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As 2020 comes to a close, GBEMTI would like to wish its members, partners and other industry professionals a safe and happy holiday season. As we reflect on the past year for the industry, we would like to provide the readers of the newsbrief a look at the most accessed articles from the year. Our regular publication will resume Thursday, Jan. 7.
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Intermittent fasting: A yay or nay for healthcare professionals?
By Amanda Ghosh
From Jan. 9: Intermittent fasting (IF) is trending in the health and fitness industry. As a style of eating, it involves cycling between periods of eating and fasting. But should healthcare professionals use it as a way to manage their weight? For shift workers, it may have some appeal. At its most basic level, IF involves periods of eating and fasting. However, there are several ways to schedule periods of eating and fasting.
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Venom from honeybees found to kill aggressive breast cancer cells
Harry Perkins Institute of Medical Research via ScienceDaily
From Sept. 10: Using the venom from 312 honeybees and bumblebees in Perth Western Australia, Ireland and England, Dr Ciara Duffy from the Harry Perkins Institute of Medical Research and The University of Western Australia, tested the effect of the venom on the clinical subtypes of breast cancer, including triple-negative breast cancer, which has limited treatment options.
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America is about to get a powerful tool in the war against cancer
CNBC
From Jan. 23: America’s war on cancer is about to get another tool in its arsenal. The country’s first carbon ion therapy center to treat cancer is being built in collaboration with Hitachi on the campus of the Mayo Clinic in Jacksonville, Florida. The cancer therapy treatment will be part of Mayo’s $233 million oncology facility. An alternative to surgery, this new treatment is viewed as the next horizon of cancer care.
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Intermittent fasting: A popular diet with serious psychological risks
Inverse
From Aug. 1: To follow most diets, you have to give something up: Dessert, carbs, or even a whole day of eating. But often, that’s not all. Sometimes your mental and emotional health can take a hit, too. Here, four experts tell Inverse the sneaky ways diets like intermittent fasting can both improve mental health and jeopardize it.
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The oncology care model and its heir apparent
Managed Healthcare Executive
From March 19: Cancer is not quite the ferocious killer that it used to be. Millions of Americans are living with cancer, not just dying from it. Reasons for the diminishing death rate include lower smoking rates, earlier detection of some cancers, and advances in treatment. Treatment costs can easily exceed $100,000 a year. In response, the Centers for Disease Control and Prvention and commercial insurers are establishing alternative payment models, which, in theory, are supposed to slow down the stampeding costs while protecting, and perhaps even improving, the quality of cancer care.
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What makes cancer patients resistant to immuno-oncology drugs? Protein signals offer a clue
FierceBiotech
From July 23: Checkpoint inhibitors like Merck's blockbuster PD-1 blocker Keytruda are now widely used to treat several tumor types, but many patients don't respond to these drugs for reasons that remain a mystery. Now, a team led by researchers at the University of Pittsburgh School of Medicine is shedding new light on a possible mechanism of resistance to PD-1 blockade.
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Telemedicine will be a mainstay in oncology long after COVID-19
Oncology Nursing News
From Aug. 13: Telehealth is likely to stay in the oncology realm, even after the novel coronavirus 2019 pandemic passes, according to findings of the first part of the State of the Physician Survey conducted by MJH Life Sciences, which focused on physician and patient communications in the era of COVID-19.
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CMS agrees to cover 'breakthrough' medical devices
Mass Device
From Sept. 10: Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released Aug. 31.
Once the Medicare Coverage of Innovative Technology final rule goes into effect, national Medicare coverage will begin on the date a breakthrough device’s FDA market authorization would begin and continue for 4 years.
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.NAMCP UPDATES
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| Biodesix, Inc., a leading data-driven diagnostic solutions company with a focus in lung disease, today announced publication of an analysis of the company’s Nodify XL2® lung nodule test. The test supports clinical decision-making for suspicious nodules by more accurately identifying patients with a very low risk of malignancy and shifting those patients into surveillance, thereby minimizing invasive procedures on those with benign nodules. Please click here to view the full press release.
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| LivaNova PLC, a market-leading medical technology and innovation company, today announced the publication of a new study in the International Journal of Bipolar Disorders that showed adding Vagus Nerve Stimulation Therapy (VNS Therapy®) to treatment as usual (TAU) significantly improves outcomes in patients with treatment-resistant bipolar depression (TRBD). The study examined patients from a five-year prospective registry and found 63% of TRBD patients treated with adjunctive VNS Therapy in addition to TAU had a significant reduction in depressive symptoms, as measured by a 50% or greater reduction in the Montgomery–Åsberg Depression Rating Scale (MADRS), compared with 39% of patients in the TAU alone group. Click here to view the entire press release. Click here to view the entire press release.
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| Additionally, LivaNova PLC announced a publication in Contemporary Clinical Trials, which details the design for “A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression” or the RECOVER clinical study. RECOVER is currently under way as part of a Coverage with Evidence Development framework of the U.S. Centers for Medicare & Medicaid Services’ (CMS) National Coverage Determination process. Click here to view the entire press release.
