CurrentViva Health PlanPolicy IC-0735

Loqtorzi (toripalimab-tpzi) (Intravenous)

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This policy governs prior authorization, medical necessity, dosing, renewal, and billing requirements for intravenous Loqtorzi in adults with specified head and neck, gastrointestinal, and anal cancers.

Policy Summary

PayerViva Health Plan

PolicyLoqtorzi (toripalimab-tpzi) (Intravenous)

Policy CodePolicy IC-0735

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Loqtorzi before treatment; initial approval is generally valid for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial prior authorization validity

18+Minimum age for initial approval

480Maximum units every 2 weeks

5Cancer categories with criteria

24 monthsMaximum head and neck combination renewal

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CurrentViva Health PlanPolicy IC-0735

Loqtorzi (toripalimab-tpzi) (Intravenous)

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Policy Summary

PayerViva Health Plan

PolicyLoqtorzi (toripalimab-tpzi) (Intravenous)

Policy CodePolicy IC-0735

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Loqtorzi before treatment; initial approval is generally valid for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial prior authorization validity

18+Minimum age for initial approval

480Maximum units every 2 weeks

5Cancer categories with criteria

24 monthsMaximum head and neck combination renewal

Medical Necessity and Coverage Criteria

Universal Initial Criteria

Covered for initial approval when all of the following are met:

Universal initial criteria

Age and prior therapy
- Member is at least 18 years of age.Age >=18
- Member has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy.
  Required for initial approval.

Head and Neck Cancers

Covered when one of the applicable head and neck cancer pathways is met:

Applicable treatment pathway

Nasopharyngeal cancer — first-line therapy
- Member has nasopharyngeal cancer with metastatic or recurrent, locally advanced disease.
- Loqtorzi is used in combination with cisplatin and gemcitabine as first-line therapy.
Nasopharyngeal cancer — subsequent therapy
- Member has recurrent unresectable or metastatic nasopharyngeal cancer.
- Permitted regimen
  - ALL of the following
    Loqtorzi is used as single-agent therapy.

Small Bowel Adenocarcinoma

Covered when all of the following are met:

Small bowel adenocarcinoma

Loqtorzi is used as single-agent treatment.
Required biomarker
- Disease is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), determined by an FDA-approved or Clinical Laboratory Improvement Amendments (CLIA)-compliant test.
- Disease has a POLE/POLD1 mutation with an ultra-hypermutated phenotype, determined by an FDA-approved or CLIA-compliant test.TMB >50 mut/Mb is an example
Disease status and treatment setting

Anal Carcinoma

Covered when all applicable conditions are met:

Anal carcinoma

Member has squamous cell carcinoma.
Treatment pathway
- ALL of the following
  - Loqtorzi is used as a single agent as subsequent therapy for metastatic disease.
- ALL of the following
  - Loqtorzi is used in combination with paclitaxel and carboplatin, then continued as a single agent.
  - Indication

Colon Cancer

Covered when all of the following are met:

Colon cancer

Loqtorzi is used as single-agent treatment.
Required biomarker
- Disease is MSI-H or dMMR, determined by an FDA-approved or CLIA-compliant test.
- Disease has a POLE/POLD1 mutation with an ultra-hypermutated phenotype, determined by an FDA-approved or CLIA-compliant test.TMB >50 mut/Mb is an example
Disease is locally unresectable, medically inoperable, advanced, or metastatic.

Appendiceal Neoplasms and Cancers

Covered when all of the following are met:

Appendiceal neoplasms and cancers

Loqtorzi is used as single-agent treatment.
Required biomarker
- Disease is MSI-H or dMMR, determined by an FDA-approved or CLIA-compliant test.
- Disease has a POLE/POLD1 mutation with an ultra-hypermutated phenotype, determined by an FDA-approved or CLIA-compliant test.TMB >50 mut/Mb is an example
Disease status
- Disease is recurrent.

