Q&A: Why Leading with Evidence is Necessary for Digital Therapeutics

Swing Therapeutics CEO Mike Rosenbluth discusses the company's fibromyalgia management tool and what's necessary to make digital therapeutics mainstream. The startup's CEO, Mike Rosenbluth, sat down with MobiHealthNews to discuss why Swing's first product is focused on fibromyalgia and what's necessary to encourage provider uptake of digital therapeutics. People with fibromyalgia and other chronic pain diseases may try to naturally figure out how to minimize symptoms in their lives, and how to change their lives to make their symptoms more manageable. And so, what ACT tries to do is to help people accept, which isn't so much to say that you're resigned to the disease, but to say that it's there, and you can live your best life alongside the symptoms and alongside the pain. So, it's really trying to think about how you can change your relationship with pain – which is a lot easier said than done - but trying to get to a point where you're living a fulfilling life where the symptoms of the disease are more an annoyance, rather than a central part of your life. We ended up speaking with a lot of physicians and a lot of patients, and really got pointed to fibromyalgia as a place to start. So, if you're a primary care physician or you're a rheumatologist, you don't have a pain psychologist in your Rolodex that you'll typically refer to unless you're in some specialty clinic or the Mayo Clinic or some chronic pain center, which most people don't have access to. But the general idea is, as we've been really understanding more and more about this patient population, realizing that a digital therapeutic can be really powerful, and additionally powerful would be to provide these patients with a care specialist that truly understands their disease.

Apixio’s New Apicare AuthAdvisor Leverages Machine Learning, Predictive Decision-Making to Automate Approvals & Reduce Manual Workload by more than 50%

AI-Driven Solution Uses Historical Decision Data to Build Custom Data Model & Automate Approvals

SAN MATEO, Calif., March 1, 2022 – Apixio, Inc., the healthcare analytics company, today announced the launch of its new Apicare AuthAdvisor, which uses machine learning and predictive analytics to automate prior authorization decisions for payers. By leveraging historical decision data, AuthAdvisor automates approval for payers, medical benefit managers, and other vendors to deliver decisions within seconds rather than days, and reduces manual reviews by over 50%.

According to the Council for Affordable Quality Healthcare (CAQH),” the cost to complete a prior authorization remains the single highest cost for the healthcare industry at $13.40 per manual transaction and $7.19 per partially electronic web portal transaction”. Not only is it costly, but it is also an administrative burden with manual reviews sometimes taking days or weeks, which delays patient treatments, creates obstacles to care, and potentially negatively impacts clinical outcomes.

Apixio’s AuthAdvisor solves these problems by automatically approving diagnostics and procedures based on historical data and decisions made by the provider and payer.

“This is a new way to use data science to accelerate one of the most burdensome aspects of healthcare delivery,” said Apixio CEO Sachin Patel. “AuthAdvisor relies on the accuracy of an organization’s past decisions to process approvals, rather than relying on rules-based approaches that are tedious to maintain and often result in a high number of manual reviews. With AuthAdvisor, approvals are delivered at the speed and scale that today’s high-performance healthcare environments demand.”

With Apixio’s Apicare AuthAdvisor solution, organizations can:

  • Drive cost savings by reducing the volume of unnecessary reviews with automated decisions driven by our AI models
  • Fine-tune thresholds with user-enabled controls on a procedure-by-procedure basis
  • Deliver immediate results by deploying into existing workflows through APIs
  • Enhance provider and member satisfaction with timely feedback on requests

“The AuthAdvisor system is transparent and customizable, giving payers and benefits managers the visibility and flexibility they need to feel confident in the decisions being made,” Patel said. “The latest addition to our AI platform, this technology has the potential to not only save tremendous time and money but also greatly improve care delivery and member satisfaction for millions of Americans.”

AuthAdvisor is already active in 16 states, automating authorization requests for over 4,000 different procedures. Apixio will be showcasing its value-based care platform, including Apicare AuthAdvisor, at both RISE National on March 7-9 in Nashville and  HIMSS 2022 at booth #1579 on March 14-18 in Orlando.

To learn more about the Apicare AuthAdivsor solution, visit www.apixio.com/apicare-authadvisor/.

About Apixio
Apixio is advancing healthcare with data-driven intelligence and analytics. Our Artificial Intelligence platform gives organizations across the healthcare spectrum the power to mine clinical information at scale, creating novel insights that will change the way healthcare is measured, care is delivered, and discoveries are made. Learn more at www.apixio.com.

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MEDIA CONTACT:
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AllStripes announces collaboration with Taysha Gene Therapies for SURF1-Associated Leigh syndrome program

SAN FRANCISCO (January 4, 2021) – AllStripes (formerly RDMD), a healthcare technology company dedicated to accelerating research for patients with rare diseases, today announced a multiyear collaboration with Taysha Gene Therapies, Inc. (NASDAQ: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations.

The collaboration will focus on advancing the development of TSHA-104, an AAV9-based gene therapy in development for SURF1-associated Leigh syndrome, a deadly rare disease that primarily affects infants. AllStripes will use its platform, which gives patients control over their health histories, to unify otherwise scattered and fragmented SURF1-associated clinical data, allowing researchers to uncover new insights into the natural history and burden of disease and better inform the development of clinical studies.

