CurrentEmblemHealthPolicy N/A

Loqtorzi (toripalimab-tpzi) clinical guideline

Defines accepted indications, usage rules, coding, and exclusion criteria for Loqtorzi (toripalimab-tpzi) for cancer treatment requests processed by Evolent on behalf of the payer network. Applies to network ordering providers and specific lines of business listed.

Policy Summary

PayerEmblemHealth

PolicyLoqtorzi (toripalimab-tpzi) clinical guideline

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for medication requests processed by Evolent; continuation requests may be exempt when the member has not progressed and other criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J3263HCPCS code

240 mgdose limit (combination)

3 mg/kgdose limit (single-agent)

Commercial, Exchange, Medicaidlines of business

Coverage Criteria for Loqtorzi (toripalimab-tpzi)

Policy Summary

PayerEmblemHealth

PolicyLoqtorzi (toripalimab-tpzi) clinical guideline

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for medication requests processed by Evolent; continuation requests may be exempt when the member has not progressed and other criteria are met.

SourceLink

On This Page

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First-line combination for NPC: Patient is an adult with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC) AND therapy is Loqtorzi (toripalimab-tpzi) combined with cisplatin or carboplatin and gemcitabine.

Based on FDA-approved indication per guideline.

Single-agent for recurrent/metastatic NPC after platinum: Patient is an adult with recurrent unresectable or metastatic NPC AND disease progression on or after platinum-containing chemotherapy AND therapy is single-agent Loqtorzi (toripalimab-tpzi).

Second-line/salvage indication.

Requests for Loqtorzi (toripalimab-tpzi) may be excluded from coverage when any of the following apply: disease progression while taking Loqtorzi; dosing that exceeds single-dose limits — specifically 240 mg when given in combination with cisplatin or carboplatin and gemcitabine, or 3 mg/kg when used as a single agent; or prior treatment with other immune checkpoint inhibitors. Prior authorization remains required for medication requests processed by Evolent; continuation requests may be considered when the member has not progressed, has had continuous use without a >30‑day lapse, and no new agents are being added (see provider authorization guidance).

Use of Loqtorzi for indications that are investigational or off‑label is not acceptable for authorization unless the request is supported by adequate evidence. Adequate evidence is defined by reference to CMS‑recognized compendia or acceptable peer‑reviewed literature and requires that the clinical characteristics of the patient and the cancer, the administered regimen, and reported study outcomes are appropriately represented. Generally, clinically meaningful outcomes follow ASCO recommendations (for example, hazard ratio < 0.80 and survival benefit for OS or PFS of at least 3 months). Non‑randomized trials with substantial subject numbers may provide supportive evidence, whereas case reports and meeting abstracts without a full peer‑reviewed article are inadequate.

Covered Regimens and Indications

Regimen	Indication	Billing code / units	Single-dose limit	Coverage
Loqtorzi (toripalimab-tpzi) in combination with cisplatin or carboplatin and gemcitabine	First-line treatment of adult members with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC)	J3263 - Injection, toripalimab-tpzi, 1 mg (bill per mg)	240 mg (single-dose limit when used in combination)	Covered

Regimen	Indication	Billing code / units	Single-dose limit	Coverage
Loqtorzi (toripalimab-tpzi) as single agent	Recurrent unresectable or metastatic NPC in adults with disease progression on or after platinum-containing chemotherapy	J3263 - Injection, toripalimab-tpzi, 1 mg (bill per mg)	3 mg/kg (single-agent single-dose limit)	Covered

Line of Therapy Criteria

first-line

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

second-line

Second-line/salvage: Single-agent Loqtorzi (toripalimab-tpzi) for recurrent unresectable or metastatic NPC for adult patients with disease progression on or after platinum-containing chemotherapy.

Provider Actions, Authorization, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for all medication requests for Loqtorzi (toripalimab-tpzi) processed by Evolent. Requests must be submitted before therapy initiation. Continuation (renewal) requests may be exempt from re‑authorization when ALL of the following are met: the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

Prior authorization mandatory for initial requests processed by Evolent
Continuation exemption allowed when all listed conditions are met

Documentation Required

Required Supporting Evidence and Documentation

Providers must ensure documentation supports use of Loqtorzi per accepted evidence sources: FDA labeling, CMS‑recognized compendia, NCCN or ASCO guidelines, or peer‑reviewed literature that meets CMS standards. Include clinical rationale, prior treatment history, evidence citations, and documentation of response or lack of progression for continuation requests.

Supportive evidence: FDA label, CMS compendia, NCCN/ASCO, or CMS‑standard peer‑reviewed literature
Provide clinical rationale, prior therapies, and objective response/progression status for continuation

Note

Provider Action Items

Action items for providers when submitting authorization requests or continuations.

Submit prior authorization to Evolent before initiating therapy
Attach supporting evidence (FDA label, CMS compendia, NCCN/ASCO, or qualifying peer‑reviewed literature)
For continuation requests, document no disease progression and verify prior authorization was active within the past year with ≤30‑day lapse
Do not add new medications to a continuation request — submit a new authorization if regimen changes are made
Include dosing information and ensure requested dose does not exceed specified single‑dose limits

Denial Risk

Triggers for Denial / Exclusion

Denial or exclusion may be triggered when any of the following apply: documented disease progression on Loqtorzi; requested dosing exceeds single‑dose limits (240 mg when combined with cisplatin or carboplatin and gemcitabine, or 3 mg/kg as a single agent); prior treatment with other immune checkpoint inhibitors; investigational or off‑label use lacking sufficient evidence per CMS compendia or acceptable peer‑reviewed literature; or supporting evidence is inadequate (e.g., only case reports or abstracts without full peer‑reviewed publication).

Disease progression while on therapy
Requested single dose exceeds 240 mg (with specified chemo) or 3 mg/kg (single agent)
Prior treatment with immune checkpoint inhibitors
Off‑label/ investigational use without CMS‑recognized compendia or adequate peer‑reviewed evidence
Evidence limited to case reports or abstracts without full peer‑reviewed article

Definitions and Regimen Descriptions

Definition — First-line combination regimen

Indication termLoqtorzi (toripalimab-tpzi) with cisplatin or carboplatin and gemcitabine for first-line treatment.

PopulationAdult members with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC).

Line of therapyFirst-line treatment for metastatic or recurrent, locally advanced NPC.

Definition — Single-agent regimen

Indication termLoqtorzi (toripalimab-tpzi) as a single agent for recurrent unresectable or metastatic NPC.

Required disease statusDisease progression on or after platinum-containing chemotherapy.

PopulationAdult members with recurrent unresectable or metastatic nasopharyngeal carcinoma (NPC).

Background

Toripalimab (Loqtorzi) is an immune checkpoint inhibitor used in the treatment of nasopharyngeal carcinoma (NPC). The policy defines both a first‑line combination indication — Loqtorzi given with cisplatin or carboplatin and gemcitabine for metastatic or recurrent, locally advanced NPC — and a single‑agent indication for recurrent unresectable or metastatic disease after progression on platinum‑containing chemotherapy. Coverage and dosing limits are guided by the FDA‑labeled regimens and the single‑dose thresholds specified in this policy.

OpenPayer