Millions of people with heart disease who take the blood thinner clopidogrel (Plavix) can now look forward to having fatter wallets. Plavix lost its patent protection this month, and on May 17 the Food and Drug Administration gave several companies the okay to sell its generic form. Clopidogrel users can now buy Plavix or an equally effective generic version in a 75-mg dose at a much lower price.
The change may also save lives. “We have seen more than a few patients have heart attacks because they had stopped taking clopidogrel due to the expense,” said Dr. Thomas Lee, professor of medicine at Harvard Medical School and co-editor in chief of the Harvard Heart Letter. “I think the lower price is going to save some lives.”
Whenever a brand-name drug goes generic, people wonder whether the generic will be as good as—or as safe as—the original.
“Because a generic must prove it has the same anti-platelet effect as clopidogrel, it’s really the same drug and should be safe. I will recommend that all my patients switch over, because it’s money wasted otherwise,” says Dr. Christopher Cannon, a cardiologist at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School.
The price difference may mean a substantial savings for the 50 million people in the United States who have been buying clopidogrel at an average cost of $200 per month. The makers of clopidogrel are offering the drug for $37 a month through the end of 2012 to people who qualify, including those with private insurance or paying case. It does not include those on Medicare and Medicaid.
But the biggest savings may be found at pharmacies in big-box stores, which have started selling the generic for a $10 co-pay to people with insurance or $40 in cash. The price may drop further when six additional generics in the standard 75-mg dose and four in 300-mg doses hit the market.
A lifesaving drug
Called “a drug of major historical significance,” clopidogrel may stand with aspirin and statins among the most important heart drugs ever developed. Its ability to interfere with platelets’ natural tendency to form clots has saved the lives of countless individuals with heart disease. Since its approval by the FDA in 1997, clopidogrel has been used to reduce the risk of death or heart attack after a recent heart attack or stroke and in people with peripheral arterial disease.
Clopidogrel combined with aspirin has also been indispensable to the success of stenting. In this nonsurgical alternative to open-heart surgery, a tiny wire cage is delivered to a narrowed coronary artery via a hollow tube inserted in the groin. Once it is positioned inside the artery, it is expanded to hold the artery open for better blood flow. Yet in the early days, the procedure was nearly doomed by blood clots from forming inside the stents. Today, the combination of clopidogrel and aspirin is given to virtually all people who receive a stent. As a result, the number of heart attacks caused by in-stent clots is negligible. The only question that remains is the length of time this dual therapy is needed.
Not without drawbacks
Despite its contribution to the treatment of heart disease, clopidogrel is not ideal for everyone who needs it. It can cause unwanted and sometimes serious or fatal bruising and bleeding. Also, an estimated one in three users lack the gene that allows their body to metabolize the drug, rendering it ineffective as a clot preventer. Genetic and platelet function tests are now available to determine whether an individual will respond to clopidogrel. Many physicians, though, haven’t adopted the habit of ordering such tests before prescribing the drug.
But the biggest threat to clopidogrel is not cost, generic competition, side effects, or lack of efficacy. The biggest threat to its role as standard of care in heart attack and stenting comes from newer drugs such as ticagrelor and prasugrel, which are already giving clopidogrel a run for its money. These drugs have shown they can do an even better job at preventing heart attacks or death in certain people with heart disease. But overthrowing the world’s best-selling drug may take time. It is likely that clopidogrel by any name will continue to save lives for years to come.