Professor Yoram Palti founded Novocure in 2000. Patients should only use Optune under the supervision of a physician properly trained in use of the device. Lacouture ME, et al. 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. All rights reserved. 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. TTFields do not attenuate over distance and can reach deep tissue. 2007:104(24):10152-10157. 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. 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. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. ... medical devices are covered … 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. 5. 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 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. 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. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. Women who are able to get pregnant must use birth control when using the device. This website intends to use cookies to improve the site and your experience. The average out-of-pocket cost for patients is $100 per month. Gutin PH, Wong ET. JAMA. 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. Learn more. 2017;318(23):2306-2316. World J Surg Oncol. The List of Remedies and Equipment describes which medical equipment are covered under compulsory health insurance. 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. Any forward-looking statements herein speak only as of the date hereof. 12. 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. 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. 8. 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. Number: 0827. 15. The science of Tumor Treating Fields extends beyond glioblastoma. “We are extremely pleased that Switzerland has established national reimbursement for Optune,” said Thomas Hefti, … 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. 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. 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. 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. Cell Death Dis. By continuing to browse the site you are agreeing to accept our use of cookies. “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. 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. Brain tumor treatment typically is covered by health insurance. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ:NVCR) announced today that Anthem, Inc. now covers Optune for members who have newly diagnosed glioblastoma (GBM). 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. Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. 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 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. Patient images reflect the health status of the patients at the time each photo was taken. 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). The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. The Private Securities Litigation Reform Act of 1995 permits this discussion. 2009;9:1. doi:10.1186/1756-6649-9-1. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. Novocure may also offer financial support to patients who qualify. “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 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. 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. This site is intended for US healthcare professionals only. 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. Anthem is the fourth and latest national commercial payer to issue a positive coverage policy for Optune. Medicare has published a proposed rule on coverage for Optune that would make most patients ineligible for this highly effective treatment. 3. Patient images reflect the health status of the patients at the time each photo or video was taken. 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. It is really, really important to show Medicare that we care about the outcome. 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. Stupp R, Taillibert S, Kanner A, et al. Novocure Vulnerability Disclosure Process. 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. Am Soc Clin Oncol Educ Book. 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. Programs are available for patients who are uninsured, underinsured, or need co-pay assistance and have a household income of ≤$150,000. 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. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. We have revised our Privacy Policy that is in effect as of May 25, 2018. Novocure 2019. J Neurooncol. Healthwell Foundation. 13. More than 107 million Americans now have coverage of Optune as a treatment for newly diagnosed and/or recurrent glioblastoma. Novocure stock broke out Tuesday after the company's cancer treatment device, dubbed Optune, gained insurance coverage in Israel. Optune therapy that may be leased from the manufacturer. World J Surg Oncol. There is no known risk to caregivers exposed to a patient receiving Optune. They will work with your insurance plan and identify resources to help minimize your cost for Optune, regardless of your financial situation. Novocure does not review the information contained on this website and/or database for content, accuracy, or completeness. Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. NovoTTF™-100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL™ system user study. The most common device-related AE, mild to moderate skin irritation, can typically be managed with topical therapies and rarely leads to treatment discontinuation.13,14, In the EF-14 phase 3 pivotal trial, patients with newly diagnosed GBM were monitored by MRI every second month from baseline until second progression or 24 months, whichever occurred first. Meet our leaders, who have extensive experience across oncology, biotechnology and medical device industries. 6. Novocure may also offer financial support to patients who qualify. 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, 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. 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. 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. 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. Int J Radiat Oncol Biol Phys. Novocure 2019. Do not use Optune in patients that are known to be sensitive to conductive hydrogels. The Optune device, which costs about $21,000 a month, caused some skin irritation but otherwise has no serious side effects. X. Optune has been tested for electromagnetic compatibility (active and passive) according to EN ISO 60601-1 standards. In December 2015, Aetna, Inc. released a medical coverage policy that affirmatively covers Optune 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. 2015;13:316. 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. 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. The average out-of-pocket cost for patients is $100 per month. Therefore, you should not rely on any such factors or forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. Novocure assists in all aspects of billing and reimbursement for Optune Lua to help achieve the best possible coverage available from your patients' insurance. We have since accomplished many significant milestones. 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 [email protected] in the European Union. Contact us. 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. Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields). On this site, videos and images identified as Optune users, caregivers or healthcare professionals depict actual patients, caregivers and healthcare professionals. On March 6, there will be a meeting to reconsider the denial of coverage. References: 1. Optune costs $21,000 per month. 11. The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. Toms SA, Kim CY, Nicholas G, Ram Z. 2. Policy. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. Disruption of cancer cell replication by alternating electric fields. Optune™ was not tested in pregnant women. In clinical practice, the frequency should ultimately be determined by the treating physician.1. 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. 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. NovoTAL—NovoTTF-100A Transducer Array Layout Software. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. 2019;141(2):467-473. 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. Kirson ED, Gurvich Z, Schneiderman R, et al. 4. 14. 2017;8(4):e2753. Talk to your doctor about it. 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. We pioneer a profoundly different approach to treating cancer called Tumor Treating Fields. Is Optune Lua covered by insurance companies for the treatment of MPM? 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. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Optune, Optune Lua, nCompass, NovoTAL, and Novocure are trademarks of Novocure. Optune Patient Information and Operation Manual. Please click here to access it. Kirson ED, Dbalý V, Tovarys F, 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. The effect of field strength on glioblastoma multiforme response in patients treated with the NovoTTF™-100A system. 10. Medicare has approved it but only for use in specific conditions. The Optune device is now generally covered by insurance. 2014;12:162. If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune treatment. 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. 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