Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Glioblastoma multiforme
Treatment: Tumor Treating Fields using Electrical Optune Plus Transducers (E0766)
The insurer denied the Tumor Treating Fields using Electrical Optune Plus Transducers (E0766).
The denial is overturned. 

The patient is a male with a diagnosis of GBM (glioblastoma multiforme) of the right parietal lobe s/p (status post) surgery, radiation therapy and chemotherapy.  Additional local therapy was recommended, and Optune TTF (tumor treating fields) was utilized and is now requested for approval.

Yes, the treatment with Tumor Treating Fields using Electrical Optune Plus Transducers (E0766) is medically necessary.

Optune Tumor Treatment Fields (TTF) therapy is a locally or regionally delivered treatment that uses electric fields within the human body that disrupt the rapid cell division exhibited by cancer cells.  TTF (Tumor Treatment Fields) therapy takes advantage of the special characteristics, geometrical shape, and rate of dividing cancer cells, all of which make them susceptible to the effects of alternating electric fields by altering the tumor cell polarity.  The frequency used for a particular treatment is specific to the cell type being treated.  TTF (Tumor Treatment Field) have been shown to disrupt mitotic spindle microtubule assembly and to lead to dielectrophoretic dislocation of intracellular macromolecules and organelles during cytokinesis. These processes lead to physical disruption of the cell membrane and to programmed cell death (apoptosis).  

Optune TTF (Tumor Treatment Fields) therapy has been shown to be a safe and effective therapy for GBM (glioblastoma multiforme).  It was FDA (Food and Drug Administration)-approved for recurrent GBM (glioblastoma multiforme) and approved for newly diagnosed GBM (glioblastoma multiforme).

A randomized phase III study evaluated TTF (Tumor Treatment Fields) versus best standard of care chemotherapy in patients with recurrent glioblastoma and prior chemoradiotherapy.  A total of 237 patients were randomized to either TTF (Tumor Treatment Fields) or chemotherapy.  Mean treatment duration was 4.4 months vs. 2.3 months, median OS (overall survival) was 6.6 vs. 6.0 months for TTF (tumor treatment fields) and BSC (best supportive care), respectively, the one-year survival rate 23.6% versus 20.8%. PFS6 (progression-free survival at six months) was 17.6% in both groups. Time to treatment failure favored the TTF (tumor treatment fields) group (P-value = 0.07). Objective responses were more common in the TTF (tumor treatment fields) arm (12%) versus the BSC (best supportive care) (6%).  The authors concluded that, "TTF [tumor treatment fields] as a single modality showed a higher response rate and longer time to treatment failure compared to best available chemotherapy. Overall survival also favored TTF [tumor treatment fields] but did not reach statistical significance. In view of the above, TTF [tumor treatment fields] should be considered a valid novel treatment modality."  Based on this study, the NCCN (National Comprehensive Cancer Network) Guidelines were updated to include tumor treatment fields treatment for recurrent GBM (glioblastoma multiforme).  

Another randomized study evaluated patients with newly diagnosed glioblastoma treated with tumor treatment fields used in combination with temozolomide maintenance treatment after chemoradiation therapy.  After completion of chemoradiotherapy, patients with glioblastoma were randomized (2:1) to receive maintenance treatment with either tumor treatment fields plus temozolomide (N-value=466) or temozolomide alone (N-value=229).  The interim analysis included 210 patients randomized to tumor treatment fields plus temozolomide and 105 randomized to temozolomide alone and was conducted at a median follow-up of 38 months.  Median progression-free survival in the intent-to-treat population was 7.1 months (95% CI [confidence interval], 5.9-8.2 months) in the tumor treatment fields plus temozolomide group and 4.0 months in the temozolomide alone group (P-value=.001). Median overall survival in the per-protocol population was 20.5 months in the tumor treatment fields plus temozolomide group (N-value=196) and 15.6 months in the temozolomide alone group.  Based on this study, Novo TTF (tumor treatment fields) was approved by the FDA (Food and Drug Administration) for newly diagnosed glioblastoma.  The NCCN (National Comprehensive Cancer Network) recently also changed their recommendation to include Novo TTF (tumor treatment fields) for newly diagnosed GBM (glioblastoma multiforme).
In this case, the patient is a male with a diagnosis of GBM (glioblastoma multiforme) of the right parietal lobe s/p (status post) surgery, radiation therapy and chemotherapy.  Additional local therapy was recommended, and Optune TTF (tumor treatment fields) was utilized and is now requested for approval.  

Studies have shown that Optune TTF (tumor treatment fields) therapy is a safe and effective treatment and has been shown to improve progression-free survival and overall survival for glioblastoma.  The patient is still young and functional, and Optune TTF (tumor treatment fields) is the best option available after the standard adjuvant chemoradiotherapy in prolonging his life and improving his quality of life.  Optune TTF (tumor treatment fiends) is, therefore, medically necessary for this patient at this time.