TTF therapy to treat glioblastoma multiforme (GBM) may be considered medically necessary as an adjunct to standard maintenance therapy with temozolomide in individuals with newly diagnosed GBM following initial treatment with surgery, radiotherapy, and/or chemotherapy when ALL of the following criteria are met:
- Adult individuals 22 years or older; and
- Supratentorial tumor; and
- Karnofsky Performance Status(KPS) score greater than or equal to 60 and
- Individual understands device use, including the requirement for a shaved head and is willing to comply with use criteria according to the Food and Drug Administration, including wearing the device at least 18 hours daily.
TTF therapy may be considered medically necessary for continued use when ALL the following criteria are met:
- MRI scan or related imaging has been performed less than two (2) to four (4) months prior to request and documents no evidence of disease progression; and
- KPS score of greater than 60; and
- Documentation that the individual has been wearing the device at least 18 hours daily.
TTF therapy not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.