NYT- FDA approves new drug that can sharply lower cholesterol - down side new drug very pricey

[littlewolf]

http://www.nytimes.com/2015/07/25/business/us-approves-drug-that-can-sharply-lower-cholesterol-levels.html?_r=1

Federal regulators on Friday approved the first of a new class of drug that can sharply lower cholesterol levels, offering a new option for millions of Americans suffering from cardiovascular disease, the nation’s leading killer.
But the drug, Praluent, which analysts project will become a huge seller, is expected to become the next flashpoint in the growing controversy of escalating pharmaceutical prices, and health plans are expected to put in place strict measures to control which patients can use the drug and prevent it from becoming a budget buster.
The list price of Praluent is about $14,600 a year, substantially higher than the $7,000 to $12,000 that some health plan executives and Wall Street analysts had been expecting. Typically insurers and government health programs get discounts or rebates.

snip

“We came to a price that is reflective of value, not what the market will bear,” said Elias Zerhouni, head of research and development at Sanofi, who said his own brother had suffered three heart attacks and needed new options to control cholesterol.
In clinical trials, Praluent reduced levels of LDL cholesterol, the so-called bad cholesterol, by 40 percent or more, even among patients already taking statins, the mainstay pills like Lipitor for controlling blood lipids. Some cardiologists say Praluent and similar drugs in the pipeline represent significant advances.

snip

Praluent, also known as alirocumab, was endorsed last month by outside advisers to the Food and Drug Administration. So was Repatha, or evolocumab, a similar drug developed by Amgen that is expected to win F.D.A. approval by the end of August.
But there was considerable debate among the advisers as to how broadly the drugs should be used. In its decision on Friday, the F.D.A. approved Praluent for patients who have had heart attacks, strokes, chest pain or related conditions, or have a genetic condition that causes high cholesterol and who require additional lowering of LDL despite taking the highest dose of a statin that they can tolerate.

snip

Studies aimed at showing that the drugs prevent heart attacks and strokes are underway, but results are not expected until about 2017. Some doctors say they will use the drugs sparingly or not at all until then.
“This is treating a lab value,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, referring to lowering cholesterol for its own sake. “I don’t think we should rush into it.”
Health plans are worried that so many patients might use the drugs, which might be taken for life, that it would cost billions or even tens of billions of dollars a year.
The health care system is still smarting from the experience with Sovaldi, a rapidly adopted drug for hepatitis C from Gilead Sciences that cost $1,000 a pill. Gilead sold $12.4 billion worth of Sovaldi and a related drug in 2014, the first full year on the market, straining the budgets of insurance companies and Medicaid programs.

much more at the link.

[Warpy]

1. Oh, great, in a country where a lot of people don't earn that much

It's obvious that the pricing is being done by executives making multi millions per year.

I suppose they think Medicare D will never be revised to force these bastards to submit bids.

They're just begging for it.

[PatrickforO]

3. Oh, and now that you mention it, Congress should pass legislation that caps

all C-level pay for corporate officers at $250K annually, and eliminate the corporate tax loophole that allows companies to deduct 'performance based' bonuses to executives.

That, coupled with my solution below (actually Bernie's, because he's said this) would go a long way to making America a LOT better place to live.

[PatrickforO]

2. This is one of the main reasons why we need single payer, and also to enable the single payer to

negotiate drug prices down. Yes, I know it sometimes takes billions to take a new drug through the FDA testing process, and big pharma routinely claims that its prices are so high because of that, but maybe we need to rethink the FDA process, maybe streamline it so it doesn't cost so much. And maybe we could force pharmaceutical companies to change their charters to 'B' corporations, so that the executive will have to take not only profit into concern, but the needs of all stakeholders, including labor (without which there could BE no profit) and consumers of the drugs.

Also, in a single payer system, tax dollars would help subsidize the cost of drugs. In the British model, they don't pay a thing. Yes taxes are higher, but hey, we already pay out the nose for rationed healthcare. Let's get it right.

And by that, I mean MORALLY right.

[Logical]

4. There is much debate about if cholesterol level matters. nt