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.ONCOLOGY
COVID-19's impact on cancer care is turning oncologists' worst fears into reality
NBC News
Recently, a patient of mine came to clinic with a new cough and shortness of breath. Though I was already treating him for stage 4 colon cancer that had studded his lungs, his acute symptoms made me even more concerned about COVID-19. Tragically, he died the next day as the coronavirus easily overpowered an immune system neutered by cancer and chemotherapy.
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A redesigned prior authorization is needed in oncology. Here's how.
Managed Healthcare Executive
Who among oncologists hasn’t grated against the process of prior authorization: the steps to seek permission to give our best patient-care efforts, the additional paperwork to fight denials, the time spent educating medical reviewers why requested therapies are needed?
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Immunomodulatory drugs improve the success rate of cancer therapies
News-Medical.Net
Immunomodulatory drugs, including the Contergan derivatives lenalidomide and pomalidomide, have significantly improved the therapy of hematologic malignancies such as multiple myeloma.
Researchers at the Technical University of Munich have now further decoded the mode of action in this class of medications. At the same time, they identified new innovative targeted cancer therapies.
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.GENOMICS
Genomic sequencing in pandemics
The Lancet
Advanced genetic sequencing techniques have undoubtedly provided valuable information on the biology and evolution of SARS-CoV-2. Never have the nearly 30,000 nucleotides of a virus been so closely considered by scientists, public health experts and politicians alike. But the use and application of genetic surveillance of SARS-CoV-2 has varied, risking an insufficient response to a rapidly changing pandemic.
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Unusual DNA folding increases the rates of mutations
Penn State via ScienceDaily
DNA sequences that can fold into shapes other than the classic double helix tend to have higher mutation rates than other regions in the human genome. New research shows that the elevated mutation rate in these sequences plays a major role in determining regional variation in mutation rates across the genome.
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Genomics is secret weapon in the fight against COVID-19 variants
The Times
Global medical revolutions rarely arrive with a knock on a Maidstone front door, but this week, with all the banality of an Amazon delivery, that’s exactly what has been happening.
In eight postcodes in the southeast, the northwest and the West Midlands, home swab kits are being delivered to 80,000 people as part of Operation Eagle, a surge testing program.
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.EMERGING MEDICAL TECHNOLOGIES
Liquid biopsy helps to assess effectiveness of therapy for colorectal cancer
Technology Networks
A new study from Washington University School of Medicine in St. Louis demonstrates that a liquid biopsy examining blood or urine can help gauge the effectiveness of therapy for colorectal cancer that has just begun to spread beyond the original tumor. Such a biopsy can detect lingering disease and could serve as a guide for deciding whether a patient should undergo further treatments due to some tumor cells evading an initial attempt to eradicate the cancer.
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Wearables and AI transforming health care diagnosis
Analytics Insight
Artificial intelligence has a significant role to play in the increasing digitization and automation of various industries. Advanced technologies like AI, machine learning, NLP, etc., have increased the pace and quality of digital transformation. Life becomes convenient and easier with these technological advancements. Healthcare is an important industry that has been crippling with shortcomings and quality erosion.
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Child brain tumors can be classified by advanced imaging and AI
Medical Xpress
Diffusion weighted imaging and machine learning can successfully classify the diagnosis and characteristics of common types of pediatric brain tumors a U.K.-based multi-center study, including WMG at the University of Warwick has found. This means that the tumor can be characterized and treated more efficiently.
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.BIOTECH/DIAGNOSTICS/PERSONALIZED MEDICINE
Precision medicine program analyzes diverse genetic dataset
HealthITAnalytics
Researchers from the University of Maryland School of Medicine have analyzed diverse genetic datasets in an effort to advance precision medicine for minority populations.
The early analysis is part of a large-scale program funded by the National Heart, Lung, and Blood Institute, and examines one of the largest and most diverse datasets of high-quality whole genome sequencing – which makes up a person’s DNA.
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.REGENERATIVE MEDICINE
Enzyme plays key role in waking brain stem cells from dormant state
Genetic Engineering & Biotechnology News
Scientists studying an enzyme in fruit fly larvae report that they have found that it plays an important role in waking up brain stem cells from their dormant quiescent state, enabling them to proliferate and generate new neurons. The Duke-NUS Medical School, Singapore team, which published its study “Histone lysine methyltransferase Pr‐set7/SETD8 promotes neural stem cell reactivation,” in EMBO Reports, says their work could help clarify how some neurological disorders such as autism and microcephaly occur.
