Package advice cemiplimab (Libtayo®) for the treatment of non-small cell lung carcinoma (NSCLC)

Zorginstituut Nederland has completed its assessment whether cemiplimab (Libtayo®) as primary care treatment for stage IIIBC-IV non-small cell lung cancer (NSCLC) can be included in the insured package. The reason for this advice was that cemiplimab was being placed in the so-called ‘package lock’ for expensive medicinal products. The Zorginstituut has concluded that the assessed combination meets the statutory criterion of ‘established medical science and medical practice’ for the indication mentioned. The therapeutic value of cemiplimab is equal to the value of pembrolizumab. However, the use of cemiplimab is associated with additional costs. We advise the Minister to include cemiplimab in the package, provided the price negotiations with the marketing authorisation holder successfully deliver a net price that does not exceed that of the existing treatment.

Registered indication

Cemiplimab (Libtayo®) is indicated for the primary care treatment of stage IIIBC-IV non-small cell lung carcinoma (NSCLC) in adult patients with PD-L1 expression ≥50%, without EGFR/ALK/ROS1 aberrations.

Zorginstuut's advice

The Zorginstituut advises the Minister to include cemiplimab in the package, provided the price negotiations with the marketing authorisation holder successfully deliver a net price that does not exceed that of the existing treatment.

This report is a summary of recommendations by Zorginstituut Nederland. The original text is in Dutch.