Rectal Cancer

Covered when all of the following are met:

Rectal cancer

Loqtorzi is used as single-agent treatment.
Required biomarker
- Disease is MSI-H or dMMR, determined by an FDA-approved or CLIA-compliant test.
- Disease has a POLE/POLD1 mutation with an ultra-hypermutated phenotype, determined by an FDA-approved or CLIA-compliant test.TMB >50 mut/Mb is an example
Disease is locally unresectable, medically inoperable, advanced, or metastatic.

Renewal Therapy

Renewal requires all of the following:

Renewal criteria

Member continues to meet the universal and other relevant indication-specific criteria.
The duration of authorization has not been exceeded.
Treatment has produced disease stabilization or a decrease in tumor size or tumor spread.Disease stabilization or decreased tumor size or spread
There is no unacceptable toxicity from the drug.
Examples include severe infusion-related reactions; severe immune-mediated adverse reactions such as pneumonitis, hepatotoxicity or hepatitis, colitis, endocrinopathies, nephritis with renal dysfunction, and dermatologic adverse reactions; complications of allogeneic HSCT; and other serious toxicities listed in the policy.

For initial approval, the member must be at least 18 years of age and must not have received prior therapy directed at PD-1/PD-L1. Previous treatment with a PD-1/PD-L1-directed therapy therefore does not meet the universal initial-approval criteria.

Treatment Line Requirements

First-Line Treatment

Covered first-line treatment includes the following applicable pathway:

First-line treatment pathway

Member has metastatic or recurrent, locally advanced nasopharyngeal cancer and receives Loqtorzi in combination with cisplatin and gemcitabine as first-line therapy.First-line therapy

Second-Line Treatment

Covered subsequent therapy includes the following applicable pathways:

Subsequent therapy pathways

Member has recurrent unresectable or metastatic nasopharyngeal cancer, receives single-agent Loqtorzi, and experienced disease progression on or after a platinum-containing chemotherapy regimen.Progression on or after platinum-containing chemotherapy

Required Biomarker Findings

MSI-H/dMMR

Qualifying biomarker statusDisease must be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

Approved testing requirementThe biomarker status must be determined by an FDA-approved or Clinical Laboratory Improvement Amendments (CLIA)-compliant test.

Applicable treatment settingsRequired for single-agent treatment of small bowel adenocarcinoma, colon cancer, appendiceal neoplasms and cancers, or rectal cancer.

POLE/POLD1 Mutation With Ultra-Hypermutated Phenotype

Required mutationA polymerase epsilon/delta (POLE/POLD1) mutation is required for this alternative biomarker pathway.

Ultra-hypermutated phenotypeAn example threshold is tumor mutational burden (TMB) greater than 50 mutations per megabase (mut/Mb).

Eligible Treatment Regimens

Coverage	Indication	Regimen	Key requirements
Covered	Metastatic or recurrent, locally advanced nasopharyngeal cancer	Toripalimab-tpzi in combination with cisplatin and gemcitabine	First-line therapy

Coverage	Indication	Regimen	Key requirements
Covered	Recurrent, unresectable or metastatic nasopharyngeal cancer; or selected very advanced head and neck cancer	Toripalimab-tpzi single-agent therapy	For nasopharyngeal cancer, use after disease progression on or after platinum-containing chemotherapy. For very advanced head and neck cancer, use as an alternate subsequent-line option after progression on or after platinum-containing therapy; applicable disease includes unresectable disease with prior radiation therapy or recurrent/persistent disease with distant metastases.

Coverage	Indication	Regimen	Key requirements
Covered	Metastatic nasopharyngeal cancer or very advanced head and neck cancer	Toripalimab-tpzi in combination with cisplatin and gemcitabine	For nasopharyngeal cancer, combination therapy applies to metastatic disease. For very advanced head and neck cancer, the member must have applicable disease and a performance status of 0–1.

