Entries in Provenge (4)


Medicare to Cover Costly Prostate Cancer Drug

Paul Tearle/Thinkstock(WASHINGTON) -- The Centers for Medicare & Medicaid (CMS) says it will cover the cost of the pricey drug Provenge, recently approved for men with metastatic prostate cancer.

Provenge is said to extend patient survival by an average of four months, but costs about $93,000 per patient.  A CMS administrator said Thursday that the agency wants to assure patients can get the treatment they need according to their wishes.

"We are optimistic that innovative strategies may improve the experience of care for our beneficiaries who have cancer," said Dr. Donald M. Berwick, a CMS administrator. "CMS is dedicated to assuring that these patients can seek the treatments they need in accordance with their wishes."

Although research says that Provenge can lengthen survival time for men with prostate cancer that has spread beyond the prostate, experts note the drug is a therapeutic treatment and not a preventative one.   

Provenge has also reportedly presented fewer side effects in patients, researchers say.

Copyright 2011 ABC News Radio


Medicare Agrees to Cover Expensive Prostate Cancer Treatment

Creatas Images/Thinkstock(BALTIMORE) -- The Centers for Medicare and Medicaid Services (CMS) announced that Medicare will pay for Provenge, an immunotherapy for prostate cancer. 

In a proposed decision memo, the agency said, "The evidence is adequate to conclude that the use of…[Provenge] improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication."

CMS has decided against endorsing or prohibiting nationwide off-label coverage, but will allow for local contractors to cover off-label uses according to their own judgment.

CMS will evaluate public comments on the memo, whereafter a final decision will be issued by June 30.

Copyright 2011 ABC News Radio


FDA Approves Increased Availability of Prostate-Cancer Drug Provenge

Comstock/Thinkstock(NEW YORK) -- The U.S. Food and Drug Administration has approved an increase in production of prostate cancer drug Provenge to four times its current capacity.

The drug was initially approved by the FDA last April, but demand for the drug exceeded the company's original production constraints.

Provenge combats prostate cancer by inducing an immune response to the disease with the use of a patient's own cells.  After the cells are shipped to Dendreon Corporation, the drug's manufacturer, they are processed and returned to the patient's medical doctor and administered through an IV.  This process must take place three times over a four week period.

The FDA's approval to increase production now allows Dendreon to grow its number of workstations from 12 to 48.

Chief Executive Mitchell Gold told The Wall Street Journal Thursday, "The availability of the increased capacity is going to allow more treatment centers across the country to access Provenge."

Originally, Provenge was offered at 50 clinical sites at last year's launch.  But the company expects the drug to be available at around 500 sites by the end of this year.

Copyright 2011 ABC News Radio


Should the Government Pay for Costly Cancer Therapies; Debate Reignites Over New Drug


Photo Courtesy - Getty Images(WASHINGTON) -- Government officials are reviewing Provenge, a costly new vaccine for treating prostate cancer that's stirring debates about whether cost should be considered when drugs are approved by federal health care programs, according to The Washington Post.

Provenge, approved in April, cost about $93,000 per patient and can extend a patients’ life up to four months.  The new cancer therapy is under review just as the Food and Drug Administration considers a withdrawal of approval for Avastin, another costly treatment meant for metastatic breast cancer.

For Medicare, Medicaid and the FDA, cost is not supposed to be a factor in determining approval or coverage.  However, the costly nature of these treatments has caused some alarm by officials, prompting the launch of a formal examination.

“At some point, if we keep paying these very high prices for treatments that provide very limited benefit, we’re going to reach the point where we can no longer afford health care,” Alan Garber, a Stanford University professor of medicine and economist, told The Post.

Copyright 2010 ABC News Radio

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