Money, Mandate Are Keys to FDA's Drive for Use of Real-World Evidence, Gottlieb Says
November 12th 2019Former FDA Commissioner Scott Gottlieb, MD, who has returned to the American Enterprise Institute, left FDA in April after 2 whirlwind years that saw a record pace of approvals and policy actions that covered everything from high drug prices to teen vaping. He spoke Friday in Philadelphia at Patient-Centered Oncology Care®, the annual meeting of oncology reimbursement stakeholders held by The American Journal of Managed Care®.
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Early Warning Signs of CKD Going Unnoticed in Veterans, Especially Those With Hypertension
November 12th 2019The federal government wants to lower the rate of end-stage renal disease (ESRD) and improve kidney care outcomes, but such efforts will require earlier identification of chronic kidney disease (CKD), especially in veterans. At the American Society of Nephrology's (ASN) Kidney Week 2019, one poster described the gaps in identifying CKD in this population.
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Dr Jeffrey Curtis Discusses Using Live Virus Vaccines in Immunocompromised Patients
November 11th 2019Patients with immunosuppressive conditions, particularly those being treated with tumor necrosis factor inhibitors, are vulnerable to infections, but rheumatologists have mostly been hesitant to use any live virus vaccines in these patients, said Jeffrey R. Curtis, MD, MS, MPH, professor of medicine in the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham.
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Dr Holly Kramer Discusses Components of the Advancing American Kidney Health Initiative
November 11th 2019The Advancing American Kidney Health initiative launched by HHS has a broad range of focus that includes kidney disease awareness, early diagnosis, and improvements in transplantation, according to Holly Kramer, MD, MPH, professor of medicine and public health sciences at Loyola University Chicago and president of the National Kidney Foundation.
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Using Patient Characteristics to Predict Clinical Outcomes in RA
November 11th 2019Grouping patients into clusters based on shared characteristics, such as disease control and general health, may be helpful in understanding and predicting clinical outcomes in patients with rheumatoid arthritis (RA), according to an abstract presented at the 2019 ACR/ARP Annual Meeting, held November 8-13 in Atlanta, Georgia.
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Dr Daniel Clauw Highlights the Turn Toward Nondrug Therapies to Treat Chronic Pain
November 11th 2019Nondrug therapies that might have been dismissed 30 years ago are now the sorts of treatments physicians are turning to instead of overused treatments like surgical procedures, opioids, and injections, said Daniel Clauw, MD, professor of anesthesiology, medicine (rheumatology), and psychiatry; director of translational research; and director of the Center for Chronic Pain and Fatigue Research.
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Dr Yusuf Yazici Discusses Disease Activity Assessment Tools in RA, Osteoarthritis
November 11th 2019Disease activity assessments can help physicians treat to targets, but in some areas those targets have not been set yet, said Yusuf Yazici, MD, clinical associate professor in the Department of Medicine at NYU Langone Health.
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2019 Brought Impressive Results for TNF Inhibitors, Research Into Monotherapy, Interest in CBD
November 10th 2019This year has been an exciting time for rheumatologists with impressive clinical trial results and promising outcomes for patients, said Susan Manzi, MD, MPH, codirector of the Lupus Center of Excellence and chair of the Department of Medicine of West Penn Allegheny Health System, during a session at the American College of Rheumatology annual meeting in Atlanta, Georgia.
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Physicians, Patient Discuss Intentional Nonadherence in Hypertension Therapy
November 10th 2019What should providers do about intentional nonadherence, and what strategies should they try to get their patients to take their hypertension medicine? At a session at the American Society of Nephrology (ASN)’s Kidney Week 2019, physicians discussed direct observation therapy (DOT), drug monitoring, case studies, and other published work about patients who don’t take their medications. Then they heard from a directly from a patient who shared why she stopped taking her medication and the scary consequence that developed as a result.
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Patients on Dialysis Have More Hospitalizations in Areas With More Black Residents
November 10th 2019Patients receiving dialysis living in communities with a high percentage of black residents are known to have worse morbidity and mortality outcomes, and a study presented Saturday at the American Society of Nephrology Kidney Week 2019 meeting found that patients receiving dialysis in those communities also had higher hospitalization rates.
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The Fast Pace of CAR T-Cell Innovation Caused an Array of Challenges in Treatment
November 10th 2019The evidence shows that chimeric antigen receptor (CAR) T-cell therapies are effective, but the price tags on these treatments are high and have raised concerns about how many patients will get treated. During a discussion at The American Journal of Managed Care®’s Patient-Centered Oncology Care® meeting, held Friday in Philadelphia, panelists outlined the efficacy of the 2 FDA-approved therapies, Medicare reimbursement for CAR T-cell therapies, and the pace of innovation in healthcare.
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Dr Jay Wish Explains Implications of New Roxadustat Data
November 9th 2019The results of phase 3 studies of roxadustat, a drug in the new class of hypoxia-inducible factor stabilizers, are satisfying in terms of both efficacy and safety, said Jay Wish, MD, professor of clinical medicine at Indiana University and chief medical officer for dialysis at Indiana University Health.
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Pooled Cardiovascular Data on Roxadustat Show No Increased Risk to Patients With CKD
November 9th 2019The risk of major adverse cardiovascular events was comparable with placebo in patients not treated with dialysis who received the investigational drug roxadustat, according to pooled cardiovascular safety data about the first-in-class oral therapy for patients with chronic kidney disease (CKD).
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Paul Conway: Respect, Listening Are Keys to Engaging Patients in Kidney Care
November 9th 2019The large number of patient participants at the American Society of Nephrology’s Kidney Week 2019 meeting reflects the understanding that patients should be elevated in the conversations around kidney care, said Paul Conway, chair of global affairs and public policy and immediate past president, American Association of Kidney Patients.
