Libtayo
Drug - Libtayo® (cemiplimab-rwlc) [Regeneron Pharmaceuticals, Inc.]
August 2019
Therapeutic area - Oncology
Initial approval criteria
- Patient has an FDA-approved indication
OR
- 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.
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411