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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. How much you can expect to pay out of pocket for brain tumor treatment, including what people paid. TTFields do not attenuate over distance and can reach deep tissue. Covered Treatments include:Avastin, Gliadel, Optune (Novocure), Temodar. The science of Tumor Treating Fields extends beyond glioblastoma. 15. In addition, Novocure has a financial assistance program that provides for me to pay a nominal amount ($200/$300) based on my income in case my insurance does not pay for it. 10. 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. 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. 12. For example, patients could not get coverage unless they were being treated at a major cancer center, showed no signs of progression, and started immediately after undergoing chemo and radiation treatment. ST. HELIER, Jersey– ( BUSINESS WIRE )–Novocure (NASDAQ:NVCR) announced today that Humana now covers Optune for members who have recurrent glioblastoma (GBM). Novocure Inc. 2018. Humana is the ninth commercial payer in the United States to issue a positive … Optune is covered by many insurance plans and Novocure ensures that both you and your patient know in advance what, if any, financial obligation your patient has prior to the patient starting therapy. Chaudhry A, Benson L, Varshaver M, et al. Medicare’s position: Until now, Medicare has not covered the cost of the Optune device. Learn more. Any forward-looking statements herein speak only as of the date hereof. By continuing to browse the site you are agreeing to accept our use of cookies. Medicare has published a proposed rule on coverage for Optune that would make most patients ineligible for this highly effective treatment. Brain tumor treatment typically is covered by health insurance. The foundation helps to bridge the gap by providing financial assistance to eligible patients to cover certain out-of-pocket costs related to copayments, deductibles and insurance premiums. User Manual. Do not use Optune in patients that are known to be sensitive to conductive hydrogels. Optune costs $21,000 per month. 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. Cell Death Dis. With this ruling, they propose to now cover the cost…but with restrictions. Kirson ED, Dbalý V, Tovarys F, et al. Novocure’s U.S. operations are based in Portsmouth, New Hampshire, and New York City. Effective from April 2021, the Swiss agency will provide complete reimbursement for Optune cancer treatment. 2017;318(23):2306-2316. There is no known risk to caregivers exposed to a patient receiving Optune. The nCompass ™ team has helped many patients and caregivers—in a range of financial situations—start treatment with Optune. Am Soc Clin Oncol Educ Book. Kirson ED, Gurvich Z, Schneiderman R, et al. Anthem Inc. Issues Positive Coverage Decision For Optune in Newly Diagnosed Glioblastoma. We have since accomplished many significant milestones. Possibly. Stopping treatment prior to completion of a 4-week treatment course will most likely lead to continued tumor growth and appearance of symptoms within approximately 1-2 weeks.1. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. In the European Union, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ:NVCR) announced today that Anthem, Inc. now covers Optune for members who have newly diagnosed glioblastoma (GBM). Novocure may also offer financial support to patients who qualify. In this case, skin contact with the gel used with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure. We have revised our Privacy Policy that is in effect as of May 25, 2018. 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. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Proc Natl Acad Sci USA. The National Comprehensive Cancer Network (NCCN), a group of leading cancer centers including UW Carbone, says that research evidence supports using Optune and gives it its highest "category one recommendation" for newly diagnosed GBM patients. As the global impacts of COVID-19 evolve, Novocure® is taking proactive steps to protect and support the health and well-being of our colleagues, our patients and caregivers, and all of our partners, while we continue to deliver our therapy to patients in need. 7. The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death. Optune™ was not tested in pregnant women. Collectively, health plans covering more than 97 million Americans now provide positive coverage of Optune. 2012:126-131. Novocure assists in all aspects of billing and reimbursement for Optune Lua to help achieve the best possible coverage available from your patients' insurance. 11. Novocure announces national … We pioneer a profoundly different approach to treating cancer called Tumor Treating Fields. The most common (≥10%) adverse events seen with Optune monotherapy were medical device site reaction and headache. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Aetna considers devices to generate electric tumor treatment fields (ETTF) and temozolomide medically necessary for persons with histologically confirmed glioblastoma (World Health Organization grade IV astrocytoma), after histologically or radiologically confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. Novocure may also offer financial support to patients who qualify. 