Al's Comment:

The NCCN guidelines define the standard of care in the USA. Insurance companies- including Medicare - use the guidelines to deny claims for treatments that are not given a good rating by the guidelines. We have that problem with Optune (which used to be called the Novocure Novo-TTF100a system and the NCCN refers to as 'alternating electric field therapy').  The NCCN guidelines for GBM originally gave this treatment a fairly good rating - at least as good as many other treatments in use. This was reasonable, as the large trial for recurrent GBM  directly compared tumor treating fields to all of these other treatments and did at least as well or better. Then at the last update, the NCCN unexpectedly  lowered the rating to the worst category - even though all of the research articles that came out from the time they first listed it until this update were all very positive - not one negative report.  Just at that time, I met with Medicare to discuss coverage of this treatment, and they pointed out that the NCCN lowered the rating and used that as an excuse not to approve payment.

 

  Since that time, the groundbreaking results of the large phase 3 trial for newly diagnosed GBM patients came out with a 50% increase in the 2 year survival rate compared to standard therapy.  The FDA halted the trial because it actually was working and at that point said it was unethical to withhold the treatment from the control group.   This was the largest increase in survival since we started using radiation a LONG time ago. Much better than any of the other treatments the NCCN have given a higher rating than Optune.

 

I wrote a letter to the NCCN requesting they reconsider the rating for Optune, giving them this new data. They had a meeting to consider it and we are waiting for the results. IF they did not raise Optune to the highest rating, I think it is time for us to fight it as this group of lung cancer patient in the attached article did:  a massive letter writing campaign to the NCCN, as well as to each of the doctors who make up the committee.

 

 

BTW: While this fight is going on, the company that makes Optune has been excellent about giving easy access to this treatment to patients.  I do not know if that will continue if we lose this battle.  

 


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