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| In late 2018, the National Association of Managed Care Physicians (NAMCP) decided to create the Value Based Care Council (VBCC). The VBCC mission supports empowering medical directors with information and resources to assist them in making value based decisions that support achieving the Triple AIM of improved outcomes and the patient experience while reducing overall costs. The goal is to improve the integration of cost, quality, and access in the clinical decision making process so as to enhance the effectiveness and efficiency of extracting value from the associated spend in order to optimize outcomes.
Pursuant to the above, and in response to an unmet need in the marketplace, the VBCC developed a short form in order to enhance the effectiveness and efficiency with which value propositions can be shared between industry and the medical leadership of various payers throughout the country. This same short form provides a concise and consistent manner with which value propositions can be shared and provides the ability to align expectations prior to actually conducting conversations or having a meeting regarding a product or service.
The Product Value Proposition Customer Engagement Short Form can be found on the NAMCP website (www.namcp.org) in the Value Based Care Council subsection of the Councils tab, under tools and resources. Please contact Will Williams at wwilliams@namcp.org with questions or for additional information.
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| Jazz Pharmaceuticals is excited to announce the approval of ZEPZELCA™ (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. ZEPZELCA is a second-line therapy that has been studied in both platinum-sensitive and -resistant SCLC patients. Please click here for more information.
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| Takeda Pharmaceuticals is part of, "The Fight Is In Us", an initiative to maximize the individual and societal benefit of COVID-19 plasma. The campaign will focus on recruiting COVID-19 survivors to donate their plasma at licensed blood and plasma donor centers.- If you’ve recovered from #COVID19, your immune system has antibodies that could be used as a treatment. See if you can help others by donating plasma www.TheFightIsInUs.org. #TheFightIsInUS
- The antibodies that helped you or someone you know fight off COVID-19 may be able to help others. Visit www.TheFightIsInUs.org to see if you qualify to donate plasma. #TheFightIsInUs
You are a survivor, now you could be a hero. Plasma from recovered #COVID19 patients could play a key role in creating a potential therapy for coronavirus. Learn how you can donate at www.TheFightIsInUs.org #TheFightIsInUs
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| Biodesix, Inc., a leading diagnostic company in lung disease, recently announced a partnership with Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) to bring a COVID-19 Droplet Digital PCR (ddPCR) test to the FDA for an Emergency Use Authorization (EUA) approval to support the escalating need for testing in the U.S. Two studies published this month, ahead of peer review, reported that ddPCR testing showed superior sensitivity and precision for clinical detection of SARS-CoV-2 (the virus that causes COVID-19) compared to existing test methods that are performed using qPCR. Biodesix currently has a focus on lung disease and offers other diagnostic testing for lung cancer utilizing the ddPCR platform.Click here for more information.
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| "Modeling Cost-Effectiveness of On-Demand Treatment for Hereditary Angioedema Attack" was recently published in the Journal of Managed Care Pharmacy's February 2020 issue. Hereditary angioedema (HAE) is a rare disease that causes painful and potentially fatal episodes of swelling (attacks). HAE attacks can be unpredictable and the need to treat sudden attacks promptly and effectively is critical to minimize risk of hospitalization, morbidity, and mortality. A cost-effectiveness model was evaluated that considers evaluation of on-demand medications, healthcare utilization and patient well-being. For access to the publication, please click here.
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| Biodesix, Inc. announced initiation of the next phase of their biomarker development program with Merck KGaA, Darmstadt, Germany and Pfizer Inc. The companies have completed initial discovery and development of a new proteomic test that identifies likely responders to the anti-PD-L1 checkpoint inhibitor (BAVENCIO®) (avelumab). Development efforts will now focus on transferring the test into Biodesix's CLIA lab in Boulder, CO for clinical phase test validation. The new test was developed through retrospective analysis of the circulating proteome of cancer patients treated with the investigational drug candidate, utilizing the proprietary Biodesix Diagnostic Cortex™ artificial intelligence (AI) platform. Click here to read the full press release.
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| The NAMCP Medical Directors Institute recently held the first meeting of its Executive Leadership Council (ELC) at the recent Fall Managed Care Forum. The NAMCP Medical Directors Institute decided in late 2018 to create the Value Based Care Council (VBCC) with a mission to empower medical directors with information and resources to assist them in making value based decisions that support achieving the Triple AIM of improved outcomes and the patient experience while reducing overall costs. Click here to view an overview of the genesis, formation, and work of NAMCP's Value Based Care Council. Please click here to view the press release.
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| LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced the first patient enrolled in "A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression" (RECOVER). The study will evaluate Vagus Nerve Stimulation Therapy (VNS Therapy) for Treatment-Resistant Depression (TRD) in accordance with the U.S. Centers for Medicare & Medicaid Services (CMS) National Coverage Determination as part of its Coverage with Evidence Development Program. The first patient was enrolled by Dr. Azfar Malik in St. Louis. Click here to read the full press release.
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| Biodesix, Inc. this week highlighted findings from multiple studies demonstrating the significance and clinical utility of its VeriStrat® blood-based proteomic test as a predictive biomarker for patient survival outcomes and as a diagnostic tool to improve the clinical management of patients with non-small cell lung cancer (NSCLC). This information is vital to implementing optimal treatment strategies for patients and supports disease state monitoring. To date, VeriStrat testing has helped more than 50,000 patients in determining the best treatment for their lung cancer. Click here to see the full press release. | |
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