Commenter: Whitesel, Robert
Date: 07/29/2010
Comment:
Autologous cellular immunotherapy Is it "reasonable and necessary" under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act? My name is Robert Whitesel. [PHI Redacted]
[PHI Redacted] Autologous cellular immunotherapy seems more "reasonable" to me than other Medicare accepted prostate cancer therapies, e.g., radical prostatectomy and chemotherapy. To treat aggressive, advanced cancers, to be sure, it would seem to me at least as "necessary" as the aforementioned therapies already accepted as reasonable.
I wish to make three (3) points in support of my affirmative response to the question above:
[PHI Redacted]
2. It is important to minimize treatments with destructive side effects. Quality of life suffers and the patient's immune system may be weakened and left vulnerable to other diseases. This therapy has been designed to build on the immune- system-boosting-capability of GM-CSF (granulocyte macrophage-colony stimulating factor) agents and doesn't leave one's immune system compromised by the destructive effects of taxane-based chemotherapy agents.
3. Some way must be found to reduce the cost of this out- patient-administered therapy. Long-term costs could be reduced by treating the largest possible number of qualified patients early in their disease progression, thereby putting the cancer cells at least into dormancy and reducing or eliminating the subsequent need of today's similarly costly and less-effective treatments for these men.
Sunday, November 14, 2010
Urologist Dr Mark Scholz on Provenge as Treatment
Dear CMS Reviewers,
As an oncologist who specializes in treating
prostate cancer patients, I was extremely pleased
when the U.S. Food and Drug Administration
approved Provenge for the treatment of
metastatic, castrate resistant prostate cancer as
it represents an important advancement not only
in the treatment of prostate cancer, but the
beginning of a new treatment paradigm for the
treatment of all cancers.
I have used Provenge in my practice and continue
to be impressed by the ease of administration
with the treatment, as well as the almost total
lack of side effects experienced by patients. As
someone who has worked with prostate cancer
patients for nearly 20 years, I am all too
familiar with the difficult issues that patients
sometimes face with other treatments. Provenge
marks a new chapter in how I am able to treat my
patients, one that offers an improved survival
benefit, as well as an extremely mild side effect
profile and treatment duration when compared to
other treatments, such as chemotherapy. The
limited toxicity is so critical in maintaining a
good quality of life in these elderly ,
testosterone deprived individuals.
In addition to my clinical work, I am also the co-
founder and executive director of the Prostate
Cancer Research Institute, a non-profit
educational and research institute the focuses on
disseminating state-of-the-art information about
the diagnosis, staging and treatment of prostate
cancer. Provenge’s availability provides
healthcare professionals, as well as the patients
we treat, with a long-awaited and much-needed
alternative therapy for one of the neediest
patient populations in the prostate cancer
community.
There is a great deal of excitement among the
prostate cancer community to have a new and
effective treatment in the form of an
immunotherapy. I firmly believe that CMS has a
duty to both patients and their healthcare
providers to fully reimburse Provenge for the
indication in which it was approved, ensuring
that patients who have long awaited a new
treatment option to help them in their battle
with prostate cancer will have access to it. I
ask you, as a physician and an advocate for the
prostate cancer community, please do not delay or
inhibit access to Provenge.
Mark Scholz, M.D.
Medical Director of Prostate Oncology
Specialists, Inc., Marina Del Ray, CA
Associate clinical professor at the University of
Southern California School of Medicine
Co-Founder and Executive Director of the Prostate
Cancer Research Institute
As an oncologist who specializes in treating
prostate cancer patients, I was extremely pleased
when the U.S. Food and Drug Administration
approved Provenge for the treatment of
metastatic, castrate resistant prostate cancer as
it represents an important advancement not only
in the treatment of prostate cancer, but the
beginning of a new treatment paradigm for the
treatment of all cancers.
I have used Provenge in my practice and continue
to be impressed by the ease of administration
with the treatment, as well as the almost total
lack of side effects experienced by patients. As
someone who has worked with prostate cancer
patients for nearly 20 years, I am all too
familiar with the difficult issues that patients
sometimes face with other treatments. Provenge
marks a new chapter in how I am able to treat my
patients, one that offers an improved survival
benefit, as well as an extremely mild side effect
profile and treatment duration when compared to
other treatments, such as chemotherapy. The
limited toxicity is so critical in maintaining a
good quality of life in these elderly ,
testosterone deprived individuals.
