Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Glioblastoma. 
Treatment: Electrical Stimulation Device (E0766RR x 6) (Durable Medical Equipment). 
The insurer denied coverage for Electrical Stimulation Device (E0766RR x 6) (Durable Medical Equipment). 
The denial is overturned. 

This patient was diagnosed with glioblastoma. The patient received chemoradiation with concurrent Temodar. The patient began adjuvant temozolomide and began utilizing Optune Tumor Treating Fields (TTFields). The patient was trained in Optune use and was informed of the importance of wearing the device at least 18 hours per day. 

Novo Tumor Treating Fields (TTF) (Optune) was Food and Drug Administration (FDA) approved in 04/2011 under orphan disease designation for recurrent glioblastoma, and after approved for first line. TTF therapy has been shown in vitro and in vivo to effectively inhibit tumor growth by inducing cell death. TTF takes advantage of the electrical characteristics, geometrical shape and replication rate of dividing cancer cells - all of which makes them susceptible to the effects of alternating electric fields. TTF therapy is delivered using non-invasive, insulated transducer arrays that are placed directly on the skin in the region of the tumor. TTF therapy does not deliver any electric current to the tissue; it does not stimulate nerves or muscles or heat the tissue. It creates an artificial, alternating electric field within the tumor which disrupts cancer cell division and can cause complete destruction of the dividing cancer cells. 

The Electrical Stimulation Device (E0766RR x 6) (Durable Medical Equipment) is considered medically necessary for this patient. 

The updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines In Oncology (NCCN Guidelines) for Central Nervous System Cancers now include alternating electric field therapy (Optune) in combination with temozolomide (TMZ) following standard brain radiation therapy with concurrent TMZ as a Category 2A recommended postoperative adjuvant treatment option for patients with newly diagnosed supratentorial glioblastoma (GBM). Optune is intended as a treatment for adult patients (22 years of age or older) with histologically confirmed glioblastoma multiforme (GBM). 

Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy. 

"Tumor treating fields (TTFields) are a non-invasive antimitotic therapy that delivers alternating electric fields via the Optune system. The Phase III EF-14 trial in newly diagnosed glioblastoma multiforme (GBM) showed significantly improved progression-free, overall and long-term survival when Optune was used together with maintenance temozolomide (TMZ) compared with TMZ alone. Compliance (average monthly use) was associated with better clinical outcome" (Kinzel, A., et al. 2019). 

"In the final analysis of this randomized clinical trial of patients with glioblastoma who had received standard radiochemotherapy, the addition of TTFields to maintenance temozolomide chemotherapy vs maintenance temozolomide alone, resulted in statistically significant improvement in progression-free survival and overall survival. These results are consistent with the previous interim analysis" (Stupp, R. et al. 2017).                                    

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Electrical Stimulation Device (E0766RR x 6) (Durable Medical Equipment) is substantiated.