Overcoming Barriers to Development of Novel Therapies for Cardiovascular Disease: Insights From the Oncology Drug Development Experience

Abstract

Despite the fact that cardiovascular disease (CVD) is the number 1 cause of death globally, investment in drug development and new drug approvals for CVD are precipitously declining. In contrast, the trajectory of both investment in development as well as new drug approvals for oncology have been increasing steadily over the same time frame. The factors that have spurred drug development in oncology may be applicable to new efforts to overcome barriers to drug development for CVD. Greater investment in basic research and application of expedited regulatory pathways have contributed to a lowering of development barriers in oncology. Barriers in implementation are also critical. More rapid adoption of guideline-based therapies and lower access barriers by payers have contributed to fewer implementation barriers for oncology therapeutics. There is substantially greater advocacy among patients and physicians for new oncology therapeutics, and such advocacy efforts are likely to have had a meaningful impact on lowering barriers to develop new oncology therapeutics. Broad support of patient and physician advocacy efforts directed towards CVD may help overcome existing development and implementation barriers to new drug development, thereby spurring more rapid progress in the fight to eradicate cardiovascular disease.

Keywords: ARNI, angiotensin receptor neprilysin inhibitor; ASCVD, atherosclerotic cardiovascular disease; CVD, cardiovascular disease; advocacy; cardiovascular disease; drug development; expedited regulatory pathways.

Graphical abstract

Central Illustration

The Development and Implementation Barriers That Impede the Generation of Novel Therapies for Cardiovascular Disease Could Be Overcome by a Cardiovascular Disease “Moonshot Program” The generation of novel cardiovascular therapeutics is impeded by a lack of investment due to barriers that limit investment in research in development as well as barriers that slow adoption of safe and effective therapies that limit their implementation. A “CVD Moonshot Program,” consisting of elements that have fueled the rapid development of new cancer therapeutics- increased research funding, novel surrogate endpoints in clinical trials, expedited regulatory pathways, and government mandated coverage- could pave a road towards eradication of CVD. CVD = cardiovascular disease.

Figure 1

U.S. Food and Drug Administration Approvals for Cardiovascular Disease and Cancer From 1980 to 2017 Adapted from Tufts Center for the Study of Drug Development Impact Report 2016 . NBE = new molecular entity; NME = new molecular entity.