U.S. panel backs Dendreon's Provenge for Medicare
WASHINGTON (Reuters) - A U.S. advisory panel backed Dendreon Corp's Provenge prostate cancer therapy on Wednesday, telling the Medicare insurance program for the elderly that available data showed it could help patients.
Shares in the biotech company rose nearly 6 percent after hours. A majority of the outside advisers said there was enough evidence to show that Dendreon's therapeutic vaccine helped patients live longer. The agency is weighing whether to pay for the product nationwide.
"We have some pretty good evidence here," said the panel's chairman, Lewin Group Senior Vice President Clifford Goodman. But he said the evidence is "not really wide, it's not really deep, so much work is needed to collect" more data.
Centers for Medicare and Medicaid Services (CMS) officials will take the panel's advice into account in making a final ruling, expected next year.
Their decision is not only critical for patients but also for Provenge sales, which could reach $1.9 billion by 2014, according to data from Thomson Reuters.
J.P. Morgan analyst Cory Kasimov said the panel's assessment "was a clear positive" for Dendreon.
"It's increasingly clear that CMS will cover Provenge" for approved uses, Kasimov wrote in a research note. "Investors should take a significant amount of comfort."
Medicare coverage could also encourage more private insurers to follow suit.
Aetna Inc, Humana Inc and several other health insurers have already agreed to pay for the vaccine, which does not prevent cancer but fights the tumors.
Patients, doctors and the company urged Medicare's advisers to support their pleas to have the federal government pay for the treatment regardless of its hefty price tag.
"This is a new agent that is clearly beneficial for patients," said Dr. Mark Scholz, a California-based prostate oncologist and one of nearly two dozen public speakers urging the Medicare panel's support.
Provenge was approved for the U.S. market in April to treat men with advanced prostate cancer after company data showed it help men live another 4.1 months on average.
It costs $93,000 for three infusions given over the course of about one month. While many cancer therapies are also expensive, their costs are spread out over more time or are stopped when they do not seem to be helping.
Dendreon says the high price reflects a unique manufacturing process that takes cells from a patient's tumor, mixes them with some of the patient's own immune cells and then infuses the cells back into the patient to attack malignant cells. Most side-effects are related to infusion of the drug.
At the meeting, Medicare's advisers said they were fairly confident in Provenge's effect on survival, but were less sure over whether it helped patients avoid side effects and other treatment issues. They told CMS they had less confidence in wider uses not approved by the Food and Drug Administration.
They also urged Medicare to collect more data as part of its payment decision to learn more about the therapy's use.
In a statement after the meeting, Dendreon said patients can still get Provenge from regional Medicare contractors until CMS makes its national decision.
DRUG COST RAISES FINANCIAL CONCERN
Dendreon Chief Medical Officer Mark Frohlich told the panel that Provenge, also known as sipuleucel-T, is one of few available options that actually helps patients live longer with fewer side effects, providing "an important new treatment."
While the FDA approved Provenge as safe and effective, CMS is deciding whether its use is "reasonable and appropriate." By law, it cannot consider the vaccine's cost in that decision.
Still, there are larger financial concerns for Medicare, and patients have worried that the therapy's price was an unspoken stumbling block, especially since most men with prostate cancer are older and likely covered by the program.
Medicare covers roughly 45 million older or disabled Americans -- 40 percent of whom are men -- but faces financial instability that has drawn the attention of a U.S. deficit panel as well as lawmakers.
"One has to wonder if today's meeting is indeed about something other than the science, namely the cost," said Brad Loncar of Kansas, whose grandfather had the disease.
It was not immediately clear how much of a co-pay Medicare patients would face even if CMS covers Provenge.
Nearly 218,000 U.S. men will be diagnosed with prostate cancer this year, according to the National Cancer Institute, although not all those men will either qualify for Provenge or be enrolled in Medicare.
Other treatment options include chemotherapy, surgery and hormonal therapies, and some patients may need such options even after using Provenge, some doctors told the panel.
CMS has said it is only looking at the data in weighing Provenge. Goodman, the panel chairman, noted the agency in the past has declined to pay for FDA-cleared drugs and devices but has also covered other, experimental ones not yet approved.
Dendreon shares have fallen nearly 38 percent in the wake of FDA's Provenge approval, in part over concerns about its launch. Its shares were halted until late on Wednesday.
(Reporting by Susan Heavey. Editing by Gerald E. McCormick and Robert MacMillan)