2009;9:1. doi:10.1186/1756-6649-9-1. 12. 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. 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. 2019;141(2):467-473. 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. Therefore, you should not rely on any such factors or forward-looking statements. Optune™ is FDA approved, so there is no reason for the insurance companies to deny it. We have revised our Privacy Policy that is in effect as of May 25, 2018. 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. Novocure 2019. Please click here to see the Optune Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Aetna is one of the top three commercial payers in the U.S., covering 23.5 million lives. In the case of progression, an unscheduled MRI was obtained within 1 week of the investigator becoming aware. ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ:NVCR) announced today that Anthem, Inc. now covers Optune for members who have newly diagnosed glioblastoma (GBM). Anthem is the fourth and latest national commercial payer to issue a positive coverage policy for Optune. Novocure may also offer financial support to patients who qualify. 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. Covered Treatments include:Avastin, Gliadel, Optune (Novocure), Temodar. 8. Kirson ED, Schneiderman RS, Dbalý V, et al. Am Soc Clin Oncol Educ Book. The science of Tumor Treating Fields extends beyond glioblastoma. Optune offers hope of a longer, better quality life for patients who are diagnosed with this devastating disease.”. “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. It is unknown what side effects the device may cause to … 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. 11. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. 2004;64(9):3288-3295. 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. Medicare’s position: Until now, Medicare has not covered the cost of the Optune device. Patients should only use Optune under the supervision of a physician properly trained in use of the device. Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. ©2020 Novocure. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped. If a patient complains about a heat or electric sensation, it might be because contact between the transducer arrays and the skin is suboptimal. Novocure Inc. 2018. In EF-11, patients with recurrent GBM needed to have a period of at least 4 weeks from surgery for recurrence and from any prior chemotherapy or radiation therapy.1, As TTFields are a slow antimitotic therapy, we do not expect to see a response quickly with therapy. Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields). Anthem, the largest member of the Blue Cross Blue Shield Association, is one of the nation’s leading … Brain tumor treatment typically is covered by health insurance. 2012:126-131. Possibly. 14. We have since accomplished many significant milestones. 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. 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. NovoTAL—NovoTTF-100A Transducer Array Layout Software. Novocure assists in all aspects of billing and reimbursement for Optune Lua to help achieve the best possible coverage available from your patients' insurance. The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. “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 … On this site, videos and images identified as Optune users, caregivers or healthcare professionals depict actual patients, caregivers and healthcare professionals. Use of and access to this information is subject to the terms, limitations, and conditions set by the website and/or database producer. Patients should also make sure that any wigs, scarves, or hats are loose fitting and well ventilated.14 Complaints should be reported to the Novocure Customer Care Team at 1-855-281-9301. 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. Please click here to access it. Cancer Res. 2. 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. Covered Services Learn more about what we cover - including health, dental, and pharmacy. 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. 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. Noninvasive application of alternating electric fields in glioblastoma: a fourth cancer treatment modality. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. Contact us. By continuing to browse the site you are agreeing to accept our use of cookies. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Quarterly Report on Form 10-Q filed on Oct. 27, 2015, with the U.S. Securities and Exchange Commission. Lacouture ME, et al. 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. 4. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. More than 107 million Americans now have coverage of Optune as a treatment for newly diagnosed and/or recurrent glioblastoma. The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. Learn more. Healthwell Foundation. “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. Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy. 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. NovocureAshley Cordova, 212 767 7558acordova@novocure.com. Kirson ED, Dbalý V, Tovarys F, et al. Medicare has published a proposed rule on coverage for Optune that would make most patients ineligible for this highly effective treatment. Novocure DOF OPT-103. NovoTTF™-100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL™ system user study. Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy. The main restriction that could have a grave impact is not allowing coverage of Optune for patients who are not treated at an NCI designated cancer center. 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. World J Surg Oncol. 2014;12:162. User Manual. “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. The most common (≥10%) adverse events seen with Optune monotherapy were medical device site reaction and headache. 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. Meet our leaders, who have extensive experience across oncology, biotechnology and medical device industries. 