Anti-Prostate Cancer Vaccine is Approved for Medicare Patients

Provenge, a new prostate cancer vaccine that was approved by the FDA in April 2010 was recently reviewed by The Medicare Evidence Development & Coverage Advisory Committee (MEDAC). The Committee approved the vaccine for treatment of Medicare patients.

While MEDAC’s recommendations are not mandatory, Medicare most often accepts the Committee’s recommendations. This would allow oncologists to offer the $39,000 treatment to their Medicare patients. In the light of the recent political debates over healthcare costs this particular approval process was the center of a good deal more scrutiny than usual. Previously such decisions were made with little attention paid to cost.

The approval is a potentail windfall for the Dendeon Coporation the manufacturer of the vaccine. Mitchel H. Gold, MD, President and CEO of Dendreon Corporation, said: "Provenge is an important new treatment for patients with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.

Unlike tradition prohpylactic vaccines that are deisgned to prevent a disease, Provenge actually treats the disease. The treatment leverages the patient’s own immune sytem to combat the cancer. Physcians extract a patient's white blood cells. The blood product is then incubated with a fusion protein consisting of two parts, the antigen prostatic acid phosphatase, which is present in most prostate cancer cells and an immune signaling factor. This process induces maturation of antigen-presenting cells. When the activated blood is then re-infused into the patients, it causes and immune reposnse against these specific prostate cancer cells.

In Phase Three trials, Provenge extended the life of patients by an average of only four months. However, as with many cancer protocols, the hope is that using Provenge early in the course of the disease will have a greater impact on outcomes and longevity.

Prostate cancer forms in tissues of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum). In 2010 The National Institute of Health estimates that there will be 217,730 new cases diagnosed and 32,050 deaths.


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