In addition to my clinical work, I am also the co-
founder and executive director of the Prostate
Cancer Research Institute, a non-profit
educational and research institute the focuses on
disseminating state-of-the-art information about
the diagnosis, staging and treatment of prostate
cancer. Provenge’s availability provides
healthcare professionals, as well as the patients
we treat, with a long-awaited and much-needed
alternative therapy for one of the neediest
patient populations in the prostate cancer
community.
There is a great deal of excitement among the
prostate cancer community to have a new and
effective treatment in the form of an
immunotherapy. I firmly believe that CMS has a
duty to both patients and their healthcare
providers to fully reimburse Provenge for the
indication in which it was approved, ensuring
that patients who have long awaited a new
treatment option to help them in their battle
with prostate cancer will have access to it. I
ask you, as a physician and an advocate for the
prostate cancer community, please do not delay or
inhibit access to Provenge.
Mark Scholz, M.D.
Medical Director of Prostate Oncology
Specialists, Inc., Marina Del Ray, CA
Associate clinical professor at the University of
Southern California School of Medicine
Co-Founder and Executive Director of the Prostate
Cancer Research Institute
Medical Phyicist Robert Baker to MEDCAC on Provenge
View Public Comment for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)
Commenter: Baker, Robert
Title: Consultant, CEO
Organization: RJB Consulting
Date: 07/14/2010
Comment:
I am a Medical Physicist (Ph. D., licensed by the
American Board of Radiology), and have worked in
the medical field for more than 35 years. My role
always involves patients being treated with
radiation, e.g. from a linear accelerator treating
a cancer patient, or implanted radioactive seeds;
both of these techniques are often directed at
prostate cancer
I began my career in the early 1970’s, at the
University of California, San Francisco Medical
Center, (now a clinical trial center, with
researchers enthused about Provenge, and a very
long waiting list of patients!). Chemotherapy was
new and experimental then; Radiation Oncologists
began prescribing these new drugs (there were no
Medical Oncologists yet); doctors called them the
“telephone drugs”, because they had names like
Roche 7473. (These doctors also referred to them
as “poison”). Now we have enough of these drugs
to fill a phone book!
Then President Nixon declared the “War on
Cancer”. After several decades, and billions of
dollars had been spent on this “war”, I have heard
many of these same physicians say, in effect, “we
should just admit we have lost the war!” Cancer
incidence was up, not down, survival was not much
affected.
Since that time, we have had improvements in
treatment delivery involving radiation (IMRT,
Gamma Knife, Cyberknife, etc), but radiation’s
effect is explained statistically; radiation never
completely eliminates the tumor cells; it merely
reduces the tumor burden to the level that the
body’s own innate defenses can eradicate it.
The Holy Grail of Cancer research has always been
to activate the body’s natural defenses (the
immune system) to destroy the tumor. Provenge has
finally accomplished just this task, and as such,
it is the FIRST FDA approved product to do so!
Provenge has greatly reduced side effects,
compared to any and all chemotherapies. The
specific clinical trial leading to the final
approval of Provenge, involved patients with very
advanced stage prostate cancer, that had already
failed multiple other existing treatment regimens,
and in the majority of cases had already
metastasized; “compassionate use” allowed these
clinical trial patients in the Standard of Care
arm (Taxotere) to “cross over”, if they were
failing treatment under the standard treatment;
many did so (I believe the majority), and even
these were helped by Provenge, even though they
were provided the drug late, and with a preserved
(frozen) form of Provenge.
This is truly a remarkable accomplishment, a
dramatic result, and supporters of this product
believe (and there is evidence) that Provenge can
be even more effective when applied earlier and in
broader circumstances.
In summary: Provenge is a breakthrough,
disruptive, new, dramatic, life extending, quality
of life preserving, treatment, that should be made
available to all prostate cancer patients whose
doctors determine they will benefit!
Commenter: Baker, Robert
Title: Consultant, CEO
Organization: RJB Consulting
Date: 07/14/2010
Comment:
I am a Medical Physicist (Ph. D., licensed by the
American Board of Radiology), and have worked in
the medical field for more than 35 years. My role
always involves patients being treated with
radiation, e.g. from a linear accelerator treating
a cancer patient, or implanted radioactive seeds;
both of these techniques are often directed at
prostate cancer
I began my career in the early 1970’s, at the
University of California, San Francisco Medical
Center, (now a clinical trial center, with
researchers enthused about Provenge, and a very
long waiting list of patients!). Chemotherapy was
new and experimental then; Radiation Oncologists
began prescribing these new drugs (there were no
Medical Oncologists yet); doctors called them the
“telephone drugs”, because they had names like
Roche 7473. (These doctors also referred to them
as “poison”). Now we have enough of these drugs
to fill a phone book!
