CurrentViva HealthPolicy IC-0735

Loqtorzi (toripalimab-tpzi) prior authorization and coverage criteria

Coverage and prior authorization criteria for intravenous Loqtorzi (toripalimab-tpzi) for oncology indications, including dosing, authorization length, and indication-specific medical necessity requirements for Viva Health members.

Policy Summary

PayerViva Health

PolicyLoqtorzi (toripalimab-tpzi) prior authorization and coverage criteria

Policy CodePolicy IC-0735

Change TypeNo material clinical or coverage changes

Effective Date12/07/2023

Next Review Date

Key ActionObtain prior authorization (initial validity 6 months, renewable every 6 months; document dosing and submit an appropriate ICD-10 diagnosis code).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial prior authorization validity

480Max billable units/2 weeks

24 moMax renewal for H&N with chemo

J3263HCPCS code

240 mg vialNDC presentation

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Coverage and Medical Necessity Criteria

Universal Criteria

Covered when ALL of the following are met

Universal requirements: Member is at least 18 years of age

PD-1/PD-L1 therapy-naive: Member has not received previous therapy with a PD-1/PD-L1-directed therapy

Prior receipt of PD-1/PD-L1-directed therapy is excluded from initial approval

Head and Neck Cancers

Head and Neck Cancers (Nasopharynx and Very Advanced H&N)

Nasopharynx — first-line, combination: Member has cancer of the nasopharynx AND used as first-line therapy AND member has metastatic OR recurrent, locally advanced disease AND used in combination with cisplatin and gemcitabine

Nasopharynx — subsequent-line, single agent or combination: Member has cancer of the nasopharynx AND used as subsequent therapy for recurrent unresectable or metastatic disease AND used as single-agent therapy after disease progression on or after a platinum-containing chemotherapy regimen OR used in combination with cisplatin and gemcitabine for metastatic disease

Very Advanced Head and Neck Cancer: Member has Very Advanced Head and Neck Cancer (includes newly diagnosed locally advanced T4b N0-3, newly diagnosed unresectable regional nodal disease, unfit for surgery, metastatic disease at presentation (M1), or recurrent/persistent disease) AND member has nasopharyngeal cancer AND used either as single agent (alternate subsequent-line after progression on platinum-containing therapy) OR in combination with cisplatin and gemcitabine AND member has performance status 0-1

Small Bowel Adenocarcinoma

Small bowel MSI-H/dMMR or POLE/POLD1: Used as single agent treatment AND member 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 test AND member has advanced or metastatic disease OR locally unresectable or medically inoperable disease AND used as primary treatmentTMB >50 mut/Mb example

Anal Carcinoma

Anal carcinoma coverage: Member has squamous cell carcinoma AND used as a single agent as subsequent therapy for metastatic disease OR used in combination with paclitaxel and carboplatin then continued as a single agent AND used for treatment of inguinal node recurrence OR used as first-line treatment for metastatic disease

Colon Cancer

Colon MSI-H/dMMR or POLE/POLD1: Used as single agent treatment AND member 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 test AND used for locally unresectable, medically inoperable, advanced, or metastatic diseaseTMB >50 mut/Mb example

Appendiceal Neoplasms and Cancers

Appendiceal MSI-H/dMMR or POLE/POLD1: Used as single agent treatment AND member 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 test AND used for recurrent, progressive, metastatic peritoneal-only, or extraperitoneal disease

Rectal Cancer

Rectal MSI-H/dMMR or POLE/POLD1: Used as single agent treatment AND member 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 test AND used for locally unresectable, medically inoperable, advanced or metastatic disease

For initial approval, the member must be PD-1/PD-L1 therapy–naïve. Specifically, the member must not have received prior therapy with a programmed death (PD-1/PD-L1)–directed agent.

The policy statements above are intended for non‑Medicare coverage determinations. Where applicable, Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs), and the Medicare Benefit Policy Manual (Pub. 100‑02, Chapter 15 §50) take precedence and must be followed; use the CMS Medicare Coverage Database to locate any relevant NCD/LCD/LCA.

Renewal of prior authorization will not be supported if the member demonstrates unacceptable toxicity to toripalimab‑tpzi or if there is no disease response. Renewal requires continued meeting of applicable criteria, that the authorization duration has not been exceeded, and documentation of disease stabilization or decrease in tumor size/spread. Examples of unacceptable toxicity include severe infusion‑related reactions, severe immune‑mediated adverse events (e.g., pneumonitis, hepatotoxicity/hepatitis, colitis, endocrinopathies, nephritis with renal dysfunction, severe dermatologic reactions), and complications of allogeneic HSCT.

