Package advice ipilimumab (Yervoy®) in combination with nivolumab (Opdivo®)

The National Health Care Institute has completed its assessment whether ipilimumab (Yervoy®) in combination with nivolumab (Opdivo®) and two cycles of platinum-based chemotherapy as primary care treatment for metastatic non-small cell lung cancer (NSCLC) in adults without a sensitising EGFR mutation or ALK translocation, can be included in the insured package. The reason for this advice was that ipilimumab was being placed in the so-called ‘package lock’ for expensive medicinal products. The National Health Care Institute 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 this combination is equal to the value of existing combinations. However, the combination of ipilimumab with nivolumab and two cycles of platinum-containing chemotherapy involves a significant additional cost for the package. We advise the Minister not to include the new combination in the package, unless price negotiations with the Marketing authorisation holder successfully deliver a net price that does not exceed that of the existing combinations.