RECOMMENDATIONS FROM REIMBURSEMENT AGENCIES FOR ADDITIONAL POST-LAUNCH RESEARCH. THE NEXT HURDLE
Author(s)
Deborah Marshall, PhD, Vice President, Global Health Economics and Outcomes1, Hai Ein Yong, MASc, Research Analyst1, Stuart MacLeod, MD, PhD, FRCPC, Executive Director2, Mike F Drummond, PhD, Professor31i3 Innovus, Burlington, ON, Canada; 2 British Columbia Child & Family Research Institute, Vancouver, BC, Canada; 3 University of York, York, Heslington, United Kingdom
OBJECTIVES: There is increased interest in post-launch economic studies as more jurisdictions require economic data for the formal decision process of pricing and reimbursement of drugs. METHODS: We reviewed all of the final recommendations regarding all pharmaceutical submissions to the CDR from its inception in May 2004 through January 2007. Decisions were categorised as: listed, listed with criteria or not listed. Recommendations for further research post-launch were reviewed and categorized regarding the specifics of the type of data requested. Using a comparative framework to examine the recommendations of CDR and NICE, we describe the frequency of the different types of data recommended for collection post-launch to highlight trends across jurisdictions RESULTS: Thirty-four of 64 CDR submissions recommended ‘no listing', 17 ‘list with criteria', and 13 ‘list or list in similar manner as other drugs in the same category'. Of the 64 appraisals, 41 were recommended to conduct further research to either collect specific items of data (n=28), conduct subgroup analysis (n=13), or collect data using a more appropriate study design (n=19). The most commonly requested item was long-term adverse events or safety data (16/28), and this observation is consistent with the fact that, to date, most post-launch studies are safety surveillance studies. In addition 11 of 28 recommended the collection of clinically important outcomes, long-term effectiveness (7/28). Similarly, 41 of 48 NICE appraisals recommended further research to collect real-world data, including treatment pathways, effectiveness, and long-term effectiveness or adverse events. CONCLUSION: This review suggests that recommendations for post-launch research from CDR and NICE appear to be similar. This highlights the inherent weakness of regulatory trials as a piece of evidence in informing reimbursement decisions.
Conference/Value in Health Info
2007-10, ISPOR Europe 2007, Dublin, Ireland
Value in Health, Vol. 10, No. 6 (November/December 2007)
Code
PHP17
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Study Approaches
Topic Subcategory
Formulary Development, Post Marketing Studies, Reimbursement & Access Policy
Disease
Multiple Diseases