Updated with new headline, analyst comments
The meeting announcement was posted Tuesday on the web site of the Centers for Medicare and Medicaid Services (CMS).
"The Centers for Medicare and Medicaid Services (CMS) has called this meeting to consider the currently available evidence regarding the impact of labeled and unlabeled use of autologous cellular immunotherapy treatment on health outcomes of patients with metastatic prostate cancer," the agency's announcement stated.The fact that CMS is focusing its attention on which prostate cancer patients to treat with Provenge and will not consider the broader question of whether or not to reimburse at all for the $93,000-per-treatment drug is a positive and should help allay investor concerns. Deutsche Bank biotech analyst Robyn Karnauskas in a note to clients Tuesday night said she expects CMS will conclude that Provenge coverage should hue closely to the type of prostate cancer patients that were treated in the Provenge clinical trials. That outcome "will not change street estimates in our view," Karnauskas writes, adding, "These eligibility criteria we expect to be put in place are in-line with those of the IMPACT trial. This is the way that we, and the Street, model Provenge's market opportunity." Karnauskas has a buy rating on Dendreon with a $44 price target. Dendreon shares rollercoastered in June when CMS announced that it was opening an assessment to determine a national coverage decision of Provenge, which received FDA approval earlier this year as a treatment for advanced prostate cancer. Since that announcement, Dendreon has indicated that 14 of the 15 regional Medicare carriers are either already reimbursing patients for Provenge or have signaled their intention to do so. Strong demand for Provenge in the form of patients on waiting lists to receive the drug has also been reported by the company. Dendreon shares closed Tuesday up 15 cents to $35.84 but jumped another 66 cents, or almost 2% to $36.50 once investors became aware of the scheduling of the Medicare meeting. --Written by Adam Feuerstein in Boston.
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