Libtayo

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

August 2019

Therapeutic area - Oncology

Initial approval criteria

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

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

Libtayo must be billed as a medical claim.

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