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Tuesday, April 2, 2019

Nektar presents data on its immuno-oncology pipeline candidates

Nektar Therapeutics presented preclinical data on its immuno-oncology pipeline candidates, bempegaldesleukin,NKTR-214 or bempeg, a CD122-preferential IL-2 pathway agonist, and NKTR-255, an IL-15 receptor agonist, at the American Association for Cancer Research Annual Meeting 2019. The meeting is being held on March 29 to April 3, 2019 at the Georgia World Congress Center in Atlanta. “We’re excited to showcase our promising immuno-oncology pipeline, which is strategically developed to target multiple points in the cancer immunity cycle to amplify the body’s ability to fight tumor cells,” said Jonathan Zalevsky, Ph.D., Chief Scientific Officer at Nektar. “The preclinical studies presented at AACR 2019, by both Nektar scientists and our collaborators highlight the promise of targeting the IL-2 and IL-15 pathways to activate the immune system to induce durable anti-tumor responses in combination with complementary mechanisms such as personalized T cell vaccines and tumor-directed antibody therapies. We plan to explore these combinations further and look forward to advancing them into the clinic.”

Doctors Unclear on Legal Obligations in Caring for Patients With Disability

Practicing physicians might not understand their legal responsibilities when caring for people with disability, which may contribute to inequalities in their care, according to a study published online April 1 in Health Affairs.
Nicole D. Agaronnik, from Massachusetts General Hospital in Boston, and colleagues interviewed 20 practicing physicians across five specialties to examine the knowledge of their obligations to accommodate patients with disability under federal civil rights law.
The researchers found that in three potentially problematic areas, interviewees reported having had little formal training about their obligations and demonstrated superficial or incorrect understanding of their obligations; these areas were deciding which accommodations their practices should implement, refusing patients with disability, and holding patients accountable for accommodation costs.
“Our findings suggest that physicians have little formal training in legal requirements to provide equitable care to people with disability. Thus, perhaps not surprisingly, our results also suggest that practicing physicians might not fully understand their legal responsibilities when caring for people with disability,” the authors write. “Therefore, one critical future direction involves educating physicians on several levels — about disability disparities, their legal obligation to provide equitable care and reasonable accommodations, and approaches to accommodating disability.”

Reduction in Autism Diagnoses Observed With Revised Diagnostics Manual

Use of the Diagnostic and Statistical Manual 5 (DSM-5) criteria for autism spectrum disorder (ASD) seems to have reduced the number of ASD diagnoses, according to a review published online March 9 in the Journal of Autism and Developmental Disorders.
Kristine M. Kulage, M.P.H., from the Columbia University School of Nursing in New York City, and colleagues examined changes in the frequency of ASD diagnoses since the DSM-5 publication in a five-year follow-up systematic review and meta-analysis. Data were included for 33 studies.
The researchers found that use of DSM-5 criteria indicates reductions in the diagnosis of ASD (20.8 percent; P < 0.001), DSM-IV-TR autistic disorder (10.1 percent; P < 0.001), and Asperger syndrome (23.3 percent; P = 0.001); a nonsignificant decrease was seen in pervasive developmental disorder-not otherwise specified (46.1 percent; P = 0.52). Overall, 28.8 percent (P = 0.06) of individuals diagnosed with DSM-IV-TR but not DSM-5 ASD would qualify for social communication disorder. Compared with earlier reviews, the findings suggested smaller decreases in ASD diagnoses.
“Our findings provide further insight regarding how the DSM-5 is being used nationally and internationally to diagnose, or failing to diagnose, those with ASD,” Kulage said in a statement. “Future research is needed, as concerns remain for impaired individuals, who, because of the change in diagnostic criteria for ASD, may no longer qualify for treatment but still demonstrate a need for services.”

