I was recently admitted to the PC Club with a PSA that had spiked from 1 to 7 over six months (then retreated to 4.5 at my biopsy). Gleason is 3+3.
I went over the options with my urologist, including Cyberknife. After a lot of study and discussion and reading these boards (thanks to RMJ3 and ViperFred) I decided to proceed with Cyberknife.
Then my insurance got hold of things.
They've denied coverage three times, including peer-to-peer appeal because "Documentation does not support that cyberknife sterotactic radiosurgery has been shown to be superior to standard treatment for prostate cancer."
The issue may be further complicated that the only hospital in my area that does cyberknife - University Hospital - Cleveland - is not part of my insurance network. That said, I would probably be willing to pay the difference in out of pocket (30% instead of 20%) if the procedure was approved.
Does anyone have experience in working through denial for treatment appeals?
CyberKnife delivery of SBRT is still clearly investigational, though we now have the King team's recent very encouraging report with five year median follow-up. However, being investigational is no reason for it not to be covered, thought it is a consideration on the scale for coverage decision making.
The best organization I know of for help with coverage is PAACTUSA, a non-profit organization. Here is a brief statment about their legal arm. CSAP refers to cryosurgery, an approach where the organization was instrumental in the drive for coverage prior to cryo's being determined to be a standard therapy.
"PAACT’s Legal Action Committee (LAC-PAACT) prepared legal documents (LAC-PAACT KIT) including bibliographies, copies of published studies showing the effectiveness and safety of CSAP and favorable court decisions that claimants denied payment for cryosurgery found helpful in obtaining reimbursement from Medicare and insurance companies. To date nearly every PAACT member originally denied payment has won favorable decisions using the LAC-PAACT KIT in presenting their case for reimbursement. In July 1999 the Health Care Financing Administration (HCFA) finally reversed the national non-coverage policy and approved medical coverage for CSAP as a primary treatment for clinically localized PC."
I have not used their services, but I believe the organization depends on donations and does not charge. The organization has an excellent reputation among survivors.
Please keep us informed.
The Following User Says Thank You to IADT3since2000 For This Useful Post: jeffq (02-25-2011)
Starting in late 2007 I was denied 6 times by my insuracnce company. I won an apperal through the dept of managed health care in CA which forced BS of CA to pay for the CyberKnife. Treatment was completed May 5, 2008. Two months after the insurer was exposed on CBS/SF for denial, CK was added to their policy two months later.
Appeal the denial, the denial has no basis, at a MEDCAC meeting in Baltimore MD April 21, 2010 for radiotherapy of prostate cancer the outcome was that no therapy was proven better than the other.
Insurance denial of the CyberKnife is completey without justification. There are two new papers with median of 5 year data.
The Following User Says Thank You to viperfred For This Useful Post: jeffq (02-25-2011)
I suppose you are now engaged in the appeal process, but I'm hoping you are still tracking your thread.
I just posted a new thread about SBRT with CK about new documentation of success with cancer control and side effects at four years (median) of follow-up plus an abstract indicating superior cost effectiveness of CK SBRT (not proof, in my mind, but useful evidence). To me these fresh documents should boost chances of having CK SBRT covered. While these conference posters are not as convincing as formal publications after peer review in major journals, they are still promising evidence. I anticipate they will soon be published.
The Following User Says Thank You to IADT3since2000 For This Useful Post: jeffq (02-25-2011)
Thanks for all your helpful responses. A brief follow-up:
While I was interested in pursuing Cyberknife as a treatment, I didn't want to put all other treatment options on hold while I went through a lengthy appeal process. So I got a second opinion from a urologist/radiation oncologist team at the Cleveland Clinic - which is covered within my insurance network.
They discussed the same treatments my team at UH had presented (minus CK) and felt that brachy would be a good fit. I must admit to going in with a bit of a chip on my shoulder, having been denied CK. That said, I quickly became comfortable with my team at the Clinic, because of their thoughtful and complete answers to my questions and the amount of time they devoted to my case. As a result I've decided to move forward with brachy - I'm scheduled for next month, so by April I'll glow in the dark.
