The US economic stimulus bill allocated $1.1bn (€734m) to CER, pushing the topic into the limelight, and John Doyle, vice president (VP), practice leader at Quintiles Consulting, believes pharma needs to capitalise on this opportunity.
In a white paper Doyle states that if pharma takes the lead on this issue it can put itself in a position where it “can drive the establishment of a product valuation system that compensates innovation fairly”.
To achieve this pharma will need to embrace CER, which evaluates the real world performance of a new product against the current standard of care, and this could create opportunities for contract research organisations (CRO).
Doyle envisages a new product being compared to the existing treatment in a variety of patient populations across multiple benefit and risk metrics. The clinical trial expertise at CROs, and pharma’s desire to outsource, could see them benefit if CER becomes commonplace.
Pharma perspective
Doyle believes that pharma “can simply not afford to wait passively for policy-makers to dictate comparative effectiveness requirements”. By a proactive approach Doyle believes that pharma can play a role in discussions regarding the proper design and use of CER.
This could lead to the development of a widely accepted, standardised format for CER that companies can use alongside a product’s traditional data demonstrations.
Doyle added that products supported by CER will be better equipped to demonstrate value to multiple stakeholders, ensuring that companies with truly innovative therapeutics that have real benefit to patients will be paid accordingly.
Furthermore, Doyle believes that CER can complement randomised clinical trials to help companies refine development and product positioning before a drug’s launch.
The complete white paper is available here.