RESULTS AND OUTCOMES OF NICE SINGLE TECHNOLOGY APPRAISALS
Author(s)
Rina Karia, BSc, (Hons), Health Outcomes Analyst, Ray Gani, PhD, Health Economics Modeller, Annabel Boler, BSc, PGDip, Scientific Officer Heron Evidence Development Ltd, Letchworth Garden City, Hertfordshire, United Kingdom
OBJECTIVES: The new Single Technology Appraisal (STA) process introduced by NICE attempts to shorten the process of assessment. The purpose of this study was to review, summarise and critique all of the STAs published to date and to analyse themes and trends. METHODS: A database was developed to collate key data from the STAs completed to date with an initial focus on oncology submissions. Clinical and economic data as well as summaries of all key comments were extracted from the manufacturer submission, evidence review group report, expert submission and the final appraisal determination. Data were then analysed for associations between ICER values, clinical and economic evidence and submission outcome. RESULTS: Since the introduction of the STA process, six STAs have been completed for drugs in oncology. A further 27 STAs are in development, with 10 more in oncology. Three out of the six oncology submissions were considered to have resulted in positive guidance from NICE, recommending the use of the drug in the NHS. Reasons for negative guidance included uncertainties in the clinical evidence presented; and lack of a robust economic argument. Completed industry submissions in oncology presented ICERs ranging from £4 726 to £30,100. The corresponding ERG group estimates of ICERs ranged from £4,726 to £86,770. The ERG's criticisms of the industry submissions included omission of a systematic review, failure to use recommended approaches to evidence synthesis and failure to adhere to the reference case. CONCLUSION: The single technology appraisal process is in its infancy with contributors gaining valuable experience with each new appraisal. Acknowledging and acting upon the criticism from ERGs will help improve the quality, and possibly the outcomes of future STAs. Reviewing completed STAs and analysing trends and themes may inform future strategic and tactical planning of submissions.
Conference/Value in Health Info
2007-10, ISPOR Europe 2007, Dublin, Ireland
Value in Health, Vol. 10, No. 6 (November/December 2007)
Code
PHP33
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Multiple Diseases