Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what the criteria is for interim access arrangements for oncology products licensed through Project Orbis.

In view of the rapid approval of Project Orbis medicines, NHS England and NHS Improvement and the National Institute for Health and Care Excellence (NICE) have developed an interim process to support patient access to medicines between Project Orbis licensing approval and publication of NICE guidance. It is anticipated that this will only be required in the short term. Consideration is given to:

- whether there is expected to be three months or longer between regulatory approval by the Medicines and Healthcare products Regulatory Agency and publication by NICE of its final draft guidance;

- if there are any direct competitors expected to go through the NICE technology appraisal process within the next six months;

- if the treatment will make a fundamental, positive change to the existing treatment pathway; and

- whether the company will offer the medicine or treatment on a cost neutral basis.

NHS England and NHS Improvement and NICE are continuing to work with the manufacturer to explore options for interim access to Trodelvy.