Then President Nixon declared the “War on
Cancer”. After several decades, and billions of
dollars had been spent on this “war”, I have heard
many of these same physicians say, in effect, “we
should just admit we have lost the war!” Cancer
incidence was up, not down, survival was not much
affected.
Since that time, we have had improvements in
treatment delivery involving radiation (IMRT,
Gamma Knife, Cyberknife, etc), but radiation’s
effect is explained statistically; radiation never
completely eliminates the tumor cells; it merely
reduces the tumor burden to the level that the
body’s own innate defenses can eradicate it.
The Holy Grail of Cancer research has always been
to activate the body’s natural defenses (the
immune system) to destroy the tumor. Provenge has
finally accomplished just this task, and as such,
it is the FIRST FDA approved product to do so!
Provenge has greatly reduced side effects,
compared to any and all chemotherapies. The
specific clinical trial leading to the final
approval of Provenge, involved patients with very
advanced stage prostate cancer, that had already
failed multiple other existing treatment regimens,
and in the majority of cases had already
metastasized; “compassionate use” allowed these
clinical trial patients in the Standard of Care
arm (Taxotere) to “cross over”, if they were
failing treatment under the standard treatment;
many did so (I believe the majority), and even
these were helped by Provenge, even though they
were provided the drug late, and with a preserved
(frozen) form of Provenge.
This is truly a remarkable accomplishment, a
dramatic result, and supporters of this product
believe (and there is evidence) that Provenge can
be even more effective when applied earlier and in
broader circumstances.
In summary: Provenge is a breakthrough,
disruptive, new, dramatic, life extending, quality
of life preserving, treatment, that should be made
available to all prostate cancer patients whose
doctors determine they will benefit!
Sunday, November 7, 2010
New Biomarker for Prostate Cancer
PROTEIN ARRAY ACCURATE
FOR PROSTATE CA
A panel of prostate cancer-derived
autoantibodies distinguished cancer
from benign prostatic hyperplasia and
healthy tissue with greater than 90%
accuracy, according to a preliminary
report from the 2010 American Association
for Cancer Research meeting.
The functional protein microarray had
similar accuracy for detecting cancer
(sensitivity) and for ruling it out when
used to evaluate noncancerous tissue
(specificity).
Prostate specific antigen (PSA) testing
also has a sensitivity of about 90% but a
specificity of less than 50%, John Anson,
PhD, said at a press briefing during
the American Association for Cancer
Research International Conference on
Molecular Diagnostics in Cancer Therapeutic
Development.
“What that means is there are lots of
potential false-positives,” said Anson, of
Oxford Gene Technology in the UK.
“What that translates to in clinical practice
is that a lot of men are going on for
unnecessary diagnostic procedures, such
as needle biopsies, and even radical
prostatectomy, which perhaps are not
required. Biomarker panels offer the
potential to significantly improve detection
of prostate cancer
FOR PROSTATE CA
A panel of prostate cancer-derived
autoantibodies distinguished cancer
from benign prostatic hyperplasia and
healthy tissue with greater than 90%
accuracy, according to a preliminary
report from the 2010 American Association
for Cancer Research meeting.
The functional protein microarray had
similar accuracy for detecting cancer
(sensitivity) and for ruling it out when
used to evaluate noncancerous tissue
(specificity).
Prostate specific antigen (PSA) testing
also has a sensitivity of about 90% but a
specificity of less than 50%, John Anson,
PhD, said at a press briefing during
the American Association for Cancer
Research International Conference on
Molecular Diagnostics in Cancer Therapeutic
Development.
“What that means is there are lots of
potential false-positives,” said Anson, of
Oxford Gene Technology in the UK.
“What that translates to in clinical practice
is that a lot of men are going on for
unnecessary diagnostic procedures, such
as needle biopsies, and even radical
prostatectomy, which perhaps are not
required. Biomarker panels offer the
potential to significantly improve detection
of prostate cancer