DefinedHealth

Vasantha Malladi, PhD

There is no argument that the magnitude of morbidity, mortality and healthcare costs associated with Diabetes is headed into the stratosphere. Current estimates for the US alone call for the doubling of the current known patient population (to 44 million) with an associated tripling of treatment expenses (to $336 billion) over the next 25 years. This incongruent cost vs. patient base can be explained by the anticipated advent of new, higher priced, add-on therapies to the existing generic first-line standard of care, metformin. These include, in the short term, increased usage of Januvia and other later entrant DPP-IV inhibitors, long-acting GLP-1s, insulin analogues, and, further back in the pipeline, SGLT-2 inhibitors, 11b-HSD1 inhibitors, oral incretin pathway modulators, FGF-21 inhibitors, glucokinase activators, glucagon inhibitors and anti-inflammatory agents (both oral and injectable).
While glycemic control remains an important objective (and the recognized regulatory marker) for getting to market for Type II Diabetes agents, there is a growing concern that diabetes as an underlying cause of cardiovascular disease is the dominant cost-driver in this ballooning population, and one that isn’t addressed by the new drug classes. Paradoxically, in recent years the cardiac safety concerns associated with Avandia have led to the FDA rewriting guidelines for diabetes drug approval to include a thorough assessment of CV safety prior to approval. Thus, far from needing to show cardiovascular benefit, drugs seeking approval for diabetes now need to run large trials to establish that they do not increase the risk of cardiovascular disease.

This presentation focuses on questions such as:

• Are new classes of diabetes drugs targeting improved glycemic control, weight loss reduction and/or better tolerability the path forward for patients, physicians, payers and regulators?
• How important or critical are cardiovascular outcomes studies in addition to cardiac safety studies to physicians, payers and regulators? How different are these studies in terms of cost and time investments needed?
• In the future, to what extent should/could, and how, can the diabetes and CVD drug development strategies overlap? Which novel therapeutic targets might address common risk factors between diabetes and cardiovascular disease? What would be candidate indications or patient populations to pursue drugs for such targets?
• Are there other markers that could add value to a diabetes drug in development such as - improved renal function, weight loss, beta cell preservation, renal protection or macrovascular benefit?