Rare Diseases: Drugs

(asked on 22nd May 2018) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, in what circumstances NHS England and manufacturers are able to negotiate managed access agreements as part of an evaluation of a highly specialised technology; and if he will make a statement.


Answered by
Steve Brine Portrait
Steve Brine
This question was answered on 31st May 2018

The National Institute of Health and Care Excellence (NICE) has historically taken decisions based on whether, at the price proposed by a company, the value proposition of the treatment for the National Health Service is commensurate with the evidence of benefit and level of certainty.

Since the establishment of the NHS England commercial development team in 2017, NICE has a third option, in circumstances where an improvement in the value proposition might successfully address issues that would otherwise lead to a negative decision. In those circumstances, NICE informs NHS England who hold negotiations with the company and if an improved value proposition can be agreed, NICE can make its final decision in light of the agreed improvements.

Those agreements are contained within a managed access agreement (MAA) which typically includes clinical starting and stopping criteria, patient consent and data collection, and confidential commercial terms agreed between the manufacturer and NHS England. These provide a time-limited period of access pending a reappraisal at the end of the MAA period using the improved evidence from the period of routine commissioning.

Reticulating Splines