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.
