NYUTron Clinical AI Accurately Predicts Health Outcomes
Researchers from the NYU Grossman School of Medicine have published a new paper detailing their AI NYUTron that can predict health outcomes. NYUTron uses unaltered electronic health records (EHR) and can predict hospital readmissions, hospital deaths, and length of stay with high accuracy. The tool was trained on EHR data from 336,000 patients at NYU Lagone.
The Odds Don’t Favor Merck’s Drug Price Negotiation Lawsuit
Merck filed suit against the Centers for Medicare and Medicaid Services (CMS) recently, marking the first pharmaceutical company to do so. However, according to Stephen L. Carter of Bloomberg, the lawsuit may be dead in the water. The reason, he argues, is the basis of the suit, which hinges on the idea that price caps equate to the government seizing private property without fair compensation and that the language of the bill is a violation of the First Amendment.
Talking Real-World Evidence and Biosimilar Uptake with Delphine Courmier
Biosimilars have opened up access to expensive but lifesaving biologics in recent years, but some payer organizations, providers, and regulatory agencies have reservations about them. Real-world evidence (RWE) has the potential to accelerate uptake of biosimilars. In a new interview with Delphine Courmier of Organon, learn more about the importance of RWE for biosimilar adoption.
Building a 3D Cancer Atlas with AI
Several cancer research organizations and Owkin, a company specializing in artificial intelligence (AI) are collaborating to map cancer cell interactions with MOSAIC, a new AI project. The project aims to reach near-single cell resolution using a spatial omics, which includes data mapping spatial localization of RNA in proteins in cells.
Bringing Allogeneic Cell Therapies to More Patients
Allogeneic (allo) cell therapies offer substantial benefits to patients due to their efficacy and availability. However, giving patients access to these treatments presents obstacles at the manufacturing level. Donor screening and recruiting is key to the process of building a sufficient supply chain. Doing so begins with a large donor pool.
Three Strategies for Providers Implementing Value-Based Care
Value-based care models have been put forward as a solution for rising Medicare costs, paying providers for the value their care provides patients. New laws are further incentivizing adaptation of these payment models. To jump on board successfully, Edifecs published an article earlier this year covering three strategies to help providers take on value-based care models successfully.
AI Medtech is Finally Living Up to its Potential
Artificial intelligence (AI) and machine learning (ML) has seen increasing implantation into medtech solutions in recent years, driven by advances in the field. AI technology is currently assisting in surgeries, imaging analysis, and payer decision-making. In a new Med Device Online article, learn more about the history of AI in medtech and where it is going in the coming years.
GSK’s RSV Vaccine Nabs First EU Approval of its Kind
Glaxo-Smith Klein (GSK) has received approval by the European Commission for its respiratory syncytial virus (RSV) vaccine Arexvy in adults aged 60 and up. This marks the first EU approval of a vaccine for RSV vaccine. This puts them ahead of Pfizer, whose vaccine Abrysvo has yet to be approved in the EU.
PBM Industry Pushes Back Against Pharma Lobbyists
Amid growing scrutiny of pharmacy benefit managers (PBMs) at the public and congressional level, a PBM industry group has launched an ad campaign pointing the blame back at pharma for high drug prices. The group argues that the pharmaceutical industry has spent millions of dollars on advertising and lobbying that places the onus of high drug prices on PBM practices while side skirting their own responsibility for setting list prices.
Building an Effective Real-World Evidence Strategy
Real-world evidence (RWE) is a key part of a successful product launch or indication expansion, but doing so requires a careful strategy to maximize efficiency and minimize costs. In a new article by Richard Hallquist of IQVIA, learn about how to build an evidence strategy that maximizes the odds of an excellent launch.
Medicare Drug Price Negotiations Will Include Patient Perspectives and Real-World Evidence
According to Medicare Director Meena Seshamani, upcoming drug pricing negotiations will take the patient perspective and real-world evidence (RWE) into account. The agency wants to incorporate information about how high prices of key therapeutics impacts patients, as well as how the drugs are used and work in real-world settings.
A Look at How Medicare Advantage Affects Providers
Although Medicare Advantage (MA) has been greatly beneficial for participating payer organizations, the picture is less rosy for providers, according to an analysis from the Kaiser Family Foundation (KFF). Providers must deal with a more complex policy framework when working with MA plans, resulting in an increased administrative burden and higher costs.
First Lawsuit Against US Medicare Drug Pricing Negotiations Filed by Merck
The pharma giant Merck & Co has filed a lawsuit against the US government over upcoming Medicare drug pricing negotiations included in the Inflation Reduction Act passed last year. The company argues that the negotiations would violate their 5th Amendment rights by forcing them to provide drugs at prices lower than market value.
