Cath Lab Digest

The rapidly rising costs of healthcare in the United States are driving a push to find more efficient and effective ways to provide the best healthcare for the most value.  Comparative effectiveness research (CER) is a potentially viable method used to improve health outcomes and decrease costs in the healthcare system. CER is a systematic research method that compares new drugs and therapies with established drugs and therapies. This research approach not only determines whether a therapy works, but also how well one therapy compares to another. The goal of CER is to achieve the right therapy for the right patient at the right time. By incorporating CER into early stages of drug development as well as in post-marketing and real-world studies, we can improve healthcare and de-emphasize inefficient or inferior products and services.

Currently, CER is a much-discussed topic but one that is underutilized.  Under the guidance of the FDA, most clinical drug trials are designed using a placebo-controlled strategy. This study design fails to compare a new drug product to existing products and may lack important information necessary for formulary decisions. For today’s formulary decision makers, the challenge remains of how to incorporate CER into their day-to-day practice of offering an affordable, balanced drug formulary to their health plan members.

On March 23, 2010, the Patient Protection and Affordable Care Act (ACA) became law. The ACA initiated and funded the creation of the Patient-Centered Outcomes Research Institute, a public/private entity, to coordinate CER and recommend priorities.

Decision makers will pick information resulting from CER as it is relevant to them. In the short term, there will be no consensus-based way of using CER.  Although cost-effectiveness has been excluded from the current definition of CER, cost will have to be brought into the equation in order to be truly useful.  CER needs to translate to “value,” or whether or not a drug is more cost effective.  If CER does not ultimately include cost then the utility to decision makers is mitigated.  For example, if a drug is “better” but also more expensive, decision makers still need to decide if the increase efficacy is worth the increased cost.

It is expected that the role of CER will increase as more CER results are published and accessible, and as the guidance and training on how to use CER research and results emerge. The government is viewed as a driver behind CER, while industry will shape it by adapting the clinical development and by creating increasing evidence along the lines of CER.  Decision makers have to require it though.

This blog was written by Jeffrey D. Dunn, PharmD, MBA, Formulary and Contract Manager, SelectHealth