Commenter: Schellhammer, Paul
Title: professor of urology
Organization: urology of virginia/eastern virginia medical school
Date: 07/26/2010
Comment:
I have had experience with delivery of ACI
(Provenge) over the past 10 years in their
multiple trials. I am very favorably impressed
by the clinical trial survival benefit and the
lack of toxicity. I am interested in offering
this to patients with far-advanced prostate
cancer. Please make it possible for me to do so
at the completion of review, and in the interim,
please provide a directive for current coverage.
Men who have to wait one year for a review may
indeed die or become too ill before this
treatment is available. The majority of the men
who participated in clinical trials with active
cellular immunotherapy were over the age of 65,
were found to benefit significantly from therapy,
and should not be denied the opportunity for this
therapy now and over the next year due to
reimbursement issues
The treatment is reasonable because it is not
associated with significant toxicity ( Much less
than chemotherapy (docetaxel) and it is necessary
because it provides better survival outcomes than
chemotherapy (docetaxel). Currently docetaxel is
FDA approved and reimbursed for this group of
patients. ACI is safer and more effective and
likely will be proven to be more cost-effective
as well absent the management of toxicities.
Paul Schellhammer MD
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