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is optune covered by insurance

Optune was approved by the FDA 8 years ago and is recommended as a standard of care by the NCCN guidelines, but Medicare does not pay for it. In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). 9. Humana is the ninth commercial payer in the United States to issue a positive … For patients covered by health insurance, the typical cost of brain tumor treatment will include doctor copays, drug copays and coinsurance of 10-50% or more -- most likely reaching the yearly out-of-pocket maximum. Novocure 2019. Optune, Optune Lua, nCompass, NovoTAL, and Novocure are trademarks of Novocure. Novocure’s U.S. operations are based in Portsmouth, New Hampshire, and New York City. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. The effect of field strength on glioblastoma multiforme response in patients treated with the NovoTTF™-100A system. The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. Medicare has approved it but only for use in specific conditions. 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. 8. “With positive coverage from health plans covering more than 204 million Americans, we believe patients with newly diagnosed or recurrent GBM should feel empowered to speak to their doctor about … Optune offers hope of a longer, better quality life for patients who are diagnosed with this devastating disease.”. Optune Instructions for Use. Please click here to access it. NovoTTF™-100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL™ system user study. The following adverse reactions were considered related to Optune when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall and skin ulcer. 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. Is Optune Lua covered by insurance companies for the treatment of MPM? Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. 855-426-2672. www.braintumorcopays.org. Anthem Inc. Issues Positive Coverage Decision For Optune in Newly Diagnosed Glioblastoma. We pioneer a profoundly different approach to treating cancer called Tumor Treating Fields. 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). Cancer Res. Novocure Vulnerability Disclosure Process. 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. It is really, really important to show Medicare that we care about the outcome. It is unknown what side effects the device may cause to … Women who are able to get pregnant must use birth control when using the device. The average out-of-pocket cost for patients is $100 per month. 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, 5. Turner SG, Gergel T, Wu H, et al. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. The nCompass ™ team has helped many patients and caregivers—in a range of financial situations—start treatment with Optune. The most common (≥10%) adverse events involving Optune in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression. TTFields do not attenuate over distance and can reach deep tissue. Proc Natl Acad Sci USA. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in mesothelioma, brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and liver cancer. Toms SA, Kim CY, Nicholas G, Ram Z. The List of Remedies and Equipment describes which medical equipment are covered under compulsory health insurance. “We are working diligently to build awareness of our EF-14 trial results, now published in JAMA, which show that Optune plus standard of care significantly extended both progression-free and overall survival in newly diagnosed GBM patients. 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. 2014;12:162. From your first question about Optune ® and throughout your treatment, the nCompass ™ team at Novocure provides customized support based on your needs.. For patient assistance, insurance questions, technical support, physician information, and general inquiries, please contact nCompass support by providing the information requested below. Novocure may also offer financial support to patients who qualify. 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. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped. All rights reserved. Optune delivers Tumor Treating Fields (TTFields) to selectively disrupt mitosis.1,2 TTFields are a regional, noninvasive antimitotic treatment that selectively disrupts the division of rapidly dividing cells by delivering low-intensity, intermediate-frequency (200 kHz) alternating electric fields via transducer arrays applied to the shaved scalp.3,4, Cells must be undergoing mitosis to be affected by TTFields; therefore, generally most nondividing cells will not be affected by TTFields.5 Additionally, cells undergoing mitosis will only be affected if they are in the region treated by the TTFields.3,5, TTFields are able to treat glioblastoma (GBM) tumors within the supratentorial region of the brain. Novocure assists in all aspects of billing and reimbursement for Optune Lua to help achieve the best possible coverage available from your patients' insurance. Optune™ was not tested in pregnant women. They will work with your insurance plan and identify resources to help minimize your cost for Optune, regardless of your financial situation. Medicare’s position: Until now, Medicare has not covered the cost of the Optune device. Novocure assists in all aspects of billing and reimbursement for Optune to help achieve the best possible coverage available from your patients’ insurance. Any forward-looking statements herein speak only as of the date hereof. Novocure Inc. 2018. The treatment is intended for adult patients, 18 years of age or older, and should be started more than four weeks after surgery and radiation therapy with adjuvant temozolomide. Together with maintenance temozolomide alone on survival in patients with glioblastoma: a cancer. Basser PJ, Mirandaet PC with Optune monotherapy were medical device designed for is optune covered by insurance use by patients Swiss will! 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