Cemiplimab
A PD-1 blocker that is the standard for advanced skin squamous cell carcinoma, and in 2025 became the first adjuvant immunotherapy for it.
Approved in cutaneous squamous cell carcinoma (2018; adjuvant 2025 based on C-POST), basal cell carcinoma, and NSCLC. Regeneron/Sanofi.
1.Antibody binds PD-1
- Route
- IV infusion
- Schedule
- 350 mg every 3 weeks
- Dose modifications
- Standard immune-mediated event algorithm
- Monitoring
- Thyroid, LFTs, creatinine, skin
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
- Assistance programmes
- Libtayo Surround
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Appraised for
- Advanced cutaneous squamous cell carcinoma
- Notes
- Also PD-L1 ≥50% NSCLC (TA770, 2022).
- Cancer Drugs Fund
- Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA592 · NHS England Cancer Drugs Fund list · SMC advice: cemiplimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 28 Sept 2018ApprovalUS
Advanced cutaneous squamous cell carcinoma: first systemic therapy approved for CSCC source
- 9 Feb 2021ApprovalUS
Advanced basal cell carcinoma after hedgehog inhibitor source
- 22 Feb 2021ApprovalUS
First-line PD-L1 ≥50% NSCLC (EMPOWER-Lung 1) source
- Oct 2025ApprovalUS
Adjuvant high-risk CSCC after surgery and radiation (C-POST) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2018 | Advanced cutaneous squamous cell carcinoma |
| US | 2025 | Adjuvant high-risk CSCC after surgery and radiation |
| Adverse event |
|---|
| Fatigue |
| Musculoskeletal pain |
| Rash |
| Diarrhoea |
| Anaemia |
| Hypothyroidism |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | libtayosurroundcare.com |
| United Kingdom | NICE: recommended for advanced cutaneous squamous cell carcinoma (TA592) and PD-L1 ≥50% NSCLC | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Cemiplimab" OR ABSTRACT:"Cemiplimab" OR TITLE:"Libtayo" OR ABSTRACT:"Libtayo") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Cemiplimab, not a curated reading list.
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