PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

AGS supports CMS decision to require real-world data for monoclonal antibodies

2023-07-11
(Press-News.org) New York (July 11, 2023)  — The American Geriatrics Society (AGS) supports the recently announced decision from the Centers for Medicare and Medicaid Services (CMS) to require the collection of real-world information via a registry to study monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease. This decision applies to monoclonal antibodies that receive traditional approval from the Food and Drug Administration (FDA). Currently, lecanemab (trade name Leqembi™) is the only monoclonal antibody with this approval.

In a June 22, 2023 fact sheet, CMS released new details about coverage for monoclonal antibodies that receive traditional approval. Specifically, Medicare will cover those drugs with traditional FDA approval when the prescribing physician participates in the collection of evidence about how these drugs work in the real world, also known as a registry. Further, we agree with CMS that people who are prescribed monoclonal antibodies should have access to an appropriate clinical team and follow up care.  

From the perspective of the American Geriatrics Society, what matters most to people living with Alzheimer’s disease and their care partners is whether a proposed new treatment provides clear clinical benefits to cognitive and functional performance and other key outcomes with acceptable side effects. 

Available data for lecanemab are insufficient to settle this key question for patients. The CLARITY AD trial of lecanemab provides far too little information about the response of certain subgroups, particularly older adults who are frail or living with multiple chronic conditions, and Black Americans. CLARITY AD was conducted in generally healthy adults and AGS is concerned that the FDA-approved label has no contraindications. For example, although the label states, “caution should be exercised when considering the administration of antithrombotics” their concurrent use is not an exclusion.  This gap in knowledge greatly amplifies the importance of acquiring new data through mandatory registry reporting.  

Our members understand the heavy toll of Alzheimer's disease and other dementias on patients, caregivers, and their families and remain supportive of Medicare payment for treatments that have been shown to have clinical benefit and received traditional approval from the FDA. However, we have significant concerns about the limited clinical benefit of lecanemab, its safety, and the lack of clinical and sociodemographic diversity in the study population. AGS appreciates the thoughtful approach that CMS is taking to collecting data via a registry and believes that this will ensure that we have adequate safety and efficacy data that reflects the diversity of the Medicare population without reducing access. 

On July 6th, CMS released more information about its National Patient Registry for monoclonal antibodies in this provider fact sheet and patient fact sheet. The registry portal can be accessed here.

###

About the American Geriatrics Society
Founded in 1942, the American Geriatrics Society (AGS) is a nationwide, not-for-profit society of geriatrics healthcare professionals dedicated to improving the health, independence, and quality of life of older people. Our 6,000+ members include geriatricians, geriatrics nurse practitioners, social workers, family practitioners, physician assistants, pharmacists, and internists who are pioneers in serious-illness care for older individuals, with a focus on championing interprofessional teams, eliciting personal care goals, and treating older people as whole persons. AGS believes in a just society, one where we all are supported by and able to contribute to communities where ageism, ableism, classism, homophobia, racism, sexism, xenophobia, and other forms of bias and discrimination no longer impact healthcare access, quality, and outcomes for older adults and their caregivers. AGS advocates for policies and programs that support the health, independence, and quality of life of all of us as we age. AGS works across patient care, research, professional and public education, and public policy to improve the health, independence, and quality of life of all older people. For more information, visit AmericanGeriatrics.org.

END


ELSE PRESS RELEASES FROM THIS DATE:

GSA Connects 2023: A premier international scientific meeting

2023-07-11
11 July 2023 The Geological Society of America Release no. 23-25 Contact: Justin Samuel +1-303-357-1026 jsamuel@geosociety.org For immediate release GSA Connects 2023: A Premier International Scientific Meeting The Geological Society of America visits Pittsburgh Boulder, Colo., USA: Media registration is open now for The Geological Society of America’s Connects 2023 meeting, to be held 15–18 October 2023 at the David L Lawrence Convention Center (1000 Fort Duquesne Blvd) in Pittsburgh, Pennsylvania, USA. The organizing committee is pleased to be planning a dynamic meeting centered around ...