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. Is Optune Lua covered by insurance companies for the treatment of MPM? Additional commercial payers that offer positive coverage policies for Optune include: Excellus Blue Cross and Blue Shield, Medica, The Health Plan of the Upper Ohio Valley, and Priority Health, which in total administer health plans covering 3.7 million lives. This means that no significant electric or magnetic fields are found in the vicinity of the device when it is active.15. 2014;41(3)(suppl 4):S1-S14. Humana is the ninth commercial payer in the United States to issue a positive … 6. Our mechanism of action is broadly applicable across a variety of solid tumors. Professor Yoram Palti founded Novocure in 2000. ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ:NVCR) announced today that Anthem, Inc. now covers Optune for members who have newly diagnosed glioblastoma (GBM). TTFields do not attenuate over distance and can reach deep tissue. 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. Silginer M, Weller M, Stupp R, Roth P. Biological activity of tumor-treating fields in preclinical glioma models. Optune has been tested for electromagnetic compatibility (active and passive) according to EN ISO 60601-1 standards. Policy. We pioneer a profoundly different approach to treating cancer called Tumor Treating Fields. 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. In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy. 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. ST. HELIER, Jersey– ( BUSINESS WIRE )–Novocure (NASDAQ:NVCR) announced today that Humana now covers Optune for members who have recurrent glioblastoma (GBM). 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. Do not use Optune in patients that are known to be sensitive to conductive hydrogels. Novocure may also offer financial support to patients who qualify. The List of Remedies and Equipment describes which medical equipment are covered under compulsory health insurance. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. Novocure’s U.S. operations are based in Portsmouth, New Hampshire, and New York City. With this ruling, they propose to now cover the cost…but with restrictions. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. Turner SG, Gergel T, Wu H, et al. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. 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. 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. Number: 0827. doi: 10.1038/cddis.2017.171. Novocure assists in all aspects of billing and reimbursement for Optune to help achieve the best possible coverage available from your patients’ insurance. The average out-of-pocket cost for patients is $100 per month. Optune Instructions for Use. 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. Optune™ was not tested in pregnant women. Novocure 2019. How much you can expect to pay out of pocket for brain tumor treatment, including what people paid. 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. In such instances, the patient should change the arrays. Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure® (the device manufacturer). Gutin PH, Wong ET. JAMA. 2016;94(5):1137-43. The Optune device is now generally covered by insurance. J Neurooncol. 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. Chaudhry A, Benson L, Varshaver M, et al. More than 15,000 people have started Optune. 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. In December 2015, Aetna, Inc. released a medical coverage policy that affirmatively covers Optune for the treatment of newly diagnosed GBM. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. To get in touch with nCompass, call 1-855-281-9301 (toll-free). Optune, Optune Lua, nCompass, NovoTAL, and Novocure are trademarks of Novocure. 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. 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. Improving tumor treating fields treatment efficacy in patients with glioblastoma using personalized array layouts. 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. Patient images reflect the health status of the patients at the time each photo was taken. It is really, really important to show Medicare that we care about the outcome. Additionally, the company has offices in Germany, Switzerland, and Japan and a research center in Haifa, Israel. 7. Medicare has approved it but only for use in specific conditions. 2017;8(4):e2753. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. 2007:104(24):10152-10157. Please refer to the member’s plan document for specific coverage information. The nCompass ™ team has helped many patients and caregivers—in a range of financial situations—start treatment with Optune. Novocure announces national … This website intends to use cookies to improve the site and your experience. Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial. All rights reserved. Optune costs $21,000 per month. Int J Radiat Oncol Biol Phys. If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune treatment. The Private Securities Litigation Reform Act of 1995 permits this discussion. 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, 15. World J Surg Oncol. Women who are able to get pregnant must use birth control when using the device. 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. Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. 855-426-2672. www.braintumorcopays.org. Stupp R, Taillibert S, Kanner A, et al. 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). Optune is a wearable, portable, FDA-approved treatment for glioblastoma multiforme (GBM) that creates low-intensity, wave-like electric fields called Tumor Treating Fields (TTFields), which interfere with GBM cell division. Wenger C, Salvador R, Basser PJ, Mirandaet PC. 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. Improve the site you are pregnant, think you might be pregnant, or trying... 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