“This collaboration will allow us to leverage the AllStripes technology platform to optimize our therapeutic strategy and to potentially accelerate the development of TSHA-104 in SURF1-associated Leigh syndrome,” said RA Session, II, president, founder and chief executive officer of Taysha. “We remain committed to developing a safe and effective gene therapy for patients suffering with this devastating disease, and data generated from this unique collaboration could bring us one step closer to our goal.”

Mutations in the SURF1 gene prevent mitochondria from producing enough energy for cells in the body to function normally, leading to Leigh syndrome, a severe and rare neurological disorder characterized by progressive loss of mental and movement abilities. SURF1-associated Leigh syndrome typically presents during infancy or early childhood, and often results in death within a few years. Approximately 10-15% of people with Leigh syndrome have a SURF1 mutation. There is currently no targeted treatment or cure for SURF1-associated Leigh syndrome.

“Taysha has brought together accomplished and knowledgeable gene therapy and CNS disease experts to develop potentially transformative therapies,” said Nancy Yu, co-founder and chief executive officer of AllStripes. “With no available treatment for SURF1-associated Leigh syndrome, we are very pleased to empower patients and their families with an avenue to participate in research that will support the development path of TSHA-104. We are hopeful that this novel gene therapy will bring meaningful benefit to children and their families, and give them more time together.”

TSHA-104 has been granted rare pediatric disease and orphan drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of SURF1-associated Leigh syndrome. An Investigational New Drug (IND) application for TSHA-104 in SURF1-associated Leigh syndrome is expected to be submitted to the FDA in 2021.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our team’s proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platform—an engine for potential new cures—with a goal of dramatically improving patients’ lives. More information is available at www.tayshagtx.com.

About AllStripes

AllStripes is a healthcare technology company dedicated to unlocking new treatments for people with rare diseases. AllStripes has developed a technology platform that generates FDA-ready evidence to accelerate rare disease research and drug development, as well as a patient application that empowers patients and families to securely participate in treatment research online and benefit from their own medical data. AllStripes was founded by CEO Nancy Yu and technology developer Onno Faber, following his diagnosis and journey with the rare disease neurofibromatosis type 2. The company is backed by Lux Capital, Spark Capital, Maveron Capital, Village Global, Garuda Ventures and a number of angel investors. For more information, visit www.allstripes.com.

War of Words Erupts Over Criticism of Medicare Advantage, APMs

Donald Berwick, M.D., and Richard Gilfillan, M.D., published an article in the Health Affairs Blog entitled “Medicare Advantage, Direct Contracting, And The Medicare ‘Money Machine,’ Part 2: Building on the ACO Model,” in which they criticized in the very strongest terms the new Direct Contracting program under Medicare, the ongoing evolution of the Medicare Advantage program, and some core aspects of the ways in which accountable care organizations (ACOs) are managed in the Medicare Shared Savings Program (MSSP). The Health Affairs blog by Drs. Berwick and Gilfillan was filled with intense criticism of Medicare Advantage of the way in which the MSSP is being run, and most of all, of the new Direct Contracting program. Among their core criticisms: the Medicare Advantage program is essentially providing private health insurance plans with a back door towards privatizing the Medicare program while not adding value, while the entire way in which risk is calculated both in MA and in the MSSP is riddled with errors and problems. The GEO Direct Contracting model was the most extreme, proposing to auto-assign every fee-for-service (FFS) beneficiary in a number of large geographic regions into a fully capitated MA-like “Geo DCE.” Beneficiaries were not given the right to opt out. This was, therefore, straightforward privatization of traditional Medicare, differing from MA only in that GEO Direct Contracting beneficiaries retained the right to see any Medicare provider under standard Medicare coverage.” Risk adjustment,” Crane emphasized, “was designed to estimate a beneficiary’s future health care costs and align compensation with acuity and severity of disease and the related costs of care as complex patients require the use of more resources. The adjusted compensation for high-risk patients provides physicians, healthcare organizations, and health plans resources to create additional programs and services to support and manage patients with important and impactful diseases and conditions

Google rolls out new search tools for health information on Medicare services, languages spoken by providers

