The Medicare CAC meeting on the question of paying for Optune, on last Wednesday, was much better than I thought it would be. I actually have good feelings about it.  I was  pleasantly surprised by the comments of the panelists. I completely misjudged them.  

 

The data on the safety and outcomes of using Optune for newly diagnosed GBM patients was overwhelming and easily enough to justify Medicare paying for it. However two 2 negative issues came up:

 

 

1. The trial design: One panelist criticized the trial for not using a sham device in the control arm, and requested another phase 3 trial be done using a sham device.  One of the other panelists explained how stupid that idea would be:   imagine asking a patient to participate in a clinical trial where there is a large known benefit with an FDA approved treatment, which has the highest rating in the NCCN guidelines - and ask if they are willing to be randomized into a sham treatment group. It is not ethical.  Furthermore, there was never any benefit seen with placebos in any other brain tumor trial – so there is no reason to think that attaching the arrays to the head without turning on the device would result in people living longer.  I think that issue was put to rest.

 

2. Acceptance by the medical community.  This could have been an issue 2 years ago but I think for now it is ok.  Over 700 medical centers in the USA prescribe it.  Somewhere around 95% of the comprehensive cancer centers use Optune, and the majority of community doctors use it. The one area where it is not universally accepted is in the brain tumor centers that prefer clinical trials over standard of care, and this will change as more clinical trials embrace Optune.

 

Bottom line:   Medicare will publish a proposed ruling. This can, by law,  take up to 365 days but I think it will be much sooner. Once it is published, we have about 45 days to comment on it.  No matter what the proposed ruling says, we have to make sure the brain tumor community has a huge response so Medicare knows we are watching.  Then Medicare will have another meeting – this time it is open to the public to speak and voice their concerns. Following that, Medicare will publish the final ruling.