Biosimilars Group Pushes For Medicine Access Measures
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UChicago Medicine and UIC researchers to study expanded access to rapid COVID-19 testing
Researchers at the University of Chicago Medicine and the University of Illinois at Chicago (UIC) are launching an investigational study to determine the effects of increased education and access to rapid, FDA-approved COVID-19 testing on community perceptions, access, and use of COVID-19 testing resources.
The study will be funded by $2M in support from the National Institutes for Health RADx-UP program. A part of the Rapid Acceleration of Diagnostics (RADx) initiative, the RADx Underserved Populations (RADx-UP) program supports research that aims to better understand COVID-19 testing patterns among underserved and vulnerable populations; strengthen the data on disparities in infection rates, disease progression and outcomes; and develop strategies to reduce the disparities in COVID-19 testing.
The research will be led by Ayman Al-Hendy, MD, professor of obstetrics and gynecology at UChicago Medicine, and Renee Taylor, PhD, professor of occupational therapy and Nahed Ismail MD, PhD, D(ABMM), D(ABMLI), professor of pathology and medical director of clinical microbiology at the University of Illinois at Chicago. The investigators plan to leverage existing university-community partnerships and expertise in clinical microbiology, community engagement, and epidemiological infrastructures to expand access to rapid COVID-19 testing.
“There are testing deserts in Chicago, where many people don’t have easy or affordable access to testing,” said Taylor. “We can reach individuals who maybe don’t have health insurance or are concerned about having a COVID-19 test on their medical record and provide them with an easy and private opportunity to get tested.”
The project includes collaboration with community members to co-create advertisements to recruit other participants into the trial as well as a mobile health web app, called the mHealth Literacy and Outreach Suite, that will allow individuals to not only privately order testing, but also learn how to prevent the spread of COVID-19 and care for themselves if they fall ill.
Investigators are also sending out kits so participants can collect their own samples and send them to be tested at UIC. Sample collection can be performed rapidly at home with a nasal swab, without the discomfort of the typical nasopharyngeal swab, before sending the sample to the central lab for testing.
The team hopes that the privacy offered by these options, as well as the community advocacy, will help improve the public perception of receiving a COVID-19 test.
“Many people don’t trust the test, are concerned about the expense, or are worried that they’ll be forced out of work or forced to isolate if they have a positive test, which is creating a lot of stigma,” said Ismail. “We need to expand our testing in a community setting where people have some privacy, and the mHealth Suite provides that, as well as overcoming issues of cost.”
Al-Hendy credits the skills of the interdisciplinary team and their pooled community networks for making this collaborative effort possible. “The collaboration between UIC and UChicago Medicine will allow this project to reach many underserved populations,” he said. “Our two institutions already both have robust relationships within our local communities, which will help expand the
AccessHope and Northwestern Medicine Announce Novel Collaboration to Expand Nationwide Access to Best-in-Class Cancer Expertise
DUARTE, Calif. & CHICAGO–(BUSINESS WIRE)–On the heels of AccessHope’s national launch in October, the wholly owned subsidiary of City of Hope today announced it has joined forces with Northwestern Medicine to provide specialized cancer expertise to help more people achieve the best possible cancer outcomes. This novel collaboration brings two National Cancer Institute-designated comprehensive cancer centers together, enabling some of the country’s most sought-after specialists to offer expertise that can improve care, experience, outcomes and value for patients in the treatment of complex cancers.
“The NCI designation represents an elite group of cancer centers recognized for delivering high-quality clinical care, superior outcomes and outstanding patient experiences,” said AccessHope CEO Mark Stadler. “We’re honored to have Northwestern Medicine join City of Hope in the AccessHope program.”
The collaboration, which expands the current City of Hope network to now include experts from Northwestern Medicine, comes at a crucial time considering that COVID-19 has shown to have impacted cancer diagnosis, care and treatment. “COVID-19 has resulted in the number of cancer screenings and resulting diagnoses dropping significantly over the last several months,” noted Stadler. “AccessHope anticipates that as a result, cancer diagnoses may come later, when cancer has progressed or is at a more advanced stage, making it even more vital for individuals to receive an expert review of their case and start on the right course of treatment the first time.” City of Hope recognized the tremendous benefit to cancer patients of reimagining how they can receive the most innovative care available as close to home as possible. Demand from employers across the country led City of Hope to establish AccessHope. Today, AccessHope serves approximately 1.95 million members who have its cancer support services through 34 employers including 11 Fortune 500 companies.
AccessHope’s collaboration with Northwestern Medicine furthers its commitment to optimizing care for people facing cancer, regardless of their location. Through an employer health care benefit, employees of AccessHope clients who are diagnosed with cancer and their local treating oncologist can benefit from the expertise of specialists knowledgeable in the latest cancer discoveries for review of diagnosis, treatment plan and precision medicine opportunities, as well as clinical trial information and support services, without ever needing to leave their community.