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Researchers Develop Tool to Identify Those at Risk of Future CKD
November 9th 2019A simple risk-assessment tool that helps physicians with early identification of patients at increased risk of chronic kidney disease (CKD) could lead to improved and targeted surveillance strategies, according to research published Friday.
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Dr Alan Kliger Outlines Major Safety Risks for Patients Receiving Dialysis
November 8th 2019Some of the most common safety risks for patients receiving dialysis include medication safety, infections, and falls, according to Alan Kliger, MD, clinical professor of medicine at Yale University School of Medicine.
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Dr Joseph Vassalotti Presents Findings of AJMC® Study on CKD Intervention
November 8th 2019A study published in the November issue of The American Journal of Managed Care® provides evidence from an intervention for chronic kidney disease (CKD), explained lead author Joseph Vassalotti, MD, clinical professor at Icahn School of Medicine at Mount Sinai and chief medical officer of the National Kidney Foundation.
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Data From 3 Roxadustat Trials Lead Off Kidney Week Sessions Ahead of Efficacy, Safety News
November 8th 2019Investigators presented data about 3 phase 3 trials of roxadustat at a national nephrology meeting to a standing-room only crowd, but the information the audience is really waiting to hear will have to wait until early Friday afternoon. While the trials showed promising results, day 2 of American Society of Nephrology's (ASN) Kidney Week 2019 will see the release of highly anticipated efficacy and pooled cardiovascular safety data about the first-in-class oral drug to treat chronic kidney disease in patients with anemia.
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Dr Cynthia Delgado on the Importance of Patient Input in Kidney Disease Care
November 8th 2019Clinicians treating kidney disease should view patients as stakeholders whose opinions can help drive a holistic approach to care, said Cynthia Delgado, MD, associate professor of medicine at the San Francisco Veterans Affairs Medical Center and University of California San Francisco Medical Center.
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Dr Danielle Kirkman Explains How Exercise Testing in Patients With CKD Can Improve Care
November 8th 2019Because exercise capacity is known to be linked with several key outcome measures in patients with chronic kidney disease (CKD), routine exercise testing can help clinicians prescribe individualized exercise interventions, said Danielle Kirkman, PhD, assistant professor at Virginia Commonwealth University.
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Pediatric nephrologists are a key piece of the care team for children with metabolic syndrome because they have continual opportunities to identify and treat risk factors for cardiovascular disease, according to Tammy Brady, MD, PhD, medical director of the Pediatric Hypertension Program and associate professor of pediatrics at Johns Hopkins University.
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Time to Focus on Increasing Organs for Patients With ESRD, Azar Says at Kidney Week
November 7th 2019HHS is taking additional steps to improve care for those with end-stage renal disease (ESRD), Secretary Alex Azar announced Thursday. Speaking at a tightly packed session during the American Society of Nephrology’s Kidney Week 2019, Azar said HHS is looking to speed organ transplants to those who need them as part of an overall shift away from dialysis in kidney care centers and as part of its overall desire to lower spending while improving outcomes.
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Dr Robert Dubois Details the Vital Importance of Increasing Healthcare Spending Discussions
November 1st 2019Discussions around healthcare spending have been ignored for decades, but Robert Dubois, MD, PhD, chief science officer and executive vice president at National Pharmaceutical Council, believes we have the ability to start those discussions now.
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Ceci Connolly Outlines Healthcare Spending Management and Necessary Innovations
November 1st 2019By using the available evidence, data, and facts surrounding healthcare spending, we can begin conversations on necessary innovations, said Ceci Connolly, BA, president and chief executive officer of Alliance of Community Health Plans.
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NASH Has Gone Under the Radar, but It Is the "Elephant in the Room," Panelists Say
November 1st 2019Although the number of people with nonalcoholic fatty liver disease, which progresses to nonalcoholic steatohepatitis (NASH), is growing, the health system is still trying to get a handle on which patients to target and how to identify them before the first treatments come to market, explained panelists during a session at AMCP Nexus 2019.
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Health Reform Efforts and Public Perception of Policy Changes
November 1st 2019In a session at AMCP Nexus 2019, Melissa Andel, MPP, vice president of health policy, Applied Policy, covered the current state of health insurance coverage in the United States, major actions from the Trump administration impacting the Affordable Care Act (ACA), public sentiment around the ACA, and what stances presidential candidates have taken on healthcare.
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Roger Longman Offers Strategies to Analyze the Value of Emerging Drugs With Limited Real-World Data
November 1st 2019Using value assessment models and data that predict real-world performance can assist in valuing drugs with limited or no real-world data, said Roger Longman, MA, chief executive officer of Real Endpoints.
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Dr Karen Watkins Details the Obstacles Impeding Effective Treatment for Patients With NASH
November 1st 2019The lack of FDA approvals for the treatment of nonalcoholic steatohepatitis (NASH) and safety concerns surrounding 2 recommended treatments contribute to the barriers blocking effective progress, said Karen Watkins, PharmD, pharmacist for emerging therapeutics strategy, MedImpact Healthcare Systems.
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Preparing for the Near-Term Pipeline of Therapies, and Opportunities for Cost Savings
October 31st 2019Increased competition is making its way into the specialty drug market, affecting orphan conditions, cancer types, and even common specialty conditions, which is presenting some cost savings opportunities, explained Aimee Tharaldson, PharmD, senior clinical consultant for emerging therapeutics at Express Scripts, who presented on the specialty pharmaceutical pipeline during her regular session at AMCP Nexus 2019.
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