3 Evidence

3 Evidence

3.1 The appraisal committee (section 6) considered evidence submitted by Novartis and a review of this submission by the evidence review group. This appraisal was a Cancer Drugs Fund reconsideration of the published NICE technology appraisal guidance on everolimus in combination with exemestane for treating advanced HER2-negative hormone receptor-positive breast cancer after endocrine therapy. It focused on updated overall survival data from the BOLERO‑2 trial and cost-effectiveness analyses using a patient access scheme, which provides everolimus at a reduced cost. The level of the discount is commercial in confidence. Sections 4.1 to 4.27 cover the committee's consideration of the evidence submitted in the original appraisal. Sections 4.28 to 4.33 cover the committee's consideration of the additional evidence submitted for the Cancer Drugs Fund reconsideration.

3.2 In BOLERO‑2 postmenopausal women with advanced human epidermal growth factor receptor 2 (HER2)-negative hormone receptor-positive breast cancer without symptomatic visceral disease who had previously had a non-steroidal aromatase inhibitor were randomised to either everolimus plus exemestane or to exemestane alone. The primary end point of the trial was progression-free survival as assessed by a local radiologist (study site specific).

3.3 See the committee papers for full details of the Cancer Drugs Fund reconsideration evidence and the history for full details of the evidence used for NICE's original technology appraisal guidance on everolimus in combination with exemestane for treating advanced HER2-negative hormone receptor-positive breast cancer after endocrine therapy.

  • National Institute for Health and Care Excellence (NICE)