A Medicare review committee on Wednesday expressed lukewarm support for the prostate cancer drug Provenge, suggesting that the agency is likely to implement an agency-wide approval to pay for use of the drug for treating prostate cancer but will reject off-label uses. Provenge is the first anti-cancer vaccine approved by the Food and Drug Administration and has been shown to extend the life of prostate cancer victims by a median of 4.1 months, more than twice as long as chemotherapy, and to increase three-year survival by 38%. But that improvement comes at a steep price -- $93,000. Some critics charge that Medicare has been looking for ways to refuse coverage in an effort to hold down healthcare costs.
The review apparently took place because regional offices were inconsistent on whether or not to approve payment for the drug.
The panel members were asked to give a score ranging from one to five on each of several questions regarding the drug. On efficacy, the members gave Provenge a score of 3.6, which shows intermediate confidence.
An estimated 217,000 new cases of prostate cancer are diagnosed each year and 32,000 men die from it. If Medicare decides to pay for the drug and private insurers follow suit, that could increase the nation’s healthcare costs substantially. Because many insurance companies require a co-pay of 20%, many patients will be unable to afford the drug.
The vaccine was developed by immunologist Edgar G. Engleman, then at the Stanford University School of Medicine, who collected specialized immune cells called dendritic cells from the patient’s blood. He mixed them with proteins collected from the surface of the prostate tumor cells and injected them back into the patient in three doses at two-week intervals. He eventually founded the Seattle biotech company now known as Dendreon Corp. to bring the vaccine to market.
Because of the complicated manufacturing process,the company can still make only limited quantities of the vaccine.