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The 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.

The 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).

The 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.

A 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.

Some 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.

A 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.

Investigators 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.

Clinicians 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.

Because 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.

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.

HHS 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.

Discussions 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.

By 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.

Although 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.

In 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.

Using 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.

The 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.

Increased 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.

Value needs to be considered early in the development life cycle of a therapy and should be continued throughout, even into the postlaunch space using real-world studies, according to a presentation on value-based services and their life cycles at the AMCP Nexus 2019 meeting.

Referencing patients as attributable examples of necessary care has assisted in developing strategies for pharmacy and medication benefits, said Jeremy Whalen, PharmD, BCOP, Specialty Clinical Program Director for Oncology at Prime Therapeutics.

New high-cost therapies require new financing mechanisms, but the challenge is coming to an agreement on what should be considered in these new payment models, said Jane Barlow, MD, MPH, MBA, executive vice president and chief clinical officer for Real Endpoints.

As the number of high-cost orphan drugs and gene and cell therapies continues to grow, there will be a greater need for alternative payment models to help figure out the best way to pay for these treatments.

Proposed changes to the Stark Law that would make collaboration easier have purposely excluded pharmaceutical manufacturers, according to speakers at the Community Oncology Alliance Payer Exchange Summit.

Practices participating in the Oncology Care Model (OCM) have been interested in understanding the data and what it tells them about how to focus their efforts, said Mike Fazio, senior vice president of client services, Archway Health.

The Oncology Care Model is a leading innovation in the move from fee-for-service to value-based reimbursement in large part because CMS has made adjustments based on physician feedback, according to an agency official who addressed the Community Oncology Alliance Payer Exchange Summit.

As the number of expedited FDA approvals for cancer drugs that are based on surrogate end points increases, so does the need for new ways to uncover efficacy and safety data to justify the costs associated with these treatments. With the growth of data innovations and collaborations, the answer might be found in real-world evidence.

What would a successor to the Oncology Care Model (OCM) look like? Community oncologists discuss at the Payer Exchange Summit sponsored by the Community Oncology Alliance.

Heading into 2019, the idea that oncology practices would fully embrace financial responsibility for clinical decisions still seemed far-fetched for many. And yet, when it was time to make the call, moving to 2-sided risk proved a “simple” decision, said Travis Brewer of Texas Oncology, who took part in a panel offering an update on the Oncology Care Model (OCM) at the start of the Community Oncology Alliance (COA) Payer Exchange Summit, which opened Monday in Tyson’s Corner, Virginia.

Artificial intelligence (AI) can help derive meaning from data collected in healthcare to avoid noise and wasted efforts, said John Frownfelter, MD, FACP, chief medical officer of Jvion.

As costs for cancer care continue to rise, Pontchartrain Cancer Center does benefit and cost analyses for all patients before they start therapy and also takes into account any social needs they might have, said Kathy W. Oubre, MS, chief operating officer at Pontchartrain Cancer Center.