How are funding decisions made for Medicare and Medicaid? What drugs are to be funded? These questions have recently come to our attention as many of us have attempted to have Medicare fund our use of Provenge.
The administration of Medicare is actually broken into 15 different regions, or MACs (Medicare Administrative Contractors). Each MAC is responsible for deciding what treatments and drugs are to be reimbursed by Medicare. Initially, decisions are made at the MAC level, so it is possible that some MACs will approve a treatment or drug while others will not.
In some instants, the Federal organization, the Center for Medicare & Medicaid Services (CMS) , will step in and create a national policy for all the MACs. In the instances of funding for Provenge, CMS has just announced that it will be reviewing Provenge and eventually make a national policy decision on reimbursement. This process can easily take up to one year! In the mean time, CMS has instructed the MACs to continue to make individual regional decisions. So, until CMS provides a national guideline, some MACs will pay for Provenge, some may not pay and others will continue to make you jump through hoops to get it covered!
CMS has established a thirty day (30) (the month of July) public comment period for us the public to add our own “testimony”. I believe that a large public demand will help push an approval for all men who are on Medicare and who need Provenge to extend their life. Do not under estimate the power of numbers; take a lesson from the breast cancer community. We can be as strong as the breast cancer community and rally around the national approval of Provenge for men on Medicare and Medicaid.
Comments can be left at: http://www.cms.gov/mcd/m_nca.asp?id=247:
I have included my comments which you are free to copy. Better, modify mine or write your own. It will take only a few minutes of your time, but you could help extend someone’s life.
Sipuleucel-T (Provenge) should, without question, be approved by CMS nationally for all men with advanced prostate cancer. Very quickly, after it received approval from the Food and Drug Administration (FDA), the National Comprehensive Cancer Network updated its prostate cancer management guidelines to recommend, as a category 1 recommendation, the clinical use for Sipuleucel-T for men with minimally symptomatic disease, an ECOG performance score of 0 or 1, and a life expectancy of at least 6 months. A category 1 recommendation means that, “The
recommendation is based on high level evidence (use of randomized controlled trials).
Multiple blind clinical trials demonstrated a very clear survival advantage for men in the treatment arms. The survival advantage was best (six months) with men who were in the age range of being Medicare eligible.
National coverage for Sipuleucel-T should be granted immediately. According to the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute (NCI), 32,050 men will die in 2010 from advanced prostate cancer. Continuing to delay CMS’S approval would be unethical. We cannot afford to continue to tolerate an unnecessary delay while 32,050 men face their death. These men are our veterans, our fathers, our husbands, our partners and our brothers. How can we abandon them now?
Malecare (www.malecare.org) urges CMS to approve Sipuleucel-T on a national level.
Joel T Nowak, MA, MSW
Director of Advocacy & Advanced Prostate Cancer Programs
way to go again joel, while these experts all look at the median survival of say 6 months or less and wonder if making this treatment available is worth the cost they forget that for some men provenge has provided what appears to be a total cure. This treatment should not just be limited to men who are close to death but should be available for oncologists to introduce even before the normal hormone protocol if that is what a patient wants when a low disease burden may be present or even use it simultaneously with hormone therapy if a patient desires that. As those of us who have to live with this horrible disease know, we would never wish this on anyone, however, maybe if some of these decision makers were living it they would have a whole new perspective. Ron Gerhard
Thanks. I think it makes sense to get a petition going to urge Congress and the administration to force CMS to grant an IMMEDIATE national coverage determination for this breakthrough treatment. Delaying the final decision another year is unethical and will result in shortening the lives of prostate cancer sufferers needlessly for an FDA approved treatment.
In regards to Ron Gerhard’s comment that in some cases Provenge has given what appears to be a total cure, I was just wondering if there is information out there detailing some of these success stories.
Personally, I don’t think that any treatment “cures” prostate cancer. I do believe that Provenge has put some men into a long term remission, that would probably be a more accurate description. – Joel
Thanks for your reply Joel. Speaking of Provenge: Do you have any ideas as to how being on Nilandron (Nilutamide) would affect receiving Provenge, impede or compliment? If not, who might know? My dad is qualified for Provenge, He was on Nilutamide until the end of May, and in anticipation of going on Provenge, went off of it for a time. Now his PSA has more than doubled (.29-.78 in just 20 days) and we are wondering if he should go back on it, but we don’t want to mute the effects of Provenge in any way (also want to use the combination of treatments in the most effective way). Any thoughts? Thanks, Ann
There has not been any research that can answer this question. Many, if not most, of the men who participated in the trials that led to the approval of Provenge were on some type of hormone therapy, but it still worked. I have not heard of any negative effects of Nilutamide on the ability of Provenge to work. Personally, if I had a doubling time of 20 days I would immediately go back on the Nilutamide. His goal is to keep the cancer at bay as much as possible while he waits to start Provenge. This is important because you do not want the disease to progress and become symptomatic (which would disqualify him from getting Porvenge).
Thank you for that response. I really appreciate it. One more question: one of the reasons we were a little tentative to start back on Nilutamide is that I read a study from 2008 about a trial with Nilutamide and a vaccine (not Provenge). It seemed to indicate that the men who received the vaccine first, and then crossed over to Nilutamide later had much better results than those who started with Nilutamide first and went to the vaccine later. I realize it was a commpletely different vaccine with men at a different stage, but I was wondering if it still had implications for us. Here is the link: http://www.ecancermedicalscience.com/news-insider-news.asp?itemId=235 Do you think this should have any bearing on when we should start back on Nilutamide?
My dad is scheduled to begin the Provenge procedure in just a couple of weeks (Fri July 30th). The progression of his PSA has been: May 28th PSA of .36–went off Nilutamide at this time; June 9th PSA down a little to .29; June 29th PSA up to .76.
Thanks again for your input,
My reading of that link supports the addition of hormone therapy to enhance vaccine therapy.
“Among patients with castration-resistant prostate cancer, the addition of hormone therapy following vaccine treatment improved overall survival, compared with either treatment alone, or when the vaccine followed hormone treatment. The research will be published in Clinical Cancer Research
Philip M. Arlen, M.D., from the National Cancer Institute, said the findings have important implications for guiding treatment decisions for prostate cancer patients. “Vaccines, if and when they are approved, can be safely and effectively combined with other therapies, including hormones,” said Arlen. “There appears to be an advantage in overall survival.”
As you pointed out, this is about a different vaccine, so you can not assume the results would be the same.
If I were your dad I would be in my doctors office today and start hormone therapy.
i have stage 4 i am on vantas it has brough my psa from 37 to .oo3 in 7 mounths can i use provenge with what i am taking now?an will the side effects lead to a long and less pain than i have gone thourgh to present and what do i have to take for a follow up to stay in good health after provenge
Sonny, Yes, Vantas can be used along side of Provenge, however as long as you respond positively to the Vantas you are hormone sensitive. To qualify for Provenge you must be castrate resistant (hormone insensitive). If you continue to have Vantas and your PSA starts to climb have a blood test to make sure that your testosterone levels are castrate. If they are then provenge becomes available to you (as long as you also have a bone met). – Joel