Saturday, 24 June, 2017

Cholesterol drug drops heart risks, but ignites new price debate

The injectable drug Repatha can lower cholesterol to unheard-of levels. The next question is whether the disease-prevention benefit it worth its high price Enlarge this image Dan Woodruff Illustration Works Getty Images Dan Woodruff Illustration Works Getty Images
Sammy Stanley | 21 March, 2017, 00:34

A group of patients was also treated with a placebo, and the results show that they were more likely to suffer a heart attack than patients taking Repatha.

The drug, Repatha, is called a PCSK9 inhibitor and can make cholesterol tumble to levels nearly never seen naturally in adults, or even in people taking cholesterol-lowering statins.

Experts have discovered that Repatha, a cholesterol drug, reduces the risk of heart attacks in more than 20 percent.

However, many patients are unable to tolerate the highest doses and they need to be taken consistently.

In the United States, heart disease accounts for one in every four deaths, and kills more than 600,000 people every year.

The findings were published in the New England Journal of Medicine and also reported at a meeting of the American College of Cardiology. Kaiser Health News noted that insurers aren't quite sure whether they would cover the drug, citing issues with its price and its then-unproven benefits.

Image: Amgen's Repatha (evolocumab). In the recent years, cost of many drugs has been increased by pharmaceutical companies and those drug price increases have been contested by insurance companies, politicians and consumer groups.

After about two years, Repatha, used along with statins, reduced LDL from a median of 92 to 30. If a patient has a heart attack or stroke while taking Repatha as prescribed, Amgen will refund the cost of treatment.

The study involved 27,564 men and women. But the clinical trials supporting its approval did not take the next step to show whether the therapy, known as a PCSK9 inhibitor, could actually improve or extend the lives of people taking it. The Amgen drug and a similar one, sold by Sanofi and Regeneron, were approved by the U.S. Food and Drug Administration in 2015 with the hope - and expectation - that they would lower the risk of heart attacks and strokes, and not just reduce levels of LDL cholesterol, the risky kind.

Yet Repatha's high cost could burden the USA health system, said Dr. Steve Miller, senior vice president and chief medical officer at Express Scripts, a pharmacy benefit manager.

Statin is a medicine for cholesterol which is used to treat heart diseases.

Sean Harper, executive vice president at Amgen, added: 'This is a game changer for high-risk patients'. People with naturally-occurring mutations in the gene encoding PCSK9 have lower levels of LDL cholesterol, and are protected from heart disease, strongly suggesting that an antibody against the PCSK9 protein should have the same beneficial effects - a story that remains the poster-child for exploiting human genetics to understand the biology of common diseases (such as heart disease) in the same way it revolutionised the discovery of new treatments for rare diseases a decade earlier.

But they were approved only for those with a genetic condition that means they have dangerously high cholesterol, and people with heart disease who can not cope with the side effects of statins.

Longer term, Sabatine said, there could be a reduction in deaths as well.

Amgen acknowledged during a presentation for investors that it is already selling Repatha at a discount, resulting in net prices between $US7,700 to $US11,200 per annual treatment, and believes those prices represent good value.

Current plans restrict use of Repatha through both onerous utilization criteria and a bureaucratic process that results in doctors giving up on writing a script.

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