Following an initial review of the company’s submission for this appraisal by the Evidence Review Group (ERG), it has been noted that the submission considers the population for this scope in terms of two distinct subgroups and that this considerably increases the complexity of the ERG’s task. In order to allow the ERG to provide a thorough critique of the evidence in support of both subgroups, it has been agreed that the ERG will provide reports on each of the two subgroups separately.
Consequently the ERG will first provide a report focusing on the clinical and cost effectiveness of eribulin in ‘patients with locally advanced or metastatic breast cancer whose disease has progressed after at least two prior chemotherapeutic regimens for advanced disease which includes capecitabine (if indicated)’. This will be considered by the appraisal committee at its meeting on 20 September 2016.
An ERG report on the subgroup of ‘people with locally advanced or metastatic breast cancer whose disease has progressed after one prior chemotherapy regimen in the advanced setting’ will be produced subsequently and this will be considered by the committee at a later date. The timelines will be confirmed shortly.
Therefore 2 separate pieces of guidance will be produced for this appraisal, one after the other. Updated versions of the scope for these appraisals are available on the NICE website. The changes are shown in in red and only relate to the population under consideration. No changes have been made to other aspects of the scope.