Rare Diseases: Drugs

Department of Health and Social Care written question – answered on 3rd July 2018.

Alert me about debates like this

Photo of Jim Shannon Jim Shannon Shadow DUP Spokesperson (Human Rights), Shadow DUP Spokesperson (Health)

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.

Photo of Steve Brine Steve Brine The Parliamentary Under-Secretary for Health and Social Care

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.

Does this answer the above question?

Yes0 people think so

No0 people think not

Would you like to ask a question like this yourself? Use our Freedom of Information site.