Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Glioblastoma (GBM). 
Treatment: Optune Device. 

The insurer denied coverage for Optune Device. 

The denial is overturned. 

The patient is an old female with a history of glioblastoma. She also has a history of colon and endometrioid ovarian cancer treated with maintenance nivolumab. She has undergone surgeries for recurrent glioblastoma per pathology report. She did not start chemoradiation and declined pembrolizumab. She presented for severe headache and was found to have progression of disease with a new intratumoral hemorrhage. She underwent resection and a gross total resection was achieved. Pathology positive for recurrent/residual glioblastoma, WHO (World Health Organization) grade IV. She started chemoradiation and completed treatment. Maintenance temozolomide was deferred. KPS (Karnofsky Performance Status) Score 90. The plan was to defer maintenance TMZ (temozolomide) due to out of the country trip and consider starting when she returns and will refer for Optune. 

Post treatment MRI (Magnetic Resonance Imaging) found improved and evolving right anterior frontal postoperative changes without evidence for new or increased disease. 

The denial is not consistent with the medical records. The Optune is safe and effective as a monotherapy for recurrent glioblastoma. 

The electric tumor field treatment is medically necessary for the patient's recurrent glioblastoma. Clinical trials are limited as GBM is considered an orphan disease. There are few studies that show that the Optune device is safe and effective as a salvage therapy and increases quality of life. TTF (tumor treating fields) is covered by multiple national policies for recurrent GBM and is considered an acceptable form of treatment by NCCN (National Comprehensive Cancer Network). Imaging does not show current pathology. The patient has no other choice in treatment as she does not want to take any further chemotherapy due to side effects. 

The FDA (Food and Drug Administration) approves Optune for recurrent GBM and indicated for following histologically or radiologically confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy and is intended as an alternative to standard medical therapy for GMB after surgical and radiation options have been exhausted. (1) 

Tumor treating fields (Optune) were approved for treating recurrent glioblastoma (and have more recently been approved for newly diagnosed glioblastoma as well). The treatment uses low-intensity, intermediate frequency, alternating electric fields to interfere with cell division in cancer cells. The treatment, fortunately, has very little effect on normal, healthy brain cells. Optune was initially approved because it has fewer side effects than other treatments that offered similar improvements in survival. Since that time, Optune has been found to have a benefit on survival as well. With recurrent glioblastoma, studies have found that people treated with tumor treating fields have more than double the one-year and two-year survival rates of those who do not receive the treatment. (2) 

Glioblastoma patients invariably recur after a median interval of less than 7 months, and there is no clear standard-of-care salvage therapy. NCCN guidelines list clinical trials as the preferred option for eligible patients. Surgery may have a role for symptomatic and/or large lesions. However, only patients who undergo complete resections have any survival benefit. Other options include systemic therapy such as TMZ rechallenge, nitrosoureas, bevacizumab, re-irradiation, and TTF (in the US), none of which have been shown to prolong survival in randomized trials in this setting, or palliative care for patients with poor performance status. (6) 

The health plan did not act reasonably with sound medical judgment in the best interest of the patient. 

The insurer's denial of coverage for the Optune Device is overturned. Medical Necessity is substantiated.