l****z
发帖数: 29846 | 1 New once-a-day pill for Hep C wins FDA approval
October 10, 2014 - 2:34 PM
By MATTHEW PERRONE, Associated Press
WASHINGTON (AP) — Federal health officials have approved a daily pill that
can cure the most common form of hepatitis C without the grueling pill-and-
injection cocktail long used to treat the virus.
But the drug's $1,125-per-pill price is sure to increase criticism of
drugmaker Gilead Sciences, whose pricing strategy for an older hepatitis
drug has already drawn scorn from patient groups, insurers and politicians
worldwide.
The Food and Drug Administration said Friday it cleared Gilead's Harvoni
combination pill for patients with genotype 1 of hepatitis C, a form of the
liver-destroying virus that accounts for 70 percent of the estimated 3.2
million cases in the U.S. For the first time ever these patients will not
have to take a decades-old combination of antiviral pills and shots that
causes flu-like side effects.
The new pill combines Gilead's blockbuster Sovaldi, approved last December,
with a new antiviral drug called ledipasvir, which attacks the virus using a
different mechanism. The dual-acting approach mimics drug combinations
Gilead has long used to treat HIV.
It's another breakthrough for Foster City, California-based Gilead, which
analysts expect to bring in billions of dollars in new sales. The company
says the new drug will cost $94,500 for a 12-week supply. About 40 percent
of patients may be able to take the drug for eight weeks, reducing the price
to about $63,000.
But patient advocates on Friday renewed their criticism of Gilead and the
pharmaceutical industry trend toward sky-high drug pricing.
"When history is written, this is going to be the breaking point where drug
prices went completely out of control and nobody did anything about it,"
said Michael Weinstein, president of the AIDS Healthcare Foundation. "Never
before has a drug been priced at this level for such a large population."
About 25 percent of people with HIV infection are also infected with
hepatitis C.
But other groups noted that the eight-week regimen could make the medicine
more palatable to insurers, improving access.
"With the eight-week course the price actually offers relief to 40 percent
of the population who will be taking this drug — that's significant," said
Ryan Clary, executive director of the National Viral Hepatitis Roundtable, a
coalition group which accepts funding from drugmakers, including Gilead.
Gilead executives say Harvoni's price is actually slightly lower than the
current standard treatment: Sovaldi plus a cocktail of two other drugs,
which the company estimates comes to $95,000 for 12 weeks, on average.
Despite such explanations, the new drug's approval is sure to renew scrutiny
of prices for life-saving drugs.
Members of the Senate have already asked Gilead to hand over documents
detailing its decision to price Sovaldi at $84,000 for one 12-week regimen.
The health insurance industry has been blasting Gilead for months over
Sovaldi's price, and most insurers require prior authorization before they
will pay for it. Three state Medicaid programs refuse to pay for the drug. |
|
