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Title: $1,000 Sovaldi now hepatitis treatment of choice
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Published: Jul 30, 2014
Author: RICARDO ALONSO-ZALDIVAR
Post Date: 2014-07-30 07:53:53 by Tatarewicz
Keywords: None
Views: 27

This undated handout photo provided by Gilead Sciences shows the Hepatitis-C medication Sovaldi. A $1,000-per-pill drug that insurers are reluctant to pay for has quickly become the treatment of choice for a liver-wasting viral disease that affects more than 3 million Americans. In less than six months, prescriptions for Sovaldi have eclipsed all other hepatitis-C pills combined, according to new data from IMS Health.

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WASHINGTON (AP) — The price is sky-high, but so is demand. A new $1,000-per-pill drug has become the treatment of choice for Americans with hepatitis C, a liver-wasting disease that affects more than 3 million. Related Stories

$1,000 pill now hepatitis C treatment of choice Associated Press [$$] Senate Committee Is Investigating Pricing of Hepatitis C Drug The Wall Street Journal Gilead Faces New Pressure From U.S. Senators & Europe Over Hep C Pricing The Wall Street Journal [$$] Beggar-Thy-Neighbor Medicine The Wall Street Journal Senate Zeroes in on Inflated Hepatitis-C Drug Cost The Fiscal Times

Even with insurers reluctant to pay, Sovaldi prescriptions have eclipsed those for all other hepatitis C pills combined in a matter of months, new data from IMS Health indicate. The promise of a real cure, with fewer nasty side effects, has prompted thousands to get treated.

But clinical and commercial successes are also triggering scrutiny for the drug's manufacturer, California-based Gilead Sciences Inc., which just reported second-quarter profits of $3.66 billion, or a net margin of 56 percent.

Two senators have unearthed documents that suggest the initial developers of Sovaldi considered pricing it at less than half as much. The health insurance industry is publicly scolding Gilead, and state Medicaid programs are pushing back.

The repercussions go beyond one drug and one disease. A number of promising cancer medications near approval could be drawn into the storm over costs.

"You can't put too fine a point on the sort of moral dilemma that we have here," said Michael Kleinrock, director of the IMS Institute, which studies prescription drug trends. "This is something that the research-based pharmaceutical industry reaches for all the time: a cure. But when they achieve one, can we afford it?"

New data from IMS Health, the parent company of the institute, illustrate Sovaldi's impact since its December debut:

—The number of pharmacy prescriptions for all hepatitis C pills has soared, highlighting demand. In May, more than 48,000 prescriptions were filled for four such medications, with Sovaldi accounting for three-fourths of the total. Compare that to prescriptions for May 2013, before Sovaldi became available, which totaled about 6,200.

—In Sovaldi's first 30 weeks on the market, 62,000 new patients tried the drug, nearly three times as many as had tried an earlier medication that showed promise. That makes Sovaldi the most successful launch for any hepatitis C drug. Gilead expects to have a successor soon that will make treatment easier to tolerate, because it won't require patients to take companion medications with strong side effects. View gallery This undated handout photo provided by Gilead Sciences … This undated handout photo provided by Gilead Sciences shows the Hepatitis-C medication Sovaldi. The …

—The weekly number of new patients going on Sovaldi has been gradually slowing, from more than 2,900 in February and March to about 1,600-1,800 in late June and early July. Kleinrock said that could indicate that pent-up initial demand is giving way to steadier levels, or it could mean that insurers are limiting access to protect their budgets.

Hepatitis C surpassed AIDS as a cause of death in the U.S. in 2007, claiming an estimated 15,000 lives that year. The illness is complex, with distinct virus types requiring different treatments. While it advances gradually, it can ultimately destroy the liver, and transplants average $577,000.

The cost of a 12-week regimen of Sovaldi along with two companion medications that patients must also take is around $100,000. Competing regimens with other drugs cost in the mid- to high five figures, and some are far less effective and harder to tolerate.

Hepatitis C is a public health concern, since the disease can be transmitted by contact with infected blood, by drug users sharing needles, and sometimes through sexual activity. Many people are unaware that they carry the virus. Health officials advise all baby boomers to get tested.

