Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the Written Answer by Lord Kamall on 17 May (HL147), how the National Institute for Health and Care Excellence (NICE) appraisals of (1) Sacituzumab govitecan (Trodelvy), and (2) Tucatinib (Tukysa) with trastuzumab and capecitabine, were included in the statistic cited as 100 per cent of guidance of new medicines being issued within three months of a licence in 2021/22, where NICE proceeded to appraisal.

The appraisal of sacituzumab govitecan is not included in this statistic as the National Institute for Health and Care Excellence (NICE) has not yet issued its final guidance. The appraisal of tucatinib is not recorded by the timeliness metric for 2021/22 as NICE’s final guidance was issued in the 2022/23 business year.

NICE issued final guidance within 90 days of licensing for 100% of published appraisals of new active substances where timelines were within NICE’s control. Topics outside of this timeframe were impacted by external factors such as where a company requested a delay to NICE’s evaluation.