“We believe access to the expertise we have at Northwestern Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University should not be limited by geography,” said Dean M. Harrison, president and chief executive officer, Northwestern Memorial HealthCare. “Through this collaboration, AccessHope members will benefit from the knowledge and experience of our world-class physicians and the latest in cancer research and treatment options.”
Top Ten Cancer Hospital Increases Remote Support Footprint
Northwestern Medicine is a nationally recognized health system that provides world-class compassionate care. Backed by Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Northwestern Memorial Hospital is ranked No. 8 in the nation for cancer care by U.S. News and World Report, 2020 – 2021. The Lurie Cancer Center is part of a select group of
New Northwestern Medicine location provides patients local access to highest level of thoracic surgery care
Patients in Chicago’s northwest suburbs now have local access to the surgery team that performs state-of-the-art minimally invasive and robotic chest surgery, treatment for cancers of lung and esophagus, and lung transplantation at Northwestern Memorial Hospital.
Dr. Ankit Bharat, who performed the United States’ first double lung transplant on a patient with COVID-19, began to see patients in McHenry on Oct. 20.
The new office location at Northwestern Medicine McHenry Hospital will be open to patients who have diseases of the chest, including the airways, lungs, esophagus, diaphragm and chest wall. Bharat and his surgical partners will receive referrals from medical oncologists, pulmonologists and other physicians who care for patients in the McHenry County area.
“Our goal is to provide unparalleled care of the highest quality to our patients, close to home,” Bharat said. “We are committed to providing the entire gamut of treatments for both simple and complex problems in the chest.”
“Our patients can have appointments and follow-up care in McHenry, and if they need specialized surgeries we perform them in Chicago. This approach provides patients the best of both worlds — convenience for appointments and access to highly advanced surgeries when they’re needed.”
Nick Rave, president of Northwestern Medicine McHenry Hospital, said patients will benefit from the relationships between the physicians and hospital teams.
“Our patients want the peace of mind that they’re doing all they can to address their health issues,” Rave said. “By bringing these experienced thoracic surgeons to McHenry, we’re making it easier for people who are already balancing family life, work and a health diagnosis.”
Supreme Court changes fuel moves to protect abortion access
A vast swath of West Texas has been without an abortion clinic for more than six years. Planned Parenthood plans to change that with a health center it opened recently in Lubbock.
It’s a vivid example of how abortion-rights groups are striving to preserve nationwide access to the procedure even as a reconfigured Supreme Court — with the addition of conservative Justice Amy Coney Barrett — may be open to new restrictions.
Planned Parenthood has made recent moves to serve more women in Missouri and Kentucky, and other groups are preparing to help women in other Republican-controlled states access abortion if bans are imposed.
“Abortion access in these states now faces its gravest ever threat,” said Alexis McGill Johnson, Planned Parenthood’s president. She said the new health center in Lubbock “is an example of our commitment to our patients to meet them where they are.”
The clinic opened on Oct. 23 in a one-story building that had been a medical office and was renovated after Planned Parenthood purchased it. To avoid protests and boycotts that have beset some previous expansion efforts, Planned Parenthood kept details, including the clinic’s location, secret until the opening was announced.
Planned Parenthood says the health center will start providing abortions — via surgery and medication — sometime next year. Meanwhile, it is offering other services, including cancer screenings, birth control and testing for sexually transmitted infections.
Planned Parenthood closed its previous clinic in Lubbock, a city of 255,000 people, in 2013 after the Texas Legislature slashed funding for family planning services and imposed tough restrictions on abortion clinics.
That law led to the closure of more than half the state’s 41 abortion clinics before the Supreme Court struck down key provisions in 2016. There were no clinics left providing abortion in a region of more than 1 million people stretching from Amarillo in the Texas Panhandle south to Lubbock and the oil patch cities of Odessa and Midland.
Women in Lubbock faced a 310-mile (500-kilometer) drive to the nearest abortion clinic in Fort Worth.
Anti-abortion activists have been mobilizing to prevent the return of abortion services to Lubbock — and are not giving up even with the new clinic’s opening.
“Lubbock must not surrender to the abortion industry,” said Kimberlyn Schwartz, a West Texas native who attended Texas Tech University in Lubbock and is now communications director for Texas Right to Life.
Her organization has backed a petition drive trying to persuade the City Council to pass an ordinance declaring Lubbock a “sanctuary city for the unborn.” Abortion opponents hope that designation would lead to either enforcement efforts or lawsuits seeking to block abortion services.
Thus far, the City Council has declined to adopt the ordinance, but activists say they have enough signatures to place it on the ballot in a local referendum.