Over-the-Counter Meds Save Health Care System Billions

On average, each dollar spent on over-the-counter (OTC) medicines saves the U.S. health care system $7.20, totaling nearly $146 billion in annual savings, according to a report released March 18 by the Consumer Healthcare Products Association (CHPA).
The CHPA worked with research firm IRI to consult published data sets and economic modeling and to survey more than 5,000 consumers on how they would treat symptoms if OTC medicines did not exist. Prescription drug costs were based on data from Symphony Health. The nine major therapeutic categories of OTC medicines analyzed were for acute and chronic self-treated conditions: allergy, analgesics, antifungals, cough/cold/flu, lower and upper gastrointestinal (GI), medicated skin, sleep aids, and smoking cessation.
According to the report, the value of OTC medicines is generated from nearly $95 billion in clinical cost savings (avoided doctor’s office visits and diagnostic testing) and nearly $52 billion in drug cost savings (lower-priced OTCs versus higher-priced prescription drugs). Three categories of OTC medicines — medicated skin, lower GI, and upper GI — made up 61 percent of the total OTC savings, driven primarily by the price difference between OTC and prescription products. Approximately $73.6 billion, or 50.3 percent of total savings, were captured by commercial insurance plans.
“The evidence is clear that OTC medicines help ease the tremendous burden on the health care system by empowering consumer self-care, thereby allowing over-stretched health care practitioners to focus on the diagnosis and treatment of patients with more serious diseases and medical conditions,” Scott Melville, president and chief executive officer of the CHPA, said in a statement.

Uninsured, Medicaid Covered Get Short Shrift on Hospital Stays

Folks who aren’t covered by private insurance are much more likely to get booted out of the hospital early, a new study finds.
Uninsured patients were also more than twice as likely to be transferred to another hospital and 66% more likely to be discharged outright, compared with people with private insurance, the findings showed.
People on Medicaid had nearly 20% increased odds of being transferred, but about the same odds of being discharged as those covered by private insurance, the researchers said.
“It suggests there is a disparity in access to hospital care. Based on the insurance card in your pocket, you may have different access to different hospitals for the most standard inpatient care they offer,” said lead researcher Dr. Arjun Venkatesh. He is director of Emergency Department Quality and Safety Research and Strategy with the Yale School of Medicine.
Since 1986, federal law has required hospitals to treat anyone who shows up at an emergency room for treatment, regardless of insurance status.
But experts have been hearing anecdotes for some time suggesting that hospital patients with no or low-quality insurance tend to get “dumped,” either through discharge or transfer to another hospital, Venkatesh said.
However, it’s tough to pin this down because many transfers that occur really are needed to make sure people get the care they require, he noted.
“You really do need to get transferred if, say, you have an injury to a hand and you need a hand surgeon at another hospital,” Venkatesh said.
So he and his research team picked pneumonia, chronic obstructive pulmonary disease (COPD) and asthma as three common conditions that any hospital could treat, and made their analysis even more conservative by only including hospitals that had intensive care units.
The researchers then examined more than 215,000 emergency department visits for those lung conditions that occurred in 2015 and were logged as part of a federal database used to track emergency department care in the United States.
The investigators found that people with private insurance had a much better chance of remaining as long as necessary in the hospital, compared with the uninsured and Medicaid patients. The association held even after the research team took into account other factors, such as patient income and the hospital’s ability to provide critical care.
“The insurance type they had was still very predictive of whether they would be transferred to another hospital,” Venkatesh said. “That’s just not really explicable.”
The concern is that patients who are transferred or discharged early might not be fully healed, and their condition might suffer as a result of leaving the hospital, he explained.
While the study did not examine the cause of these disparities, financial incentives for hospitals could play a role, said Venkatesh. Hospitals are not reimbursed for admitting uninsured patients and they receive lower payments for Medicaid, he noted.
Eliot Fishman, senior director of health policy for Families USA, called the findings “upsetting,” and places the study in the context of the ongoing national debate over health care coverage for everyone. Families USA is a consumer health care advocacy group.
“I think there’s a broader conversation that is starting to happen in the country about moving toward a more universal, more equal system of health insurance coverage,” Fishman said.
“As inappropriate as the behavior described in this article is, I think that does feed into the conversation around moving towards a more universal platform of payment, not just for hospital services, but for medical services in general,” Fishman added.
Venkatesh suggested that policy makers who want to change this practice could look at amending federal health care law to better structure emergency care in the United States.
“We haven’t really said what is the kind of universal access to hospital-based care that everybody in the country should get, and how we should finance and pay for that,” Venkatesh said.
In the meantime, federal agencies like the U.S. Centers for Medicare and Medicaid Services could develop regulations aimed at preventing such disparities in care, he added. These disparities also could be weighed as a factor when hospitals apply for accreditation or certification.
The new study was published online April 1 in JAMA Internal Medicine.
More information
The Kaiser Family Foundation has more about the uninsured in America.
SOURCES: Arjun Venkatesh, M.D., director, Emergency Department Quality and Safety Research and Strategy, Yale School of Medicine, New Haven, Conn.; Eliot Fishman, Ph.D., senior director, health policy, Families USA; April 1, 2019, JAMA Internal Medicine, online

