A new $1000-a-pill drug has become the treatment of choice for Americans with hepatitis C.
Even with US 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 for the liver-wasting disease, with fewer nasty side effects, has prompted thousands to get treated.
However, clinical and commercial successes are also triggering scrutiny for the drug's manufacturer, Gilead Sciences, which just reported second-quarter profits of $US3.66 billion ($A3.96 billion), or a net margin of 56 per cent.
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 healthcare 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?"
Hepatitis C surpassed AIDS as a cause of death in the US in 2007, claiming an estimated 15,000 lives that year. The illness is complex, and has distinct virus types requiring different treatments. While it advances gradually, it can ultimately destroy the liver, and transplants average $US577,000.
The cost of a 12-week regimen of Sovaldi along with two companion medications that patients must also take is about $US100,000. 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.
Senators Ron Wyden, a Democrat, and Charles Grassley, a Republican, 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 $US84,000 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 $US36,000. 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 $US36,000 ... 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.
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