1 Recommendations

1.1 Atezolizumab with nab-paclitaxel is not recommended, within its marketing authorisation, for treating triple-negative, unresectable, locally advanced or metastatic breast cancer in adults whose tumours express PD‑L1 at a level of 1% or more and who have not had previous chemotherapy for metastatic disease.

1.2 This recommendation is not intended to affect treatment with atezolizumab with nab-paclitaxel that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

There are currently no targeted, or immunotherapy treatments for triple-negative breast cancer. The only treatment option is chemotherapy, usually with taxane monotherapy. Atezolizumab is the first immunotherapy to be approved for PD‑L1-positive, triple-negative breast cancer. It is used in combination with the chemotherapy agent, nab-paclitaxel.

Clinical trial evidence shows that people having atezolizumab plus nab-paclitaxel live longer before their condition gets worse than people having placebo plus nab-paclitaxel. It also suggests that they live longer. There is no direct comparison of atezolizumab plus nab-paclitaxel with taxanes used in the NHS, such as weekly paclitaxel. However, it is reasonable to assume that nab-paclitaxel has a similar efficacy to weekly paclitaxel. There is an indirect comparison done by the company, which is unreliable and lacks face validity. It is reasonable to use nab-paclitaxel as a proxy for weekly paclitaxel and to use data from the clinical trial to model the effectiveness of atezolizumab plus nab-paclitaxel, compared with weekly paclitaxel.

Atezolizumab plus nab-paclitaxel compared with weekly paclitaxel is not cost effective, even when it is considered to be a life-extending treatment at the end of life. In addition, it does not meet NICE's criteria for inclusion in the Cancer Drugs Fund. This is because it does not have the potential to be cost effective at the current price, and there is no clear evidence that further trial data would resolve the uncertainties. Therefore, atezolizumab plus nab-paclitaxel is not recommended in adults with PD‑L1-positive, triple-negative, advanced breast cancer.