Speak now or forever hold your peace
If youre interested in market access, youll likely be familiar with comparative effectiveness research (CER). But in case youre not, it is an approach in which pharmaceutical products are evaluated in a true-to-life setting against the current standard of care. CER appraises a therapys safety and effectiveness, usually measured in clinical, economic and humanistic dimensions.
Today, Quintiles Consulting issued a challenge to pharma companies to seize the moment and take a leading role in driving the development of guidelines for the proper design and application of CER. In a just-released report entitled Rewarding Innovation and Value: What is the Role of Comparative Effectiveness Research?, John Doyle, vice president and practice leader for the group, addresses the potential for a universally accepted pharmaceutical valuation system based on a standard set of CER principles.
He encourages the broadening of metrics and study designs to accurately and fairly appraise the value of pharma innovation rather than focusing on costs. Current market factors and policy debates provide industry a chance to take the lead in establishing a valuation system that compensates innovation fairly, he writes. This market-driven CER methodology would be designed to ensure universally accepted, standardized techniques, with transparency, independence, objectivity and credible findings.
He notes that a Stanford University team even recently proposed that the US Food and Drug Administration require CER data to be included in a products label in order to separate products that truly improve outcomes from those that do not. 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, Doyle urges. By supporting the development of standard set of guidelines, the industry could rightly earn a seat at the table if initiatives are launched at the federal level.
In the coming days, well summarize the key messages from the Quintiles report for you, so keep an eye on this space. In the meantime, if its not already on your radar screen, teaming up as an industry to push for the development of a standard set of guidelines certainly seems too important a task to ignore.
After all, as Doyle suggests, by taking the lead now before the opportunity evaporates companies and trade groups can act to protect the industrys investment in innovation. And hes right when he says that engaging in these early discussions of CER stands to gain the industry influence over the form this approach takes as it evolves.
As always, leave a comment below and let us know what you think. And be sure to look for our full summary of the Quintiles Consulting report coming soon.