Interestingly, the Clinic guys acknowledged that they had spearheaded CK in Cleveland a number of years ago, but had decided not to pursue it because they weren't convinced that the outcomes were significantly different than brachy.
Thanks again for your informative and helpful posts.
Cleveland Clinic has a great reputation, and I'm sure your results will be great too. Good luck! Which brachy did they recommend? There's low dose rate (LDR) brachy (permanent seeds) and high dose rate (HDR) brachy (temporary implants). CyberKnife was developed in an attempt to mimic the results of HDR brachy. As you can see in the following link, the results seem to give better control with fewer side effects than LDR, and better than CyberKnife:
The 8-year results were 99% local control, 97% biochemical control (nadir +2), 99% distant metastasis-free survival, 99% cause-specific survival, and 95% overall survival. Genitourinary toxicity consisted of 10% transient Grade 2 urinary frequency or urgency and 3% Grade 3 episode of urinary retention. Late term gastrointestinal toxicity was <1%
The Following User Says Thank You to Tall Allen For This Useful Post: IADT3since2000 (02-25-2011)
...CyberKnife was developed in an attempt to mimic the results of HDR brachy. As you can see in the following link, the results [of a study of patients treated only with HDR] ...:
These results look impressive, at least at first glance. However, when I read the abstract, and I was surprised that they included averaged results over the whole eight years when patients were treated (stretched between 1996 - 2005), rather than reporting median results. Do you know if they report median results in the paper? I'm thinking they do not, as they likely would have used those results rather than overall results in the abstract if they were in the paper.
What I'm concerned about here is that use of results from all men in the series includes results from men recently treated with very short follow-up, just, say, one to three years. Such follow-up - for those recently treated - is too short to help us understand what is going on, and I'm concerned that it dilutes the statistics that we usually expect, the median results (half shorter follow-up, half longer than the 5.2 years median follow-up reported). The effect of going with overall results would be to downplay any shortfalls in effectiveness and long-term side effects, at least a bit, unless the median results were very close to the overall results.
I'm also hoping (and expecting) that the complete paper clarifies the breakdown between low-risk and intermediate risk patients. While those numbers reported, assuming they hold up based on median results, are impressive for a group of low-risk patients, they would be even more impressive if a significant portion of the study group patients were intermediate risk patients.
If you get a chance to look at the complete paper, please let us know the answers to these questions. Thanks again for spotting this newly published study.
I think you may have misunderstood what they are reporting. They report medians for age, PSA and follow-up time. For the rest, they report eight year results, not average results. When a paper reports eight year results, they mean that those are the results among those men after a total of eight years of tracking. They report eight years because that is the longest interval for which they have a meaningful sample size. The abstract doesn't state the eight year sample size -- it will obviously be less than the 298 total sample. Concerning risk level... Since the 1990s, most people treated by RT or RP everywhere are low risk patients, and there is usually a much smaller percentage who are intermediate risk. At their total sample size, I don't know if there would be enough to draw a statistically reliable conclusion on that subset. The pubmed abstract shows that the full paper is available for purchase if that interests you.
I'm schedule to receive LDR treatment (I get to keep the seeds!) I'm just starting to look into HDR so I can follow-up with my docs on it.
I would like to join the chorus wishing you success with this sound choice. If you get some special insights into HDR vs. LDR from the Cleveland Clinic docs, please pass them on. (As you probably know by now, the Cleveland Clinic is very highly regarded in the world of prostate cancer treatment and research.)
Here's a most encouraging report from Seattle on twelve years of experience with LDR seeds:
The median follow-up is 7.0 years. However, like the study that Allen cited earlier for HDR, the researchers report on results for the whole twelve year period (April 1995 - July 2006, 1,656 consecutive patients) rather than giving us median figures. Nonetheless, those overall figures are impressive, especially for low-risk patients: successful non-recurrence per PSA of 98.6%!
