Cosibelimab-ipdl (Unloxcyt)

Number: 1074

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses cosibelimab-ipdl (Unloxcyt) for commercial medical plans. For Medicare criteria, see Medicare Part B Criteria.

Note: Requires Precertification: 

Precertification of cosibelimab-ipdl (Unloxcyt) is required of all Aetna participating providers and members in applicable plan designs. For precertification of cosibelimab-ipdl (Unloxcyt), call (866) 752-7021, or fax (888) 267-3277. For Statement of Medical Necessity (SMN) precertification forms, see Specialty Pharmacy Precertification. 

Note: Site of Care Utilization Management Policy applies. For information on site of service for cosibelimab-ipdl (Unloxcyt), see Utilization Management Policy on Site of Care for Specialty Drug Infusions. 

1. Exclusions 

   Aetna considers members not eligible for Unloxcyt when they have experienced disease progression while on programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor therapy.

2. Criteria for Initial Approval

   Cutaneous Squamous Cell Carcinoma (CSCC)

   Aetna considers cosibelimab-ipdl (Unloxcyt) medically necessary for treatment of metastatic or locally advanced CSCC when the member is not a candidate for curative surgery or radiation.

   Aetna considers all other indications as experimental, investigational, or unproven.

3. Continuation of Therapy

   Aetna considers continuation of cosibelimab-ipdl (Unloxcyt) therapy medically necessary in members requesting reauthorization for an indication listed in Section II when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Dosage and Administration

Cosibelimab-ipdl is supplied as Unloxcyt 300 mg/5 mL (60 mg/mL) solution in a single-dose vial for injection for intravenous use.

The recommended dosage of Unloxcyt is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks.

Source: Checkpoint Therapeutics, 2024

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Other CPT codes related to the CPB:
96413	Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug
96415	each additional hour (list in addition to code for primary procedure)
HCPCS codes covered if selection criteria are met:
Cosibelimab-ipdl (Unloxcyt) – No specific code
ICD-10 codes covered if selection criteria are met:
C44.02	Squamous cell carcinoma of skin of lip
C44.121 – C44.1292	Squamous cell carcinoma of skin of eyelid, including canthus
C44.221 – C44.229	Squamous cell carcinoma of skin of ear and external auricular canal
C44.320 – C44.329	Squamous cell carcinoma of skin of other and unspecified parts of face
C44.42	Squamous cell carcinoma of skin of scalp and neck
C44.520 – C44.529	Squamous cell carcinoma of skin of trunk
C44.621 – C44.629	Squamous cell carcinoma of skin of upper limb, including shoulder
C44.721 – C44.729	Squamous cell carcinoma of skin of lower limb, including hip
C44.82	Squamous cell carcinoma of overlapping sites of skin
C44.92	Squamous cell carcinoma of skin, unspecified

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Background

U.S. Food and Drug Administration (FDA)-Approved Indications 

• Cutaneous Squamous Cell Carcinoma (CSCC)

  Unloxcyt is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.

Cosibelimab-ipdl is available as Unloxcyt (Checkpoint Therapeutics, Inc.), a human programmed death ligand-1 (PD-L1) blocking antibody. Specifically, Unloxcyt is a human IgG1 lambda monoclonal antibody that is produced in Chinese hamster ovary (CHO) cells. Unloxcyt binds PD-L1 and blocks the interaction between PD-L1 and its receptos PD-1 and B7.1. This, in turn, releases the inhibitory effects of PD-L1 on the anti-tumor immune response. Uloxcyt has also demonstrated induction of antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro (Checkpoint Therapeutics, 2024).

The prescribing information for Unloxcyt notes the following warnings and precautions and adverse reactions:

• Warnings and precautions
  
  
  • Immune-mediated adverse reactions:
    
    
    • Immune-mediated adverse reactions can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection.
    • Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
    • Withhold or permanently discontinue Unloxcyt based on the severity of reaction.
      
      
  • Infusion-related reactions: 
    
    
    • Interrupt, slow the rate of infusion, or permanently discontinue based on severity of reaction.
      
      
  • Complications of allogeneic hematopoietic stem cell transplantation (HSCT): 
    
    
    • Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.
      
      
  • Embryo-fetal toxicity: 
    
    
    • Can cause fetal harm.
    • Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
      
      
• Adverse reactions
  
  
  • The most common adverse reactions (≥ 10%) included fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritis, edema, localized infection, and urinary tract infection.
    
    

On December 13, 2024, the U.S. Food and Drug Administration (FDA) approved cosibelimab-ipdl (Unloxcyt) for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. The FDA approval was based on supporting data from Study CK-301-101 (FDA, 2024).

In Study CK-301-101, a multicenter, multicohort, open-label trial, investigators evaluated the efficacy of cosibelimab-ipdl (Unloxcyt) in 109 patients with metastatic CSCC (mCSCC) or locally advanced CSCC (laCSCC) who were not candidates for curative surgery or curative radiation. Patients were not eligible for this study if they had any of the following exclusions: active or suspected autoimmune disease, allogeneic transplant within 6 months prior to treatment, prior treatment with anti–PD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitor therapy, uncontrolled or significant cardiovascular disease, ECOG PS ≥ 2, or infection with HIV, hepatitis B or hepatitis C (Checkpoint Therapeutics, 2024; FDA, 2024). 

The investigators had tumor response assessments performed on patients every 8 weeks for the first 8 months and every 12 weeks thereafter (Checkpoint Therapeutics, 2024).

The major efficacy outcome measures included objective response rate (ORR) and duration of response (DOR) assessed by an independent central review committee (ICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR was determined by ICR assessments of digital photography (WHO criteria) for patients with laCSCC with externally visible target lesions unassessable by radiologic imaging (Checkpoint Therapeutics, 2024; FDA, 2024).

ORR was 47% (95% confidence interval [CI]: 36, 59) for patients with mCSCC (n=78) and 48% (95% CI: 30, 67) for patients with laCSCC (n=31). Median DOR was not reached (range: 1.4+, 34.1+) in patients with mCSCC and 17.7 months (range: 3.7+, 17.7) in patients with laCSCC (Checkpoint Therapeutics, 2024; FDA, 2024).

In Study CK-301-101, investigators evaluated the safety of Unloxcyt in 141 patients with metastatic or locally advanced disease. Patients received Unloxcyt 800 mg every 2 weeks (n=115) or 1,200 mg every 3 weeks (n=26) as an intravenous infusion until disease progression or unacceptable toxicity. The mean duration of exposure was 36 weeks (2 weeks to 3.7 years) (Checkpoint Therapeutics, 2024).

Thirty-one percent of patients with advanced CSCC receiving Unloxcyt experienced serious adverse reactions. The most frequent adverse reactions (≥ 2% of patients) were sepsis (2.8%), pneumonia (2.8%), and pyrexia (2.1%) (Checkpoint Therapeutics, 2024).

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References