Viva Health cosibelimab IV Coverage Update

Coverage Criteria

Initial Therapy — Covered when ALL of the following are met for the selected indication

Covered when ALL of the following are met for the selected indication

Universal: Member is >= 18 years of age AND Member has not received previous therapy with a PD-1/PD-L1–directed therapy unless otherwise specified

Universal Criteria

cSCC Indication: Locally advanced, satellitosis/in-transit metastasis, or metastatic cutaneous squamous cell carcinoma; member is not a candidate for curative surgery or curative radiation; used as a single agent

FDA approved/Compendia recommended

Colon Cancer Indication: Used as a single agent for locally unresectable, medically inoperable, advanced, or metastatic disease AND member has MSI-H/dMMR OR POLE/POLD1 mutation with ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb) determined by an FDA-approved or CLIA-compliant testTMB > 50 mut/Mb (example)

Compendia recommended

Rectal Cancer Indication: Used as a single agent for locally unresectable, medically inoperable, advanced, or metastatic disease AND member has MSI-H/dMMR OR POLE/POLD1 mutation with ultra-hypermutated phenotype determined by an FDA-approved or CLIA-compliant test

Compendia recommended

Small Bowel Adenocarcinoma Indication: Used as a single agent for advanced or metastatic disease OR for locally unresectable or medically inoperable disease (may be used as primary treatment) AND member has MSI-H/dMMR OR POLE/POLD1 mutation with ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb) determined by an FDA-approved or CLIA-compliant test

Compendia recommended

Continuation / Renewal Therapy — Renewal approval provided when ALL of the following are met

Renewal approval provided when ALL of the following are met

Renewal Criteria: Member continues to meet universal and indication-specific criteria AND disease response as defined by stabilization of disease or decrease in tumor size or spread AND absence of unacceptable toxicity (examples include severe or life-threatening infusion reactions, severe immune-mediated adverse reactions such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis with renal dysfunction, severe dermatologic reactions, or complications of allogeneic HSCT)

Renewal criteria

Regimen	Dose & Schedule	Duration / Stop Criteria	Coverage Status
Cosibelimab (single-agent)
1200 mg IV every 3 weeks
Until disease progression or unacceptable toxicity
Covered

Prior therapy with a PD-1/PD-L1–directed agent excludes coverage for cosibelimab unless an exception is explicitly stated elsewhere in this policy. Providers must verify that the member has not previously received PD‑1 or PD‑L1 checkpoint inhibitor therapy prior to authorizing treatment, per the Universal Criteria.

Use of cosibelimab outside the tumor types or clinical settings listed in this policy is not supported. For all covered indications the policy specifies single‑agent use of cosibelimab; combination regimens or use in non‑listed malignancies or settings will be considered not medically necessary.

Line of Therapy / Setting

Line of therapy: Policy specifies single‑agent use for indicated advanced/metastatic or unresectable disease; prior lines are not mandated but prior PD‑1/PD‑L1 therapy excludes approval unless otherwise specified

Indication statements

Biomarker Requirements

Documentation Required

Callout — Documentation required for authorization

Required documentation must be submitted with the prior authorization request. Include: clinical history, biomarker reports (MSI‑H/dMMR or POLE/POLD1 with TMB if applicable), prior systemic therapy including PD‑1/PD‑L1 agents, planned dosing and administration details, and ICD‑10 diagnosis code(s). Failure to supply these documents may result in denial or delay.

Required diagnosis coding must reflect the specific tumor site (colon, rectum, small bowel) and metastatic/advanced status where applicable.
Prior PD‑1/PD‑L1 therapy that demonstrates progression on therapy typically precludes coverage for repeat use per policy — document rationale if requesting despite prior PD‑1/PD‑L1 exposure.
Billing note: include HCPCS and NDC (if applicable) and administration revenue codes; document units/doses and dates.
Operational note: accept FDA‑approved or CLIA‑certified laboratory reports. If using TMB to establish ultra‑hypermutation, include the numeric TMB and assay method.

