Care To Live says BRAVO to Senator Arlen Specter (PA) and Senator John Kerry (MA) for sending a letter to the Centers for Medicare and Medicaid (CMS) asking them why they are reviewing coverage on FDA approved Provenge.

cms-senators-specter-kerry.pdf

(click to enlarge)

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In case you missed it, the American Society of Clinical Oncologists (ASCO) wrote to CMS in support of Provenge. Here is what Dr. Allen Lichter, the CEO of ASCO, posted on the Medicare website:

Dear Drs. Paserchia and Fitterman:

On behalf of our 28,000 members who treat people
with cancer, the American Society of Clinical
Oncology (ASCO) is writing to express concern
about a recent action taken by the Centers for
Medicare & Medicaid Services (CMS).

On June 30, 2010, CMS opened an internally-
generated national coverage analysis (NCA) of
sipuleucel-T (Provenge®). Although we commend
CMS for taking steps to gather scientific
information about new cancer therapies, the
information provided by CMS regarding this NCA
lacks sufficient clarity regarding the purposes
underlying this action. In particular, we are
concerned that CMS may have plans to examine the
issue of whether to cover this therapy for its
FDA-approved indications. If that is the case,
this would be both counter-productive and ill-
advised. We believe that CMS is required by the
Social Security Act to cover drugs and biologics
for FDA-approved indications used in anticancer
chemotherapeutic regimens.

Since 1993, section 1861(t)(2)(A) of the Medicare
statute has provided a definition for drugs and
biologicals covered by the Medicare program that
explicitly includes those for use “in an
anticancer chemotherapeutic regimen for a
medically accepted indication. ” The statute
further defines “medically accepted indication”
to include “any use which has been approved by
the Food and Drug Administration” in 1861(t)(2)
(B). The statute thus clearly envisions that
Medicare coverage for cancer drugs will flow from
approval by FDA, and CMS has historically
followed this practice.

We urge CMS to withdraw the current NCA and look
for other means of communication to gather
information about this therapy, such as a
potential meeting with scientific experts to
address specific questions or a meeting of the
MedCAC (conducted outside of the context of an
NCA) to address specific questions. We
appreciate the longstanding and positive working
relationship that ASCO maintains with officials
throughout CMS, and we hope that you will
continue to look to ASCO and our members for
scientific and clinical expertise on this and
future issues.

Under any scenario, we urge CMS to provide clear
public statements regarding Medicare’s current
policies governing the coverage of this therapy
and to address the issue of how any potential
future changes in coverage policies at the local
or national levels could impact individuals who
might be mid-therapy. In practice, ambiguity and
uncertainty regarding coverage policies can act
as an unacceptable barrier to medically necessary
care.

Please do not hesitate to contact ASCO with any
scientific, clinical or administrative questions
involving cancer care provided in community-based
and other settings.

http://www.cms.gov/mcd/viewpubliccomments.asp?id=&cov_id=&state_id=&list_type=&goto=viewpubliccomment&nca_id=247

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On July 28th, the Dendreon Corporation announced “the publication of data from the pivotal Phase 3 IMPACT study in the New England Journal of Medicine, showing that PROVENGE® sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (mCRPC).  The manuscript is published in the July 29, 2010 issue of the journal.”

“These results represent the beginning of a new era in the treatment of cancer, one in which a patient’s own immune system is harnessed to fight the disease,” said Philip Kantoff, M.D., lead author of the publication, co-principal investigator of IMPACT and Chief of the Division of Solid Tumor Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. “Furthermore, the magnitude of the survival benefit coupled with the side effect profile and short duration of therapy place PROVENGE as a new standard of care for men with asymptomatic or minimally symptomatic mCRPC.”

The New England Journal of Medicine (NEJM) also included an editorial in which three questions were raised.

Below Care To Live presents the answers to those questions.(click this link)>> Continue Reading Provenge Works & Costs the Same as Chemo & Comments by Bishop »

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As the comments on the Centers for Medicare & Medicaid Services (CMS) website concerning the coverage of Provenge continue to mount, some people inadvertently, and some deliberately, have submitted inaccurate information. Care To Live (CTL), with the help of two of our exceptional physician and scientist friends, Dr. Robert Rostock and Ocyan respectively, continue to set the record straight.

It remains the opinion of CTL, based on all sources of information and investigation, that the CMS review is not about coverage or non coverage of Provenge. It is about interpreting the label, and how much to require from physicians prior to granting reimbursement approval.

We believe that the CMS review could and should actually lead to more patients being covered rather than less.

The argument should not be about coverage vs. non-coverage it should be about how early in the treatment regime patients will qualify for on label use.

We believe that CMS is wrong in not being more specific in their PR release, as to the specific purposes of review. They themselves are responsible for the circus-like atmosphere they have created. They should immediately issue a clarifying statement on this topic. Again, they have no legal or medical basis to deny coverage.

Dr. Robert Rostock, a first-rate prostate cancer Radiation Oncologist, who is in the trenches as he fights each day to treat men with late stage prostate cancer, provided his expert opinion.

“The label does need to be clarified. The sad truth is that most patients are diagnosed with a bone scan when there is already significant pain. Continue Reading Setting the Record Straight »

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Dear Colleague (ahem),

Now for the cover letter that accompanied that spurious paper.

