Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 31 May 2018 to Question 146854 on Rare Diseases: Drugs, whether NHS England can be mandated by NICE to enter discussions with manufacturers on managed access agreements as part of an evaluation of highly specialised technology; and what criteria are used by NICE to decide when to initiate discussions between NHS England and manufacturers on managed access arrangements as part of an evaluation of a highly specialised technology.

The National Institute for Health and Care Excellence (NICE) has no powers to require NHS England to enter discussions with manufacturers, and there are no specific criteria used to decide when to initiate discussions with a manufacturer.

However, a managed access arrangement will be considered a potential option when the highly specialised technology evaluation committee considers that such an arrangement would have the potential to resolve the uncertainties and manage the risk for a particular topic. For example, when evidence collection could resolve a clinical uncertainty or when clear starting and stopping criteria would manage financial or economic risks.

In circumstances where a managed access agreement is a potential option, NICE will ask NHS England, companies and other stakeholders to enter into discussions on managed access agreements.