Dendreon Corp. said Medicare administrators are conducting a review to determine whether the health agency will cover the costs of its prostate cancer therapy Provenge.
Provenge is widely expected to bring Dendreon billions in revenue, but if Medicare does not cover Provenge, or offers only limited coverage of the costly therapy, it could hurt sales.
Dendreon shares skidded $4.14, or 12.8 percent, to $28.19 in premarket trading Thursday.
Late Wednesday, Dendreon said the Centers for Medicare and Medicaid Services is requesting public comments on Provenge through what is called a national coverage analysis. The analysis could be part of a decision on whether Medicare will pay for Provenge, which is an immune system-based therapy that costs $93,000 for a course of treatment.
Dendreon said the analysis does not affect current Medicare coverage decisions and does not restrict local Medicare contractors from covering Provenge.
Medicare and Dendreon did not immediately respond to requests for comment.
Provenge is designed to train a patient's immune system to attack tumors. It is made by mixing blood cells from the patient with a protein found on cancer cells and an immune system-boosting substance. It's the first drug of its kind, and in clinical testing, men who were treated with Provenge survived longer than those who received chemotherapy.
The Food and Drug Administration approved Provenge on April 29 as a treatment for prostate cancer that has spread elsewhere in the body and is not responding to hormone therapy.