3.1 The appraisal committee (section 6) considered evidence submitted by Roche and a review of this submission by the evidence review group (ERG). The appraisal was a Cancer Drugs Fund reconsideration of NICE's technology appraisal guidance 371 (TA371) on trastuzumab emtansine for the treatment of HER2‑positive, unresectable locally advanced or metastatic breast cancer after treatment with trastuzumab and a taxane. The committee also considered the updated cost-effectiveness analyses submitted by Roche after consultation and their critique by the ERG.
3.2 Sections 4.1 to 4.26 reflect the committee's consideration of the evidence submitted in December 2013 for the original appraisal and the subsequent responses to consultation received during the development of TA371. The company included 2 randomised controlled trials in its original submission: EMILIA and TH3RESA. Both trials were international, open-label trials evaluating the safety and efficacy of trastuzumab emtansine (3.6 mg/kg every 3 weeks) for human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced or metastatic breast cancer. EMILIA compared trastuzumab emtansine with lapatinib plus capecitabine, and TH3RESA compared it with the clinician's choice of treatment. The company used 4 additional randomised controlled trials, together with EMILIA, in a mixed treatment comparison of trastuzumab emtansine and the other comparators listed in the scope. Sections 4.27 to 4.35 reflect the committee's consideration of the evidence submitted for the Cancer Drugs Fund reconsideration. The new evidence included additional follow-up data from EMILIA, which was used to model overall survival. New cost-effectiveness analyses were done using a complex patient access scheme. The patient access scheme considered by the committee was subsequently replaced by a commercial access agreement between Roche and NHS England. The commercial access agreement provides similar reductions in the total costs of treatment to the latest patient access scheme offer, and a simpler operational approach. The details of the agreement are commercial in confidence.
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 in NICE's original technology appraisal guidance on trastuzumab emtansine.