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DrugLibtayo® (cemiplimab-rwlc) [Regeneron Pharmaceuticals, Inc.]

August 2019

Therapeutic area - Oncology

Initial approval criteria

  • Patient has an FDA-approved indication


  • Patient must be ≥ 18 years of age AND
  • Patient has a diagnosis of:
    • locally advanced cutaneous squamous cell carcinoma and is not a candidate for curative surgery or radiation therapy OR
    • cutaneous squamous cell carcinoma with nodal or distant metastatic disease AND
  • Patient has not received previous therapy with any of the following:
    • A programmed death (PD-1/PD-L1)-directed therapy (e.g., avelumab, pembrolizumab, atezolizumab, durvalumab, nivolumab, etc.) unless otherwise specified OR
    • A cytotoxic T-lymphocyte antigen 4 (CTLA-4) targeting agent (e.g., ipilimumab, etc.) within the previous 4 weeks prior to therapy OR
    • A BRAF-inhibitor (e.g., vemurafenib, dabrafenib, encorafenib, etc.) OR
    • A small-molecule inhibitor (phosphtidylinositol-3 kinase inhibitor [PI3-K]) therapy (e.g., idelalisib, duvelisib, etc.)
  • Initial approval is for 6 months

Renewal criteria

  • Patient continues to meet the criteria identified above AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: severe infusion reactions, severe immune-mediated adverse reactions such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis/renal dysfunction, rash, encephalitis, etc. AND
  • Tumor response with stabilization of disease or decrease in size of tumor or tumor spread has been demonstrated
  • Renewal approval is for 6 months

Quantity limits

  • 1 vial (350 mg) per 21 days

Billing for Libtayo

Libtayo must be billed as a medical claim.


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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