Google is introducing new search features to make finding health information more accessible. The new search features build upon the tech behemoth’s efforts to offer “timely and authoritative” health information to empower people in their healthcare journeys, Budaraju wrote. The features augment other health-related consumer tools introduced by the company this year, including labeling COVID-19 vaccination sites on Google Maps and offering self-assessments for mental health conditions like anxiety and depression through Google Health. While the tech giant previously took a siloed approach to healthcare, the company has focused this year on weaving health efforts into its existing business lines. Despite two reorgs in the Google Health division this summer and loss of department chief David Feinberg, M.D., to Cerner, Chief Health Officer Karen DeSalvo, M.D., said at HLTH 2021 this October that the company isn’t scaling back its healthcare efforts, but is simply adopting a broader strategy. “I want people to understand—from the moment I walked in the door, my remit, my work, has been not only to think about how we’re going to help the healthcare sector but what are we going to do to see that there’s authoritative information on all of our platforms,” she said. “It’s quite frankly one of the things that’s been most exciting to me about the company because we know that we can reach literally billions of people and give them good information to help them make better choices about their health or to navigate their care journey.” For investors and entrepreneurs, the headlines signal choppy waters ahead—venture capital dollars are slowing, startups are raising less money this year as investors remain cautious, valuations are down and public companies have seen their shares drop by double-digits amid market volatility. “I think this is one of the best times to be starting a company and one of the best times to be building responsibly,” said Hemant Taneja, managing partner at digital health venture capital firm General Catalyst said Wednesday at Collision 2022, a tech conference taking place in Toronto this week. Digital health and health tech still have significant value going forward, analysts say. Investors point out that digital health companies have stronger fundamentals than companies in the dot-com bubble. Digital health had a breakout year in 2021, with startups raising an eye-popping $29.1 billion across 729 deals, according to Rock Health, a venture fund dedicated to digital health. Digital health startups banked $6 billion in the first quarter of 2022—an eye-popping number compared to just three years ago—but investment fell significantly behind the $7.3 billion raised in the fourth quarter of 2021 and the trailing twelve month quarterly average of $7.1 billion, according to Rock Health. ‘Are you fundamentally a business that is going to generate great economics and profit?’ That’s a cultural shift companies have to go through,” Taneja said. These industry transformations are where great companies are going to start with mission-driven founders in this era,” Taneja said. It’s going to be about companies that are lean, mean, focused, and doing fewer things better,” he said. Digital health startups banked record-breaking $29.1B last year. “We’re seeing a shift overall in the environment to making sure that the companies out there are providing discrete value to customers,” Sunny Kumar, M.D., a physician and partner at GSR Ventures, told Fierce Healthcare in an interview. GSR Venture invests in early-stage digital health companies. Healthcare is more resilient in a period of downturn, but the trends we’re seeing today, whether recession or inflation, is going to affect every single large enterprise, whether health systems, pharma and device companies. Jun 23, 2022 04:45pm Jun 23, 2022 04:00pm Jun 23, 2022 03:38pm Jun 23, 2022 03:25pm On Sunday, The Spokesman-Review reported that a draft Office of Inspector General report has flagged serious patient safety risks with the new EHR system. The Department of Veterans Affairs (VA) will push off deployment of a new electronic medical records system to additional medical facilities until 2023 to address outages that have plagued the software at current sites. The VA had planned to deploy the new health records software, which was developed by Cerner, now owned by Oracle, at the Puget Sound VA Health Care System, including American Lake and Seattle VA Medical Centers, this August, but will now push that project to March 2023 instead, a VA spokesperson confirmed. Plans to deploy the platform to the VA Portland Health Care System at the Portland and Portland-Vancouver VA Medical Centers has been delayed from this November to April 2023. "VA has consistently communicated that it will review each site’s readiness for deployment to ensure a successful and safe transition to the new EHR," the VA spokesperson said. On Sunday, The Spokesman-Review reported that a draft VA Office of Inspector General report has flagged serious patient safety risks with the new system. The date was changed to allow Oracle Cerner to put important system enhancements in place and make the necessary improvements to ensure system stability, securing the 99.9% uptime Service Level Agreement (SLA) currently contracted, as well as fix outstanding issues to address research workflow challenges," the VA spokesperson said. Deborah Hellinger, vice president of global corporate communications at Oracle, said in a statement that Oracle engineers have already been on the ground making technical and operational changes, "with an emphasis on patient safety, to ensure the system exceeds the expectations of providers, patients, and the VA." "We intend to bring substantially more resources to this program and deliver a modern, state-of-the-art electronic health system that will make the VA the industry standard. Under new legislation headed to President Joe Biden's desk, the VA will be required to submit regular reports to Congress about the performance of its new $16 billion medical records system, including incidents that risk patient safety. The new EHR system, developed by Cerner, now owned by Oracle, was first rolled out to Mann-Grandstaff VA Medical Center in Spokane, Washington, in November 2020, following two monthslong delays to address the department's information technology infrastructure and training and respond to the COVID-19 pandemic. In May, VA Secretary Denis McDonough told the House VA Committee that he's “very concerned about execution of the program to date,” but will press ahead with the EHR rollout, Federal News Network reported. McDonough said the new EHR from Cerner has experienced five shutdowns since March 3, the first of which was so “egregious” that the company’s CEO issued a signed apology, the media outlet reported. "VA is requesting that Oracle Cerner develop an execution plan to put this regular testing and confirmation of resiliency in place," officials said.

Sharing Genomic Data for Patient Care – Sync for Genes Phase 4 Wraps Up

Myriad Genetics Teams Up with Epic to Make Genetic Testing Accessible to More Patients with Electronic Health Record (EHR) Integration

Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced a partnership with Epic, the industry leading healthcare software company, to integrate Myriad’s full line of genetic tests with Epic’s expansive network of 600,000 physicians and more than 250 million patients. The integration creates a seamless, end-to-end workflow solution for healthcare providers to order Myriad tests and review results directly within their everyday Epic platform without additional steps or manual ordering processes. With the ability to review pertinent health information, order tests, and receive results natively in Epic, providers will have the critical genetic insights and related information they need to drive better health outcomes and improve the patient experience. Increasing access to genetic insights and integrating our tests into Epic’s vast network of healthcare systems represents a significant step forward to better serve patients and healthcare providers.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the integration of the company’s genetic tests with Epic’s network of physicians and patients and the expected timing of the integration; the company’s growth plan to scale customer-centric, tech-enabled commercial capabilities with 600+ EHR integrations this year; the anticipated benefits of the integration, including that the integration will create an end-to-end workflow solution for healthcare providers to order Myriad tests and review results directly with their everyday Epic workflows, provide providers with critical genetic insights and related information they need to drive better health outcomes and improve the patient experience, and allow patients to easily access their Myriad test results directly from their EHR portal; and the company’s strategic imperatives under the caption. These “forward-looking statements” are management’s present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described in the forward-looking statements.

