MAKING SENSE OF NICE'S ‘NEW' MTA AND STA PROCESS GUIDE- A NARRATIVE SYNTHESIS
Author(s)
Urbich M, Mildred M
Boehringer Ingelheim Ltd, Bracknell, UK
OBJECTIVES: NICE’s guides to the process of Multiple Technology Appraisals (MTA) and Single Technology Appraisals (STA) provide a valuable source of information to enable stakeholders to engage in Health Technology Appraisals (HTAs). NICE recently conducted a review of the process guides which has implications for all stakeholders involved with MTAs and STAs. The objective of this analysis was to identify the number and type of amendments within the guides in order to highlight the most important changes for consultees and commentators. METHODS: Narrative synthesis was used to systematically identify, classify and explore the impact of the proposed amendments to the MTA and STA process guides. The hypothesis was that the amalgamation of the MTA and STA guides would simplify both TA processes whilst increasing rigour and transparency. Sources of reference were the draft of the new process guide, the NICE Senior Management Team Board Cover Paper, and the 2009 MTA and STA process guides. RESULTS: Amendments were classified as relating to the process itself (26%), data and confidential information (44%), terminology (7%), and others (22%). Of the 27 amendments to the MTA and STA process guides, 4 (15%) were identified as major amendments which warrant specific appreciation. Major amendments included: (1) the STA decision problem meeting moving to after the Department of Health referral; (2) stricter rules around the marking of confidential information; (3) full publication of MTAs; and (4) MTAs now have the opportunity to go straight to Final Appraisal Determination (FAD) following the first committee meeting. CONCLUSIONS: The draft process guide suggests that the new MTA and STA processes will foster greater engagement between stakeholders early on, increase transparency, and enable patients to have quicker access to innovative medicines which are able to go straight to FAD.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PHP196
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases