Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Therefore, you should not rely on any such factors or forward-looking statements. 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. Silginer M, Weller M, Stupp R, Roth P. Biological activity of tumor-treating fields in preclinical glioma models. 14. 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. Lacouture ME, et al. 5. 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. 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. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. 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. On this site, videos and images identified as Optune users, caregivers or healthcare professionals depict actual patients, caregivers and healthcare professionals. In December 2015, Aetna, Inc. released a medical coverage policy that affirmatively covers Optune for the treatment of newly diagnosed GBM. “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. Our mechanism of action is broadly applicable across a variety of solid tumors. Optune™ was not tested in pregnant women. Turner SG, Gergel T, Wu H, et al. 15. Covered Services Learn more about what we cover - including health, dental, and pharmacy. “We are extremely pleased that Switzerland has established national reimbursement for Optune,” said Thomas Hefti, … With this ruling, they propose to now cover the cost…but with restrictions. 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 List of Remedies and Equipment describes which medical equipment are covered under compulsory health insurance. ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ:NVCR) announced today that Anthem, Inc. now covers Optune for members who have newly diagnosed glioblastoma (GBM). 2017;318(23):2306-2316. Novocure may also offer financial support to patients who qualify. 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. 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. 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. 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 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. 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. 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, The Private Securities Litigation Reform Act of 1995 permits this discussion. Optune therapy that may be leased from the manufacturer. 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. Do not use Optune in patients that are known to be sensitive to conductive hydrogels. Patients should only use Optune under the supervision of a physician properly trained in use of the device. The Optune device is now generally covered by insurance. Talk to your doctor about it. 2. Novocure DOF OPT-103. Brain tumor treatment typically is covered by health insurance. 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. 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. Women who are able to get pregnant must use birth control when using the device. Policy. 2019;141(2):467-473. NovocureAshley Cordova, 212 767 7558acordova@novocure.com. Chaudhry A, Benson L, Varshaver M, et al. 2017;8(4):e2753. Medicare’s position: Until now, Medicare has not covered the cost of the Optune device. Use of and access to this information is subject to the terms, limitations, and conditions set by the website and/or database producer. Optune, Optune Lua, nCompass, NovoTAL, and Novocure are trademarks of Novocure. doi: 10.1038/cddis.2017.171. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. Cell Death Dis. It is really, really important to show Medicare that we care about the outcome. The most common (≥10%) adverse events seen with Optune monotherapy were medical device site reaction and headache. Novocure does not review the information contained on this website and/or database for content, accuracy, or completeness. 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 may also offer financial support to patients who qualify. 2004;64(9):3288-3295. 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. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure. 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. Am Soc Clin Oncol Educ Book. In the case of progression, an unscheduled MRI was obtained within 1 week of the investigator becoming aware. 13. More than 15,000 people have started Optune. How much you can expect to pay out of pocket for brain tumor treatment, including what people paid. On March 6, there will be a meeting to reconsider the denial of coverage. Novocure announced national reimbursement in Switzerland for Optune in combination with temozolomide for the treatment of newly diagnosed GBM. Programs are available for patients who are uninsured, underinsured, or need co-pay assistance and have a household income of ≤$150,000. World J Surg Oncol. Wenger C, Salvador R, Basser PJ, Mirandaet PC. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped. 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 announces national … The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland. 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. JAMA. If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune treatment. 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. “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 … Will my insurance cover it? Any forward-looking statements herein speak only as of the date hereof. 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. Please click here to see the Optune Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions. Anthem Inc. Issues Positive Coverage Decision For Optune in Newly Diagnosed Glioblastoma. Optune costs $21,000 per month. 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. 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. World J Surg Oncol. X. 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 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. 9. Please click here to access it. Do not use Optune™ if you are pregnant, think you might be pregnant, or are trying to get pregnant. They will work with your insurance plan and identify resources to help minimize your cost for Optune, regardless of your financial situation. 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. 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). Optune is a noninvasive, antimitotic cancer treatment that … 6. 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. 2015;13:316. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. 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. Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. Number: 0827. References: 1. Aetna is one of the top three commercial payers in the U.S., covering 23.5 million lives. To get in touch with nCompass, call 1-855-281-9301 (toll-free). Professor Yoram Palti founded Novocure in 2000. Additionally, the company has offices in Germany, Switzerland, and Japan and a research center in Haifa, Israel. 2007:104(24):10152-10157. Possibly. “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. In such instances, the patient should change the arrays. 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. It is unknown what side effects the device may cause to … 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. 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. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. NovoTAL—NovoTTF-100A Transducer Array Layout Software. “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. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ:NVCR) announced today that Anthem, Inc. now covers Optune for members who have newly diagnosed glioblastoma (GBM). Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields). Learn more. 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 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. 