cover image: NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE  CENTRE FOR HEALTH TECHNOLOGY EVALUATION

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NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE CENTRE FOR HEALTH TECHNOLOGY EVALUATION

27 Jan 2016

NICE EAMS meeting – The NICE Office for Market Access offers companies the opportunity to have a supplementary meeting with NICE to discuss the company’s data collection plans during the EAMS period, in order to help ensure the company is well prepared for a potential Technology Appraisal (TA) or Highly Specialised Technologies (HST) evaluation. [...] The NICE EAMS meeting aims to help companies gain insight into the NICE processes and evaluation frameworks, as well as to learn more about the option to develop and propose managed access arrangements and patient access schemes to support adoption following the EAMS period and NICE appraisal. [...] When NICE is notified that a PIM designation has been given and that the company has requested a pre-submission meeting with the MHRA, the NICE Office for Market Access offers the company an optional NICE EAMS meeting. [...] The company is asked to provide the pre-submission template submitted to the MHRA and to complete a NICE pro-forma to describe any plans for further evidence collection, for patient access schemes or flexible pricing. [...] Where there is likely to be high uncertainty at the point of NICE appraisal or evaluation, the NICE EAMS meeting provides an opportunity to discuss the options for ‘managed access arrangements’ after the EAMS period.

Authors

Andrew Dillon

Pages
8
Published in
United Kingdom