Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what discussions his Department has had with the National Institute for Health Care Excellence on accelerating the publication of its advice on whether Sacituzumab Govitecan, marketed as Trodelvy, is a clinically and cost-effective use of NHS resources.

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for scheduling the development of technology appraisal guidance on individual medicines in discussion with the manufacturer. Following discussion with Gilead, the manufacturer of sacituzumab govitecan, NICE has been able to accelerate its appraisal and now expects to issue guidance in June 2022, with draft guidance expected in April 2022.

In view of the challenge for the health system presented by the more rapid approval of Project Orbis drugs, NHS England and NHS Improvement and NICE have agreed a set of principles to allow potential interim access to drugs licensed through this route ahead of NICE’s guidance.