Example of Trial Design Data Relevant for All Stakeholders

8 September, 2014, by ClinCaptureTeam

BioCentury has lead article this week “Betting Big on Hearts” by Emily Cukier-Meisner, Senior Writer, discussing a breakthrough drug for cardiovascular disease developed by Novartis. LCZ696 for heart failure will replace ACE inhibitors widely, so long as its price is not prohibitive. The Novartis pulled out all the stops in designing a study that provides the kind of evidence that is hard to ignore on part of payers, hospitals, and physician groups. Ms. Cukier-Meisner notes “The study design is a model for how companies can provide robust data — even against generics — in the brave new world in which regulators, payers, physicians and patients all have different data requirements.” The protocol was designed with the trial goals (1) that would show outcomes relevant to multiple stakeholders and (2) thoroughly supplant angiotensin-converting enzyme inhibitors in the indication of heart failure.

We hope the drug is affordable for this large indication and not priced like a specialty drug. The article notes that at the end of August, Novartis Pharmaceuticals Division Head David Epstein said LCZ696 won’t be priced like a generic, but that Novartis doesn’t think a high price is necessary for the company to continue developing products. “Companies have a responsibility to price reasonably, and we will do that,” he (Epstein) said.

With the large number of patients with heart failure in the U.S. alone, there’s no need to price the drug exorbitantly to reach blockbuster status. The volume of patients with the indication will produce blockbuster sales easilty for the drug if approved. The CDC provides the following statistics on the disease:

“Heart Failure in the United States

• About 5.1 million people in the United States have heart failure.
• One in 9 deaths in 2009 included heart failure as contributing cause.
• About half of people who develop heart failure die within 5 years of diagnosis.
• Heart failure costs the nation an estimated $32 billion each year. This total includes the cost of health care services, medications to treat heart failure, and missed days of work.”

Reposted from Audrey Erbes’ blog: Audrey’s Network

Audrey’s Network includes Bay Area bioscience professionals from all sectors who are working in broad array of functions in the industry. The group originated, first, with members sourced from Audrey’s UC Extension intensive courses in Bioscience Business and Marketing (now numbering over former 1,250 students), the Syntex Syva Alumni Association, the Bio2Device Group (now has over 1,000 members) and other industry professional groups and individuals with whom Audrey has worked. The mission is to assist industry professionals continue to keep up-to-date in their fields through “sharpening the saw” regularly and building and maintaining a vibrant network.