After 7 Appraisal Committee Meetings, NICE has decided not to issue guidance for the use of lapatinib in people with advanced or metastatic HER2-positive breast cancer. The current draft guidance, which included consideration of work undertaken by the DSU to examine methodological issues within the company’s submission, recommends lapatinib only in the context of clinical trials. The main issue that has proudced this outcome, and one of the issues considered by the DSU, is the impact that a unlicensed comparator – transtuzumab – has on the incremental analysis. NICE now wish to carry out an appraisal on the use of (unlicensed) trastuzumab for advanced and metastatic breast cancer together with an updated lapatinib appraisal. In order to do this, NICE requires permission from the Department of Health.