BriaCell announces clinical trial collaboration agreement with Incyte

BriaCell Therapeutics announced a clinical trial collaboration and supply agreement with Incyte. Under the terms of the agreement, BriaCell will evaluate combinations of novel therapeutics for the treatment of patients with advanced breast cancer. Under the agreement, Incyte will provide compounds from its development portfolio, including INCMGA0012, an anti-PD-1 monoclonal antibody, and epacadostat, an IDO1 inhibitor, for use in combination studies with BriaCell’s lead candidate, Bria-IMT, in advanced breast cancer patients.
https://thefly.com/landingPageNews.php?id=2887629

Minimally invasive uterine fibroid treatment safer, as effective as surgery

Uterine fibroid embolization (UFE) effectively treats uterine fibroids with fewer post-procedure complications compared to myomectomy, according to new research presented at the Society of Interventional Radiology's 2019 Annual Scientific Meeting.  Women who received this minimally-invasive treatment also had a slightly lower need for additional treatment than those who underwent surgery.
UFE is a minimally-invasive treatment for uterine fibroids that is less painful, preserves the uterus and allows women to get back to their lives sooner than surgical options. However, past research suggests U.S. women, a majority of whom will experience uterine fibroids by age 50, are largely unaware of UFE despite more than 30 years as an evidence-based treatment.
"Women have options for treating their uterine fibroids. UFE and myomectomy are procedures with similar efficacy and durability for treating fibroids, but UFE has fewer complications and shorter hospital stays," said Jemianne Bautista-Jia, MD, radiology resident at Kaiser Permanente and lead author of the study. "There are important factors women should consider when choosing between the procedures, including risk of bleeding, possibility of infections, and recovery time."
In the retrospective cohort study, researchers analyzed treatment outcomes of 950 uterine fibroid patients from Jan. 1, 2008 through Dec. 31, 2014. Half of the patients underwent UFE, a non-surgical treatment that eliminates the blood supply to fibroids, causing them to shrink or disappear. The other half were treated surgically through myomectomy.
After an average seven-year follow up, the study found that women who underwent myomectomy had a higher rate of postprocedural complications, including a 2.9 percent rate of blood transfusion, significantly higher than 1.1 percent of patient who were treated using UFE. The two methods were comparably effective based on the rate at which secondary interventions were needed.
A uterine fibroid (leiomyoma) is a noncancerous tumor that occurs in the muscle cells of the uterus. These growths do not spread to other regions of the body and are typically not dangerous. While some women do not experience symptoms, others have very heavy and prolonged bleeding that can be debilitating, as well as pelvic pain and abdominal enlargement.
Learn more about UFE and fibroids at sirweb.org/fibroidfix.
Abstract 137: Comparison of uterine artery embolization and myomectomy for treatment of symptomatic uterine fibroids: A long-term retrospective analysis.
https://www.biospace.com/article/releases/minimally-invasive-uterine-fibroid-treatment-safer-and-as-effective-as-surgical-treatment/