Quintiles calls for standard set of CER principles for assessing pharma innovation
Integrated biopharmaceutical services company Quintiles has called for a universally accepted pharmaceutical valuation system based on a standard set of comparative effectiveness research (CER) principles rather than cost.
Integrated biopharmaceutical services company Quintiles has called for a universally accepted pharmaceutical valuation system based on a standard set of comparative effectiveness research (CER) principles rather than cost.
In a new report, Dr John Doyle, vice president and practice leader for Quintiles Consulting and an expert on pharmaceutical market access, looks at the complex issue of Comparative Effectiveness Research (CER) and its strategic importance in successful and efficient biopharmaceutical development.
"Current market factors and policy debates provide industry a chance to take the lead in establishing a valuation system that compensates innovation fairly," he says.
The report, Rewarding Innovation and Value: What is the Role of Comparative Effectiveness Research?, addresses the potential for a universally accepted pharmaceutical valuation system based on a standard set of CER principles. CER is an approach in which pharmaceutical products are evaluated in a true-to-life setting against the current standard of care. CER includes an appraisal of a therapy's safety and effectiveness, often measured in clinical, economic, and humanistic dimensions.
In the report, Dr Doyle discusses the concept of broadening metrics and study designs to "accurately and fairly" appraise the value of pharmaceutical innovation rather than focusing on costs. "This market-driven CER methodology would be designed to ensure universally accepted, standardised techniques, with transparency, independence, objectivity and credible findings," he added.
The issue of CER has been brought to the forefront since being allocated US$1.1bn out of the $787.2bn budget of the economic stimulus bill. In the report, Dr Doyle issues a challenge to pharmaceutical companies regarding their role in driving CER methodology.
"As comparative effectiveness research gains more influence, pharma can simply not afford to wait passively for policy-makers to dictate comparative effectiveness requirements and not actively participate in the discussions concerning the proper design and use of CER. By supporting the development of a standard set of guidelines, the industry could rightly earn a seat at the table if initiatives are launched at the federal level."
He also urges biopharma companies to engage in discussions to assist in developing guidelines for the proper design and application of CER. "Biopharmaceutical manufacturers need to examine the data which shows exactly how their medicines are being used, and by whom. This will enable decisions to be made all along the development process that are more rooted in real-world data.
"By taking the lead now - before the opportunity evaporates - companies and trade groups can drive the establishment of a product valuation system that compensates innovation fairly."
The report is available for download at Quintiles Consulting.