These anonymous dolts are truly grasping at straws, alluding to fictional dreams of bloodshed and birth defects.

We are not about harming people. Au contraire. We want people to live longer with better quality of life.

If I were to mention Thalidomide, which caused birth defects in thousands of women, in the same sentence as the safe, non toxic, non invasive immunotherapy Provenge that helps men with prostate cancer add years to their lives, I would want to remain anonymous too.

Who are these physicians and scientists in favor of suffering and death?

Okay, okay, I will shut up and present the letter.

anonymous-misinformation-cover-letter.pdf

Our previous blog covered the bogus report making the rounds, falsely disparaging Provenge. (see blog below Provenge is Approved but the Lies Continue)

This further dispels that bogus report. Care To Live has learned,

Dendritic/other immune cells are extravascular, not in the blood. Removing less than 3% of immune system. If you check 3 weeks after apheresis, level of immune cells in blood is same as prior to apheresis.

The immune cell count calculation within the report appears to be wrong. Based on the article, the calculation discussed the immunodepletion of the cells within the blood. However, the majority of immune cells are in the TISSUE, and not just in the blood. Dendreon measured the immunodepletion 3 weeks into the trial and that was normalized.

Within the clinical trials no increase in infection was seen between placebo arm and Provenge arm. This suggests a normalized immune system.

The survival in the control arm was no different than historical normals for Prostate Cancer.

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A bogus 27 page paper is being aggressively sent around wall street, and the medical, scientific regulatory and legal community, asking people to contact the FDA and the CMS. The cover letter touts the nonsense that they are scared to voice their concerns publicly. Feigning their safety fears is the same ploy they used last time, hiring bodyguards, at the taxpayers expense, fabricating non-existent threats, while no police reports ever turned up. This time we are determined to get to the bottom of it.

provenge-approval-fud.pdf

Their poor argument about the Phase III trial is dispelled here by Provenge advocate Ocyan:

This was a serious piece of work to support an argument that Dr. Hussain put up during the 2007 AC meeting when she said that the placebo protocol might have been active and could hurt patients. At that time, she gave no explanation of how that could be the case. Now, the argument is that it is immuno-depletion.

The basic idea is that a large number of immune cells were taken from a patient in a leukapheresis procedure. If a patient was on the treatment arm, he would get most of them back on reinfusion. However, if a patient was on the control arm, he only got back less than a third of what was taken during the leukapheresis procedure. Therefore, the immune system of a placebo patient was suppressed. That is called immuno-depletion.

The immuno-depletion attack on Provenge goes like this. Because of immuno-depletion, Continue Reading Provenge Is Approved But The Lies Continue »

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Friends, Patients, and Families,

Do not worry about CMS coverage of Provenge. Provenge will be covered by Medicare for the FDA-approved indication. Of this, you have our absolute guarantee!

The supply issue is the real problem. However, we are expecting 36 more hoods to come on line in the very near future. This will allow more men to get access to Provenge right away.

Our current understanding of the CMS concern, is the use of Provenge on the entire prostate cancer patient population versus the HRPC/AIPC patient population. The issue appears to have been taken up by CMS in order to provide uniform local coverage of on label use.

Provenge is not being reviewed on the issue of whether Provenge is to be covered. It is now, and will continue to be covered.

Furthermore, CMS is neither interested in negotiating or cutting the reimbursement amount to Dendreon, nor for any other reason contrary to the best interest of the company and the patients it is striving to serve, or reviewing the reimbursement of the cost to the attending physicians. 

The Provenge treatment is a new paradigm, and local Medicare offices do not know how to classify and otherwise handle the reimbursement issue. Thus the need for the review and clarification.

Care To Live will continue to carefully monitor, and strenuously object to, any attempt by our government to interfere in the doctor patient relationship. If the recently filed Freedom of Information request sheds light on any other modus operandi, it will be shared here.

Any attempt by the government to use Dendreon as a test case, at the expense of the little biotech that could, will not be tolerated.

Any attempt by the FDA to use CMS as a means to control the issue of off label use, is also being watched carefully.

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Today, CareToLive sent a FOIA request to:

Centers for Medicare & Medicaid Services
Office of Strategic Operations and Regulatory Affairs
Freedom of Information Group
Room N2-20-16
7500 Security Boulevard
Baltimore, Maryland 21244-1850

The request was sent via Express Mail and was also sent via their website,  http://www.cms.gov/foia/

Here is a copy of the request:    ctl-foia-request.pdf

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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
Continue Reading The Centers for Medicare and Medicaid Services are requesting comments. »

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Dr. Myers’s thoughts on Provenge.
http://askdrmyers.wordpress.com/2010/07/07/provenge-case-study/ (video)

About Dr. Snuffy Myers http://askdrmyers.wordpress.com/about/
With over 250 research papers published, Myers is one of the leading developers of today’s prostate cancer canon on both the research and treatment side of the test tube. Prostate Forum is the educational arm of his world-renowned practice that is dedicated to providing men with the comprehensive care that saved his own life.

Care To Live friend M.C. Lee summed it up.

- Longer survival
- Less side effect
- Comparable cost
- Productive life

M. C. Lee Edit: Forgot that demand will definitely outstrip supply in the FORESEEABLE future.  So if you want it you better bug your doctor about it.

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