Hello All
I wanted to solicit the group on ideas to fight the silly rules of my insurance and convince drug providers to support my doctors request.
Quick background:
This June will be my 4 year anniversary of GBM resection and Standard of care treatments.
Since then, I have had a couple of re-occurrences battled with additional resections and DNX2401 trial, including Keytruda infusions.
My last resection was in October of 2018 and since then I have been getting CCNU every 6 weeks, Keytruda every 3 weeks and completed 10 rounds of additional radiation. Basically stable MRI's since the radiation.
after the last resection, my NO prescribed tragresso and Optune. Both have been denied thru 3 rounds of appeals. Also since I am still working I do not qualify for any financial assistance from Optune or lilly.
So any good recommendations to battle the bureaucracy? My company does provide a Health advocate but they are only good for contacting the insurance company for status on appeals. They do not provide any assistance with fighting for approval.
My NO and his team have been very helpful with submitting all the appeals and necessary supporting documentation but with out success. I am stuck in this grey area where I have completed the SOC and the only available treatments available are off label non FDA approved for GBM protocols that the insurance company will not pay for.
So thanks in advance for any recommendations.
Marc
This is not my area of expertise (maybe others reading this blog will chime in). You could also try reaching out to Al Musella of the Musella Foundation/ virtual trials.com as he has a lot of experience with this sort of thing.
ReplyDeleteI've not heard of anyone being refused access to Optune in the USA for financial reasons, and Novocure has been exemplary in providing access to those whose insurance won't cover it. Given the expense of Optune, even those working normal jobs could not afford it without financial assistance. Have you been corresponding with Novocure directly?
I'm surprised your insurance is rejecting Optune. Optune was approved by United Healthcare for coverage back in January of 2017. You can try to get on a Clinical Trial that is still recruiting with Optune, normally the sponsor covers the treatment. There's a Phase II trial in Miami with Optune, Nivolumab Plus/Minus Ipilimumab for Bevacizumab. You may be excluded due to your past treatments, if so you may want to try the FDA Expanded Access program to join such a trial. Sponsors do not always cover treatment costs via Expanded Access/ Right To Try use.
ReplyDelete- https://www.novocure.com/united-healthcare-issues-positive-coverage-decision-for-optune/
- https://clinicaltrials.gov/ct2/show/NCT03430791?term=recurrent&recrs=ac&type=Intr&cond=Glioblastoma+Multiforme&titles=Optune&rank=2
If you are unsuccessful with joining a Clinical Trial, a reasonable response at this point is to report a consumer complaint against your health insurer with your local news station/ paper and spread the word via social media. The public is unhappy with our health insurer situation and many journalists would love to run with such a story. Identifying the insurer's doctors and their credentials who rejected the appeals against your Neuro-Oncologists is important to note, especially if you have been seeking treatment via a tertiary cancer facility.
As to the off label use of Tagrisso, it is uncommon for insurers to pay for expensive treatments that lack published empirical value. Even with a coupon via GoodRx, Tagrisso is $15k for 30 tablets of 80mg. There is good evidence associated with Optune.
Kind regards... Guy
Optune is FDA approved for GBM and considered SOC (not off label). When you speak with insurance representatives always ask their name (politely, of course). If you do not make progress, ask for the name and number of person who you can appeal decision to. Novocure reps should assist you with gaining insurance approval. They have staff dedicated to these negotiations. Novocure does have a generous policy even for patients earning a decent living so worth exploring that if you hit a dead end with your insurance. Good luck!
ReplyDeleteThanks for your insight I have been working with novocure and they have been extremely helpful in the appeal process and have basically provided all the required appeal information for the multiple level appeals to my NO for submission to the insurance company. but sadly FDA approval for optune was based on 1st occurrence clinal trials and not re-ocurrence. This is from both Novocure and my insurance. Also, the Financial assistance initially offered by Novocure based on my income was a $500 per month co-payment but that only applied if my insurance covered the rest.
ReplyDeleteNovocure is only FDA approved for 1st occurrence.
My NO believes something has changed with the Insurance companies because before he was able to get off label approval fro treatments but not any more. They are becoming stricter in their approvals. It should be noted that my company does provide one of the best health care plans available and until this year I did not have any issue with approvals on treatments recommended by my NO. Same insurance plan even approved Novocure before FDA approval for my 1st occurrence 4 years ago at that time I chose not to wear the device because the initial data was not enough to modify lifestyle like it is now.
Marc