Cost-Effectiveness Research: Sorely Needed for Interventional Therapies

Proceedings from 12th Biennial Meeting of the International Andreas Gruentzig Society:  Brazil – 2014
From SESSION 11 – Industry Roundtable
Moderator: Jeff Marshall, MD
Panelists: Sam Conaway, Matt Franklin, Lillian Garcia Palmer, Melissa Gindling, Paul Goodman, David Kallend, Richard Shaw, Jason Struck, Mike Vonesh

Framing the question at hand, what is the state of the current knowledge?
In a rapidly changing world where cost, value and quality are increasingly important, cost effectiveness research needs to be more abundantly integrated into the clinical decision-making processes. This must start with interventional device trial design with embedded cost effectiveness measures and end points so that data can be collected prospectively. The design of these trials often includes a disproportionate number of non-interventional investigators. Even when well-designed cost effectiveness research is performed it is often difficult to get government agencies and payers to actually hear what the data means for payers. Cost alone does not equate to the value of a particular interventional device or strategy. Long-term avoidance of future costs need to be carefully considered when discussing cost and value.

What are the Gaps in the current knowledge?
 Gaps in the current knowledge include the simple lack of good cost effectiveness data even when the tools exist to collect this data prospectively.  There is the difficulty of incremental or iterative changes in technology and how these may affect the value and cost effectiveness of small but meaningful advancements in interventional therapies.  The government and payers are concerned that the ultimate number of interventional procedures cannot be estimated with certainty with new devices.  This uncertainty in the final expenditure by payers, especially the government, may be in part an impetus to issue non-coverage decisions.  Interventionalists from all subspecialties, in general, are not well versed on the methods and tools needed to accurately include cost effectiveness data in interventional trials.

Our Summary and Recommendations:
In the United States and now even to some degree Western Europe, there is a reluctance on government funding agencies (e.g. NIH) to fund such expensive interventional research that includes cost effectiveness data.  While we all agree this type of cost effectiveness research should be performed, the key question is who should pay for it?  A more collaborative approach including representatives from CMS, the FDA, private payers, patient advocacy groups, industry, clinicians and others should be convened to establish what data and prospectively economic endpoints are most meaningful to be used routinely in interventional device research.  These data could then be utilized to establish reimbursement rates based on the value of an individual cardiovascular intervention.