A Federal Advisory Committee said on Wednesday that Medicare pay treatment for the $93.000 gave evidence that the drug Provenge it probably extended the lives of people with advanced prostate cancer, an endorsement that makes.
Medicare coverage of Advisory Committee voted that it had "intermediate confidence" in the strength of the data, that the drug developed by Dendreon, improves survival. "
The session on Wednesday is part of a process where the Centers for Medicare and Medicaid Services is decide whether the figures for Provenge, by the food and Drug Administration was approved in April.
Medicare's action has been partially controversial as unusually ist.Einige prostate cancer patients and lawyers, doctors and investors in Dendreon say such a review, which had already decided since the f.d.a the drug helps patients that Medicare's review was based more on cost and in a manner was the beginning of health care rationing.
"For a second Government agency to open second guess that is not constructive," said Brad Loncar, an investor in Dendreon, whose grandfather died of prostate cancer in the Committee which met in Baltimore. " One must wonder if other is meeting today about something than science, namely the cost. "
Medicare officials denied that the session costs and instead more about attempted to come up with a single national policy for, whether the drug should be covered rather than leaving it up to Medicare's regional contractor.
"I think people tried, read more in our motives than honestly would justify," said Dr. Louis Jacques, Director of the reporting and analysis group for Medicare and Medicaid, in an interview Wednesday. "
The Advisory Committee, consisting of doctors and health policy experts, the cost of Provenge to discuss or even make a cover recommendation.It examines the data from clinical trials.
Provenge is a treatment in a patient taking blood and processing of patient immune system against the tumour to trainieren.In clinical studies advanced that median survival of about four months compared to a Kontrollgruppe.Dendreon is charging $93.000 for each patient treatment.Some private insurance companies and some Medicare carriers are already cover.
Panel members agreed then on how convinced were that the data on a scale of 1 to 5 supported different possible conclusions.
10 Voting members had an average vote from 3.6 to the question whether the evidence was, which is strong enough to complete that Provenge life verlängert.Das something about 3, intermediate confidence, but less than 5, high level of trust.
Analysts say that level that reporting by providing sollte.Die panelists were about equally confident the drug helped patients to avoid side effects of treatment.
However, the panelists had very little confidence in the evidence for use of the drug in patients who are sicker than those in the clinical trial or not so sick.
A way to cover so-called off-label use of Provenge could refuse, the Medicare bieten.Solche off label are used quite usual in cancer, try desperate patients from various therapies in the hope it will work.
Provenge is approved for men whose Krebs has spread beyond the prostate gland and who no longer respond to androgen deprivation therapy but have still minimal or no symptoms.
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Any seven Medicare-receiver which is in the hospital it is General for the problems with the medical care according to a new study from the Office of Inspector Department of health and human services damaged.
The study, said unexpected adverse events added at least $4.4 billion per year Government health care costs and helped the deaths of approximately 180,000 patients per year.
In a single month, October 2008, estimates the report that some 134,000 Medicare patients setback, experienced at least one adverse event of a temporary health to death during a hospital stay.It said, 44 percent were "clearly or probably avoidable."
Hospital infections as a major source of problems, but the Inspector General's report cited this study found other events häufiger.Die common problems which classified said it as adverse events relating to drugs, such as excessive bleeding, those relating to patient care, such as intravenous fluid overload and those relating to surgery and infection followed.
The most serious events such as surgery on the wrong patient, amounted to less than 1% of the count according to Ruth Ann Dorrill, team leader for the Inspector General of the study group Ereignisse.Diejenigen are known as "never events" - who said national quality Forum, a leading non-profit group, you "should never occur in a health care setting."
An American Hospital Association official, Nancy Foster, said the study highlighted the importance of improving the procedure, so that the medication errors and other problems, described in the report.
"" Hospitals and doctors and nurses to damage prevents", said Ms. foster, Vice President of the Association for quality and patient safety, on Monday.""But as this report suggests, we have a ways to go before we are where we have our performance to want."
Concerned experts reviews a representative sample of 780 Patientendateien.Es is planned the study, visit the Inspector General are booked on Tuesday.
In a written reply, in the report said included Dr. Carolyn M. Clancy, head of the Federal Agency for healthcare concern research and quality that adverse events were hospital patients with an "alarming rate" and promised to work to improve it.
Mrs Dorrill, team leader for the study group, headquartered in Dallas, said it was the seventh and most important 10 reports of adverse events that law by Congress 2006 made the Agency in response to a health care in.
"There were lot of momentum in the late 1970s, early 1980s when the safety of the patients movement began, and a progress check wanted" said Mrs Dorrill.
Kevin k. Golladay who Regional Inspector General for evaluation and inspections, said: "We also recommend a broader view of the damage in a hospital."
The report calls for more supervision and financial incentives for hospitals, error to reduzieren.In of his written answer, Dr. Donald M. Berwick, administrator who said Center for Medicare and Medicaid Services, it would be aggressively pursue recommendations to the definition of adverse events to expand to monitor and prevent that you.
The problem had won widespread attention with a 1999 report by the Institute of medicine, titled "to err is human: building a safer health system."The report cited studies use different methodology to estimate from 44,000 to 98.000 Americans die each year due to a preventable medical errors in hospitals.
The officials said the Chief of staff of the study which was to obtain first a statistically valid national incidence rate of adverse events in a hospital population. previous estimates had more limited data extrapolated.
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