After decades of the same old treatments, people fighting cholesterol could have a new, revolutionary alternative.
But, with most new ways to treat an existing problem, it’s not that simple.
The old methods in the battle against high cholesterol include changes in diet and a type of pill known as a statin, which is a drug that prevents the body from making more bad cholesterol, a defensive move.
And a new class of drugs — two of which the FDA has approved in the last two months — that works on the offence is entering the scene. They are called PCSK9 inhibitors, and instead of preventing the body from making more bad cholesterol, they help the liver flush it out.
Here’s the catch: Some pharmacologists and health insurers aren’t excited about the prospect of these expensive alternatives — and a recent report suggests the cost should be about 85% less of what it is now.
What’s different about these new drugs?
It’s been a big summer for PCSK9 inhibitors. At the end of July, the FDA approved a drug called Praluent that helps the liver get rid of bad cholesterol.
About a month later, the FDA followed up with the approval of Repatha, a similar drug that treats an inherited cholesterol condition. Both drugs are biologics, or medications made from living things.
Unlike traditional methods, like diet and statins, biologics work to inhibit, or block, the PCSK9 protein to pave the way for bad cholesterol to get cleared out of the body. PCSK9 is a protein that prevents the liver from clearing out bad cholesterol by binding with the receptors that normally work to get the bad kind out.
There are two types of cholesterol in our body: Good (HDL) and bad (LDL). While HDL ferries the bad kind to the liver, where it is processed and removed from the body, LDL creates buildup in the arteries that can keep blood from reaching the heart and the brain, potentially leading to heart disease and stroke.
Statins interfere with a protein that helps produce bad cholesterol, helping to prevent it from making more. Taking them daily has been shown to lower cholesterol levels even more, and studies have shown that patients can take them for years typically without any long-term health problems.
The drugs don’t need to be taken as frequently as statins: Praluent and Repatha every two weeks. And now a third, called ALN-PCSsc, from Alnylam Pharmaceuticals and Medicines Co showed promising results in early trials for an injection that only has to be taken every three to six months.
David Gortler, a pharmacology professor at Georgetown University and former senior medical officer for the FDA told Business Insider that he’s worried that prescribers will be too quick to prescribe these new PCSK9 inhibitor medications instead of sticking with just statins.
So far, the FDA has only approved them for a specific type of hereditary high cholesterol, but the goal is to expand to a wider high cholesterol audience.
Why is the cost of PCSK9 cholesterol medications a big deal?
The CDC estimates that more than 102 million Americans have cholesterol levels higher than what’s considered healthy. Of that group, 35 million have high enough levels of cholesterol in their body to put them at high risk of heart disease, the leading cause of death in America.
And anywhere from 5 to 10 million Americans live with the kind of high cholesterol that these new PCSK9 inhibitors treat, according to Express Scripts, a company that manages pharmacy benefits. A year’s supply of Praluent costs $US14,600, and Repatha costs almost as much at $US14,100 a year. In contrast, generic statins can cost as little as a few dollars a month.
So why are they so expensive, compared to other cholesterol medications? Drugs like biologics tend to have a higher cost than pills because they take a lot of resources to make, Gortler said. But, to add a grain of salt, Gortler worked as an early-phase investigational medicine scientist at Pfizer (the company that makes Lipitor) before joining the FDA.
There’s been a trend in rising drug prices. But for the most part, the highest priced drugs have been for revolutionary treatments for cancer or cures for diseases such as hepatitis C. This is one of the first to come out for a more general population.
Express Scripts’ Chief Medical Officer wrote in a note about the new class of cholesterol drugs that “it is clear that PCSK9 inhibitors are on a path to become the costliest therapy class this country has ever seen.”
And according to the Institute for Clinical and Economic Review, a nonprofit that evaluates costs in the health care system, the price should be much lower: $US2,177 a year for treatment rather than the $US14,000+ price tag.
The ICER’s number comes from a number of different criteria, such as mortality reduction rates, and it’s adjusted to fit into existing health plans so that the number of prescriptions allowed wouldn’t have to be limited. Amgen, the makers of Repatha, told the Wall Street Journal that the “believes in the clinical and economic value of Repatha,” and that it’s “concerned that ICER’s review does not place value on addressing a significant unmet medical need.”
The Center for Medicare and Medicaid Services projects that the amount spent by the US government on prescription drugs will reach $US564 billion by 2024, compared to the $US271 billion spent on prescription drugs in 2013.
Praluent has only been available for a few weeks, and Repatha is expected to launch soon. Until then, It remains to be seen if they start getting prescribed at the same intensity as statins.
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