Dosing Regimens and Authorized Treatment Courses

Regimen	Dose/Schedule	Indication	Coverage
Combination therapy with cisplatin and gemcitabine	240 mg IV every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months	Head and neck cancers (including nasopharyngeal carcinoma) as combination regimen	Covered

Regimen	Dose/Schedule	Indication	Coverage
Single‑agent toripalimab	3 mg/kg IV every 2 weeks until disease progression or unacceptable toxicity (up to 24 months where specified)	Head and neck cancers (single‑agent use)	Covered

Regimen	Dose/Schedule	Indication	Coverage
Combination with paclitaxel and carboplatin, then continuation as single agent	3 mg/kg IV on day 1 and 15 of a 28‑day cycle with paclitaxel and carboplatin for 6 cycles, then continued as single agent for up to 7 additional cycles, until disease progression or unacceptable toxicity	Anal carcinoma (squamous cell) for indicated settings	Covered

Regimen	Dose/Schedule	Indication	Coverage
Single‑agent toripalimab (general/other indications)	3 mg/kg IV every 2 weeks until disease progression or unacceptable toxicity	All other labeled or compendium‑supported indications not otherwise specified above	Covered

Study	Regimen	Setting	Notes / Reference
JUPITER‑02 (Hai‑Qiang Mai et al., JCO 2023)	Toripalimab in combination with gemcitabine and cisplatin	First‑line treatment for recurrent or metastatic nasopharyngeal carcinoma	Final overall survival analysis cited (JCO abstract); referenced in policy references section

Billing Codes and Diagnosis Mapping

Covered HCPCS CodesHCPCSCovered

J3263

Injection, toripalimab-tpzi, 1 mg; 1 billable unit = 1 mg

NDCNDC

70114-0340-xx

Loqtorzi 240 mg/6 mL solution in a single-dose vial

Covered ICD-10 Diagnosis CodesICD-10Covered

C11.0	Malignant neoplasm of superior wall of nasopharynx.
C11.1	Malignant neoplasm of posterior wall of nasopharynx.
C11.2	Malignant neoplasm of lateral wall of nasopharynx
C11.3	Malignant neoplasm of anterior wall of nasopharynx.
C11.8	Malignant neoplasm of overlapping sites of nasopharynx.
C11.9	Malignant neoplasm of nasopharynx, unspecified.
C14.0	Malignant neoplasm of pharynx, unspecified.
C14.2	Malignant neoplasm of Waldeyer's ring.
C17.0	Malignant neoplasm of duodenum.
C17.1	Malignant neoplasm of jejunum.

1–10 of 46

1/5

Medicare Part B Covered Diagnosis CodesICD-10

No codes listed

Maximum HCPCS units — billing threshold

Maximum HCPCS units480 billable units every 2 weeks

Authorization, Documentation, and Denial Risk

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial prior authorization validity will be provided for 6 months (180 days) and may be renewed every 6 months (180 days) thereafter unless otherwise specified. NOTE: For some indications there are maximum renewal limits (e.g., Head and Neck cancers in combination with chemotherapy: renewals up to a maximum of 24 months [35 total doses]; Anal carcinoma in combination with chemotherapy then continued as single agent: renewals up to a maximum of 12 months [26 total doses]).

Initial PA validity: 6 months (180 days).
Renewal frequency: every 6 months (180 days) unless otherwise specified.
Indication-specific maximums: Head & Neck cancers — up to 24 months (35 doses); Anal carcinoma — up to 12 months (26 doses).

Billing Rule

Dosing and Billing Documentation

Providers should document the dosing regimen administered and the associated billing identifiers for the drug. Include the specific dosing schedule per indication and the HCPCS and NDC when submitting claims.

Document the dosing regimen and treatment intent (combination vs single-agent).
HCPCS: J3263 - Injection, toripalimab-tpzi, 1 mg (1 billable unit = 1 mg).
NDC: Loqtorzi 240 mg/6 mL vial — 70114-0340-xx.

Documentation Required

Required Diagnosis Coding

Submit an appropriate ICD-10 diagnosis code from Appendix 1 that matches the member's malignant neoplasm. The submitted diagnosis must correspond to one of the listed covered diagnosis codes.

Examples of covered ICD-10 codes include (not exhaustive): C11.0–C11.9 (nasopharynx), C14.0, C18.0–C18.9, C20, C21.0–C21.2, C30.0, C31.0–C31.1, C78.00–C78.02, C78.6–C78.7, C79.89, D37.05, D37.3, D38.5–D38.6, Z85.038, Z85.068, Z85.818.

Denial Risk

Renewal Denial Triggers

Renewal of prior authorization may be denied if any of the following are present: duration of authorization has been exceeded, unacceptable toxicity has occurred, or there is lack of disease response.

Denial triggers include: authorization duration exceeded (see Section I).
Unacceptable toxicity such as severe infusion-related reactions or severe immune-mediated adverse events (e.g., pneumonitis, hepatotoxicity/hepatitis, colitis, endocrinopathies, nephritis, severe dermatologic reactions).
Lack of disease response — no stabilization or decrease in tumor size/spread.

