Tag Archive | "Provenge"

Prostate Cancer Patients on ADT Not Affected by Provenge


A recent study, led by Tomasz Beer, MD, Professor of Medicine at Oregon Health & Science University (OHSU) in Portland, Oregon, found that prostate cancer (PCa) patients on androgen deprivation therapy (ADT) and receiving sipuleucel-T (Provenge) have no adverse outcomes in terms of quality of life.  These findings were presented at the 47th Annual Meeting of the American Society of Clinical Oncology.

The study involved 176 men who were placed on ADT for three to four months after experiencing PSA recurrence after radical prostatectomy.  Sipuleucel-T, which received FDA approval for the treatment of late-stage PCa last year, is not usually used in men with earlier states of prostate cancer.  This is the first study to explore the effect of the autologous cellular immunotherapy on quality of life.

After three to four months, ADT was stopped and all men were randomized to treatment with sipuleucel-T (117 patients) or control (59 patients). Using survey techniques, the researchers assessed quality of life at baseline (following ADT and prior to randomization) and at weeks 13 and 26 after treatment.  Ninety-eight percent of subjects completed baseline quality of life assessment and 92% had at least one post-treatment assessment.  During ADT in the three months before sipuleucel-T treatment, quality of life measures decreased comparably in both study arms.  After the start of the study treatment, there were no significant differences found in the quality of life between the two groups.

Dr. Beer emphasized that the results from the study suggest that a larger study in early disease patients is needed.

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Provenge is Now Covered by Medicare


Patrick Conway, MD, Centers for Medicare and Medicaid Services (CMS) chief medical officer has announced that Medicare will pay for the expensive immunotherapeutic agent sipuleucel-T (Provenge) for the treatment of advanced castrate resistant prostate cancer treatment.  CMS has determined that the drug is effective in metastatic hormone-refractory disease, and it had previously proposed to pay for treatment for Medicare beneficiaries, but it needed to collect and evaluate public comments.    Medicare will cover the expenses for men for whom prostate cancer is at an advanced stage and for whom the cancer does not respond to radiation or hormone therapy.

Treatment with Provenge requires a multi-day regimen during which the patient’s white blood cells are collected and exposed to proteins that direct the white blood cells to fight prostate cancer cells.  The cells, which then become primed to recognize tumor cells and direct an immune-system attack on them, are then returned to the patient. These patients receive a total of three treatments.

The FDA approved Provenge in April 2010.  The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) found that the treatment, with a score of 3.7 out of 5, significantly improved survical in patients with metastatic hormone-refractory prostate cancer.  Provenge, which is made by Dendreon Corp., is estimated to cost about $93,000 per patient.

Dr. Conway has announced that CMS will only cover indications supported by the label, which stipulates that Provenge is for patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.  He urges patients to discuss the risks and benefits with their physicians before making the decision to use Provenge.

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Provenge for Prostate Cancer—A Bust?


Controversy has existed for months over the newly approved prostate cancer drug Provenge. The drug, which was developed by Dendreon, a Seattle-based biotechnology company, costs about $93,000 per patient and extends lives by about four months in clinical trials.
Provenge is the first therapeutic cancer vaccine that has been approved by the FDA. Because it is a cancer vaccine, it is expected to train the patient’s immune system to attack the tumor. Yet studies are showing there is only “moderate” evidence that the drug actually helps patients.
The major point of debate stems from the fact that Medicare and Medicaid may be expected to pay for it. But in an economy that is just barely starting to climb out of a depression, many think that our current health care system just cannot afford it, especially if the drug is only “moderately” effective.
Medicare generally pays for drugs that are approved by the FDA, yet it is participating in the debate over paying for Provenge. This has raised concerns among cancer patients, doctors, and investors who say the government is reconsidering automatically paying for approved medicines just because of cost.
“Not only is the Center for Medicare and Medicaid Services’ action contrary to Congress’s intent to ensure beneficiary access to drugs and biologicals used in an anticancer chemotherapeutic regimen, but it threatens to stifle future innovation and cancer research for years to come,” Dr. Al B. Benson III, president of the Association of Community Cancer Centers, said in a comment submitted to the Centers for Medicare and Medicaid Services.
The opponents of Medicare/Medicaid paying for the expensive drug say that the health care system cannot afford to continue paying high prices for all therapies.
However, Medicare is not supposed to consider price when determining whether to cover a drug. And some analysts think the payout may not be quite so high as they already assumed that Medicare would pay for Provenge only if patients specified in the drug’s label—or those with advanced prostate cancer who are resistant to hormone-deprivation therapy but who are experiencing no or minimal symptoms—were using it.
For those patients who are resistant to hormone-deprivation therapy but whom already have symptoms, an off-label use of Provenge may be a better fit for all parties involved. The review for Medicare said there is still insufficient evidence to judge whether Provenge would work if used off-label, so that decision cannot yet be made.
Although the reviews of Provenge and its studies do not seem quite as enthusiastic as once hoped, Medicare and Medicaid may still decide to cover the cost anyway. “Historically, moderate means that CMS will reimburse the product for its on-label indication,” said Robyn Karnauskas, a biotechnology analyst at Deutsche Bank. The assessment of moderate evidence in support of Provenge may bode well for reimbursement after all.

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