Texas is one of several red states where Planned Parenthood has sought to expand abortion access. Earlier this year, its health center in Louisville, Kentucky, began providing abortions after obtaining a license
More US patients to have easy, free access to doctor’s notes
More U.S. patients will soon have free, electronic access to the notes their doctors write about them under a new federal requirement for transparency.
Many health systems are opening up records Monday, the original deadline. At the last minute, federal health officials week gave an extension until April because of the coronavirus pandemic.
Britta Bloomquist of Duluth, Minnesota, has been reading her clinical notes for years, first struggling through red tape and more recently clicking into a secure online patient website.
“It means information about your care can no longer be hidden from you. And you have a say in your care,” said Bloomquist, 32, who has a rare type of arthritis that took years to diagnose.
WHAT’S CHANGING?
Patients have long had a right to their medical records, including doctor notes, but obtaining them could mean filling out requests, waiting for a response and paying fees. A 2016 law said delays and barriers must be removed.
If you already use a patient portal such as MyChart to email your doctor or schedule an appointment, you may soon see new options allowing you to view your doctor’s notes and see your test results as soon as they are available. You may get an email explaining where to look, how to share access with a caregiver and how to keep other eyes off your information.
Many people won’t notice a change. About 15% of health care systems already are letting patients read doctor notes online without charge. That means about 53 million patients already have access to their doctor’s notes.
WILL THIS HELP ME?
Studies have shown that patients who read their notes understand more about their health, take their medications as prescribed more often and feel more in control of their care.
That’s true for Bloomquist. Diagnosed with a rare type of arthritis called ankylosing spondylitis, she had extensive surgery to straighten her right leg in 2018. She gets regular drug infusions and sees multiple specialists. It’s a lot to remember.
“I’ve become a health nerd,” Bloomquist said. “Reading the notes has kept me on the same page as my providers about what’s going on.”
WILL I UNDERSTAND THE JARGON?
You may have to look up terms. Or ask you doctor to translate at your next visit. And doctor’s notes tend to use abbreviations. “SOB” means short of breath, by the way. “BS” can mean bowel sounds.
And brace yourself if your weight is an issue.
“I’m a heavy-set person, OK? And their favorite word to use is obese,” said Rosie Bartel, 71, of Chilton, Wisconsin. “You have to get used to that. Doctors use that word.”
To Bartel, who became more involved in her care after getting an infection in the hospital, reading notes means she’s doing what she can to prevent errors and stay healthy.
“I don’t have to remember everything said to me in a 15-minute appointment,” she said.
WHAT IF I SPOT AN ERROR?
Patients do find mistakes in their notes and some errors
More US Patients to Have Easy, Free Access to Doctor’s Notes | Political News
By CARLA K. JOHNSON, AP Medical Writer
More U.S. patients will soon have free, electronic access to the notes their doctors write about them under a new federal requirement for transparency.
Many health systems are opening up records Monday, the original deadline. At the last minute, federal health officials week gave an extension until April because of the coronavirus pandemic.
Britta Bloomquist of Duluth, Minnesota, has been reading her clinical notes for years, first struggling through red tape and more recently clicking into a secure online patient website.
“It means information about your care can no longer be hidden from you. And you have a say in your care,” said Bloomquist, 32, who has a rare type of arthritis that took years to diagnose.
Patients have long had a right to their medical records, including doctor notes, but obtaining them could mean filling out requests, waiting for a response and paying fees. A 2016 law said delays and barriers must be removed.
If you already use a patient portal such as MyChart to email your doctor or schedule an appointment, you may soon see new options allowing you to view your doctor’s notes and see your test results as soon as they are available. You may get an email explaining where to look, how to share access with a caregiver and how to keep other eyes off your information.
Many people won’t notice a change. About 15% of health care systems already are letting patients read doctor notes online without charge. That means about 53 million patients already have access to their doctor’s notes.
Studies have shown that patients who read their notes understand more about their health, take their medications as prescribed more often and feel more in control of their care.
That’s true for Bloomquist. Diagnosed with a rare type of arthritis called ankylosing spondylitis, she had extensive surgery to straighten her right leg in 2018. She gets regular drug infusions and sees multiple specialists. It’s a lot to remember.
“I’ve become a health nerd,” Bloomquist said. “Reading the notes has kept me on the same page as my providers about what’s going on.”
WILL I UNDERSTAND THE JARGON?
You may have to look up terms. Or ask you doctor to translate at your next visit. And doctor’s notes tend to use abbreviations. “SOB” means short of breath, by the way. “BS” can mean bowel sounds.
And brace yourself if your weight is an issue.