More Hospital Systems Embracing Anchor Role

Healthcare Anchor Network’s David Zuckerman and Atrium Health’s Kinneil Coltman describe ways health systems are advocating for changes in policy on housing, transportation and food insecurity. During a recent webinar, David Zuckerman, president and founder of the Healthcare Anchor Network (HAN), gave several examples of ways that health systems are using their roles as large employers to make community investments and partner with other community groups to advocate for changes in policy on housing, transportation and food insecurity. The health system members of HAN embrace their roles as catalysts for health, economic, and racial equity by leveraging their everyday operations, including hiring, purchasing, and investment for equitable, local economic impact and to build community wealth. “Our focus has been how to consistently change your institutional behaviors, but one of the things we learned early on was that there was also a need to help health systems be more effective advocates around a broader vision of health equity,” Zuckerman said.

Trinity Health worked in coalition with community partners to advocate for the Cares Act funds for rental and utility assistance in Idaho. “It's really important that they brought their voice to a broad coalition to help create the enactment of the Idaho Fair Warning Act, which gives tenants notice before eviction.” In the other example, UMass Memorial Health in Worcester was part of a coalition to help allocate ARPA funding for housing, including the first affordable housing trust fund in the city of Worcester, Massachusetts. “I think that this is a really important shift that we're seeing around these organizations being involved in other areas of social determinants of health policy that are so critical to helping us achieve health equity in this country,” he said. As the largest employer in North Carolina, Atrium Health is rethinking its social impact on the community. Atrium had been building a lot of infrastructure around health equity for a long time, Coltman said, “so when COVID started to roll into our communities, we had seen some of the headlines pouring in from other parts of the country about the profound and dramatic disparities along racial and socio-economic lines related to COVID, and we did not want to see that happen.”

Rethinking the Patient Experience starting with Patient Education

Scientific studies show that the quality of patient education has a significant impact on patient health outcomes and the need for postoperative care. Furthermore, audio-visual patient education improves patient understanding, patient satisfaction, and overall adherence and compliance towards the medical treatment process. Conversely, doctors must invest their valuable time in bridging the information gap starting with the basics during patient consultation and repeating information over and over again. Our solution enables doctors to create individualized patient videos within seconds while ensuring that the content is legally compliant and tailored to patients’ needs. This approach saves time for doctors in the educational process and overall, gives patients a better feeling of empowerment. Being able to bridge this information gap in patient education and empowering patients so they are not feeling stressed or anxious about their medical procedure, helps them to be more optimistic about the overall treatment process.

This gives patients the opportunity to take the information home and share it with family and friends, and discuss the procedure that they’re going to have, enabling them to take a more active part in their treatment process. Mona Ciotta:  As per current legal requirements, the status quo with the paper sheets is not entirely compliant because patients are not empowered to make an informed decision. Secondly, by standardizing the process of informed consent using a solution that gives patients the same quality of information based on their specific needs. The medical information that patients are given during their treatment process lacks patient-focused language and visuals. Doctors just cross out information that is not relevant to the patient, which is not ideal. We see a tremendous need and desire for patients to receive personalized information and specifically validated information. When doctors can create videos tailored to patients’ needs, one can be sure that the content patients receive is validated, medically sound, and fit for patient purposes. While it has its downsides of having access to all kinds of information, democratizing it has been a huge step toward empowering patients and enabling them to make better decisions regarding their treatment process. This transformation is about eliminating the barriers of this medical paternalism age and enabling patients to make informed decisions by giving them the information they need and want.

BAYADA Caregiver Wins PHA’s 2022 DCW of the Year Award

Pennsylvania Direct Care Workers Recognized for Outstanding Service, Exceptional Care

PHA’s 2022 Direct Care Worker of the Year Awards Recognize Statewide, Regional Winners

Today, the Pennsylvania Homecare Association and the Pennsylvania Department of Aging announced the recipients of the 2022 Direct Care Worker of the Year Awards. For more than fifteen years, PHA has recognized direct care workers who display outstanding service and exceptional care in their communities.

In 2020, PHA expanded the awards program to recognize three regional winners, in addition to the overall statewide “Vicki Hoak Direct Care Worker of the Year.” This year, 168 direct care workers from across Pennsylvania were nominated for awards.

Dina Berzin, BAYADA Home Health Care – Willow Grove, was the overall statewide winner, recognized for the love, compassion, and understanding that she brings to her work and her consumers.

Kelli Carper, Superior Home Care, Allegheny County, Kereen Wright, Main Line Health Home Care and Hospice, Delaware County, and Patty McVicker, First Choice in Home Care, Bedford County, were this year’s regional winners. Each was recognized for their compassion, reliability,  and commitment to caring for others.

While the annual awards program has a long history of highlighting the valuable role of direct care workers in our community, this year’s program is especially important as the home care industry continues to face a crisis-level shortage of direct care workers.