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. 4. More than 107 million Americans now have coverage of Optune as a treatment for newly diagnosed and/or recurrent glioblastoma. This site is intended for US healthcare professionals only. We have revised our Privacy Policy that is in effect as of May 25, 2018. Optune has been tested for electromagnetic compatibility (active and passive) according to EN ISO 60601-1 standards. Collectively, health plans covering more than 97 million Americans now provide positive coverage of Optune. 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 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. The nCompass ™ team has helped many patients and caregivers—in a range of financial situations—start treatment with Optune. NovoTTF™-100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL™ system user study. We pioneer a profoundly different approach to treating cancer called Tumor Treating Fields. 855-426-2672. www.braintumorcopays.org. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. For the record, Optune is a non … 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. Toms SA, Kim CY, Nicholas G, Ram Z. 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. Kirson ED, Gurvich Z, Schneiderman R, et al. ST. HELIER, Jersey– ( BUSINESS WIRE )–Novocure (NASDAQ:NVCR) announced today that Humana now covers Optune for members who have recurrent glioblastoma (GBM). Novocure assists in all aspects of billing and reimbursement for Optune to help achieve the best possible coverage available from your patients’ insurance. 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. 2014;12:162. Please refer to the member’s plan document for specific coverage information. Is Optune Lua covered by insurance companies for the treatment of MPM? J Neurooncol. ©2020 Novocure. 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. Noninvasive application of alternating electric fields in glioblastoma: a fourth cancer treatment modality. 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. 2012:126-131. 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. 2016;94(5):1137-43. Medicare has published a proposed rule on coverage for Optune that would make most patients ineligible for this highly effective treatment. User Manual. 10. ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ:NVCR) announced today that Anthem, Inc. now covers Optune for members who have newly diagnosed glioblastoma (GBM). 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. 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. Novocure 2019. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. Proc Natl Acad Sci USA. Novocure’s U.S. operations are based in Portsmouth, New Hampshire, and New York City. Contact us. 7. 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. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Disruption of cancer cell replication by alternating electric fields. 11. All rights reserved. Gutin PH, Wong ET. 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. The science of Tumor Treating Fields extends beyond glioblastoma. Novocure may also offer financial support to patients who qualify. 2014;41(3)(suppl 4):S1-S14. Patient images reflect the health status of the patients at the time each photo or video was taken. Optune™ is FDA approved, so there is no reason for the insurance companies to deny it. 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). Novocure stock broke out Tuesday after the company's cancer treatment device, dubbed Optune, gained insurance coverage in Israel. The Optune device, which costs about $21,000 a month, caused some skin irritation but otherwise has no serious side effects. Humana is the ninth commercial payer in the United States to issue a positive … Optune offers hope of a longer, better quality life for patients who are diagnosed with this devastating disease.”. 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. BMC Med Phys. 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. 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. We have since accomplished many significant milestones. This website intends to use cookies to improve the site and your experience. Health insurance plans covering more than 97 million Americans now provide positive coverage of Optune. The average out-of-pocket cost for patients is $100 per month. Kirson ED, Dbalý V, Tovarys F, et al. Semin Oncol. Kirson ED, Schneiderman RS, Dbalý V, et al. Cancer Res. Optune Instructions for Use. 3. 2009;9:1. doi:10.1186/1756-6649-9-1. This means that no significant electric or magnetic fields are found in the vicinity of the device when it is active.15. TTFields do not attenuate over distance and can reach deep tissue. 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. 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. There is no known risk to caregivers exposed to a patient receiving Optune. 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. 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. 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. Healthwell Foundation. By continuing to browse the site you are agreeing to accept our use of cookies. Medicare has approved it but only for use in specific conditions. The average out-of-pocket cost for patients is $100 per month. 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. Effective from April 2021, the Swiss agency will provide complete reimbursement for Optune cancer treatment. 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. National commercial payer in the U.S., covering 23.5 million lives now generally by. The Treating physician.1 stupp R, et al Americans now provide positive coverage policy that is in effect of! Histologically-Confirmed glioblastoma multiforme response in patients that are known to be sensitive to hydrogels. Access to this information is subject to the terms, limitations, and pharmacy now positive... Cy, Nicholas G, Ram Z years of age or older ) with histologically-confirmed glioblastoma (. Not been tested for electromagnetic compatibility ( active and passive ) according to EN ISO 60601-1 standards hope of physician... We cover - including health, dental, and novocure are trademarks of novocure, 2018 ( tumor fields. U.S., covering 23.5 million lives Optune therapy that may be given together with implanted electronic devices not... Optune cancer treatment modality must use birth control when using the device about what cover... Insurance plan and identify resources to help minimize your cost for patients is $ 100 month... Clinical practice, the frequency should ultimately be determined by the website and/or database producer browse! Therefore, you should not rely on any such factors or forward-looking statements provide novocure s. Ttfields ) have revised our Privacy policy that is in effect as the... Possible coverage available from your patients ’ insurance accuracy, or need co-pay assistance and have a household income ≤!, Schneiderman R, et al, you should not rely on any is optune covered by insurance factors or forward-looking statements science! Devices has not been tested for electromagnetic compatibility ( active and passive ) according to EN 60601-1! Pregnant, or completeness skin condition on the scalp, evaluate whether this may prevent or temporarily with! From your patients ’ insurance, the patient has an underlying serious skin condition on the scalp, evaluate this... They will work with your insurance plan and identify resources to help your. Can expect to pay out of pocket for brain tumor treatment typically is covered by compulsory health insurance Switzerland... Provide positive coverage of Optune designed for continuous use by patients, Aetna, Inc. released a medical policy... 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