Saturday, 27 May, 2017

The cholesterol drug that outperforms statins

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
Tracy Craig | 21 March, 2017, 00:31

Trials showed Repatha taken alongside statins reduced the cholesterol levels by 60 per cent more than taking statins alone. It also proved safe - side effects were similar to those from a dummy drug.

Others said they expected more from the $14,000-a-year drug. The new study, published in the New England Journal of Medicine, offers some evidence, however, not as big a benefit as some doctors had hoped. After a follow-up period of around two years, it showed that the risk of heart attack, stroke and coronary revascularisation was cut by 27%, 21% and 22%, respectively. But looked at by themselves, deaths were not reduced by the drug.

"These results, I think, will mean the guidelines are adjusted slightly, but unless the price comes down it won't mean we give it to anyone by any means", said Professor Naveed Sattar, a metabolic medicine expert of the University of Glasgow, according to The Daily Mail.

Amgen research and development executive vice president Dr Sean Harper said: "This is a game changer for high-risk patients". The man-made antibody helps in cutting down the risk of cardiovascular and heart diseases related death in people by 20%.

Evolocumab is part of a new class of cholesterol-lowering drugs called PCSK9 inhibitors, which dramatically lower bad cholesterol, or low-density lipoprotein (LDL).

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The drug was designed for people already taking the maximum dose of cholesterol-lowering statins but who had been unable to lower their cholesterol level sufficiently to ward off heart disease, in some cases because of an inherited genetic condition. The British Heart Foundation said the findings were a significant advance in fighting the biggest killer in the world. But he called the study "a solid outcomes trial" and said "we should celebrate" that it showed the drug is capable of reducing risk.

Aiming to address questions about its cognitive effects, researchers at Brigham and Women's Hospital in collaboration with Brown University and the University of Geneva ran cognitive tests on almost 2,000 people enrolled in a two-year study of the drug. Symphony Health data shows that commercial insurers rejected nearly three-fourths of PCSK9 requests past year, and Medicare coverage was denied at a rate of 61%. The companies also are in a patent war over the drugs. The drug is manufactured by the pharmaceutical company Amgen. That committee - 15 doctors and a pharmacist - reviews the information that federal regulators used to approve a drug and then decides whether it should be covered. JP Morgan's view is that, given the data and the current payer environment, physicians will choose to reserve treatment for patients with multiple comorbidities and relatively higher LDLs than the cutoff for FOURIER ( 70mg/dL). That can limit patient access.

"It's a small reduction for a super expensive drug", said Dr. John Mandrola, a cardiologist at Baptist Health in Louisville, Ky., and chief cardiology correspondent for Medscape, who wasn't involved in the study. After diving deeper into the data, we think it will be sufficient to change treatment guidelines, and our assumptions for net USA prices-going from roughly $10,000 today to $8,000 annually over the next couple of years as payers loosen restrictions-still hold.

Stubbornly high cholesterol is a key risk factor.

Among them, is a relatively new drug named Repatha which was cleared by the FDA in 2015. But once the drugmaker AbbVie produced a third option, Viekira Pak, with a similar cure rate, Express Scripts was able to negotiate a price discount and switched to covering only Viekira Pak.

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