Generative AI ‘fools’ scientists with artificial data, bringing automated data analysis closer

Generative AI ‘fools’ scientists with artificial data, bringing automated data analysis closer
2023-07-11
The same AI technology used to mimic human art can now synthesize artificial scientific data, advancing efforts toward fully automated data analysis. Researchers at the University of Illinois Urbana-Champaign have developed an AI that generates artificial data from microscopy experiments commonly used to characterize atomic-level material structures. Drawing from the technology underlying art generators, the AI allows the researchers to incorporate background noise and experimental imperfections into the generated ...

Satisfaction with online dating app depends on what you’re looking for

2023-07-11
With an estimated 75 million active users each month, Tinder is the most popular dating app in the world. But a new study by Stanford Medicine researchers and collaborators has found, surprisingly - though perhaps not to users of the app - that many users are not swiping for dates. In a survey of more than a thousand Tinder users, half said they were not interested in meeting offline, and nearly two-thirds were already married or "in a relationship." In fact, the psychological motivations behind people's use of the app varied widely and had a strong influence on their satisfaction with the app and the dates it led to, according to the study published June 23 ...

University of Illinois study finds turning food waste into bioenergy can become a profitable industry

University of Illinois study finds turning food waste into bioenergy can become a profitable industry
2023-07-11
URBANA, Ill. — Food waste is a major problem around the world. In the United States, an estimated 30 to 40% of edible food is lost or wasted, costing billions of dollars each year. One potential solution is to divert food waste from landfills to renewable energy production, but this isn’t done on a large scale anywhere. A new study from the University of Illinois Urbana-Champaign investigates the feasibility of implementing energy production from food waste in the state of Illinois. “We have a large amount of organic waste in the U.S., which eventually enters landfills and emits greenhouse gasses. However, this material ...

Hepatic hydrogen sulfide levels are reduced in mouse model of progeria

Hepatic hydrogen sulfide levels are reduced in mouse model of progeria
2023-07-11
“To date, no studies have directly measured [hydrogen sulfide] production in Hutchinson-Gilford Progeria Syndrome [...]” BUFFALO, NY- July 11, 2023 – A new research paper was published in Aging (listed by MEDLINE/PubMed as "Aging (Albany NY)" and "Aging-US" by Web of Science) Volume 15, Issue 12, entitled, “Hepatic hydrogen sulfide levels are reduced in mouse model of Hutchinson-Gilford progeria syndrome.” Hutchinson-Gilford progeria syndrome (HGPS) is a rare ...

Missing a rare cause of hereditary cancer

Missing a rare cause of hereditary cancer
2023-07-11
New research from Cedars-Sinai Cancer investigators could warrant reconsideration of current screening guidelines to include a poorly recognized cause of Lynch syndrome, the most common cause of hereditary colorectal and endometrial cancers. Their study, published today in the JNCCN—Journal of the National Comprehensive Cancer Network, concluded that the guidelines leave a significant number of patients undiagnosed. “When patients with Lynch syndrome—whose first cancers generally appear at an early age—aren’t diagnosed promptly, they don’t get appropriate follow-up or surveillance,” said Megan Hitchins, ...

U of M Medical School receives DARPA award to develop detection tools for early symptoms of depression, psychosis and suicidality

2023-07-11
MINNEAPOLIS/ST. PAUL (07/11/2023) — Researchers at the University of Minnesota Medical School recently received a four-year award from the Defense Advanced Research Projects Agency’s (DARPA’s) Neural Evidence Aggregation Tool program. The goal of their project— titled Fast, Reliable Electrical Unconscious Detection (FREUD)—is to develop tools to better detect early symptoms of depression, psychosis and suicidality, with the intent that treatment can be started as early in a condition’s trajectory as possible. “It’s exactly those early moments when getting someone therapy or mental health services could save their life or ...

