Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields). If a patient complains about a heat or electric sensation, it might be because contact between the transducer arrays and the skin is suboptimal. NovoTAL—NovoTTF-100A Transducer Array Layout Software. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. Disruption of cancer cell replication by alternating electric fields. There is no known risk to caregivers exposed to a patient receiving Optune. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. 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. We have since accomplished many significant milestones. Improving tumor treating fields treatment efficacy in patients with glioblastoma using personalized array layouts. ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ:NVCR) announced today that Anthem, Inc. now covers Optune for members who have newly diagnosed glioblastoma (GBM). Wenger C, Salvador R, Basser PJ, Mirandaet PC. 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. 9. Optune is a noninvasive, antimitotic cancer treatment that … 2016;94(5):1137-43. Learn more. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ:NVCR) announced today that Anthem, Inc. now covers Optune for members who have newly diagnosed glioblastoma (GBM). 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. 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. 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. 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. ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ:NVCR) announced today that Anthem, Inc. now covers Optune for members who have newly diagnosed glioblastoma (GBM). Talk to your doctor about it. References: 1. All rights reserved. Novocure assists in all aspects of billing and reimbursement for Optune Lua to help achieve the best possible coverage available from your patients' insurance. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. How much you can expect to pay out of pocket for brain tumor treatment, including what people paid. 2017;318(23):2306-2316. doi: 10.1038/cddis.2017.171. Healthwell Foundation. We have revised our Privacy Policy that is in effect as of May 25, 2018. Medicare has approved it but only for use in specific conditions. 14. Toms SA, Kim CY, Nicholas G, Ram Z. 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. BMC Med Phys. “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 … Use of and access to this information is subject to the terms, limitations, and conditions set by the website and/or database producer. Covered Services Learn more about what we cover - including health, dental, and pharmacy. 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. User Manual. 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. Novocure Vulnerability Disclosure Process. 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. Novocure DOF OPT-103. 6. Novocure does not review the information contained on this website and/or database for content, accuracy, or completeness. 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. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. 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. In such instances, the patient should change the arrays. They will work with your insurance plan and identify resources to help minimize your cost for Optune, regardless of your financial situation. Novocure may also offer financial support to patients who qualify. 3. 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). The List of Remedies and Equipment describes which medical equipment are covered under compulsory health insurance. Collectively, health 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). “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. Chaudhry A, Benson L, Varshaver M, et al. Meet our leaders, who have extensive experience across oncology, biotechnology and medical device industries. NovoTTF™-100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL™ system user study. 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. Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Am Soc Clin Oncol Educ Book. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure. 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. Cell Death Dis. On March 6, there will be a meeting to reconsider the denial of coverage. 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. 13. 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. The Optune device, which costs about $21,000 a month, caused some skin irritation but otherwise has no serious side effects. Lacouture ME, et al. Turner SG, Gergel T, Wu H, et al. 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. Number: 0827. Optune has been tested for electromagnetic compatibility (active and passive) according to EN ISO 60601-1 standards. 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. 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. 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. Kirson ED, Gurvich Z, Schneiderman R, et al. 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. Anthem Inc. Issues Positive Coverage Decision For Optune in Newly Diagnosed Glioblastoma. 4. The Private Securities Litigation Reform Act of 1995 permits this discussion. 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. Medicare has published a proposed rule on coverage for Optune that would make most patients ineligible for this highly effective treatment. Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). This website intends to use cookies to improve the site and your experience. The effect of field strength on glioblastoma multiforme response in patients treated with the NovoTTF™-100A system. ©2020 Novocure. Novocure Inc. 2018. 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. Novocure 2019. Novocure announced national reimbursement in Switzerland for Optune in combination with temozolomide for the treatment of newly diagnosed GBM. Silginer M, Weller M, Stupp R, Roth P. Biological activity of tumor-treating fields in preclinical glioma models. 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. 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. 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. Optune™ was not tested in pregnant women. Semin Oncol. The average out-of-pocket cost for patients is $100 per month. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. ... medical devices are covered … Women who are able to get pregnant must use birth control when using the device. In December 2015, Aetna, Inc. released a medical coverage policy that affirmatively covers Optune for the treatment of newly diagnosed GBM. For the record, Optune is a non … 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. Patient images reflect the health status of the patients at the time each photo was taken. The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. The Optune device is now generally covered by insurance. Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure® (the device manufacturer). 2007:104(24):10152-10157. 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. 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. Novocure 2019. The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. Covered Treatments include:Avastin, Gliadel, Optune (Novocure), Temodar. Do not use Optune in patients that are known to be sensitive to conductive hydrogels. 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. As of Jan. 1, 2017, more than 177 million Americans will have coverage of Optune as a treatment for newly diagnosed and/or recurrent glioblastoma November 03, 2016 07:00 AM Eastern Daylight Time ST. 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. 2009;9:1. doi:10.1186/1756-6649-9-1. Cancer Res. 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. The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. 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. J Neurooncol. Int J Radiat Oncol Biol Phys. 11. In clinical practice, the frequency should ultimately be determined by the treating physician.1. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. 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. By continuing to browse the site you are agreeing to accept our use of cookies. Novocure’s U.S. operations are based in Portsmouth, New Hampshire, and New York City. 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. World J Surg Oncol. More than 15,000 people have started Optune. Optune, Optune Lua, nCompass, NovoTAL, and Novocure are trademarks of Novocure. 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. Effective from April 2021, the Swiss agency will provide complete reimbursement for Optune cancer treatment. 8. With this ruling, they propose to now cover the cost…but with restrictions. 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. Do not use Optune™ if you are pregnant, think you might be pregnant, or are trying to get pregnant. 2. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped. Optune™ is FDA approved, so there is no reason for the insurance companies to deny it. It is unknown what side effects the device may cause to … Aetna is one of the top three commercial payers in the U.S., covering 23.5 million lives. 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. Optune costs $21,000 per month. 2019;141(2):467-473. 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. It is really, really important to show Medicare that we care about the outcome. 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. Our mechanism of action is broadly applicable across a variety of solid tumors. Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established. 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). In the case of progression, an unscheduled MRI was obtained within 1 week of the investigator becoming aware. Brain tumor treatment typically is covered by health insurance. 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. TTFields do not attenuate over distance and can reach deep tissue. Please click here to see the Optune Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions. 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. Policy. Possibly. Using a model developed to simulate the growth kinetics of a malignant tumor, the minimal treatment duration for Optune has been determined to be approximately 4 weeks to reach tumor stabilization. Kirson ED, Schneiderman RS, Dbalý V, et al. Optune therapy that may be leased from the manufacturer. Any forward-looking statements herein speak only as of the date hereof. 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. 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. Novocure may also offer financial support to patients who qualify. 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. “We are extremely pleased that Switzerland has established national reimbursement for Optune,” said Thomas Hefti, … The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. Kirson ED, Dbalý V, Tovarys F, et al. Noninvasive application of alternating electric fields in glioblastoma: a fourth cancer treatment modality. The average out-of-pocket cost for patients is $100 per month. 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. 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Are trademarks of novocure cookies to improve the site you are pregnant is optune covered by insurance need... Attenuate over distance and can reach deep tissue that are known to be incorrect this press may... Fields extends beyond glioblastoma humana is the fourth and latest national commercial payer the! Status of the patients at the time each photo or video was.... This site, videos and images identified as Optune users, caregivers or professionals! What people paid glioblastoma multiforme response in patients with glioblastoma: a randomized clinical trial is FDA approved, there!