Coverage	Cancer type	Regimen	Key requirements
Covered	Small bowel adenocarcinoma	Toripalimab-tpzi single-agent therapy	MSI-H/dMMR disease or a POLE/POLD1 mutation with an ultra-hypermutated phenotype, determined by an FDA-approved or CLIA-compliant test; disease must be advanced or metastatic, or locally unresectable or medically inoperable when used as primary treatment.
Covered	Colon cancer	Toripalimab-tpzi single-agent therapy	MSI-H/dMMR disease or a POLE/POLD1 mutation with an ultra-hypermutated phenotype, determined by an FDA-approved or CLIA-compliant test; disease must be locally unresectable, medically inoperable, advanced, or metastatic.
Covered	Appendiceal neoplasms and cancers	Toripalimab-tpzi single-agent therapy	MSI-H/dMMR disease or a POLE/POLD1 mutation with an ultra-hypermutated phenotype, determined by an FDA-approved or CLIA-compliant test; disease must be recurrent, progressive, metastatic peritoneal-only, or extraperitoneal.
Covered	Rectal cancer	Toripalimab-tpzi single-agent therapy	MSI-H/dMMR disease or a POLE/POLD1 mutation with an ultra-hypermutated phenotype, determined by an FDA-approved or CLIA-compliant test; disease must be locally unresectable, medically inoperable, advanced, or metastatic.

Coverage	Indication	Regimen	Key requirements
Covered	Anal squamous cell carcinoma with inguinal node recurrence or metastatic disease	Toripalimab-tpzi with paclitaxel and carboplatin, followed by single-agent maintenance	Use for inguinal node recurrence or as first-line treatment for metastatic disease.

Coverage	Indication	Regimen	Key requirements
Covered	Metastatic anal squamous cell carcinoma	Toripalimab-tpzi single-agent therapy	Subsequent therapy for metastatic disease.

Billing and Diagnosis Coding

HCPCS CodeHCPCS

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 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

Maximum HCPCS Units

Maximum units480 billable units

Time intervalEvery 2 weeks

Billing basisHCPCS units

Ultra-Hypermutated Phenotype

PhenotypeUltra-hypermutated phenotype

TMB thresholdGreater than 50 mutations per megabase (TMB > 50 mut/Mb).

Use in policy

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for Loqtorzi® (toripalimab-tpzi). Initial authorization is valid for 6 months (180 days).

Submit the prior authorization request before treatment begins.
Initial approval validity: 6 months (180 days).

Billing Rule

Indication-Specific Authorization Limits

Renewal authorization is generally available every 6 months (180 days), subject to renewal criteria and indication-specific maximums.

Head and neck cancers with chemotherapy: renewal may continue up to a maximum of 24 months.

Therapy Overview

Loqtorzi (toripalimab-tpzi) is an intravenous PD-1-directed therapy covered under this policy for selected advanced, recurrent, metastatic, unresectable, or medically inoperable malignancies. Covered settings include nasopharyngeal and very advanced head and neck cancers, anal carcinoma, and biomarker-selected small bowel, colon, appendiceal, and rectal cancers. Coverage depends on the applicable disease setting, treatment line, biomarker findings, and regimen; renewal also requires ongoing clinical benefit without unacceptable toxicity.

Policy Definitions

Very Advanced Head and Neck Cancer

Newly diagnosed locally advanced diseaseM0 locally advanced T4b, N0-3 disease or newly diagnosed unresectable regional nodal disease.

Surgical statusDisease in members who are unfit for surgery.

Metastatic presentationMetastatic disease at initial presentation (M1).

Recurrent or persistent diseaseRecurrent or persistent disease with or without distant metastases.

Treatment contextFor qualifying nasopharyngeal disease, treatment may be single-agent therapy after progression on or after platinum-containing therapy, or combination therapy with cisplatin and gemcitabine; combination therapy requires performance status 0-1.

