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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