Research aims to identify better COPD diagnosis in African American patients

2023-07-11
DENVER — Recently published research suggests that despite showing clear symptoms of chronic obstructive pulmonary disease (COPD), many African Americans are not officially diagnosed with the disease due to flaws in diagnosis methods.  The Research was led by National Jewish Health and recently published in the Journal of General Internal Medicine from the COPDGene study.  Fixed-ratio spirometry, a standard method of measuring respiratory capacity, has long been used as a method of detecting COPD. ...

With a comfort promise, new clinic aims to eliminate pain in kids

2023-07-11
Each year, too many kids in the East Bay suffer needlessly from pain related to long-term serious illness, including migraines, joint and abdominal pain, sickle cell anemia and more. A new UCSF Health pain clinic in Walnut Creek is opening to provide relief. The new clinic extends the reach of the Stad Center for Pediatric Pain, Palliative & Integrative Medicine beyond UCSF Benioff Children’s Hospitals in San Francisco and Oakland. The Center is one of the nation’s most innovative and comprehensive integrative ...

Potential targets to delay motor aging revealed by C. elegans genome-wide screen

Potential targets to delay motor aging revealed by C. elegans genome-wide screen
2023-07-11
Genome-wide screen in the nematode Caenorhabditis elegans reveals potential targets to delay motor aging, including the phosphatidylinositol 3-kinase VPS-34; genetic and pharmacological partial inhibition of VPS-34 improves neurotransmission and muscle integrity through increased PI(3)P-PI-PI(4)P conversion, ameliorating motor aging in both worms and mice. ##### In your coverage, please use this URL to provide access to the freely available paper in PLOS Biology:   http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.3002165 Article ...

LAST 30 PRESS RELEASES:

The most effective diabetes drugs don't reach enough patients yet

Breast cancer risk in younger women may be influenced by hormone therapy

Strategies for staying smoke-free after rehab

Commentary questions the potential benefit of levothyroxine treatment of mild hypothyroidism during pregnancy

Study projects over 14 million preventable deaths by 2030 if USAID defunding continues

New study reveals 33% gap in transplant access for UK’s poorest children

Dysregulated epigenetic memory in early embryos offers new clues to the inheritance of polycystic ovary syndrome (PCOS)

IVF and IUI pregnancy rates remain stable across Europe, despite an increasing uptake of single embryo transfer

It takes a village: Chimpanzee babies do better when their moms have social connections

From lab to market: how renewable polymers could transform medicine

Striking increase in obesity observed among youth between 2011 and 2023

No evidence that medications trigger microscopic colitis in older adults

NYUAD researchers find link between brain growth and mental health disorders

Aging-related inflammation is not universal across human populations, new study finds

University of Oregon to create national children’s mental health center with $11 million federal grant

Rare achievement: UTA undergrad publishes research

Fact or fiction? The ADHD info dilemma

Genetic ancestry linked to risk of severe dengue

Genomes reveal the Norwegian lemming as one of the youngest mammal species

Early birds get the burn: Monash study finds early bedtimes associated with more physical activity

Groundbreaking analysis provides day-by-day insight into prehistoric plankton’s capacity for change

Southern Ocean saltier, hotter and losing ice fast as decades-long trend unexpectedly reverses

Human fishing reshaped Caribbean reef food webs, 7000-year old exposed fossilized reefs reveal

Killer whales, kind gestures: Orcas offer food to humans in the wild

Hurricane ecology research reveals critical vulnerabilities of coastal ecosystems

Montana State geologist’s Antarctic research focuses on accumulations of rare earth elements

Groundbreaking cancer therapy clinical trial with US Department of Energy’s accelerator-produced actinium-225 set to begin this summer

Tens of thousands of heart attacks and strokes could be avoided each year if cholesterol-lowering drugs were used according to guidelines

Leading cancer and metabolic disease expert Michael Karin joins Sanford Burnham Prebys

Low-intensity brain stimulation may restore neuron health in Alzheimer's disease

[Press-News.org] AGS supports CMS decision to require real-world data for monoclonal antibodies