MSI-H/dMMR or POLE/POLD1 Ultra-Hypermutated Disease

Policy Summary

PayerViva Health Plan

PolicyLoqtorzi (toripalimab-tpzi) (Intravenous)

Policy CodePolicy IC-0735

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Loqtorzi before treatment; initial approval is generally valid for 6 months.

SourceLink

On This Page

Member experienced disease progression on or after a platinum-containing chemotherapy regimen.

ALL of the following

Loqtorzi is used in combination with cisplatin and gemcitabine.
This combination pathway applies only to metastatic disease.

Very advanced head and neck cancer

Member has very advanced head and neck cancer with nasopharyngeal cancer.
Very advanced disease includes newly diagnosed M0 locally advanced T4b, N0-3 disease; newly diagnosed unresectable regional nodal disease; disease in members unfit for surgery; metastatic disease at initial presentation (M1); or recurrent or persistent disease with or without distant metastases.
Disease setting
- Member has unresectable disease with prior radiation therapy.
- Member has recurrent or persistent disease with distant metastases.
Permitted regimen
- ALL of the following
  - Loqtorzi is used as a single agent.
  - Used as an alternate subsequent-line option after disease progression on or after platinum-containing therapy.
- ALL of the following
  - Loqtorzi is used in combination with cisplatin and gemcitabine.
  - Member has a performance status of 0-1.Performance status 0-1

Member has advanced or metastatic disease.

ALL of the following

Member has locally unresectable or medically inoperable disease.
Loqtorzi is used as primary treatment.

Treatment is for inguinal node recurrence.

Treatment is first-line therapy for metastatic disease.

Disease is progressive.

Disease is metastatic peritoneal-only.

Disease is extraperitoneal.

Member has very advanced head and neck cancer, receives single-agent Loqtorzi as an alternate subsequent-line option, and experienced disease progression on or after platinum-containing therapy.Progression on or after platinum-containing therapy

Member has metastatic anal squamous cell carcinoma and receives single-agent Loqtorzi as subsequent therapy.

Testing requirementThe mutation and phenotype must be determined by an FDA-approved or CLIA-compliant test.

This phenotype may qualify as the alternative to MSI-H/dMMR disease for specified single-agent gastrointestinal cancer treatment.

Anal carcinoma with paclitaxel and carboplatin followed by single-agent therapy: renewal may continue up to a maximum of 12 months.

Maximum doses depend on dosing frequency and treatment duration; refer to dosage limits.

Documentation Required

Biomarker Test Documentation

Document the qualifying biomarker result for small bowel, colon, appendiceal, or rectal cancer when required by the indication. Testing must establish MSI-H/dMMR disease or a POLE/POLD1 mutation with an ultra-hypermutated phenotype.

Acceptable findings: microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease; or POLE/POLD1 mutation with an ultra-hypermutated phenotype, such as tumor mutational burden (TMB) >50 mut/Mb.
Use an FDA-approved assay or a Clinical Laboratory Improvement Amendments (CLIA)-compliant test.
If confirmed using an FDA-approved assay, consult the FDA companion diagnostics resource: http://www.fda.gov/CompanionDiagnostics.
Include the test report and result with the authorization request.

Documentation Required

Diagnosis and Treatment Details

Provide the diagnosis, disease extent, treatment line, prior therapy, regimen, and relevant clinical documentation supporting the applicable indication.

Head and neck/nasopharyngeal cancer: document first-line or subsequent-line use, metastatic, recurrent, locally advanced, unresectable, persistent, or recurrent disease as applicable; prior platinum-containing therapy and progression when required; cisplatin/gemcitabine combination or single-agent regimen; and performance status 0–1 when required for very advanced disease.
Small bowel adenocarcinoma: document single-agent treatment, MSI-H/dMMR or qualifying POLE/POLD1 ultra-hypermutated disease, and advanced/metastatic disease or locally unresectable/medically inoperable disease when used as primary treatment.
Anal carcinoma: document squamous cell carcinoma and the applicable regimen: single-agent subsequent therapy for metastatic disease, or paclitaxel/carboplatin followed by single-agent therapy for inguinal node recurrence or first-line metastatic disease.
Colon cancer: document single-agent treatment, qualifying MSI-H/dMMR or POLE/POLD1 ultra-hypermutated disease, and locally unresectable, medically inoperable, advanced, or metastatic disease.
Appendiceal neoplasms/cancers: document single-agent treatment, qualifying biomarker status, and recurrent, progressive, metastatic peritoneal-only, or extraperitoneal disease.
Rectal cancer: document single-agent treatment, qualifying biomarker status, and locally unresectable, medically inoperable, advanced, or metastatic disease.

