Atezolizumab with nab-paclitaxel will not be approved for use within the NHS for treatment-naïve, triple-negative, unresectable, advanced breast cancer with PD‑L1 >1%, if new draft NICE guidance is passed.
In draft guidance, NICE says the treatment is not cost-effective compared with weekly paclitaxel based on the current price. The decision will not affect treatment with atezolizumab with nab-paclitaxel that was started in the NHS before the 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.
Referring to the double-blind randomised IMpassion130 of atezolizumab plus nab-paclitaxel versus placebo plus nab-paclitaxel, NICE acknowledged a significant improvement in progression-free survival (PFS) (7.5 months vs 5.0 months, respectively; hazard ratio [HR] 0.62; 95% CI 0.49-0.78).
However, in the intention-to-treat population, the difference in overall survival (OS) in the first interim analysis were not statistically significant, and formal testing of overall survival in the PD‑L1-positive subgroup was not possible.
There is no direct comparison of atezolizumab plus nab-paclitaxel with taxanes used in the NHS, such as weekly paclitaxel and the appraisal committee concluded that the results of an indirect comparison done by the company is unreliable and lacks face validity.
NICE concluded that 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 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.
The draft guidance is now open for public consultation until October 24, 2019. The final decision is expected in February 2020.