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Aug. 20, 2020
 
 
ONCOLOGY
 
 
Disruptions to global oncology trials have fallen to a 3-month low
Clinical Trials Arena
The global COVID-19 pandemic has impacted clinical research significantly. Focusing primarily on oncology, clinical research disruptions involving experimental cancer therapeutics raise severe challenges, as these trials can be highly time-sensitive and even small administrative delays can prove highly detrimental to patient populations.
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ASCO releases position statement on home infusion of anticancer treatments
Cancer Therapy Advisor
The American Society of Clinical Oncology released a position statement about the administration of anticancer therapies in the home setting, in which concerns were raised about patient and caregiver safety, lack of adequate oncology nursing staff and payer reimbursement issues.
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Delaying prostate cancer radiation therapy offers room for flexibility in pandemic peak
Medical Xpress
For cancer patients receiving radiation treatment during a surge in COVID-19 cases, adhering to the stay-at-home orders of quarantine is not always an option. The daily hospital trips potentially increase exposure, which is especially dangerous because cancer patients are at high risk for COVID-19 mortality.
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GENOMICS
 
 
Rare diseases: Innovation, collaboration and genomics
Health Europa
Professor Hackett discusses public-private collaboration, secure data sharing and the potential of genomic sequencing for the treatment of rare diseases. Professor Joanne Hackett, General Partner, Healthcare at early stage venture and growth stage advisory firm Izy Capital, joined the company from Genomics England, where she oversaw industry engagement and commercial collaboration.
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How genomics will help us track COVID-19
Newsroom
New Zealand has found itself suddenly plunged into a dire situation: Four new cases of COVID-19 in the community with no obvious link to the border, managed isolation and quarantine facilities or overseas travel. While contact tracing is underway to attempt to find out who infected Aug. 11's four cases and search for more links to the border, it could still come up blank.
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Combining genomic, EHR data could improve epilepsy treatment
Xtelligent Healthcare Media
By combining EHR data and genomic information, researchers were able to identify gene-specific signatures in childhood epilepsies, according to a study published in Genetics in Medicine. The findings could lead to better treatments for the disorder, as well as improved clinical decision support tools.
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EMERGING MEDICAL TECHNOLOGIES
 
 
Lung cancer deaths are declining faster than new cases. Advances in treatment are making the difference
STAT News
This year’s annual release of cancer statistics generated more buzz than usual. Perhaps the most publicized finding in the Cancer Facts & Figures 2020 report was the 2.2% decline in overall cancer deaths from 2016 to 2017, the last year for which we have final statistics.
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Breast cancer 'ecosystem' reveals possible new targets for treatment
Medical Xpress
Researchers from the Garvan Institute of Medical Research have uncovered four new subtypes of cells within triple negative breast cancer, which contain promising new therapeutic targets for the aggressive disease. Using cellular genomics, the team revealed one of the new cell types produces molecules that suppress immune cells, which may help cancer cells evade the body's immune system.
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Why medical manufacturers must embrace factory of the future
Medical Tech Outlook
In medical education and training, the conventional training model has been the accepted teaching standard for years. During the training period, each trainee's exposure differs, and it is nearly impossible to make sure that all learning opportunities will be available to them in the clinical environment.
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BIOTECH/DIAGNOSTICS/PERSONALIZED MEDICINE
 
 
HHS invests $6.5M in diagnostic labs to expand COVID-19 testing
Reuters
The U.S. government is investing $6.5 million in two diagnostic laboratories to increase the country’s COVID-19 testing capacity and perform an additional 1 million tests each week by early October.
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Why is precision medicine gaining popularity in health care?
Healthcare Tech Outlook
The idea behind precision medicine has always been the aim of the healthcare providers, and it's becoming truly achievable with recent technological advancements. The healthcare environment is in the turmoil of disruptive changes, with new technologies promising revolutionary advances in medicine and life-extending therapies.
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RENEGERATIVE MEDICINE
 
 
3D printing technique differentiates stem cells into heart cells
Drug Target Review
A new study has shown that 3D printing can be used to control stem cell differentiation into embryoid bodies that replicate heart cells. Scientists report that they have printed heart cells using additive manufacturing to control stem cell differentiation in embryoid bodies, which are stem cells packed into small cellular aggregates or spheres.
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Role of stem-cell transplantation in leukemia treatment
Dovepress
Stem cells play a major role in advanced fields of regenerative medicine and other research areas. They are involved in the regeneration of damaged tissue or cells, due to their self-renewal characteristics. Tissue or cells can be damaged through a variety of diseases, including hematologic and nonhematologic malignancies.
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MANAGED HEALTHCARE NEWS
 
 
How to ensure COVID-19 doesn’t delay value-based care
Health Affairs
The prognosis of COVID-19 on the U.S. health care system may include yet another devastating outcome: delaying its transition to value-based care. The Centers for Medicare and Medicaid Services has stopped accepting applications for new accountable care organizations in 2021.
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Despite pandemic, health system and payer profits up due to less utilization
By Scott E. Rupp
Second-quarter headlines reporting the financial windfalls of payer organizations and health systems have been copious recently, despite what experts and analysts predicted would be devastating hits to the ledger because of the 2020 COVID-19 pandemic. Even as many health systems treated only virus cases and most others shut down all elective surgeries, all of the nation's largest for-profit hospital chains saw a rise in profits.
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FDA: NEW TREATMENTS AND TECHNOLOGY
 
 
FDA approves new opioid for intravenous use in hospitals, other controlled clinical settings
U.S. Food & Drug Administration
On Aug. 7, the U.S. Food and Drug Administration approved Olinvyk, an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.
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FDA approves Guardant’s tumor-sequencing blood test as a Tagrisso lung cancer diagnostic
Fierce Biotech
Guardant Health received a milestone approval from the FDA for its cancer test, as the first liquid biopsy able to genetically profile solid tumors anywhere in the body through a single blood draw.
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ACCOUNTABLE CARE ORGANIZATIONS
 
 
CMS unveils new value-based care, ACO options for rural providers
Xtelligent Healthcare Media
A new rural health model recently unveiled by CMS will offer rural providers and their communities new funding opportunities to bolster value-based care through capitated payments and accountable care organization participation.
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What will COVID-19 mean for value-based models?
Medical Economics
Six months into the COVID-19 pandemic, its impact on medical practices is becoming clear: fewer in-person visits, more care provided via telehealth and, for many, lower revenue. But even as doctors struggle with the day-to-day challenges of practicing under radically new circumstances, some health care policy makers, academics and payers are asking another question.
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NAMCP UPDATES
 
 

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.


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.


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


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.


"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.


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.


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.


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.


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.
 
 
Genomics Biotech and Emerging Medical Technologies Institute eBrief
 
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Dennis Hall, Director of Publishing, 469-420-2656 | Download media kit
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