WIDER CONSULTATION IN HEALTH TECHNOLOGY ASSESSMENT (HTA) DECISIONS- BETTER UNDERSTANDING OR A LOBBYING OPPORTUNITY?
Author(s)
Bending MW1, Hutton J1, McGrath C21University of York, York Health Economics Consortium, York, United Kingdom, 2Pfizer, Surrey, United Kingdom
OBJECTIVES: HTA agencies worldwide have varying processes that allow consultation with stakeholders during decision-making. The objective of this study is to determine the impact of the National Institute for Health and Clinical Excellence (NICE) Single Technology Appraisal (STA) consultation stage on reimbursement decisions of pharmaceuticals. METHODS: Documentation was accessed from the NICE website for all STA’s conducted between 2006 and August 2010. Details of the first Appraisal Consultation Document (ACD) draft decision, subsequent ACDs, Final Appraisal Determination (FAD) and final guidance decision were extracted. The decisions were categorised with respect to the licensed indication (recommended, restricted, not recommended, only in research). Details of the further analysis and evidence submitted by the manufacturer as a result of consultation were extracted. These data were analysed for the different stages of decision-making. RESULTS: The website search identified 55 NICE appraisals of which over fifty percent were for cancer medicines. Final decisions (draft first provisional decision) included 36% (13%) recommended, 36% (20%) restricted decision, 16% (56%) not recommended decision and 11% (11%) terminated decision. One appraisal contained only in research recommendations in addition for use in routine practice. An ACD was produced in 42 appraisals, followed by the manufacturer providing further economic analysis in 26 appraisals, a patient access scheme in 5 appraisals and new clinical evidence in 2 appraisals. Types of further economic analysis provided by the manufacturer were for other treatments/strategies; different modelling assumptions; alternative survival distributions; further sensitivity analysis; and other. CONCLUSIONS: NICE’s iterative consultation process allows consideration of evidence and wide consultation with stakeholders. This results in evidence that is more appropriate for the evaluation of pharmaceutical’s and partly explains the higher recommendation rate when compared with similar international reimbursement agencies. There is a need for further research to understand the impact of the different processes employed across countries’ decision-making.
Conference/Value in Health Info
2011-05, ISPOR 2011, Baltimore, MD, USA
Value in Health, Vol. 14, No. 3 (May 2011)
Code
PHP61
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Multiple Diseases