Note

NQTL-driven Prior Authorization Consideration

Prior authorization may be applied due to non-quantitative treatment limitation (NQTL) factors considered during policy design. Indication and cost were identified as factors supporting consideration for prior authorization.

NQTL checklist conclusions: Indication — consider for PA. Cost of drug — consider for PA. Safety/efficacy and potential for misuse/abuse were not identified as primary PA drivers.
Utilization management (e.g., PA) is applied comparably across MH/SUD and M/S benefits.

Step Therapy

Step therapy: no specific step therapy requirements are defined in this appendix. Providers should follow any applicable plan-wide step therapy programs if present; absent those, prior authorization requirements and the criteria in this policy govern coverage.

No indication-specific step therapy steps are provided in this appendix.
If plan-level step therapy programs exist, they remain applicable and may require adherence in addition to this policy's PA criteria.

Key Terms and Clinical Definitions

Very Advanced Head and Neck Cancer — definition & inclusion criteria

DefinitionVery Advanced Head and Neck Cancer includes: newly diagnosed (M0) locally advanced T4b, N0-3; newly diagnosed unresectable regional nodal disease; or those unfit for surgery; metastatic disease at initial presentation (M1); or recurrent or persistent disease with or without distant metastases.

Inclusion—nasopharyngeal siteMember has nasopharyngeal cancer and disease meets criteria for Very Advanced Head and Neck Cancer.

Use casesAllowed as single-agent (alternate subsequent-line after progression on platinum therapy) or in combination with cisplatin and gemcitabine (requires performance status 0–1 when used with chemotherapy).

Specific clinical scenariosUnresectable locoregional recurrence, unresectable second primary, unresectable persistent disease after prior radiation, or recurrent/persistent disease with distant metastases.

Non-Quantitative Treatment Limitations (NQTL) — description

NQTL definitionMethods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan (e.g., utilization review or prior authorization).

Examples of methodsUtilization review and prior authorization processes used to determine access and duration of therapy.

Factors considered for PAIndication and drug cost were identified as reasons to consider prior authorization; safety/efficacy and potential for misuse were not prioritized for PA in the checklist.

Parity noteUtilization management NQTLs apply comparably to MH/SUD and medical/surgical prescription drugs (not more stringently).

Biomarker and Molecular Testing Requirements

MSI-H / dMMR — biomarker requirements

MarkerMSI-H (microsatellite instability-high) / dMMR (mismatch repair deficient)

Required indicationsRequired for small bowel adenocarcinoma, colon cancer, appendiceal neoplasms, and rectal cancer when used as single-agent therapy per policy criteria.

Test standardsMust be determined by an FDA-approved or CLIA-compliant test.

Clinical useUse applies when disease is advanced, metastatic, locally unresectable, or medically inoperable, per the specific cancer type criteria.

POLE / POLD1 mutation (ultra-hypermutated) — biomarker requirements

MarkerPOLE/POLD1 mutation with ultra-hypermutated phenotype

TMB example thresholdExample: tumor mutational burden (TMB) >50 mutations per megabase (mut/Mb) as an ultra-hypermutated phenotype.

Required indicationsRequired for small bowel adenocarcinoma, colon cancer, appendiceal neoplasms, and rectal cancer when used as single-agent therapy per policy criteria.

Test standardsMutation status must be determined by an FDA-approved or CLIA-compliant test.

Line of Therapy Designation

first-line | subsequent-line

First-line: Indication used as first-line therapy as specified in the indication-specific criteria (e.g., nasopharynx in combination with cisplatin and gemcitabine)

Subsequent-line: Indication used as subsequent-line therapy as specified (e.g., single-agent after progression on platinum-containing chemotherapy for nasopharynx; single-agent subsequent therapy for metastatic anal squamous cell carcinoma)

Other lines (continued/maintenance): Use as continuation or maintenance following combination induction where specified (e.g., continuation as single agent after combination with paclitaxel and carboplatin for anal carcinoma; continuation after cisplatin and gemcitabine for nasopharynx up to specified duration)

See regimen-specific duration limits in Covered Regimens

Clinical Background and Evidence

Toripalimab‑tpzi (Loqtorzi) is a programmed death‑1 (PD‑1) directed monoclonal antibody used for multiple oncology indications described in this policy, including nasopharyngeal carcinoma and other tumor types where FDA approval or compendia support exists. Use is described both as single‑agent therapy and in combination regimens (for example, with cisplatin and gemcitabine for nasopharyngeal carcinoma).

Policy Revision History

2026-04-01Last reviewLatest

Policy last reviewed on 2026-04-01 as indicated in the document header.

2023-12-07Date of origin

Policy originated on 2023-12-07 (Date of Origin).