CurrentHealth NetPolicy CP PHAR.711

Cosibelimab‑ipdl (Unloxcyt)

Defines medical necessity and prior authorization requirements for cosibelimab‑ipdl (Unloxcyt) for adults with locally advanced or metastatic cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation; applies to Health Net lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerHealth Net

PolicyCosibelimab‑ipdl (Unloxcyt)

Policy CodePolicy CP PHAR.711

Change TypeNo material changes

Effective DateMar 1, 2025

Next Review Date

Key ActionPrior authorization required; provider must document diagnosis of CSCC and that the member is not a candidate for curative surgery or radiation, and request is prescribed by or in consultation with an oncologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1,200 mgmax dose q3w

300 mgvial strength

J9275HCPCS

6 monthstypical initial approval

Coverage Criteria

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Initial Approval for CSCC: 1) Diagnosis of cutaneous squamous cell carcinoma (CSCC); 2) Disease is locally advanced or metastatic; 3) Member is not a candidate for curative surgery or radiation; 4) Prescribed by or in consultation with an oncologist; 5) Age 18 years or older; 6) Dose does not exceed 1,200 mg (4 vials) every 3 weeks; 7) Request is for an FDA‑approved regimen or, for an off‑label use, the requested dose/regimen is supported by practice guidelines or peer‑reviewed literature with supporting evidence (provider must submit supporting documentation).

Approval duration: typically 6 months (Commercial) or as specified by member renewal/line of business.

inv-02: Continuation Therapy

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

Continued Therapy: 1) Member is currently receiving Unloxcyt via the health plan benefit or documentation shows the member has received Unloxcyt for at least 30 days for a covered indication; 2) Member is responding positively to therapy; 3) New dose does not exceed 1,200 mg (4 vials) every 3 weeks; 4) If request is for a dose increase, the new dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 5) Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to member renewal date, whichever is longer.

Requests for uses of cosibelimab‑ipdl (Unloxcyt) that are for non‑FDA approved indications and are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.

When Unloxcyt is requested for an off‑label indication not listed in this policy, the request must include supporting clinical documentation consistent with the referenced off‑label policies. Adequate documentation includes peer‑reviewed literature or recognized practice guidelines demonstrating the requested dose or regimen’s efficacy and safety; without that evidence, the request may be denied as not medically necessary.

Covered Regimens

Regimen	Indication	Dosing / Schedule	Duration / Notes
Cosibelimab‑ipdl (Unloxcyt) 1,200 mg IV
Cutaneous squamous cell carcinoma (locally advanced or metastatic) in adults who are not candidates for curative surgery or radiation
1,200 mg IV every 3 weeks (maximum dose: 1,200 mg / 4 vials every 3 weeks)
Continue until disease progression or unacceptable toxicity; dosing consistent with prescribing information

Coding

HCPCS CodesHCPCS

J9275

Injection, cosibelimab‑ipdl, 2 mg

Previously referenced/removed codesHCPCS

J3590	Unclassified biologics (removed)
C93991	Noted as removed code

inv-07: Maximum dose — dosing limit / schedule

Maximum dose and schedule1,200 mg (4 vials) IV every 3 weeks

Treatment duration guidanceContinue until disease progression or unacceptable toxicity

Vial equivalence1,200 mg corresponds to 4 vials per dose

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must document a diagnosis of cutaneous squamous cell carcinoma (CSCC) and that the member is not a candidate for curative surgery or radiation.

Diagnosis: CSCC documented in chart notes.
Statement that disease is locally advanced or metastatic.
Documentation that member is not a candidate for curative surgery or radiation (e.g., surgical consult, tumor board note, radiation oncology consult).
Prescriber is an oncologist or request is in consultation with an oncologist.

Note

Formulary / Off‑Label Pathways

When the requested use, dosing, or regimen is not listed in this policy, follow the applicable formulary, non‑formulary, or off‑label policies for the member's line of business.

Commercial: follow CP.CPA.190.
Health Insurance Marketplace: follow HIM.PA.33 (formulary) or HIM.PA.154 (off‑label) as applicable.
Medicaid/PDL: follow CP.PMN.255 (formulary) or CP.PMN.53 (off‑label) as applicable.
If drug is not on formulary/PDL, follow non‑formulary policies: CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid).

Documentation Required

Required Supporting Documentation

Required supporting documentation — provider must submit clinical information demonstrating the member meets all approval criteria.

Office chart notes documenting diagnosis, stage (locally advanced or metastatic), and clinical course.
Consultation notes from oncology, surgical oncology, or radiation oncology documenting that curative surgery or radiation is not appropriate.
Pathology reports, imaging reports, and relevant laboratory results.
Treatment history and prior therapies, including dates and outcomes.
If dosing is outside FDA‑labeled amounts, provide supporting evidence from practice guidelines or peer‑reviewed literature; prescriber must submit supporting references.

Denial Risk

Non‑FDA Indications

Requests for indications not FDA‑approved and not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the off‑label use policies.

Refer to off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid).
Provide evidence of efficacy and safety (peer‑reviewed literature, clinical guidelines, or evidence of coverage documents) when requesting non‑FDA indications.

Line of Therapy

inv-14: first-line

First‑line: Adults with locally advanced (laCSCC) or metastatic CSCC (mCSCC) who are not candidates for curative surgery or curative radiation.

First‑line dosing: Cosibelimab‑ipdl 1,200 mg IV every 3 weeks until disease progression or unacceptable toxicity (maximum dose 1,200 mg every 3 weeks).

Background

Cosibelimab‑ipdl (Unloxcyt) is indicated for adults with locally advanced or metastatic cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation. Coverage under this policy is limited to that FDA‑approved context; other indications require the documentation described above and review under the off‑label use policies.