Updated with Dendreon stock price.
shares took another spin on the volatility roller coaster Monday after the U.S. agency in charge of Medicare posted voting questions for an upcoming advisory panel scheduled to assess the company's prostate cancer therapy Provenge.
The U.S. Centers for Medicare and Medicaid Services (CMS) is asking a panel of advisors on Nov. 17 to assess Dendreon's Provenge as a treatment for patients with metastatic prostate cancer.
To date, Dendreon has said it is seeing very little pushback from regional Medicare carriers towards reimbursement for Provenge, which costs $93,000 a treatment. However, that could change depending on the outcome of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting.
. The questions ask the panel members to use a 1-5 scale to identify their confidence level in Provenge's ability to improve overall survival, control disease related symptoms and lessen the burden associated with cancer therapy, among other questions.
Both on-label and off-label use of Provenge is being examined, according to the panel quesitions.
Dendreon shares fell 4% to $40.95 just before 1 p.m ET when the Medicare panel questions were posted to the agency's web site. The stock has since rebounded and is down just 10 cents on the day to unchanged for the day at $42.48.
Reaction to the new Provenge development was mixed.
The Medicare voting questions on Provenge were "Exactly what we expected," said Ramsey Baghdadi, a healthcare policy analyst with Prevision Policy and Concept Capital.
Baghdadi added, "CMS has been steadfast not only that they would look at the off-label use of the therapy, but they also emphasized in their announcement that they would be looking at the on-label use. We always thought the positive reaction to the original MEDCAC announcement was odd and the negative reaction to this is equally odd because CMS telegraphed that this is exactly what was coming."
ISI Group biotech analyst Mark Schoenebaum was more cautious in his initial assessment. "Surprisingly, many of the questions focus on efficacy in the on-label indication. It asks the panel to rank efficacy on a scale of 1-5, leaving the possibility of an ambiguous outcome. This is the first time we’ve seen Medicare analyze the efficacy of a drug. This could have important read-across to the entire sector, and plays into pricing themes that have emerged in the last year," he said in an email to clients.
Deutsche Bank biotech analyst Robyn Karnauskas told her clients in a quick email that she believed the Medicare meeting assessing Provenge would be positive for Dendreon because the questions were in-line with expectations; the panel will only be using publically available data; and Provenge has shown an overall survival benefit and has no side effects.
--Written by Adam Feuerstein in Boston.
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