At Mount Sinai Health System's liver clinic in New York City, patient advocate Angela Woody said Sovaldi has brightened the outlook for patients. But it takes effort to get insurance approval.

"We have had to jump through a great deal of hoops," Woody said. "We have two patients who applied in January and did not actually go on the medication until April."

Sovaldi's implications for Medicare and Medicaid costs have prompted rare bipartisan cooperation in Congress on a health care issue.

Sens. Ron Wyden, D-Ore., and Charles Grassley, R-Iowa, are asking Gilead for a detailed explanation of its pricing. Wyden chairs the Finance Committee, which oversees health insurance programs, and Grassley is a veteran of drug safety investigations.

The senators say their staffs found public documents that call into question Gilead's $84,000 price for a full course of Sovaldi treatment, for the most common type of hepatitis C.

In 2011 filings with federal regulators, the company that originally developed Sovaldi estimated a treatment price of $36,000. That figure was developed during Gilead's negotiations to buy the original developer, Pharmasset.

Gilead spokeswoman Amy Flood said the company has no comment.

But Gilead vice president Gregg Alton recently addressed the issue at a public forum sponsored by the American Enterprise Institute.

"To suggest that a cure for a disease like hepatitis C should be priced at $36,000 ... would put a huge disincentive on investing in cures for our industry," he said.

Gilead took on most of the challenge — and risk — of getting government approval for Sovaldi, Alton added.

He suggested another standard for measuring the value of Sovaldi, something called "cost-per-cure," that makes Sovaldi look like a bargain.

The older hepatitis C treatments take longer and are less effective, and Alton estimated their cost-per-cure at somewhere between $150,000 and $200,000. Included are companion drugs that patients must also take.

Sovaldi gets that down to $115,000 per cure, said Alton. "So it is actually, on a per-cure basis, much less costly."


Poster Comment:

PETER HOLDEN ...Irresponsible journalism here. You gave us all the numbers to make us angry with the drug company but none to make us understand why it's so expensive. How much did it cost to research, test and then manufacture the drug? What if another company comes out with a better drug in two years and suddenly nobody wants Solvadi ? Yes, they are making great profits on this drug but they will put that money into research on newer drugs, many that won't work in the end so that money will eventually be lost. Before we condemn them for making profit, we should look at the overall income of all drug companies on all drugs produced. I think it's about the same as other classes of businesses. So, if we want ever better miracle drugs we have to pay the price. Or, we could take the drug business out of private business and let the government do it. Hmm. Let's see. How's the gov doing with running the VA? Yep, aspirin would be $100 a bottle and in short supply.

Michael... It was a very unfortunate event when Gilead bought Pharmasset – the real developer of Sovaldi. Pharmasset would never charge a price that high (this article states they considered pricing it "at less than half as much") – that’s why it agreed to be acquired by Gilead for $11 Billion. Now it appears that Gilead will recoup this amount in less than one year – on a single medicine! Its CEO became a billionaire already. Worst of all, after acquiring Pharmasset, Gilead stopped all collaborations started by Pharmasset (like combining Sovaldi with Bristol-Myers' Daclatasvir - a powerful combination with ~100% cure rate) because it decided to develop its own combo, so it doesn't have to share profit with others – who cares if some people die waiting. Greed is good, right? But note that majority of HCV patients are low-income, and it's estimated that about one third of them are in prison. We, taxpayers, pick up the tab. And Gilead will be responsible for quite a few percentage points in our health insurance premium raises during next few years as well6-4. [Adam] Let me guess, once again Americans will be forced to pay for all the research and development and pay $1000 a pill, and when it goes to Canada, England and Australia, they will pay $50. That's why our healthcare costs are so high, everyone else gets us to pay for the development, then they just pay for the pills.

PAUL Robert F. Cathcart, M.D., has already reported that a Vitamin C protocol kills all the Hepatitis varients, but knowing that you can pick up a kilo of it for under £20 you can maybe see why they don't let people know this. This is pure profiteering, I suggest you all look this up yourselves. 11-6

$115,000 over 20 years is Less than $700 per month Isn't it worth that to be alive? 2-5

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