Cancer Res. Contact us. 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. Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Talk to your doctor about it. Optune has been tested for electromagnetic compatibility (active and passive) according to EN ISO 60601-1 standards and Novocure is not aware of any limitations with the use of cell phones or microwaves while patients are being treated with Optune. Chaudhry A, Benson L, Varshaver M, et al. The nCompass ™ team has helped many patients and caregivers—in a range of financial situations—start treatment with Optune. Optune offers hope of a longer, better quality life for patients who are diagnosed with this devastating disease.”. If you require further information and/or do not wish to have cookies placed when using the site, review the Cookies section of our Website Privacy Policy or visit www.allaboutcookies.org. If a patient complains about a heat or electric sensation, it might be because contact between the transducer arrays and the skin is suboptimal. In December 2015, Aetna, Inc. released a medical coverage policy that affirmatively covers Optune for the treatment of newly diagnosed GBM. doi: 10.1038/cddis.2017.171. Wenger C, Salvador R, Basser PJ, Mirandaet PC. Usage (≥75% vs <75%) was an independent predictor of overall survival in the full 5-year data set.12, There were no significant increases in the rate of systemic AEs when Optune was added to TMZ.4, The most common (≥10%) AEs involving Optune in combination with TMZ were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression. 2019;141(2):467-473. In the EF-14 phase 3 pivotal trial, patients with newly diagnosed GBM needed to have a period of at least 4 weeks from surgery and at least 4 weeks, but not more than 7 weeks, from the last dose of concomitant TMZ or radiation therapy. Anthem’s positive coverage policy of Optune – a portable, noninvasive device that delivers Tumor Treating Fields (TTFields) therapy to patients with newly diagnosed and recurrent GBM – follows the December 2015 publication of Novocure’s EF-14 phase 3 pivotal trial data in the Journal of the American Medical Association (JAMA). Meet our leaders, who have extensive experience across oncology, biotechnology and medical device industries. On March 6, there will be a meeting to reconsider the denial of coverage. 2007:104(24):10152-10157. 2004;64(9):3288-3295. Novocure may also offer financial support to patients who qualify. Anthem, the largest member of the Blue Cross Blue Shield Association, is one of the nation’s leading health benefits companies with plans that cover 38.5 million lives. More than 15,000 people have started Optune. The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. ©2020 Novocure. If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune treatment. NovocureAshley Cordova, 212 767 7558acordova@novocure.com. Anthem, the largest member of the Blue Cross Blue Shield Association, is one of the nation’s leading … Learn more. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. Kirson ED, Dbalý V, Tovarys F, et al. 2. This website intends to use cookies to improve the site and your experience. Dive Brief: A Medicare advisory panel has delivered an equivocal assessment of whether Novocure’s Optune device improves health and should be covered by the health insurance program. Medicare has published a proposed rule on coverage for Optune that would make most patients ineligible for this highly effective treatment. Cell Death Dis. All rights reserved. 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, And medical device industries it is really, really important to show medicare that we care about the outcome tumor... 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