Correction: this is not the final response.

 http://caretolive.com/Pages%201%20to%2050%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%2051%20to%20100%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%20101%20to%20151%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%20152%20to%20200%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%20201%20to%20250%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%20251%20to%20300%20CTL%20CMS%20docs%20041811

http://caretolive.com/CTL%20CMS%200418%20docs%20301-385

Popularity: 24%

Good News! Provenge is becoming increasingly available. Dendreon is ramping up the supply following the recent approval of the remaining 75% of their New Jersey plant.

To find out more about Provenge, a first in class immunotherapy treatment for prostate cancer, click this link Provenge.com.

To find out where provenge is available near you, go to the bottom left of that page to this link Find a PROVENGE Provider. Then, insert your zip code to find the locations in your area.

Recently conducted channel checking indicates that demand remains strong.

That data suggests:

The number of patients prescribed Provenge within their sample is up 22.7% sequentially, while the number of new patients who actually received the treatment is up 66.7%.

This is good news indeed!

Popularity: 22%

Today Care To Live received additional documents from the Center of Medicaid and Medicare Services in response to our Freedom of Information (FOIA) requests.

part-1-cms-foia-3_30_11.pdf

part-2-cms-foia-3_30_11.pdf

part-3-cms-foia-3_30_11.pdf

part-4-cms-foia-3_30_11.pdf

part-5-cms-foia-3_30_11.pdf

part-6-cms-foia-3_30_11.pdf

part-7-cms-foia-3_30_11.pdf

part-8-cms-foia-3_30_11.pdf

part-9-cms-foia-3_30_11.pdf

part-10-cms-foia-3_30_11.pdf

Popularity: 22%

Yes!

Patients and Advocates. I come to praise CMS, not to censor them.

As Care To Live expected, the Centers for Medicare and Medicaid Services announced today that Dendreon’s Provenge will be covered. There will be a brief comment period again, before this decision is formally made final. Approval of  Provenge immunotherapy, as well as payment for Provenge, were an uphill battle, but the next step, acceptance and usage, was well worth our efforts.

Thousands of men are currently receiving and loving Provenge!

As our most recent CMS foia documents (soon to be published here) will show, CMS created a firestorm when they announced that they were going to review Provenge to determine coverage.

A groundswell of support, by patients, doctors, congress, and advocates, came forth to push for national coverage.  We thank each and every one of you wholeheartedly. Provenge approval and accessibility was a labor of love/hate for many of us. CMS writes in their Decision Summary,

“The Centers for Medicare and Medicaid Services (CMS) proposes that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication under 1862(a)(1)(A) of the Social Security Act (the Act).”

CMS also said it is “requesting public comments on this proposed determination pursuant to section 1862 (l) of the Act. After considering the public comments, we will make a final determination and issue a final decision memorandum.”

CMS decision memo link:

http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=247&ver=7NcaName=Autologous+Cellular+Immunotherapy
+Treatment+of+Metastatic+Prostate+Cancer&bc=BEAAAAAAEAAA&

Dendreon Press Release link:

http://files.shareholder.com/downloads/DNDN/1208526489×0x455544/b045427e-a6cd-4064-86db-6e43b971f829/DNDN_News_2011_3_30_General.pdf

Popularity: 15%

Care To Live has been notified by the Department of Justice (DOJ) that the final FOIA response from CMS is expected to be completed and released to CTL not later than April 15, 2011.

As soon as it is released, it will be posted here in its entirety.

Popularity: 14%

Great news from Dendreon today!

The FDA finally approved the remaining 75% of treatment stations at their New Jersey plant that manufactures Provenge.

This will quadruple their manufacturing capability and greatly help to alleviate some of the current supply/demand problem.

Two more plants in Los Angeles and Atlanta are also expected to be able to begin production in the near future.

Care To Live along with thousands of Patients, Urologists and Oncologists are thrilled that doctors will now be able to treat thousands more men with Provenge, however we will not sleep well until all the men who need Provenge can get it.

Popularity: 13%

Today CTL received an interim response to its two previous FOIA request made to CMS. The documents were retrieved upon a search performed by Dr Louis Jacques. We received 258 pages of which 74 pages were redacted under claimed exemptions of FOIA (5 U.S.C. 552 (b)(2), (b)(5) and (b)(6)).

Although the pdf’s are not in 100% chronological order it is probably easiest to comprehend each of the 5 individual pdfs, from back to front.

1-cms-foia-0221.pdf

2-cms-foia-02211.pdf

3-cms-foia-02-21.pdf

4-cms-foia–02-21.pdf

5-cms-foia-0221.pdf

Popularity: 16%

Matthew Herper, a writer for Forbes magazine and Forbes.com, has a biased, one-directional view of Dendreon’s Provenge, the first and only FDA-approved immunotherapeutic treatment for men with late stage prostate cancer. He continues to trip over his own feet in his attempts to lower the boom on Dendreon and Provenge. Over the past several years he even has attacked Care To Live, a prostate cancer patient advocacy group.

Mr. Herper could care less about the 30,000 men dying each year from an excruciatingly painful disease. He could care less about hurting a company financially that is attempting to cure not just prostate cancer, but many other forms of cancers as well. And he could care less about uncovering the malfeasance at the FDA Continue Reading Race To Undo The Cure »

Popularity: 13%

Yesterday, the Dendreon Corporation announced some data presentations that were to take place at the 2011 Genitourinary Cancers Symposium annual meeting in Orlando, Florida. In one of the presentations, there were data that showed subsequent treatment with APC8015F (frozen Provenge called Frovenge) may have prolonged survival of the control arm in Phase 3 Sipuleucel-T Studies.

Dendreon’s press release can be read here:

http://finance.yahoo.com/news/Dendreon-Announces-prnews-2424909414.html?x=0&.v=1

When Dendreon performed their trials, all the men gave blood samples and had that blood treated with Provenge. In the placebo control group they did not get infused with that treated blood, rather it was frozen to preserve it. It was called Frovenge, a less potent form of Provenge.

For humane reasons, upon progression of deteriorating patients in the placebo arm, Frovenge was administered, now competing against itself, as mandated by the FDA for the placebo group in the Provenge trial.

Now we are seeing results which show that Frovenge worked. It extended survival. We really do not know how good this treatment is, but so far it is performing beyond our expectations. Thinking how this groundbreaking medical science is planned for other cancers is truly exciting.

Here is another article commenting on this new data:

http://seekingalpha.com/article/253708-good-news-for-dendreon-s-provenge?source=yahoo

Popularity: 10%

Dr. Scott Gottlieb and Henry Miller (see blog below) recently criticized the FDA for its go slow, risk adverse nature, which is stifling innovation and costing patients quality of life time with family.

Here is the link to Steve Forbes recent article called: How the FDA May Kill Millions of Us.

http://www.forbes.com/forbes/2011/0214/opinions-steve-forbes-fact-comment-fda-may-kill-millions.html

Mr. Forbes states, “A more fruitful approach would be to overhaul the FDA and remove its capricious hurdles.”

The FDA needs patient advocates on staff with real authority to help patients, who can work with patient advocacy groups to enable patients to gain access to innovative treatments sooner. The FDA needs to balance the wealth of statistically rigid bureaucrats who are unable to understand how to weigh benefit - risk in a meaningful manner.

The FDA needs to accelerate approvals and streamline the process. An ongoing example of FDA incompetence is the still non-approval of Dendreon’s NJ Provenge plant, whose request they have had for 3 months now…….while men still cannot obtain the treatment due to supply shortages.

Prostate cancer patients are tired of dying while waiting for the FDA to do its job.

Popularity: 12%