The Centers for Medicare and Medicaid Services (CMS) are currently seeking public comment as to whether coverage for Provenge should be provided to Medicare beneficiaries. CareToLive (CTL) asks all of its members and friends to file a public comment. CTL firmly believes coverage should be provided.

You can send your comment by simply clicking this link:    Public Comment

Here is my comment:

Commenter: Kearney, Mike
Title: Spokesperson for CareToLive
Organization: CareToLive, a not for profit corporation advocating for men with prostate cancer
Date: 07/02/2010

Comment:

I would like to respond to the questions Dr. Louis
Jacques, the director of the Coverage and Analysis
Group at the Medicare center, heard from people in
regards to Provenge. Dr. Jacques gave these
questions to Matthew Herper of Forbes Magazine.

“We’ve been getting questions from people,” says
Jacques. “‘Well, what’s up with Provenge? Is it a
drug? Is it a biologic? Is it something else? Does
it really work? It has been interesting to look at
the evidence around it.”

http://blogs.forbes.com/sciencebiz/2010/07/why-medicare-is-reviewing-provenge/?boxes=businesschannelsections

What’s up with Provenge is that it is medical
history. It is a paradigm shift for how we treat
cancer. No, it wouldn’t be considered a drug that
you would pop in your mouth, it is a biologic. In
fact, when it was approved by FDA, it was approved
by the staff of the Center for Biologics
Evaluation & Research (CBER). All the drugs are
approved by the staff of the Center for Drug
Evaluation & Research (CDER). Not sure what the
“Is it something else?” question is referring to.
But perhaps the best question, Dr. Jacques heard
is, “Does it really work?” Let’s look at the
evidence.

Three Phase 3 studies involving 737 patients were
submitted to FDA to support licensure. Overall,
Provenge reduced the risk of death by 22.5 percent
compared to the control group. And, we haven’t
seen the full potential of this treatment as it
requires ramp up time. It appears the longer it
gets to work, the better it is.

“Provenge suggests that we may in fact be able to
stimulate our body’s own defense mechanisms to aid
our fight against cancer. This in itself is a
truly remarkable accomplishment,” said Len
Lichtenfeld, MD, deputy chief medical officer of
the American Cancer Society. “It also opens the
door for – and reignites interest in pursuing
the development of other vaccines for other types
of cancer, including melanoma and breast cancer.”

According to the American Cancer Society, the
latest estimates for prostate cancer in the United
States are for 2010:

* About 217,730 new cases of prostate cancer
will be diagnosed

* About 32,050 men will die of prostate cancer

Take 22.5% of those 32,050 lives lost each year
and note that means 7,211 lives would be extended.
That is a lot of lives.

Consider the importance of survival and the
quality of life. First, the patient lives longer
to enjoy family and friends. Second, he is able to
participate in activities with his loved ones, not
just lie around.

Like Dr. Lichtenfeld said, “the data was enough to
convince the FDA that the survival benefit was
genuine.”

Also, consider the mission of every emergency room
in every hospital in the world. Patients are
brought in in life and death situations. Doctors
and nurses race around to help them. Keeping them
alive is of utmost importance. That is how
Provenge should be viewed. A tool to help keep the
men alive.

Popularity: 81%

Tags: CareToLive, CTL, Dendreon, FDA, NCI, Pazdur, Prostate Cancer, provenge, scher

This entry was posted on Sunday, July 4th, 2010 at 12:21 pm and is filed under The Cause. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.