)

12 moApproval duration (Medicaid/HIM)

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Coverage Criteria for Toripalimab-tpzi (Loqtorzi)

Initial Therapy

Covered when ALL of the following are met for Initial Approval — Advanced Nasopharyngeal Carcinoma:

Diagnosis of nasopharyngeal carcinoma (NPC)

Disease stage: Disease is unresectable, recurrent, or metastatic

Prescriber: Prescribed by or in consultation with an oncologist

Regimen: Requested regimen is one of the following FDA‑approved options: (a) Toripalimab in combination with cisplatin and gemcitabine: 240 mg IV every 3 weeks (first‑line), up to 24 months; or (b) Toripalimab as a single agent for disease progressed on or after platinum‑containing chemotherapy: 3 mg/kg IV every 2 weeks.

Prescribed regimen must be FDA‑approved or recommended by NCCN; off‑label dosing must be supported by practice guidelines or peer‑reviewed literature (provider must submit supporting evidence).

Age: Member is >= 18 years

Prior anti-PD-(L)1 therapy: Member has not previously received treatment with an anti‑PD‑(L)1 antibody for initial approval

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy:

Current receipt: Member is currently receiving Loqtorzi via the Centene benefit, or documentation shows member has received Loqtorzi for at least 30 days for a covered indication

Clinical benefit: Member is responding positively to therapy

Continuation dosing and duration: Continuation dosing matches allowed regimens: combination therapy 240 mg IV every 3 weeks (first‑line) — total maximum up to 24 months; or single‑agent 3 mg/kg IV every 2 weeksDuration: Medicaid/HIM 12 months; Commercial 6 months or to member renewal date, whichever is longer

Requests for use of toripalimab‑tpzi (Loqtorzi) for Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the request is supported by documentation demonstrating efficacy and safety in accordance with the referenced off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53).

Use of toripalimab‑tpzi for indications not listed in this policy is not authorized unless there is sufficient supporting evidence per the off‑label use policies cited above; such requests must include documentation that meets the criteria described in those off‑label policies to be considered for coverage.

Dosing Regimens and Indications

Regimen	Indication / Line of Therapy	Dosage / Schedule	Maximum Duration	Coverage Status
Toripalimab + cisplatin + gemcitabine
First-line treatment of metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC)
Toripalimab 240 mg IV every 3 weeks (administered in combination with cisplatin and gemcitabine)
Up to 24 months
Covered with criteria

Regimen	Indication / Line of Therapy	Dosage / Schedule	Prior Therapy Requirement	Coverage Status
Toripalimab (single agent)
Previously treated unresectable or metastatic nasopharyngeal carcinoma (NPC)
Toripalimab 3 mg/kg IV every 2 weeks as a single agent
Progression on or after platinum-containing chemotherapy required
Covered with criteria

Billing and Code References

HCPCS CodesHCPCSCovered

J3263

Injection, toripalimab-tpzi, 1 mg

Previously referenced/removed HCPCS CodesHCPCS

J3590	Unclassified biologics (removed)
C9391	Not otherwise classified, antineoplastic drugs (removed)

inv-07: Maximum duration for first-line combination therapy

Maximum durationUp to 24 months for first-line combination therapy (toripalimab 240 mg IV every 3 weeks with cisplatin + gemcitabine)

Regimen dosingToripalimab 240 mg IV every 3 weeks when used in combination for first-line treatment

Applies toAdults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) receiving first-line combination therapy

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required — demonstrate criteria are met

Prior authorization is required. The provider must demonstrate the member meets the policy's initial or continued therapy criteria for Loqtorzi, including diagnosis of nasopharyngeal carcinoma, disease that is unresectable/recurrent/metastatic, appropriate prescriber (oncologist), and the requested regimen (combination or single‑agent) per the policy.

Ensure the request documents diagnosis of NPC and disease stage (unresectable, recurrent, or metastatic).
Document prescriber is an oncologist or consultation with an oncologist.
Specify the requested regimen (240 mg q3w with cisplatin + gemcitabine for first‑line or 3 mg/kg q2w single agent after platinum progression).

Step Therapy

Step therapy not defined — approvals based on criteria

This policy is not implemented as a step‑therapy rule; approvals are based on meeting the documented initial or continued therapy criteria, including prior platinum‑containing chemotherapy for single‑agent use when applicable.

Single‑agent toripalimab requires disease progression on or after platinum‑containing chemotherapy per the policy.

Documentation Required

Required supporting documentation

Submit supporting clinical documentation with the prior authorization request — office chart notes, laboratory results, or other clinical information that verify the member meets all approval criteria.

Include documentation of diagnosis, disease stage, prior therapies, and prescriber specialty.
Provide regimen details and evidence if requesting off‑label dosing (guideline or peer‑reviewed support).

Denial Risk

Non‑FDA indications require supporting evidence

Requests for non‑FDA approved indications that are not addressed in this policy are not authorized unless sufficient documentation supports the off‑label use per the referenced off‑label use policies.

Off‑label requests must include evidence of efficacy and safety consistent with CP.CPA.09 (Commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid).
Prescribed regimen must be FDA‑approved or recommended by NCCN; off‑label dosing requires supporting guideline or peer‑reviewed literature.

Denial Risk

Insufficient documentation may lead to denial or info request

Insufficient documentation that the member meets all approval criteria (diagnosis, disease stage, prior therapy, prescriber specialty) may result in denial or a request for additional information.

Failures to document current receipt for continuation requests (≥30 days) or lack of evidence of prior platinum chemotherapy when required can trigger denial.
Provide clear evidence of clinical benefit for continuation requests per policy requirements.

Definitions

inv-14: Nasopharyngeal carcinoma (NPC)

DefinitionNasopharyngeal carcinoma (NPC) is a head and neck cancer arising in the nasopharynx; policy addresses advanced, unresectable, recurrent, or metastatic disease.

Covered disease statesAdvanced, unresectable, recurrent, or metastatic NPC

Relevant FDA indicationsFirst-line combination therapy and single-agent use for recurrent unresectable/metastatic disease after platinum-containing chemotherapy

inv-15: Toripalimab-tpzi (Loqtorzi)

Drug classProgrammed death receptor-1 (PD-1) blocking monoclonal antibody

Proprietary nameToripalimab-tpzi (Loqtorzi)

Indications referenced in policyUsed per FDA indications for NPC as described in this policy (combination and single-agent settings)

Line of Therapy Definitions

first-line

First-line: Toripalimab in combination with cisplatin and gemcitabine for adults with metastatic or recurrent locally advanced NPC (240 mg IV every 3 weeks)Up to 24 months

FDA‑approved indication

second-line

Second-line/Previously treated: Single‑agent toripalimab for adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum‑containing chemotherapy (3 mg/kg IV every 2 weeks)

FDA‑approved indication

Background

Toripalimab‑tpzi (Loqtorzi) is a programmed death receptor‑1 (PD‑1) blocking monoclonal antibody. The U.S. Food and Drug Administration approves Loqtorzi for two indications in nasopharyngeal carcinoma (NPC): (1) in combination with cisplatin and gemcitabine for first‑line treatment of adults with metastatic or recurrent locally advanced NPC (dosage: 240 mg IV every 3 weeks, up to 24 months), and (2) as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum‑containing chemotherapy (dosage: 3 mg/kg IV every 2 weeks).