PRESS RELEASE
June 27, 2012, 8:45 a.m. EDT
Clinical Trial Results Alone do Not Determine Reimbursement
PHILADELPHIA, Jun 27, 2012 (GlobeNewswire via COMTEX) -- A recent global comparison between clinical outcomes and Health Technology Assessments (HTAs) -- which are often influential in decision making for approving and/or providing reimbursement for pharmaceuticals and other medical technology -- for Hepatitis C drugs found that while clinical trial outcomes were generally broader in scope, and their results often overlapped, they do not always account for measures found in HTAs that had a direct impact on reimbursement decisions. The analysis was presented today at DIA's 2012 international conference.
"While clinical trial data certainly provides the broadest range of outcomes to pharmaceutical companies, the outcomes that drive regulatory approval are not always inclusive of those that drive reimbursement," said Yin Ho, MD, MBA, CEO of New York-based Context Matters, and co-author of the study. "HTAs often weigh patient-reported measures, which clinical trial outcomes do to a lesser extent. When we evaluate the copious amounts of data available for both approval and reimbursement, it is instructive to recognize the trends of which measures were influential in making both regulatory and reimbursement decisions, in order to best predict future outcomes for Hepatitis C and other treatment areas."
The study examined clinical outcomes for Hepatitis C drugs from 42 technology assessments across seven agencies, as well as 41 current Phase 3 clinical trials from 2006-2012. While the most common outcome in both HTAs and clinical trials was sustained virological response at 24 weeks post-treatment, clinical trial outcomes trended toward virological response at different time frames and other quantitative measures, including relapse rates (time), treatment failure, drug resistance and others. Comparatively, HTAs were more likely to also include qualitative measures, including liver quality (1.5 times as often) and quality of life (twice as often).
The study was sponsored and performed by Context Matters, Inc.
Context Matters, Inc. is the next generation of healthcare data analytics, focusing on risk assessment metrics for pharmaceutical and biotechnology products. Its data-driven /evidence-based approach begins with our proprietary software database platform of intelligently culled, curated, and relevant business information and data to answer strategic business questions and provide actionable analysis. Its platform and approach result in more informed decision-making by allowing users to access and understand complex data that has never before been quantified or aggregated through a tailored, needs-based approach.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Context Matters
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