“The need to recognize and reward direct care workers has never been greater,” said Teri Henning, CEO of the Pennsylvania Homecare Association. “At a time when the state has significant COVID-related and other funds, this year’s budget must increase Medicaid reimbursement rates to recognize the value of these dedicated healthcare workers. PHA and the Department of Aging’s annual program is one small way to show how much we respect and value their role in the delivery of care. We urge Pennsylvania lawmakers and the administration to join us this budget season to recognize the worth of this workforce to allow for higher wages.”

About PHA… The Pennsylvania Homecare Association is a statewide membership organization of more than 700 homecare, home health and hospice providers. PHA members provide quality care and serve as advocates for their patients and clients on a variety of healthcare related issues. PHA and its members work to improve professional standards and ensure access to quality homecare throughout the Commonwealth. To learn more, visit www.pahomecare.org.

See the original press release announcing the winner 

ALXN1840 Shows Rapid and Sustained Improvement in Copper Mobilization From Tissues, Potentially Closing Treatment Gaps for

June 23, 2022, 12:35 PM UTC

ALXN1840 Shows Rapid and Sustained Improvement in Copper Mobilization From  Tissues, Potentially Closing Treatment Gaps for Wilson Disease Community

  FoCus Phase III trial evaluates new approach to copper mobilization for   patients with Wilson disease who have not seen meaningful innovation in  decades

In Wilson disease, excess copper build-up in organs and tissues can lead to        liver disease as well as neurological and psychiatric symptoms

Business Wire

WILMINGTON, Del. – June 23, 2022

Detailed results from the positive FoCus Phase III trial in Wilson disease showed that ALXN1840, an investigational once-daily, oral medicine, met its primary endpoint demonstrating three-times greater copper mobilization from tissues compared to the standard of care (SoC) arm (Least Square Mean Difference [LSM Diff] 2.18 µmol/L; p< 0.0001), including in patients who had been treated previously for an average of 10 years.^1

In the trial, people taking ALXN1840 experienced rapid copper mobilization, with a response at four weeks and sustained through 48 weeks.^1

Results from the trial will be presented on June 23 at the 2022 International Liver Congress (ILC) in London.

Wilson disease is a rare and progressive genetic condition in which the body’s pathway for removing excess copper is compromised. This may result in the accumulation of copper in a person’s liver, brain or other vital organs. Damage from excess copper build-up in tissues and organs may lead to symptoms of liver, neurological and psychiatric diseases, which may be irreversible.^2,3,4 Even after SoC treatment is initiated, some patients experience worsening of disease, especially of neurologic symptoms.^3,4

Change in neurological scale scores and clinician-reported functional assessments with ALXN1840 treatment were also evaluated in a post-hoc analysis as secondary endpoints in the Phase III trial.^1

In patients who were symptomatic at baseline, there were greater improvements in neurological scores for those treated with ALXN1840 compared to SoC (Unified Wilson Disease Rating Scale [UWDRS] part II symptomatic ALXN1840 -1.7, SoC -0.8; UWDRS Part III symptomatic ALXN1840 -2.91, SoC -1.31). However, there were no significant differences between treatment groups observed at 48 weeks.^1

Most patients in the trial had low symptom scores at baseline, so there was minimal room for total score improvement (UWDRS Part II ALXN1840 -0.6, SoC -0.3; UWDRS Part III ALXN1840 -2.20, SoC -1.02).^1 As people with Wilson disease experience a highly varied degree of symptoms^4, this total score may not reflect the extent of disease severity.

ALXN1840 was well tolerated and the long-term safety and efficacy of ALXN1840 is being assessed in an up to 60-month extension period.^1

Professor Karl Heinz Weiss, MD, Director of the Department of Internal Medicine at Salem Medical Center Heidelberg and investigator in the FoCus Phase III trial, said: “These data from the largest global trial in Wilson disease to date show significant copper mobilization from the tissues with ALXN1840, even in patients who were on standard of care for over a decade on average. These results have the potential to reframe the way doctors can think about the disease given that current therapies focus on removing copper from the blood. We are also encouraged by initial neurological improvement with ALXN1840 in those who were symptomatic and believe that assessing individual patient experiences may provide a better understanding of the impact on daily life.”

Marc Dunoyer, Chief Executive Officer, Alexion, said: “Many people with Wilson disease continue to experience symptoms even after years of intervention with current therapies, illuminating an urgent need to re-evaluate the standard of care. Applying our 30 years of experience in rare disease clinical development, Alexion has conducted rigorous scientific research to bring fresh thinking to Wilson disease around the importance of copper mobilization from the tissues. These data further our efforts to potentially introduce a novel treatment for patients who have gone decades without meaningful innovation.”

