NICE has made a preliminary decision not to recommend pertuzumab for the adjuvant treatment of early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults with high risk of disease recurrence.
In the absence of mature data, the appraisal committee based its decision on the primary outcome of the APHINITY trial of pertuzumab versus placebo as standard adjuvant chemotherapy plus one year of treatment with trastuzumab. The primary outcome was invasive disease-free survival (DFS) excluding second primary non-breast cancer events. After three years, there was only a minor difference in disease-free survival between the two treatment groups (0.9%) in the intention-to-treat population.
Based on the evidence, the appraisal committee concluded that the cost-effectiveness estimates are implausible, because the model appears to overestimate overall survival and there is uncertainty about the effectiveness of pertuzumab as adjuvant treatment. The most plausible cost-effectiveness estimate is likely to be much higher than those presented by the company, it said.
NICE is now inviting comments on the draft guidance. Comments can be submitted by consultees and commentators for this appraisal, as well as from members of the public. The closing date for receipt of comments is 6 July 2018. The appraisal committee will meet again on 19 July to review the evidence and comments. The final guidance is expected to be published on 24 October 2018.