Expert panel to endorse newly approved therapeutic vaccine for advanced prostate cancer

Medicare Officials Will Consider the Panel's Endorsement When Deciding Whether Provenge Should Be Covered

Provenge is one step closer to being covered by Medicare. An expert panel voted Wednesday to endorse the newly approved therapeutic vaccine for men with advanced prostate cancer.

The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting was part of a national coverage analysis of Provenge, following rekindled debate on whether some treatments are too costly for Medicare to cover. The vaccine, approved by the U.S. Food and Drug Administration in April, costs $93,000 per patient, and clinical trials have shown it extends a patient's life by four months on average. However, several individuals have lived two years or longer following their treatment.

Medicare is not supposed to take cost into consideration when making reimbursement decisions. When you take a look at other treatments like chemotherapy – which is given to patients over many months – Provenge is given over a four-week period, making the amount of cost very comparable. Provenge has also been shown to have fewer severe side effects, thus improving a patient's quality of life.

"We cannot balance the budget on the back of cancer patients," said Skip Lockwood, CEO of ZERO – The Project to End Prostate Cancer. "Our military has a long and noble tradition of leaving no man on the battlefield, and we should not start a civic tradition of leaving cancer patients on the healthcare battlefield because we lack the will, creativity and courage to solve a difficult problem."

The MEDCAC panel opened the floor for public comments and then voted on five questions about Provenge. (For example: "How confident are you that there is adequate evidence to conclude that (Provenge) significantly improves overall survival in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer?). In the end, the panel decided to give the vaccine its endorsement.

"Even though this is great news, I believe the panel chairman tried to downplay some solid support for Provenge by saying that the evidence needed to be 'broader and deeper,' when there is clearly more than a fair amount of confidence in the vaccine," said Kevin Johnson, ZERO's Senior Vice President of Government Relations and Advocacy who attended the MEDCAC meeting. "We need to continue to push the government on men's health issues like this, and we need to ensure all men have access to preventive services and testing."

Experts say a decision on whether Medicare will pay for Provenge should be made in several months.