Tumor treating fields therapy to treat glioblastoma multiforme (GBM) is 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 under the following conditions:
Individuals ≥18 years of age,
Supratentorial tumor,
Karnofsky Performance Status score ≥70%,
Individual understands device use, including the requirement for a shaved head, and is willing to comply with use criteria according to the U.S. Food and Drug Administration label (see Policy Guidelines).
Tumor treating fields therapy is considered investigational in all other conditions, including but not limited to the following situations:
As an adjunct to standard medical therapy (eg, bevacizumab, chemotherapy) for individuals with progressive or recurrent GBM,
As an alternative to standard medical therapy for individuals with progressive or recurrent GBM,
For brain metastases,
For cancer in areas other than the brain,
As an adjunct to standard medical therapy (pemetrexed and platinum-based chemotherapy) for individuals with malignant pleural mesothelioma.