Summary of efficacy and safety results^i

The primary endpoint gauged the daily mean Area Under the Effect Curve (AUEC) for directly measured non-ceruloplasmin-bound copper (dNCC)^ii over 48 weeks. ^ The dNCC parameter includes copper bound in an inert complex with ALXN1840.^1

                        Cohort 1^iii          Cohort 2^iii                     Treatment-experienced   Naïve/minimally        Total Statistic                                        treated                    ALXN 1840      SoC      ALXN 1840    SoC    ALXN     SoC                     N = 104      N= 56       N = 33   N = 14   1840   N = 70                                                               N = 137 n^iv                    91          51          27       12      118     63 Mean (Standard         2.68    0.72 (0.643)    4.58     1.09    3.12    0.79 Deviation)           (2.118)                 (2.526)   (0.484) (2.347) (0.629) LSM^v                  2.50    0.87 (0.204)    4.76     0.96    3.18    1.00 (Standard Error)     (0.150)                 (0.319)   (0.487) (0.167) (0.219) LSM Difference ^         1.64 (0.254)          3.79 (0.584)     2.18 (0.244) (SE) p-value                     <0.0001              <0.0001           <0.0001

 1. Results analyzed using ANCOVA model, model included treatment, cohort, and    baseline value. For cohort analysis, analysis was performed on each cohort    using ANCOVA model, cohort term was removed from model. Analysis results    were combined using Rubin’s rules.  2. Daily Mean AUEC for dNCC measured in µmol/L.  3. Cohort 1= Prior WD Treatment >28 days; Cohort 2= Treatment Naïve or Prior    WD Treatment ≤ 28 days.  4. Patient numbers for calculation of mean; all patients were included in the    calculation of LSM, LSM difference and p values.  5. LSM is a statistical method that determines the line of best fit for a    dataset.

Most adverse events (AEs) were not considered serious (ALXN1840, 85.4%; SoC, 75.7%) and/or were not considered related to trial treatment (ALXN1840, 77.4%; SoC, 75.7%). The most common AE associated with ALXN1840 was a reversible increase in alanine aminotransferase levels (ALXN1840, 14.6%; SoC, 2.9%). Two deaths were also reported but were unrelated to ALXN1840.^1

In addition to the Phase III trial, two ongoing mechanistic trials in Wilson disease are also underway. Alexion is working closely with health authorities worldwide and intends to submit these data for review.

Notes

Wilson disease

Wilson disease is an inherited condition in which the body’s pathway for removing excess copper is compromised. Over time, that results in the build-up of excess copper levels in the liver, brain and other organs leading to damage that greatly impacts patients.^2

Although the disease is present at birth, the age of diagnosis occurs between five to 35 years.^3,4 People can develop a wide range of symptoms, including liver disease and/or psychiatric or neurological symptoms.^2,3,4

FoCus

FoCus (301) is a pivotal Phase III, randomized, controlled, rater-blinded trial designed to evaluate the efficacy and safety of ALXN1840 versus SoC in patients with Wilson disease aged 12 years and older. The primary endpoint assessed copper mobilization over 48 weeks, defined as daily mean AUEC for dNCC. In the trial, 214 patients were enrolled in one of two cohorts on a 3:1 basis (treatment-experienced:treatment-naïve). Each cohort was then randomized 2:1 (ALXN1840:SoC). The first cohort enrolled 161 patients who received SoC (chelation therapy with penicillamine or trientine, zinc therapy or a combination of both chelation and zinc therapy) for more than 28 days and the second cohort enrolled 53 patients who were treatment-naïve or had received SoC for 28 days or less.^1,5 Key secondary endpoints assessed over the 48-week period included change in neurological function as measured by the UWDRS Part II and III.^1

ALXN1840

ALXN1840 is a potential new once-daily, oral medicine in development for the treatment of Wilson disease. This investigational, novel molecule is designed to selectively and tightly bind to and remove copper from the body’s tissues and blood. ALXN1840 has been granted Orphan Drug Designation in the United States and orphan designation in the European Union for Wilson disease.

Alexion

Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. As a leader in rare diseases for 30 years, Alexion is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology and ophthalmology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. For more information, please visit www.alexion.com.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

References

 

1. Weiss, KH., Schilsky, M., et al. Efficacy and safety of ALXN1840 versus    standard of care in Wilson disease: primary results from an ongoing phase    3, randomized, controlled, rater-blinded trial. Oral presentation at:    International Liver Congress (ICL or EASL); June 23, 2022; Abstract No.    1816.  

2. Patil, M., et al. (2013) J Clin Exp Hepatol, 3, 321-336.  

3. Roberts, E.A., Schilsky, M.L. American Association for the Study of Liver    D. (2008). Diagnosis and treatment of Wilson disease: An update.    Hepatology, 47(6), 2089-2111.

 4. European Association for the Study of the Liver. (2012). EASL clinical    practice guidelines: Wilson’s disease. J Hepatol, 56(3), 671-685

.  5. ClinicalTrials.gov. Efficacy and Safety of ALXN1840 (Formerly Named    WTX101) Administered for 48 Weeks Versus Standard of Care in Participants    With Wilson Disease With an Extension Period of up to 60 Months. NCT    Identifier: NCT03403205. Available online. Accessed May 2022.

