On Thursday, June 20, six members of the ABTA staff delivered oral statements to Medicare in regard to the issue outlined below. We invite you to review the information and if in agreement, download the below template with your information and email the letter to TTFTLCDComments@cgsadmin.com by June 24.
The treatment landscape for Glioblastoma (GBM), the most aggressive and cancerous form of all primary tumor types, has only seen one new treatment emerge in the past decade. The treatment is called tumor treatment fields (TTF) therapy. It’s an innovative treatment approach that has proven to extend progression free survival and overall survival, giving patients diagnosed with GBM an opportunity to live longer. Based on clinical trial data, the FDA approved TTF therapy for newly diagnosed and recurring GBM.
The issue at hand
While nearly all private insurers reimburse this treatment, Medicare has yet to determine its coverage. Medicare recently proposed strict coverage criteria that we believe would limit a patient’s access to this life-extending treatment. View the proposed local coverage determination here.
Of the coverage criteria Medicare proposed, two criteria will contribute to an unnecessary burden upon the patient’s ability to receive access and reimbursement.
- Medicare proposes reimbursement only if the patient receives treatment from a National Cancer Institute-designated cancer center. This criteria has no merit, as delineation of acceptable providers is not mentioned within the FDA label for TTF therapy. Furthermore, an elderly or disabled patient with GBM should not be expected to travel long distances to access an NCI-designated cancer center, as many states do not have an NCI-cancer center. There is no data supporting this proposed criteria and we urge Medicare to remove it from its proposed criteria.
- Medicare proposes an extended duration of use of 18 hours versus 12 hours which has shown to produce the same impact on overall survival. We believe the patient’s healthcare provider should decide duration of use based on the patient’s health, not Medicare.
Please, take a moment to review the response letter to Medicare and if comfortable, update the template with your information and submit it to Medicare for consideration. Medicare is accepting letters of support through June 24.
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Wilfred Mamuya, M.D., PhD.
Noridian, LLC
PO Box 6742
Fargo, ND 58108-6742
Dear Dr. Mamuya:
This letter is in response to the request for comments for the proposed local coverage determination (LCD) of tumor treatment field (TTF) therapy. As [insert your personal relationship to GBM or the community], I commend the decision to cover TTF therapy, but believe the LCD limitations gravely restrict access to many who are already coping with a devastating diagnosis.
The FDA approval of TTF therapy was based on extensive clinical data and rigorous FDA premarket review that clearly demonstrated progression free survival and overall survival. Based on this evidence, TTF therapy is now reimbursed by nearly every private payor in the U.S., giving GBM patients the potential to live longer. This begs the question as to why Medicare has created more aggressive and strict restrictions than those provided in the FDA guidelines.
Barrier #1: “The beneficiary is receiving care for GBM at a National Cancer Institute-designated Cancer Center, National Cancer Institute-designated Comprehensive Cancer Center, or National Cancer Institute-designated Cancer Research Network facility.”
The Vision of Medicare is that “all CMS beneficiaries have achieved their highest level of health, and disparities in health care quality and access have been eliminated.” Considering 80 percent of cancer patients are cared for within the community setting and half of all Medicare beneficiaries live on annual per capita income of less than $26,200, the proposed LCD for TTF therapy will undoubtedly create “disparities in health care quality and access.”
NCI-designated facilities are not present in every state and tend to be located in larger metropolitan cities. By restricting access of life-extending TTF therapy to GBM patients by basis of locality, Medicare sends the message that only those who are able to financially afford to travel, are allowed to take time off from their place of employment AND are physically capable of traveling to these facilities are worthy of life-extending FDA-approved treatment.
[Insert any personal experiences that relate to this LCD. Examples: Would you or a loved one have been able to easily access a NCI-designated facility? If not, what was your story? Would this potentially mandated change in providers have disrupted your care continuity?]
Barrier #2: “The beneficiary will use TTFT for at least 18 hours/day.”
Although 18 hours a day is recommended for maximal efficacy, there is published evidence to indicate wearing TTF therapy for 12 hours or more provides a survival benefit to the patient. The FDA indication for TTF treatment does not require specific duration of use. Given the potential side effects with TTF treatment, albeit minimal, physicians may choose to decrease duration to allow for skin irritation to decrease or heal. If this happens, the proposed LCD will result in the Medicare beneficiary losing reimbursement coverage.
[Insert any personal experiences that relate to this LCD. Examples: Did you or a loved one wear TTF? Is 18 hours/day realistic? What side effects were experienced? What would the daily regimen look like and would this interrupt your daily life, proposing a significant barrier?]
Ultimately, the decision about whether or not a patient is eligible for tumor treatment fields should be one between the patient and the treating provider. Medicare is choosing to place additional unnecessary burdens and obstacles in the way of patient care during an already burdensome situation rather than empowering patients and providers to make appropriate treatment decisions together.
We need to decrease barriers for access to these treatments so that every option can be considered. Tumor treatment fields is the only therapy proven to extend the lives of those with the already dismal GBM prognosis. Any person diagnosed with GBM deserves the opportunity to live longer. You can help make this happen. I appreciate your consideration and look forward to your final decision.
Sincerely,
[Insert Full Name]
[Sign Here]
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