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New research aims to explore functions of bile acids in the gut stem cell niche
News-Medical.Net
Examining gut health from a different angle, Flinders University’s Associate Professor Robyn Meech is looking at what can trigger colon cancer – and she believes bile acids may provide a significant piece of the puzzle.
Associate Professor Meech recently received Australian Research Council Discovery funding to investigate this under-explored area of gut and intestinal health, and aims to answer wide-ranging questions about the functions of bile acids in the gut stem cell niche.
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.MANAGED HEALTHCARE NEWS
Health spending of GDP could decrease over next two decades
Managed Healthcare Executive
Healthcare spending in the U.S. topped $3.8 trillion dollars in 2019 — nearly 18% of the gross domestic product — as projected by the CMS Office of the Actuary.
Prior to the COVID-19 pandemic, CMS had projected health spending would continue to grow at a rate of 5.3% a year, reaching nearly $6.2 trillion by 2028. If those increases were to continue unabated over the next 20 years, health spending could reach a staggering $11.8 trillion by 2040.
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COVID-19 vaccines OK for immunocompromised
Managed Healthcare Executive
As distribution of the COVID-19 vaccines sputters along, this question will be asked: Should people who are immunocompromised get vaccinated? Mostly, the answer is yes, according to the FDA and CDC. They both weighed in when the Pfizer-BioNTech and Moderna vaccines received emergency use authorizations from the FDA in December.
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.FDA: NEW TREATMENTS AND TECHNOLOGY
FDA approves drug to reduce bone marrow suppression caused by chemotherapy
FDA
On Feb. 12, the U.S. Food and Drug Administration approved Cosela as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer. Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin-dependent kinase 4/6, a type of enzyme.
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.ACCOUNTABLE CARE ORGANIZATIONS
How to bring specialists into the ACO fold: 9 strategies for success
Fierce Healthcare
Although specialty care drives 40% to 60% of medical costs, specialists are often disconnected from accountable care organizations. Their fee and incentive structures are distinct, and too many care management systems don’t try to bring specialists into the fold. Specialists, however, are critical to care delivery — and they should be viewed as care partners and not cost drivers.
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Medicaid managed care: Further reform needed to deliver on promise
AJMC
Evidence indicates a need for further reform in Medicaid managed care to ensure that private managed care organizations are improving spending, access and quality outcomes for beneficiaries. Private managed care organizations are increasingly responsible for administering Medicaid benefits across the U.S., yet there is little research on how they affect access, spending and care quality.
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.NAMCP UPDATES
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| Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that its resubmitted New Drug Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy for the treatment of molluscum contagiosum (molluscum), has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is June 23, 2021. Click here to view the full press release.
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| Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, today announced that the company has partnered with Chicago Public Schools (CPS) to provide antigen and Droplet Digital PCR (ddPCR)™ testing for Chicago Public School teachers and staff. The CPS testing program, which launched in January, is a surveillance testing protocol and uses rapid antigen tests to monitor the prevalence of COVID-19 among asymptomatic employees, followed by confirmatory ddPCR testing. Biodesix was one of the earlier laboratories to join in the fight against COVID-19, offering two COVID tests that earned Food and Drug Administration (FDA) Emergency Use Authorization (EUA) during the onset of the pandemic. Please click here to view the entire press release.
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| Home Instead, the leading provider of in-home care for older adults, has launched a new brand identity and campaign to promote the evolving organization. Formerly known as Home Instead Senior Care, the company was founded in 1994 by Paul and Lori Hogan to address a need for personalized care to allow adults to age at home, inspired by Paul’s own grandmother. It has since grown to more than 1,200 independently owned and operated franchises across the globe, which employ 90,000 professional caregivers and deliver more than 80 million hours of care annually. Created in partnership with creative agency Energy BBDO, the brand’s update includes a simplified logo and the removal of the term “senior care” from the official name – Home Instead. The changes are meant to be more inclusive and a reflection of the evolving global language around the way people talk about older adults. The name change also allows the brand to more broadly address helping aging adults meet their needs wherever they are on their care journey. Please click here to view the full press release.
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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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