Health Care Consultants Assess Impact of FDA Policy Intervention for Evaluating Cardiovascular Risk in New Diabetes Drugs

March 13, 2014

A paper coauthored by members of Analysis Group's Health Care Consulting practice was recently published in Pharmacoepidemiology & Drug Safety (PDS). The paper, "Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies," was coauthored by an Analysis Group team, including Managing Principal Anita Chawla and Vice President Dave Nellesen, along with researchers Daniel Mytelka, Daniel Ball, and Anupama Kalsekar from Eli Lilly, and academic researchers Adrian Towse from the Office of Health Economics and Louis P. Garrison of the University of Washington. The research, supported by Eli Lilly, was published online in January 2014 (DOI: 10.1002/pds.3559).

This research investigated the costs and benefits of an FDA policy designed to reduce the likelihood that new therapies approved to treat type 2 diabetes are associated with an unacceptable increase in cardiovascular (CV) risk. In February 2008, the FDA offered draft guidance for safety requirements related to CV risk associated with new type 2 diabetes drugs, and implemented a revised final guidance in December 2008. The authors compared expected outcomes under the December 2008 guidance to those under the earlier February 2008 draft guidance. The research found that although the new policy is expected to reduce exposure to CV risk, as intended, the adverse impact of fewer approved novel diabetes therapies and delayed access to drugs outweighed the benefits associated with this outcome. On net, the authors found that the December 2008 FDA policy compared with the draft guidance earlier that year is expected to reduce U.S. diabetes population health by over 1.5 million years of life over 35 years. The analysis illustrates the use of a quantitative approach to evaluating alternative policy approaches, where the health outcomes impact of all potential benefits and risks -- including health gain from avoided adverse events and lost health benefits from delayed or forgone efficacious products -- are included.

Read the paper