Tips - We want to fight all of the restrictions, but we do not want all of the emails to be the same. Write from the heart but be polite. Explain how important it is to you that Medicare covers this treatment without the proposed restrictions and share your own experiences. Pick 1 or 2 of the restrictions to write about. We have selected a couple to feature below:
Subject: Comment on Proposed LCD TTFT (DL34823)
I am writing as an advocate for the brain tumor community. Insert personal experience with a brain tumor.
I applaud your decision to cover Optune for newly diagnosed Glioblastoma patients. However, I would question the decision to limit coverage with such severe restrictions. Glioblastoma is a horrendous diagnosis and these patients need fast, easy access to the best approved treatments. Optune is FDA approved and has a level 1 recommendation from the NCCN guidelines as one of the standards of care.
I object to all of the restrictions, but most imporantly, I have sincere issues with the following (choose a few that matter to you):
1. "Must receive care at a NCI designated cancer facility." I know that many patients are treated at locations that are not NCI designated centers because of lack of access, but that designation does not mean that the need for Optune treatment doesn't exist. You may say that patients could still travel to other clinics that have this designation, but travel is not always an option for patients or practical. Some of the patients have neurological problems and a propensity for blood clots that interfere with easy travel – some cannot fly, or sit in a car for long periods of time. Some patients may not be able to work so finances become an issue, and this restriction will force these patients to pay for frequent travel to far away places. Adding this large expense to the other expenses these patients already have is not fair. If the restriction must stay in place, I would request that Medicare allow payments for travel and hotels to allow these patients to get to these centers.
There are also a few states that do not even have a NCI designated cancer center. What are these patients expected to do?
If doctors do not practice at an NCI designated cancer centers, this restriction would prevent them from being able to prescribe what is currently the standard treatment for Glioblastoma. These doctors would have to refer the patients to major centers, and that may put many of these doctors and many of the smaller centers out of business.
Please remove this restriction.
2. “Must start within 7 weeks of end of chemo-radiation”. Not everyone has chemo-radiation. And for those that do have it, some patients develop complications such as burns on the skin of the head or nonhealing head wounds which need to heal before Optune can be used. Some patients might not learn about Optune in time. It is a very chaotic time in these patients' lives and putting an artificial time limit on making such a life changing decision adds stress to what is already the most stressful time in the families’ lives. Either eliminate the restriction, or make it relative to the time of diagnosis.
3. And finally, the requirement for “benefitting from use between days 60-90” may be too early to see the benefits. It has been shown that Optune is slow and steady and that most of the long term responders had an apparent recurrence (pseudoprogression) early on but continued therapy to shrink the tumors. In the EF-14 trial, Optune was used through the first recurrence and stopped at the second recurrence. Since the LCD is pretty much based on this trial, you should follow the trial's guidelines in this respect. Please change the requirement to “benefitting from use by 3-6 months of use”.
Thank you for your time and consideration!