Provenge at SCCA
The U.S. Food and Drug Administration (FDA) approved use of the prostate cancer treatment Provenge® (sipuleucel-T), made by Dendreon Corporation of Seattle. The company said the treatment is now widely available at sites across the country, including Seattle Cancer Care Alliance. SCCA was the location for several of the clinical studies to test Provenge prior to regulatory approval. These were led by Celestia S. Higano, MD, a medical oncologist who specializes in prostate cancer and a professor of medical oncology at the University of Washington.
The following questions and answers address common questions about Provenge and its use at SCCA.
Q: How many patients will SCCA treat with Provenge?
A: Provenge is now widely available and SCCA is able to treat appropriate patients with the therapy.
Q: How do patients qualify to receive Provenge?
A: Patients must meet disease indications as outlined by the FDA. Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body (metastatic) and is resistant to standard hormone treatment.
Q: How soon will Provenge be available?
A: Provenge is now widely available. Patients should contact SCCA’s Intake Office at (206) 288-6542 if they believe that they may be a candidate for Provenge therapy. Medical staff will review each patient’s medical records. If it appears that a patient may be a candidate for Provenge, an appointment will be scheduled to see a prostate cancer doctor for further evaluation.
Q: How much does Provenge cost?
A: The total cost for a full course of treatment with Provenge (three doses) is approximately $93,000. Medicare and all major insurance plans cover the cost of Provenge for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. The makers of Provenge provide the therapy free of charge to eligible patients with no health insurance or who are denied coverage after all claims appeals, and also support independent foundations that offer assistance with co-pays and co-insurance charges, and assistance for treatment-related travel costs. Patients should talk with their insurance providers about this new treatment, discuss this with an SCCA patient financial assistance staff member, or contact the Provenge support center, known as Dendreon on call, at 1-877-336-3736.
Q: Will public and private insurance cover the cost?
A: Yes. Medicare and all major insurance plans cover the cost of Provenge for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Patients should talk with their insurance providers about this new treatment, discuss this with an SCCA patient financial assistance staff member, or contact the Provenge support center, known as Dendreon ON Call, at 1-877-336-3736.
Q: How many patients could benefit from Provenge?
A: Over 100,000 men have the advanced form of prostate cancer for which the treatment would initially be prescribed. According to the American Cancer Society, prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than two million men in the United States have prostate cancer, with an estimated 240,890 new cases and approximately 33,720 men expected to die from the disease in 2011.
Q: Who is Provenge for?
A: Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body (metastatic) and is resistant to standard hormone treatment.
Q: What is Provenge and how is it made?
A: Provenge is an autologous (made from a patient’s own immune cells) cellular immunotherapy designed to stimulate a patient’s immune system to identify and target prostate cancer cells. Each dose is manufactured specifically for each patient using his own immune cells.
This is done by obtaining a patient’s immune cells from the blood using a machine in a process known as leukapheresis. In the greater Seattle area, the collection procedure will be performed at the Puget Sound Blood Center. The immune cells are then sent to a Dendreon manufacturing facility. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune-stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Treatment with Provenge includes three doses given approximately two weeks apart.
Q: How effective is Provenge?
A: The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment–refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial. It showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months compared with 21.7 months for those who did not receive the treatment. This may sound modest; however, other standard-of-care prostate cancer treatments were shown to have even more modest survival benefits.
For the most part, the patients treated with Provenge did not experience any different side effects than those side effects seen when a patient receives any blood product. The most common side effects were mild and included chills, fatigue, fever, back pain, nausea, joint ache, and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one-quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.