“I’m a heavy-set person, OK? And their favorite word to use is obese,” said Rosie Bartel, 71, of Chilton, Wisconsin. “You have to get used to that. Doctors use that word.”
To Bartel, who became more involved in her care after getting an infection in the hospital, reading notes means she’s doing what she can to prevent errors and stay healthy.
“I don’t have to remember everything said to me in a 15-minute appointment,” she said.
Patients do find mistakes in their notes and some errors are serious enough to affect their care,
MHRA Grants HAE Patients Early Access to BioCryst’s Berotralstat in United Kingdom
RESEARCH TRIANGLE PARK, N.C., Oct. 30, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted oral, once-daily berotralstat a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).
Under the EAMS, hereditary angioedema (HAE) patients in the UK aged 12 years and older can gain access to berotralstat for the routine prevention of recurrent attacks of HAE before the drug is granted marketing authorization by the European Commission (EC).
HAE is a serious, and potentially life-threatening, rare genetic illness characterised by periodic episodes of acute swelling of the skin, pharynx, larynx, gastrointestinal tract, genitals and/or extremities.
Medicines included in the EAMS are those that have a high unmet need, are intended to treat, diagnose or prevent seriously debilitating or life-threatening conditions where there are no adequate treatment options, and are likely to offer significant advantage over methods currently used in the UK. Under the scheme, the MHRA provides a scientific opinion on the benefit-risk balance of the medicine, based on the data available when the EAMS submission was made.
“There are many patients in the UK that don’t have a realistic option for effective HAE prophylaxis. The addition of berotralstat through the EAMS will bring a much needed option for HAE patients suffering with this debilitating disease,” said Dr. Sorena Kiani, Consultant Immunologist at Royal London Hospital, London.
“HAE patients around the world are waiting for an oral, once-daily therapy to prevent attacks and reduce their burden of therapy. With this decision by the MHRA, the wait for many HAE patients in the UK can end sooner,” said Jon Stonehouse, chief executive officer of BioCryst.
The European Medicines Agency (EMA) is reviewing the marketing authorisation application (MAA) for berotralstat under the centralized procedure. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected approximately 12 months from MAA validation, which the company announced on March 30, 2020.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including ORLADEYO™ (berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.BioCryst.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements are identified by use of terms such as “expect,” “will,” and similar words, although
Philips empowers medical image access for over 5,000 clinicians in the Region of Southern Denmark
Clinician reads radiology images
October 26, 2020
Philips Clinical Collaboration Platform supports telehealth and other connectivity initiatives to increase collaboration across hospitals
Amsterdam, The Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the completion of a regional informatics project that consolidates radiology and nuclear medicine imaging data. The Region of Southern Denmark now has a single system for storing, retrieving, and viewing clinical images across all the locations and specialties in its extensive healthcare system.
The Region of Southern Denmark health service encompasses four hospital groups with a total of 12 hospitals that serve a population of over 1.2 million people living on both on the mainland and the region’s many islands. The unified imaging ecosystem will serve all of the region’s approximately 300 radiologists and nuclear medicine specialists, performing 1.5 million exams yearly. The related images are now accessible to the over 5,000 clinicians in the region.
“Easy access to medical patient data across complex healthcare systems fosters clinical collaboration and is essential to advance precision diagnosis,” said Calum Cunningham, General Manager of Enterprise Diagnostic Informatics at Philips. “We were able to implement our Enterprise Imaging solution in record time, helping the Region of Southern Denmark to move to the next step of digital maturity, improve collaboration, and ultimately enhance patient care.”
“An important requirement was solid integration with the national image registry in Region Sjælland,” said Jørgen Balle Kristensen, Senior IT Project Manager for the Region of Southern Denmark. “The Philips Vendor-Neutral Archive has an open, standards-based design that’s compatible with images in virtually any clinical format, from any source, so it’s a perfect fit for our integration needs.”
The region decided to partner with Philips to advance its digital transformation towards precision diagnosis. The adoption of Philips Enterprise Imaging solutions has started with implementing the Philips Vendor-Neutral Archive (VNA) and Philips Universal Viewer as part of its strategy to replace the existing systems. These modules provide a single source of archiving and distribution of imaging information that enables viewing of clinical images virtually, anytime anywhere by authorized users via a web browser or mobile device.
Philips Enterprise Imaging solutions combine scalable, modular architecture that integrates with existing systems to deliver data and tools across and beyond the enterprise – from radiology data reporting to enterprise-wide ingestion, distribution and archiving, to full patient and clinical data management. It consolidates multiple specialty workstations into a single, multifunctional workspace that allows radiologists to enhance reporting quality. For more information, visit https://www.philips.com/collaboration.
For further information, please contact:
Hans Driessen
Philips Global Press Office
Tel. : +31 6 10610417
E-mail : [email protected]
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the