Remote Patient Monitoring in an App Boosts Quality at Atrium Health Wake Forest Baptist

The health system found a virtual care app for its weight management program that effectively engaged patients in their care and helped staff improve their patient experience. There's nothing about a person's day that doesn't have an impact on their weight and that's why the team at the Weight Management Center at Atrium Health Wake Forest Baptist needs to be able to interact and engage with patients as much as possible. "We realized we needed a patient engagement tool that could also support our weight management needs. We wanted to provide an app that patients liked to use as a part of their weight management experience." "In healthcare, there is such a focus on seeing patients in the office, but we've learned we can provide better patient experiences by engaging patients outside of the office in a way that isn't captured by an appointment." Ninety-four percent of patients in the weight management program agree the app was helpful in their weight loss journey, according to studies conducted by Atrium Health Wake Forest Baptist. "Carium doesn't feel like a weight management app; it feels like an app to help patients on their health journey, and our patients find that refreshing," Ard noted. The weight management program already was moving along this path when the pandemic hit, so even though patients' clinic visits transitioned to virtual modes, staff were able to continue to engage patients in a way that was meaningful, Ard said. "In healthcare, there is such a focus on seeing patients in the office, but we've learned we can provide better patient experiences by engaging patients outside of the office in a way that isn't captured by an appointment," Ard advised.

Innovaccer Expands into the UK Market to Accelerate Healthcare Innovation and Digital Transformation

SAN FRANCISCO--()--Today Innovaccer Inc., the Health Cloud company, announced that it is opening a London-based office as part of its expansion in the UK healthcare market. Innovaccer provides data-driven technology solutions to help accelerate innovation and digital transformation to support the policy reforms of the NHS Health and Care Act 2022. Opening the London office supports the company’s long-term growth strategy and commitment to making healthcare more accessible, more affordable, and higher quality globally.

In 2019 the NHS included in its recommendations the need to transform its architecture to “increase coordination of services through the creation of Integrated Care Systems”. The Health and Care Act of 2021 provided a framework to facilitate collaboration between NHS, local government and other partners, and to support the recovery from the pandemic. The Health and Care Act 2022 expanded the bill with a wide range of policy reforms aimed at transforming health, and in particular, improving health and care services through better health and care integration and tackling growing health inequalities.

UK health professionals, commissioners, and patients need a means of building confidence across domains so caregivers can fulfil their duty to provide the best care to patients and the best value to the system. With the Innovaccer® Health Cloud’s Data Activation Platform, which was recently ranked the #1 Best in KLAS data and analytics platform, the NHS and its Integrated Care Systems (ICSs) and agencies focused on improving community health can unify patient data across systems and rapidly develop scalable applications that improve clinical, operational, and financial outcomes.

“The UK healthcare landscape is one of the best in the world”, said John Gurnett, General Manager, UK and Europe, Innovaccer. “NHS England’s long-term plan clearly sets the direction for widespread digital services that can support and empower people to stay healthy and independent for longer. But they also acknowledge the challenge of identifying a technology provider that’s experienced with healthcare data. With Innovaccer’s data and analytics platform backed by a unified patient record, we can move towards addressing inequalities in health and population health, as well as wellbeing and the quality of services as part of the triple aim for NHS”.

Innovaccer’s solutions have been implemented in more than 1,600 care settings. It has unified patient records for more than 39 million people and helped over 96,000 caregivers work more collaboratively and save more than £800 million. Leading healthcare providers have experienced outcomes such as a 7% reduction in readmissions, a 13% increase in referral success rate, and a 6.6% reduction in emergency department utilisation.

“This is a milestone for the company in achieving our vision and for healthcare”, said Abhinav Shashank, co-founder and CEO of Innovaccer. “By integrating data from multiple domains within the NHS and from local agencies, Innovaccer can help bridge the collaboration gap and provide analytics and actionable insights to meet the goals as set out by the Health and Care Act 2022—to improve the quality of care and reduce costs. Innovaccer’s capabilities in care coordination and population health will accelerate NHS’s vision of enabling people to live healthier and more independent lives through high-quality, seamless care”.

About Innovaccer

Innovaccer Inc., the Health Cloud company, is dedicated to accelerating innovation in healthcare. The Innovaccer® Health Cloud unifies patient data across systems and care settings, and empowers healthcare organisations to develop scalable, modern applications that improve clinical, financial, and operational outcomes. Innovaccer’s solutions have been deployed across more than 1,600 care settings in the U.S., enabling more than 96,000 caregivers to transform care delivery and work collaboratively with payers and life sciences companies. Innovaccer has helped its customers unify health records for more than 39 million people and generate over £800 million in cumulative cost savings. Innovaccer is the #1 rated Data and Analytics Platform by KLAS, and the #1 rated population health technology platform by Black Book. For more information, please visit uk.innovaccer.com.

Abbott and Women as One Partner to Help More Underrepresented Physicians Lead Clinical Trials

Abbott and Women as One Partner to Help More Underrepresented Physicians Lead Clinical Trials

  • New partnership will provide physician training to drive improved diversity in clinical trials
  • Training program is open to underrepresented groups including female, Black, Native American, Asian, South Asian, Hispanic and non-binary cardiologists
  • Provides opportunities for underrepresented physicians to receive training on the clinical trials process, learn new skills, expand their networks and increase visibility with industry partners

, /PRNewswire/ -- Abbott (NYSE: ABT) today announced a new partnership with Women as One to launch a new program designed to train more female and underrepresented physicians to pursue clinical trial research and help recruit clinical trial participants from historically underrepresented groups.

Women as One is a nonprofit organization with the mission to promote talent in medicine by providing women physicians with unique professional opportunities. Abbott provided funding to develop a new program called CLIMB Research, which provides skills training for underrepresented cardiologists.

The new program builds upon Abbott's diversity in clinical trials initiative that was established in 2021 to further develop and create a more inclusive clinical trial ecosystem in the U.S.

