PROVENGE WILL BE COVERED BY MEDICARE
July 8th, 2010 | Posted by CTLFriends, 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.
Popularity: 93%
Tags: CMS, Dendreon, FDA, Medicare, Prostate Cancer, provenge
July 8th, 2010 at 8:14 am
Thank you for this post, and thank you for all the work you have done to get Provenge to the market place. I personally am very grateful to you. I think you are almost certainly right about why CMS is going through the NCD review, and I don’t think there is ultimately much to worry about. But for some added comfort, can you share whether your post is based on any communication with a CMS official, or is it just general optimism based on CMS’s history with other treatements? Thank you again.
July 8th, 2010 at 9:01 am
I feel your alert today was a little disingenuous. Ammass later says that this is according to the law that Provenge will be paid for by medicare. The alert reads like this is information from Dendreon or CMS. It still may be true that this alert was generated by something learned from Dendreon or CMS. I don’t think you want to go down the road again of Kerry guarenteeing that Provenge would be approved by last Christmas. Appreciate your efforts.
July 8th, 2010 at 10:41 am
Did you all see the Pharmawire/FT article today. A lot of anonymous sources quoted. If the allegations of hospitals cutting back are true though, I think you all need to raise this in a comment to CMS, to other media outlets, and to Congress that an IMMEDIATE national coverage approval needs to be implemented so that patients do not suffer needlessly because of CMS’s decision.
July 8th, 2010 at 8:24 pm
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July 14th, 2010 at 8:14 am
An Editorial – What Has Caused the Recent Review of Provenge by the CMS
From the Advanced Prostate Cancer blog at: http://advancedprostatecancer.net/?p=1765
There has been a lot of questions raised about why the Centers for Medicaid and Medicare Services (CMS) has out of the clear blue, launched a review of Provenge, a review that could ultimately make Provenge unavailable to men on Medicare and Medicaid (see the post:Medicare Funding for Provenge, We Urgently Need Your HELP). There has been speculation on why we are having the review, now an article in the Investors Business Daily may have shed some light on the subject.
They raise the question, has President Obama wandered into the area of health care rationing which has been previously unheard of in the United States?
The president made a recess appointment (with Congress being on recess for the July 4th holiday) of Dr. Donald Berwick, a fan of rationing and Britain’s National Health Service, to direct the CMS. By making this appointment during a congressional recess, is the president intentionally keeping hidden from the American public, Dr. Berwick’s views and its potential impact on our health care delivery system?
Dr. Berwick wrote in an earlier National Institutes of Health publication that “The decision is not whether or not we will ration care; the decision is whether we will ration with our eyes open.” Without a formal nomination hearing, none of which has been scheduled, we will not be able to explore Dr. Berwick’s positions.
The CMS, an agency that oversees a third of all health care spending in the U.S., clearly has a major impact on our health delivery. Now, one must raise the question, is this recess appointment an attempt to circumvent the American public as Senate Minority Leader Mitch McConnell has stated?
Under the rules, Dr. Berwick could serve through 2011 without Senate confirmation. In this position, Dr. Berwick will control one third of the country’s health care costs, a significant portion of the entire American economy, all without giving us the opportunity to explore his views.
Dr. Berwick has praised the U.K’s National Institute for Health and Clinical Excellence (NICE), which he says has “developed very good and very disciplined scientifically grounded, policy-connected models for the evaluation of medical treatments from which we ought to learn.”
Last year, NICE unveiled plans to cut annual steroid injections for severe back pain to 3,000 from 60,000. “The consequences of the NICE decision will be devastating for thousands of patients,” Jonathan Richardson of Bradford Hospital’s Trust told London’s Daily Telegraph. “It will mean,” said Dr. Richardson, “more people on opiates, which are addictive and kill 2,000 a year. It will mean more people having spinal surgery, which is incredibly risky and has a 50% failure rate.”
It has been pointed out that breast cancer in America has a 25% mortality rate while in Britain it’s almost double at 46%. Prostate cancer is fatal to 19% of American men who get it; in Britain it kills 57% of those it strikes. These are striking numbers.
The comment from the Investors Business Daily “and here we thought the first rule of medicine was to do no harm,” is particularly poignant.
Dr. Berwick’s comment, “We can make a sensible social decision and say, ‘Well, at this point, to have access to a particular additional benefit (new drug or medical intervention) is so expensive that our taxpayers have better use for those funds,” is a directive for rationing, maybe even a denial of care. In the case in point, could we modify his state to read….Well, at this point, to have access to Provenge is so expensive that our taxpayers have better use for those funds?
Perhaps Dr. Berwick’s beliefs are consistent with what the American public wants, but shouldn’t major issues like these be in the fore front of a national debate? Whether or not Dr. Berwick’s opinions are correct is an issue that deserves a national conversation, but to move in this direction without an honest airing is anti-democratic and totally unacceptable.
Joel T Nowak, MA, MSW
Director of Advocacy & Advanced Prostate Cancer Programs
Malecare – Men Fighting Cancer Together
Survivor – Advanced Prostate Cancer, Melanoma, Thyroid & Renal Cancers
August 13th, 2010 at 1:53 pm
These are the sorts of stories we are seeing - I still think a petition or something would be advised. Waiting a year for CMS to decide is unethical.
I just got a call from my oncologist at the Moffett Center in Tampa where I had been approved for treatment with provenge.
“Medicare will not approve payment for Provenge treatment for at least six months to a year. As a result we will no longer be a provider for this treatment.” Folks, this is a disappointment to me as a patient but it is something you investors should consider too.