What’s Keeping the Cardiac Polypill off the Market?

Jul 3, 2014, 10:05 AM, Posted by Sheree Crute

No matter how busy Lisa Ranson’s morning gets, somewhere between preparing breakfast and suiting up for work or play, she takes the first cluster of eight pills that protect her from a family legacy of heart disease so powerful she had bypass surgery at 34.

Even at that young age, she was no stranger to daily prescription regimens. Growing up, she watched her dad struggle. These days they compare notes. “He’s survived two heart attacks, had bypass surgery, and he has a pacemaker,” Ranson says.

An avid walker who treks three and a half miles most days near her home in the small town of Dunbar, W.Va., Ranson is now 51 and in great shape. But her healthy lifestyle is no match for her genetic inheritance—she is one of 34 million people living with hypercholesterolemia.

“My cholesterol was 350 in my 20s,” Ranson recalls. “By the time I was 34, I had a 99 percent blockage in two arteries.”

A compeer coordinator for people with behavioral health problems at KISRA, a West Virginia nonprofit, Ranson says she’s grateful for the $246-a-month (with health insurance) prescription ritual that cuts her heart attack risk, but she adds: “I take a handful of pills in the morning and a handful at night, that’s the only way I can keep up with them. Bless people who don’t have health insurance. I don’t know how they would do this.”

Saving Lives, Saving Millions

The estimated cost of cardiovascular disease (CVD) in the United States in 2010 was $443 billion. CVD is responsible for one in four deaths each year and it affects more than 83 million Americans, according to the American Heart Association.

Surely, if there were a treatment that might prevent CVD, keep people healthy longer, and lower costs, it would be swiftly brought to market. But it’s not that simple, argue the authors of a new RAND report, Redirecting Innovation in U.S. Health Care: Options to Decrease Spending and Increase Value, co-authored by Art Kellermann, a Robert Wood Johnson Foundation (RWJF) Health Policy Fellow (2006-2007) and RWJF Clinical Scholar (1983-1985). (Read a Human Capital Blog post by Kellerman here.)  

The Power of a Single Pill

The “polypill” just might be that treatment. It is a combination of generic medications that have been proven to combat heart disease, hypertension and stroke that could replace one or more of the medications patients like Ranson take each day.

People with heart disease are so overwhelmed by complicated treatment regimens that only 50 percent take their prescribed daily medications. “No one is happy when I take out my prescription pad,” says Nihar Desai, MD, MPH, a cardiologist at Yale School of Medicine and author of the Rand report case study: A Cardiovascular Polypill. “Most patients that I see are taking more than five pills, and some take that many twice a day.”

Working with his mentor, Harlan Krumholz, MD, director of the RWJF Clinical Scholars program at Yale University, Desai decided to investigate why the polypill has not made it to market after 11 years of trials.

Several studies, including “the Indian Polycap Study and the UMPIRE trial, have shown that some formulation of a generic polypill—a blood pressure medication, beta blockers, and a statin, possibly combined with aspirin—is safe, effective and increases patient adherence with few side effects,” Desai explains.  “The UMPIRE trial showed 86 percent adherence to a prescription regimen in the polypill group versus 65 percent in the multiple pill group.”

Desai adds: “Most experts believe that a multidrug combination pill that simplifies care delivery, reduces costs, and improves adherence would have far-reaching implications for reducing the global burden of CVD. Estimates suggest it could reduce the burden by more than half. We are sure it could save hundreds of millions of dollars.”

Used as primary prevention in countries where people have poor access to care, a polypill could dramatically lower rates of heart disease. In the United States, polypill use for the primary prevention of heart disease is analogous to the current use of statins. But, Desai adds: “In the U.S. people are reluctant to take medication unless they are sure they need the treatment.”

The more important role for a polypill here would be treating people who already have heart disease, like Ransom and her dad.

Yet, at a time when the nation is fighting to cut health costs, the polypill’s ability to do exactly that is one of the major factors keeping it out of the hands of consumers.

Blocking Progress

“The current economics of drug development reward the creation of patentable products that can command high prices,” Desai says. 

The polypill has been proven safe in phase 2 trials. The components of the pill are taken in individual doses by millions of people each day, though there are some pharmacologic concerns about developing a multi-component pill. But a costly phase 3 trial is needed before a polypill can make it to market. Because it would be a generic drug, pharmaceutical companies are reluctant to invest in such expensive research.

Desai points out: “This case illustrates one of the limitations of our medical innovation system. It is not optimized to ensure development of inexpensive, but highly effective therapies. The interests are not necessarily aligned with the interests of the patients.”

Investing in Public-Centered Innovation

“To be fair, pharmaceutical companies have finite resources,” Desai adds. “Perhaps this is a perfect time for the creation of a government-academic-generic drug manufacturer innovation partnership. The government can look at vaccines as a model because the polypill has a similar ability to produce significant public health benefits.”

Ultimately, Desai says, it comes back to the patients. “Millions of people are in an ongoing battle with heart disease. In the end, this is about helping them live healthy and productive lives, and enabling them to do the things they really want to do.”