Coding (HCPCS, NDC, ICD-10)

Covered HCPCS CodesHCPCSCovered

J9275

Injection, cosibelimab-ipdl, 2 mg; 1 billable unit = 2 mg

NDCsNDC

83444-0301-xx	Unloxcyt 300 mg/5 mL single-dose vial
70095-0130-xx	Unloxcyt 300 mg/5 mL single-dose vial

Covered Diagnosis Codes (ICD-10)ICD-10Covered

C17.0	Malignant neoplasm of duodenum
C17.1	Malignant neoplasm of jejunum
C17.2	Malignant neoplasm of ileum
C17.3	Meckel's diverticulum, malignant
C17.8	Malignant neoplasm of overlapping sites of small intestine
C17.9	Malignant neoplasm of small intestine, unspecified
C18.0	Malignant neoplasm of cecum
C18.2	Malignant neoplasm of ascending colon
C18.3	Malignant neoplasm of hepatic flexure
C18.4	Malignant neoplasm of transverse colon

1–10 of 48

1/5

Covered ICD-10 Diagnosis CodesICD-10Covered

C18.2	Malignant neoplasm of ascending colon
C18.3	Malignant neoplasm of hepatic flexure
C18.4	Malignant neoplasm of transverse colon
C18.5	Malignant neoplasm of splenic flexure
C18.6	Malignant neoplasm of descending colon
C18.7	Malignant neoplasm of sigmoid colon
C18.8	Malignant neoplasm of overlapping sites of colon
C18.9	Malignant neoplasm of colon, unspecified
C19	Malignant neoplasm of rectosigmoid junction
C20	Malignant neoplasm of rectum

1–10 of 41

1/5

Tumor Mutational Burden (TMB) — > 50 mut/Mb

Threshold nameTumor Mutational Burden (TMB)

Numeric threshold> 50 mut/Mb

Use caseExample threshold for POLE/POLD1 ultra-hypermutated phenotype to support colon/rectal/small bowel indications

Assay noteTMB must be determined by an FDA-approved or CLIA-compliant test

Provider Actions, Documentation & Billing

Prior Authorization

Prior authorization required; initial and renewal validity

When requesting prior authorization for cosibelimab (J9275), obtain authorization before therapy. Initial approvals are issued for 6 months (180 days) and may be renewed every 6 months. The member must be at least 18 years of age and meet the indication‑specific and universal criteria in the policy.

Initial authorization period: 6 months (180 days).
Renewal interval: may be renewed every 6 months (180 days).
Minimum age for approval: ≥18 years.

Note

Check CMS NCD/LCD/LCA determinations

Verify whether any Medicare National or Local Coverage Determinations (NCDs/LCDs) or Local Coverage Articles (LCAs) apply to the claim; plan-level additional indications may be applied at the health plan’s discretion.

Use the CMS Coverage Database to search for applicable NCDs, LCDs, or LCAs: https://www.cms.gov/medicare-coverage-database/search.aspx.

Definitions & Diagnosis Examples

Malignant neoplasm of colon (various sites) — C18.* codes

ICD-10 rangeC18.* (examples listed include C18.2–C18.9)

Related rectal codesC19, C20, C21.8 (rectosigmoid/rectum/overlapping sites)

Clinical contextUsed to support coverage for colon and rectal malignancy indications in Appendix 1

Most actionableUse one of the listed colon/rectal ICD-10 codes from Appendix 1 on claims to support coverage

Squamous cell carcinoma of skin (various sites) — C44.* codes

ICD-10 rangeC44.* (multiple specific C44.xx codes listed for squamous cell carcinoma of skin)

Background

Cosibelimab (Unloxcyt) is an anti‑PD‑L1 monoclonal antibody administered intravenously for FDA‑approved and compendium‑recommended malignancies. The agent is dosed as 1200 mg IV every 3 weeks and is used until disease progression or unacceptable toxicity. Indications included in this policy cover locally advanced or metastatic cutaneous squamous cell carcinoma and biomarker‑selected colorectal, rectal, and small bowel adenocarcinomas where MSI‑H/dMMR or POLE/POLD1 ultra‑hypermutated phenotype (for example, TMB > 50 mut/Mb) is required for the colon/rectal/small bowel indications.

Revision History

2026-04-01Policy reviewLatest

Last review completed; document marked with Last Review Date 04/01/2026 and Dates Reviewed include 04/2026.

2026-01-01Periodic review

Policy reviewed (Dates Reviewed list includes 01/2026) as part of routine update cycle.

2025-10-01Periodic review

OpenPayer

Unloxcyt (cosibelimab-ipdl) IV therapy coverage

Coverage Criteria

Line of Therapy / Setting

Biomarker Requirements

Coding (HCPCS, NDC, ICD-10)

Provider Actions, Documentation & Billing

Definitions & Diagnosis Examples

Background

Revision History