Medicare published the final rule this morning. This is the one that we have been battling for the last few months, trying to get them to remove the proposed restrictions. Medicare listened to every comment we sent. (Their point by point response is in the link on the article below), and removed the worst ones. We can live with it the way it is. Not perfect, but much better than the proposed rule. I call our campaign a win! The brain tumor community came together on this one. There were 301 comments submitted, 5 from advocacy groups (including the Musella Foundation), and 209 from patients or caregivers, 80 from doctors! Very impressive. Thanks!
They removed the big restriction on where you had to go for treatment.
As for surgery, we commented that some people can't get "maximal debulking surgery". So they did not remove that requirement, but did add the words "where feasible". which effectively removes that one!
They did keep the need to start within 7 weeks of the end of concomitant chemotherapy, but did change from "Temodar" to "chemotherapy", so those that are use a different chemotherapy are still covered.
They kept the restriction on using Optune for 18 hours a day but added an exclusion for those days that you have to limit or interrupt treatment,
They did not change the need to have no evidence of progression but in their comments they mentioned the RANO criteria considers pseudoprogression. Reading the RANO criteria closely, for the time period in which the decision needs to be made, it is hard to claim it is progression even if the MRI is
worse - so I do not think this will be much of a problem.
They did not remove the karnofsky score of 70., and the need for it to be a GBM.
They also added a way for people who were already on Optune and then switch to Medicare can continue if they are using the device and show it is helping.
And they opened the door to appeals if you do not meet any of the criteria!
Overall, much better than I thought we would get, and it was much faster than I thought! Thanks to Medicare for conducting the process in the right way.
ImmunoCellular Therapeutics Announces Asset Purchase Agreement with Private Biotechnology Company This is great news. ICT-107 is an off the shelf vaccine for GBM. The early clinical trials looked very good, but the final clinical trial "failed" and they stopped development of it. However, there were quite a few responses and long term survivors from that trial. There were probably some mistakes made in that trial design. Patients that had certain biomarkers did well enough (adding over a year to median time to progression compared to those without the biomarker) get FDA approval but patients without those biomarkers had no benefit. Hopefully this new company will run the correct trial and make this vaccine available. This is literally a shot in the arm (or leg) with the same side effects profile as the flu shot, and there are a few long term survivors out over 7 years who are not only alive, but in good shape, happy and still working.
Electricity helps control man’s brain tumor The doctor mentioned, Dr Peereboom, is one of the best neuro-oncologists in the world, and one of my favorites. However, I disagree with what he says in the article. He talks about the average benefit is living 5 months longer with Optune than without. That is true but I look at it in a different way. I would probably not choose something that only adds 5 months to the average survival (if there were any other choices). I look at it as your chances of being alive in 5 years goes from about 4% without Optune, to 29% if you use Optune with at least a 90% compliance rate. That is definitely worth choosing.
