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AetnaCommercial · Coverage · Medical Policy · Oncology, Dermatology, Pulmonology +2 moreMedium impact

Cemiplimab-rwlc (Libtayo) (CPB 0942, reviewed 2026-06-12)

Effective date
Not stated in the notice
Identified
Aug 12, 2026

Summary

Aetna's Clinical Policy Bulletin 0942 sets the commercial coverage criteria for cemiplimab-rwlc (Libtayo). Aetna considers Libtayo medically necessary for cutaneous squamous cell carcinoma, basal cell carcinoma, non-small cell lung cancer, and the vulvar, cervical, vaginal, anal, small bowel, colon, appendiceal and rectal cancers listed in the policy when the stated criteria are met. Aetna considers all other indications experimental, investigational, or unproven, including hepatocellular carcinoma, Merkel cell carcinoma, penile cancer, Marjolin ulcer and xeroderma pigmentosum.

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What to do

Action · 9 steps
01REQUIREMENTS: Precertification of Libtayo is required for all Aetna participating providers and members in applicable plan designs.
02Call (866) 752-7021 or fax (888) 267-3277, using the Statement of Medical Necessity precertification forms.
03The Site of Care Utilization Management Policy applies to Libtayo, so review the Utilization Management Policy on Site of Care for Specialty Drug Infusions.
04For initial approval in cutaneous squamous cell carcinoma, the member must not be a candidate for curative surgery or curative radiation, and the drug must be used as a single agent.
05For non-small cell lung cancer, the tumor must not have EGFR exon 19 deletions or L858R mutations, or ALK, RET or ROS1 gene fusions, unless testing is not feasible due to insufficient tissue.
06Aetna considers members not eligible for Libtayo when they have experienced disease progression while on a PD-1 or PD-L1 inhibitor.
07HCPCS J9119 (cemiplimab-rwlc, 1 mg) is covered if the selection criteria are met.
08For reauthorization, adjuvant cutaneous squamous cell carcinoma treatment is approved for up to 48 weeks total for members who have not experienced disease recurrence or an unacceptable toxicity.
09Basal cell carcinoma and non-adjuvant cutaneous squamous cell carcinoma reauthorization is approved for up to 24 months total for members who have not experienced disease progression or an unacceptable toxicity.

Codes mentioned

J9119C20C44.01C44.02C44.92C52Q87.89

Original notice

Cemiplimab-rwlc (Libtayo) (CPB 0942, reviewed 2026-06-12)
aetna.com · Always check the source before changing claims.
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