Prior Authorization

Renewal: Response and Toxicity

For renewal, document that the member continues to meet universal and indication-specific criteria, remains within the authorized duration, is responding or has stable disease, and has no unacceptable toxicity.

Disease response may be shown by stabilization of disease or a decrease in tumor size or tumor spread.
Document absence of unacceptable toxicity, including severe infusion-related or immune-mediated reactions.
Relevant toxicities include pneumonitis, hepatotoxicity/hepatitis, colitis, endocrinopathies, nephritis with renal dysfunction, dermatologic reactions/rash, and complications of allogeneic HSCT.

Denial Risk

Prior PD-1/PD-L1 Therapy

Initial authorization may be denied when the member has received previous therapy directed at programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1).

Verify and document the member's prior systemic therapy history before submitting the request.

Denial Risk

Age or Indication Criteria Not Met

Authorization may be denied when the member is younger than 18 or when the requested use does not satisfy the cancer-specific diagnosis, biomarker, disease-extent, treatment-line, prior-therapy, regimen, or other criteria.

Member must be at least 18 years of age.
Denial risk applies when the diagnosis is not a covered indication or when required disease extent is absent, such as metastatic, recurrent, locally advanced, unresectable, medically inoperable, or specified peritoneal disease.
For biomarker-defined gastrointestinal indications, denial risk applies when MSI-H/dMMR or qualifying POLE/POLD1 ultra-hypermutated disease is not documented by an FDA-approved or CLIA-compliant test.
Denial risk applies when required treatment line, prior platinum therapy or progression, single-agent or combination regimen, chemotherapy partners, or performance status is not met.

Denial Risk

Renewal Requirements Not Met

Renewal may be denied when ongoing criteria, the applicable authorization duration, treatment response, or toxicity requirements are not met.

Denial risk applies if universal or indication-specific criteria are no longer satisfied.
Denial risk applies when the duration limit in Section I has been exceeded.
Denial risk applies without disease stabilization or tumor reduction, or when unacceptable toxicity is present.

Denial Risk

Dose or Duration Exceeds Policy Limits

Claims and authorization requests may be denied when the requested dose, frequency, duration, or billed units exceed policy limits.

Maximum billing allowance: 480 HCPCS billable units every 2 weeks per dose and over time.
Head and neck combination therapy: 240 mg IV every 3 weeks until progression, unacceptable toxicity, or up to 24 months; single-agent therapy: 3 mg/kg IV every 2 weeks until progression or unacceptable toxicity.
Anal carcinoma combination therapy: 3 mg/kg IV every 2 weeks; combination therapy may continue up to 24 weeks before single-agent maintenance, with authorization up to 12 months where specified.
All other indications: 3 mg/kg IV every 2 weeks until disease progression or unacceptable toxicity.
Dose-frequency maximums include 26 doses at every-2-week dosing and 35 doses at every-3-week dosing, subject to the applicable duration and indication limits.

MSI-H/dMMR pathwayDisease is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

POLE/POLD1 pathwayDisease has a polymerase epsilon/delta (POLE/POLD1) mutation with an ultra-hypermutated phenotype.

Example phenotype thresholdTumor mutational burden greater than 50 mutations per megabase (TMB > 50 mut/Mb) is an example of an ultra-hypermutated phenotype.