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New HTA Decisions in England
June 2020
Drug name
KADCYLA® (trastuzumab emtansine)
Company
Roche
Decision date
07/05/2020
Therapeutic area
Cancer
Therapeutic sub area
Breast cancer
Decision
Recommended
Indication
Trastuzumab emtansine is recommended, within its marketing authorisation, as an option for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)‑positive early breast cancer in adults who have residual invasive disease in the breast or lymph nodes after neoadjuvant taxane-based and HER2‑targeted therapy.
Decision Detail
It is recommended only if the company provides trastuzumab emtansine according to the commercial arrangement.
Summary
Clinical evidence was provided via KATHERINE, an open-label, randomised, multicentre trial of adjuvant trastuzumab emtansine compared with adjuvant trastuzumab, in people with HER2 positive early breast cancer who had residual invasive disease after trastuzumab-based neoadjuvant therapy with chemotherapy. The committee concluded that in people with residual invasive disease after neoadjuvant therapy and surgery, trastuzumab emtansine improves invasive disease-free survival compared with trastuzumab. However, it is not known whether trastuzumab emtansine increases overall survival because the data are immature. No study directly compared trastuzumab emtansine with pertuzumab plus trastuzumab with chemotherapy. The company therefore did an indirect comparison using data from KATHERINE and the APHINITY trial (a double-blind, randomised, multicentre trial of adjuvant pertuzumab plus trastuzumab and chemotherapy compared with adjuvant placebo with trastuzumab and chemotherapy, in people with HER2 positive early breast cancer who had not had neoadjuvant therapy). The indirect comparison hazard ratio for invasive disease-free survival in the node-positive subgroup was 0.722 (95% CI 0.50 to 1.04). Both the company and the ERG considered the results uncertain because all patients in KATHERINE had residual invasive disease after neoadjuvant therapy, whereas patients in APHINITY had not had neoadjuvant therapy before surgery. The ERG's preferred ICER for trastuzumab emtansine compared with trastuzumab in the ITT population was £7,213 per QALY gained. For trastuzumab emtansine compared with pertuzumab plus trastuzumab with chemotherapy, the ERG's preferred ICER for the ITT population was £6,388 per QALY gained. The cost-effectiveness estimates are within what NICE considers an acceptable use of NHS resources, therefore, trastuzumab emtansine is recommended.