There are a number of other longer-term studies with LDR seeds that also have impressive results in the upper 90s. However, there are also some studies that cluster around the 90% mark, all within the range of 85% to 95% non-recurrence success.
I don't know what accounts for the difference, but I suspect it is expertise in doing brachytherapy. The docs who are expert in doing LDR brachy therapy aren't leaving much room for improvement for other therapy options, but it's good to see that at least HDR and CK SBRT are looking competitive.
Our thoughts here may be of limited interest, but they do bear on the value of the studies of the therapies Jeff is considering, so here goes.
I'm still trying to sort this out, but I've re-looked at the abstract after reading your post and am still coming to the same conclusions. I'll explain in comments in green in response to your post #11.
[QUOTE=Tall Allen;4693439]Hi Jim,
I think you may have misunderstood what they are reporting. They report medians for age, PSA and follow-up time. For the rest, they report eight year results, not average results.
I don't think I'm misunderstanding, but I am surprised in looking at several seeds studies that they are using the same approach: quoting median follow-up, but giving results statistics for the overall group. (For instance, check out my comment to Jeff in a post a short while ago on the Seattle group that also used that approach.)
When a paper reports eight year results, they mean that those are the results among those men after a total of eight years of tracking. They report eight years because that is the longest interval for which they have a meaningful sample size. The abstract doesn't state the eight year sample size -- it will obviously be less than the 298 total sample.
It appears to me that they are including all 298 men and giving us a simple average (mean) based on all those men. I'm thinking this because I'm seeing just simple descriptive statistics in the report, not inferential statistics that depend on qualifying samples (often randomized, etc.). There are no "p values" or "confidence intervals" that would accompany such inferential statistics.
These details always pop out for me because I've had a rigorous background in statistics. Frankly, I'm not so impressed with the statistical background of doctors I talk to and even with the statistical backgrounds of many researchers. On the one hand, that is disappointing. On the other hand, I'm glad they are intently focusing on their medicine.
Here's an unlikely hypothetical example of how the results could be badly skewed. Suppose that half the men had a follow-up of more than 5.2 years and half had shorter follow-up, which would cause the median to be 5.2 years, as reported in the study. But now suppose that the UCLA doctors got wildly enthusiastic about some other therapy, such as HIFU, for a few years, and did very few seed implants until resuming in 2003, at which time they went full throttle and in just two years did seed therapy on close to half of the remaining patients in the 298 patient series, until the study period closed in 2005. That would mean that the mean (average) follow-up would be close to about 50% X 5.2 years plus 50% X 1.0 years, or around 3.1 years of mean follow-up. The results they report would not be impressive at a follow-up of just three years. As I noted, this scenario is not likely. It is likely that the patients were spread fairly evenly over the years, or perhaps with a modest increasing volume. But the scenario does show why there is substantial uncertainty in the meaning of the results as we see them in the abstract. Does that make sense? I think I've got it right.
Concerning risk level... Since the 1990s, most people treated by RT or RP everywhere are low risk patients, and there is usually a much smaller percentage who are intermediate risk. At their total sample size, I don't know if there would be enough to draw a statistically reliable conclusion on that subset. The pubmed abstract shows that the full paper is available for purchase if that interests you.
I too am thinking the number of intermediate patients is likely quite small. However, I'm curious on the off chance that the proportion of intermediate risk patients is not small in this study. All of the men had "localized prostate cancer, so that would rule out stage 3 or 4. That leaves three areas open for risk, using the standard risk criteria, that would cause a staging of intermediate: stage 2b, a PSA of >10.0, or GS 7 - 10. I see the sample size issue the way you do - probably would be too small to do any convincing analysis, but knowing the number of intermediate risk patients might give us a better rough feel for the robustness of the overall results.
I wish I had unlimited funds to buy all the papers that looked interesting, but I'll admit I'm cheap. I can get the paper for free by making a request of my local hospital library, but I may not get around to that - to much other stuff to keep up with.