Research shows there is systemic underrepresentation of women and under-resourced populations such as Hispanic and Black participants in clinical trials1,2. By training physicians, Abbott, in conjunction with Women as One, is helping close the gaps and overcome the existing barriers to clinical trial participation: lack of trust, lack of access, lack of understanding and lack of a common language.

Through six monthly sessions, which include a mix of instruction, case reviews and group discussions, participants in the new CLIMB Research skills training program will receive:

  • Global Connection Among Underrepresented Physicians
    Learn new skills, expand their networks and increase visibility with industry partners.
  • In-Depth Knowledge from Experts in the Field
    Enhanced curriculum includes renowned guest faculty and training in research such as Good Clinical Practice (GCP) protocol oversight, Institutional Review Board reporting, safety management and practical applications in the clinical trial environment.
  • A "New to Research" Track
    Provides skills training for physicians who are interested in pursuing clinical research.
  • An "Enhanced Research" Track
    Enhanced skills training for physicians with some knowledge and experience in clinical research.

"Clinical trials are the basis of modern medicine and have the power to drive innovative therapies to fight diseases. Today, women and populations from under-resourced communities are vastly underrepresented in clinical trials," said Lisa Earnhardt, executive vice president, Medical Devices, Abbott, and the co-executive sponsor for the company's Diversity in Research steering committee that she leads alongside Andrea Wainer, executive vice president, Rapid and Molecular Diagnostics, Abbott. "Through our new partnership with the Women as One CLIMB Research skills training program, we are actively changing the trajectory of how underrepresented physicians address clinical trial care for underrepresented groups."

The collaboration with Women as One is the latest addition to Abbott's broad corporate initiative designed to improve diversity in medical research. A key focus of the company's efforts is to increase the number of diverse investigators leading trial sites, a situation that compounds the challenges of increasing enrollment into clinical studies. The new training program is open to underrepresented groups including female, Black, Native American, Asian, South Asian, Hispanic and non-binary cardiologists.

Abbott provided funding of $150,000 for the CLIMB Research program which adds to the more than $5 million Abbott has committed since last year, which includes nearly 300 scholarships to medical schools at Historically Black Colleges and Universities (HBCUs) and minority nursing associations. The company has also established a Diversity in Clinical Trials Medical Advisory Board and dedicated funding to increase diversity enrollment within Abbott trials.

"Women and underrepresented groups are too often absent from industry-driven activities. Enhancing the representation of these groups leading clinical trials will have a direct impact on the number of diverse trial participants," said Roxana Mehran, M.D., Women as One Founding director. "By advancing our training program with Abbott, we are actively increasing the number of diverse researchers in clinical trials to create a safe haven of trust to ultimately support underrepresented patients."

CLIMB Research 2022 is co-sponsored by the Global Cardiovascular Clinical Trialists (CVCT) Forum. CVCT is a unique annual educational forum aimed at discussing the latest and most critical cardiovascular, cardiorenal and cardiometabolic trials. In line with the goals of CVCT to increase the number of underrepresented individuals in cardiovascular clinical trial leadership, CVCT is an active collaborator on CLIMB Research.

To learn more about Women as One Climb Skills Training program #TIMETOCLIMB sponsored by Abbott, visit: womenasone.org/CLIMB2022       

About Abbott:

Abbott is a global health care leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of health care, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

1 Clark, L.T., et al., Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol, 2019. 44(5): p. 148-172.

2 Yates, Byrne, Susan Donahue, Linda McCarty, & Mathews, 2020.

SOURCE Abbott

For further information: Media, Alicia Swanson, (669) 210-7204; Financial, Mike Comilla, (224) 668-1872

EHR browser extensions optimize value-based care and more

One of the most meaningful proposals from the U.S. Department of Health and Human Services (HHS) is  a new rule to support seamless and secure access, exchange and use of electronic health information (EHI). The impact of this new rule upon payors, providers and patients will resonate in terms of increased innovation, competition and transparency. Patients and their healthcare providers can look forward to secure access to health information, as well as new tools, allowing for more choices in care and treatment. 



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Keys to Putting Behavioral Health Integration into Practice

Prior to his positions with Penn Medicine, Press was a member of the senior leadership team at the Center for Medicare and Medicaid Innovation at CMS, where he helped develop and implement several new payment and care delivery models including ACOs, bundled payments, integrated mental health, and medical homes. “When I was at CMS, we were looking for ways that we could help support integrated mental health, and I got to know the collaborative care model. It is an evidence-based model of integrating mental health into primary care that's been around for a few decades,” Press explained. “Then when I when I came to Penn Medicine, with the charge of leading primary care transformation and population health management, I felt that we would never be successful in the world of population health management and value-based payment without a really effective, integrated mental health program. So our first priority was to launch an integrated mental health program that is based almost entirely on the collaborative care model. For many patients with mild to moderate depression, anxiety, and/or substance use disorder, they can effectively be treated and all of their mental health needs met in the primary care setting through this evidence-based model, Press said. The VA does have mental health integration staff within its primary care medical home model, the patient-activated care team. “We made a decision early on that the expertise and the need for supervision for the collaborative care model would really have us focus on nurses or social workers or even clinical pharmacists as care managers within the integrated mental health team,” Post said.