2007:104(24):10152-10157. Cancer Res. Will my insurance cover it? Optune is a noninvasive, antimitotic cancer treatment that … Forward-looking statements provide Novocure’s current expectations or forecasts of future events. Patient images reflect the health status of the patients at the time each photo or video was taken. World J Surg Oncol. Covered Services Learn more about what we cover - including health, dental, and pharmacy. Optune Instructions for Use. 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). 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. I am glad my insurance (that I brought through the Obamacare exchange since I am a freelancer) has been paying for most of it throughout. “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. doi: 10.1038/cddis.2017.171. Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Lacouture ME, et al. Medicare has approved it but only for use in specific conditions. Therefore, you should not rely on any such factors or forward-looking statements. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy. On this site, videos and images identified as Optune users, caregivers or healthcare professionals depict actual patients, caregivers and healthcare professionals. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. Gutin PH, Wong ET. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped. “We are extremely pleased that Switzerland has established national reimbursement for Optune,” said Thomas Hefti, … In the European Union, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. 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. ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ:NVCR) announced today that Anthem, Inc. now covers Optune for members who have newly diagnosed glioblastoma (GBM). Novocure makes no representation as to the accuracy or any other aspect of the information contained on such website and/or database, nor does Novocure necessarily endorse such website and/or database. Optune Patient Information and Operation Manual. NovoTTF™-100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL™ system user study. Additionally, the company has offices in Germany, Switzerland, and Japan and a research center in Haifa, Israel. In the case of progression, an unscheduled MRI was obtained within 1 week of the investigator becoming aware. 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. 2009;9:1. doi:10.1186/1756-6649-9-1. Do not use Optune™ if you are pregnant, think you might be pregnant, or are trying to get pregnant. The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. This site is intended for US healthcare professionals only. 855-426-2672. www.braintumorcopays.org. To get in touch with nCompass, call 1-855-281-9301 (toll-free). Professor Yoram Palti founded Novocure in 2000. Novocure DOF OPT-103. Optune has been tested for electromagnetic compatibility (active and passive) according to EN ISO 60601-1 standards. Do not use Optune in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. BMC Med Phys. Novocure assists in all aspects of billing and reimbursement for Optune to help achieve the best possible coverage available from your patients’ insurance. Kirson ED, Schneiderman RS, Dbalý V, et al. Its purpose is to determine the optimal location of the transducer arrays based on the individual’s most recent magnetic resonance imaging (MRI) scan, head size, and tumor location. 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. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective. Silginer M, Weller M, Stupp R, Roth P. Biological activity of tumor-treating fields in preclinical glioma models. Meet our leaders, who have extensive experience across oncology, biotechnology and medical device industries. “We are pleased that nine of the ten 1 largest U.S. private insurers have decided to cover Optune as a treatment for newly diagnosed and/or recurrent GBM.” said Asaf Danziger, Novocure’s CEO. Cigna and HealthNet – administering medical benefits for 14.5 million and 6 million lives, respectively – offer coverage of Optune for members who have recurrent GBM. Use of Optune in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune in these patients could lead to tissue damage or lower the chance of Optune being effective. 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. J Neurooncol. 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. 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, On this site, patient and healthcare professional videos as well as all images labeled as Optune users, caregivers, or healthcare professionals depict actual patients, caregivers, and healthcare professionals. Stupp R, Taillibert S, Kanner A, et al. Anthem, the largest member of the Blue Cross Blue Shield Association, is one of the nation’s leading … For the record, Optune is a non … Healthwell Foundation. In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. Talk to your doctor about it. 2015;13:316. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the US or by email at supportEMEA@novocure.com in the European Union. Int J Radiat Oncol Biol Phys. ©2020 Novocure. Optune offers hope of a longer, better quality life for patients who are diagnosed with this devastating disease.”. The effect of field strength on glioblastoma multiforme response in patients treated with the NovoTTF™-100A system. 13. 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