The study, entitled The NICE Single Technology Appraisal Process: Lessons from the first four years, was co-authored by Dr Eva Kaltenthaler and Diana Papaioannou from the University of Sheffield and Angela Boland and Rumona Dickson of the University of Liverpool.
The National Institute for Health and Clinical Excellence, (NICE) set up the Single Technology Appraisal (STA) process in 2005 as a method of examining whether new drugs are both clinically and cost effective.
During the STA process, manufacturers prepare a submission of evidence to support their drug. The University of Sheffield’s School of Health and Related Research (ScHARR) is one of seven centres in the UK that provides independent academic analysis of these submissions to identify strengths and weaknesses. These academic groups are known as Evidence Review Groups (ERGs). Two of the academic centres, ScHARR and the University of Liverpool’s Liverpool Reviews and Implementations Group (LRiG) carried out the research into the STA process.
The research aimed to see if the STAs were carried out within the expected time lines and also to identify reasons for delays as well as the decisions NICE made on the use of the drugs. The study was funded by the National Institute for Health Research Health Technology Assessment programme.
The research examined the first 95 STAs performed since 2005 and found that the STA process is slower than originally planned. However, the research found that this was largely due to factors outside of NICE’s control, for example one third of topics submitted for STA were cancelled due to drugs not being licensed in time by the European Medicines Agency (EMA).
Although NICE has received criticism in the media for not allowing drugs to be made available on the NHS, the research found that, contrary to popular opinion, 76% of drugs submitted through the STA process were approved for use in the NHS by NICE.
The report recommended changes that would improve the STA process, including:
•Improving access to information and guidance through the NICE website
•Giving manufacturers better guidance to ensure that more appropriate submissions are received in the future
•Training and guidance for ERG team members to ensure reporting methods are transparent
•Changes to the report template used by the ERG teams
Dr Kaltenthaler commented: “This is the first independent assessment of the NICE STA process. Most delays are primarily due to events outside of NICE’s direct control. The recommendations from this research will help to make the NICE STA process more efficient and transparent.”
Dr Angela Boland and Dr Rumona Dickson commented: “Examination of what we have been doing has provided information to assist us in moving forward to provide clear, comprehensive and useful information to the NICE Appraisal Committees to assist them in making their decisions.”
The research paper is to be published and discussed in volume 14 issue 8, of Value in Health, the official journal of the International Society for Pharmacoeconomics and Outcomes Research in December 2011.
Notes for Editors:
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