There is only "moderate" evidence that the newly approved Provenge prostate cancer drug helps patients, according to an analysis for Medicare, released on Wednesday. "
The analysis is part of the controversial review by the Centers for Medicare and Medicaid Services, whether for Provenge, the cost of $93.000 per patient and extended life of about four months in clinical trials to zahlen.Medicare meet consultants on Wednesday to discuss by Dendreon the drug, a Seattle-based biotechnology company was developed.
Provenge is the first so-called therapeutic cancer vaccine - i.e., it works by training patient's immune system against the tumour - f.d.a permission to gewinnen.Die handled for each patient in his own blood. sales have been small, because Dendreon production capacity was limited.
While Medicare generally for drugs that the food and drug administration pays, has the debate about the payment for Provenge expressed concern some cancer patients, physicians and investors who say shot send the Government of an alert is that it does not automatically for high-priced medicines pay.
"Not only is CMS's action contrary to the intention of Congress beneficiary access to drugs and Biologicals used in an anti-cancer chemotherapy treatment, but it threatens to future innovation and cancer research for the coming years," Dr. Al B. Benson III, President of the Association of Community Cancer Center, said in a comment, CMS presented. "
But others say that cannot afford health care system, continued high prices to pay for all treatments, in particular cancer drugs to prolong the life of only a few months.
With expensive medicines a dual licensing system, especially with private insurers type already exists.First f.d.a must get a drug approval and then a manufacturer must often go through a lengthy process to convince to pay insurer for the drug.
Medicare should not consider price in the determine whether a drug to cover.
Some analysts have assumed that Medicare will pay for Provenge, for patients who's using those label - advanced prostate cancer, specified in the drug therapy is resistant to hormone deprivation, but if you experience no or minimal symptoms.
The Medicare review may be more off-label use of the drug expensive, as for example to limit already be scanned.the designed symptoms for patients review for Medicare said, there was insufficient evidence to assess whether Provenge would work if off-label uses.
The f.d.a declined, Provenge in 2007, approve setting from the protests of patients and investors in Dendreon.Nachdem Dendreon a further study confirms a survival benefit in the treatment is performed Provenge April of this year was approved.
But the analysis for Medicare said that there were issues such as the studies was, it was difficult, how effectively Provenge really judge designed wurde.Ein problem was, that used the placebo in the control group not really inert.
"Robyn Karnauskas said biotechnology analyst at Deutsche Bank in a note to clients Wednesday that the assessment of the moderate evidence to support the Provenge well for reimbursement boded."Historically, moderate means that CMS will reimburse the product for its on label indication, "she wrote.
Dendreon's shares rose in trading after the end of the market.
The evaluation was a technology test group with the Blue Cross and Blue Shield Association on behalf of the Government Agency for healthcare research and quality done.
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