Optune costs $21,000 per month. The most common (≥10%) adverse events seen with Optune monotherapy were medical device site reaction and headache. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted. “The recent positive coverage by Anthem and Aetna of Optune for newly diagnosed glioblastoma signals that leading healthcare payers view Optune as a medical necessity for newly diagnosed glioblastoma patients,” said Asaf Danziger, Novocure’s CEO. Contact us. Policy. Stupp R, Taillibert S, Kanner A, et al. Transducer array layout mapping is performed using the NovoTAL™ software.7-9, Preclinical studies in glioblastoma cell lines suggest additive cytotoxic effects when cancer cell lines are exposed to a combination of TTFields and TMZ.10,11, The results of an EF-14 sub-group analysis further supported a threshold usage rate of ≥75% for a survival benefit when compared to a usage rate of <75% in patients with newly diagnosed GBM who were treated with TTFields plus TMZ. The most common device-related AE, mild to moderate skin irritation, can typically be managed with topical therapies and rarely leads to treatment discontinuation.13,14, In the EF-14 phase 3 pivotal trial, patients with newly diagnosed GBM were monitored by MRI every second month from baseline until second progression or 24 months, whichever occurred first. On March 6, there will be a meeting to reconsider the denial of coverage. Novocure may also offer financial support to patients who qualify. 2014;12:162. X. World J Surg Oncol. Covered Treatments include:Avastin, Gliadel, Optune (Novocure), Temodar. Do not use Optune™ if you are pregnant, think you might be pregnant, or are trying to get pregnant. If a patient complains about a heat or electric sensation, it might be because contact between the transducer arrays and the skin is suboptimal. “We are extremely pleased that Switzerland has established national reimbursement for Optune,” said Thomas Hefti, … 2. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted. The transducer array layout is planned to maximize the intensity delivered to the tumor(s) while still covering the entire supratentorial region.1,6, Preclinical studies have shown that the optimal tuning frequency for TTFields is inversely related to cell size and that the optimal frequency for GBM cell lines is 200 kHz.1,3,5, These treatment parameters are preset by Novocure® into the Optune system, so no electric output adjustments are available.1, If a patient’s MRI demonstrates major changes from baseline, the transducer array layout can be remapped to ensure the TTFields are targeted to all areas of the suspected tumor. Optune™ is FDA approved, so there is no reason for the insurance companies to deny it. Electric Tumor Treatment Fields (Optune®) Page 1 of 2 Policy Name: Electric Tumor Treatment Fields (Optune®) Effective Date: 10/16/2019 Important Information – Please Read Before Using This Policy These services may or may not be covered by all Medica plans. According to the LCD, Optune will be covered initially by Medicare when the following criteria are met: The beneficiary has histologically confirmed (World Health Organization (WHO) grade IV astrocytoma), newly diagnosed, supratentorial GBM; and, It is really, really important to show Medicare that we care about the outcome. Women who are able to get pregnant must use birth control when using the device. 13. The Optune device, which costs about $21,000 a month, caused some skin irritation but otherwise has no serious side effects. 2014 ; 41 ( 3 ) ( suppl 4 ): S1-S14 Treating extends... Gbm ) member ’ s current expectations or forecasts of future events a receiving. This discussion alternating electric fields Optune together with maintenance temozolomide vs maintenance temozolomide is stopped the investigator becoming.... Was obtained within 1 week of the implanted device and medical device designed for continuous use patients. 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