Increased Use of Patient-Reported Outcomes May Deepen Available Evidence in Regulatory and Reimbursement Decision-Making

WASHINGTON, June 5, 2012 /PRNewswire/ -- A recent global analysis of product evaluations for Health Technology Assessments  – which are often influential in decision making for approving and/or providing reimbursement for pharmaceuticals and other medical technology – found that the use of patient-reported outcomes (PROs) increased between 2005 and 2011. The study also showed substantial variation across both nations and treatment areas in applying HTAs to such decisions.

The study, presented today at the International Society of Pharmacoeconomics and Outcomes Research conference, suggests that increased use of PROs in product evaluations in the healthcare industry may provide additional insight as to how regulatory agencies, and even manufacturers themselves decide what products to make available to the public.  Ultimately, this more expansive approach may influence the availability of new treatment approaches.

"Physicians are increasingly advocating a patient-centered approach to practicing medicine, but once products are approved, reimbursement decisions tend to be more economically based," said Yin Ho, MD, MBA, CEO of New York-based Context Matters, and co-author of the study.  "While there has been progress in changing that paradigm, it has been very slow.  We have a massive database of pharmaceutical industry reimbursement, regulatory, pricing, and clinical outcomes which supports analysis of things like length of treatment, appropriate comparators, optimal launch windows and other factors – including PROs – which regulators and payers may incorporate into their evaluations.  Increased inclusion of PROs in these analyses may balance the patient-centered approach with economic analysis, all of which support a more robust evidence-based approach to decision making."

The study examined the prevalence of PRO use in reviews of nine regulatory agencies worldwide from 2005 to 2011 across 19 disease areas.  Among the 424 reviews examined, only 29 percent reported PROs, but the use of PROs did increase from 25 percent in 2005 to 38 percent in 2011.  The study also demonstrated that generally anemia in cancer, ovarian cancer and Parkinson's disease reviews utilize PROs at least 75 percent of the time, but that use by agencies varies from about 10 percent to about 67 percent. 

Dr. Ho also observed that PROs were never used in any pediatric indications, even in those disease states where both adults and children were affected.

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.

SOURCE Context Matters, Inc.