AstraZeneca Looking Toward Early Full Approval for Anticoagulant Reversal Medication
Following positive results in a phase IV clinical trial, Astrazeneca is making moves to apply for full approval for its anticoagulant reversal drug Andexxa earlier than expected. Data from the trial, which is being ended early based on outside recommendations, showed that the drug was effective in patients on certain anticoagulants who are experiencing an intracranial hemorrhage.
Inflation Reduction Act R&D Cost Request May Prove Problematic
The US Inflation Reduction Act requires drugmakers to justify new drug prices based on the R&D costs needed to develop a therapeutic during drug pricing negotiations. However, this policy may be short-sighted, according to some experts, as it doesn’t account for the lost investments in failed drugs or the overall value provided to patients.
Bristol Myers Squibb’s Heart Medication Camzyos Receives NICE Recommendation
Bristol Myers Squibb (BMS) has received a recommendation for approval from the UK’s National Institute for Health and Care Excellence (NICE) for its heart drug Camzyos (mavacamten). The recommendation covers the use of the drug as a adjunct treatment for symtompatic obstructive hypertrophic cardiomyopathy, a condition of reduced blood flow caused by thickening of certain walls in the heart.
Real-World Data Study Finds Two Year Immunotherapy Regimens Appropriate for Advanced Lung Cancer
A real-world data (RWD) study published in JAMA Oncology finds that administering immunotherapy to patients with advanced non-small cell lung cancer (NSCLC) is appropriate. The study, which followed 1091 patients at Penn Medicine’s Abramson Cancer Center, found that patients whose cancer hasn’t progressed after two years of immunotherapy did not gain any clinical benefits by prolonging treatment past a 2-year period.
CMS Drug Price Negotiations Complicated by Therapeutic Alternatives Clause
As part of the upcoming drug pricing negotiations from the Inflation Reduction Act, drugmakers will need to justify high US drug prices by comparing efficacy and value with therapeutic alternatives. The problem, according to industry leaders, is that the definition of therapeutic alternatives is unclear. Beyond that, these filings have a small max word count, making applications even trickier.
EMA Calls for Novartis’ Sickle Cell Treatment to Lose Market Authorization
Novartis took a hit this week as the European Medicines Agency (EMA) has recommended that its market authorization for Adakveo, a sickle cell medication, be revoked. Although initial data suggested the drug could help reduce pain crises in patients 16 and older, the agency argues that new data showing increased levels of serious side effects do not outweigh the modest treatment effect.
Better Employee Health Through Specialty Rx Carve-Outs
Specialty Rx carve-outs allow for dedicated management of high-cost specialty medications by bypassing traditional pharmacy benefit managers (PBMs). Doing so, according to a new article in Corporate Wellness Magazine, can help improve employee health by applying specialized expertise to coverage decisions, better coordinating care management, and reducing costs.
Using Real-World Evidence to Accelerate Medical Device Development
Korea’s Ministry of Food and Drug Safety is now accepting real-world evidence (RWE) as clinical data for medical device approval decision-making. This opens up a pathway for medical device manufacturers to accelerate development with real-world data (RWD) resources like clinical data from devices, electronic health records (EHR), and claims data.
Working with Pharma to Advance NHS Health Equity Efforts
A key priority in the UK’s National Health Service (NHS) Operational Planning Guidance 2023/2024 is improving health outcomes for the poorest 20% of patients in the nation. Partnerships between NHS systems and the pharmaceutical industry represent one way to help address health disparities. Doing so, however, requires understanding the problem at hand and acting precisely.
Targeting Health Equity at the Neighborhood-Level
A person’s living environment is an important social determinant of health (SODH), affecting access to care and employment, exposure to environmental hazards, and financial pressures. As a result, health equity efforts need to zoom down to the neighborhood level to improve health outcomes. In a new Health Affairs article, learn more about addressing health equity efforts by analyzing SODH from a neighborhood-focused perspective.
Molecular Templates’ Multiple Myeloma Trial Partial Hold Lifted
Molecular Templates’ clinical trial for MT-0169, its experimental multiple myeloma therapeutic, is back on, following the US Food and Drug Administration (FDA) lifting a partial hold. The hold was placed on the trial following two adverse events experienced by patients, who both recovered. The move comes after the company laid off half its employees to focus on this drug, along with two others.
Addressing Barriers to Care in Rural America
Rural US residents face significant barriers to care that significantly worsen health outcomes. Addressing these barriers is a complex task due to the underlying reasons behind them. In a new Becker’s Hospital Review article, Karen Joynt-Maddox, MD, MPH, associate professor at the Washington University School of Medicine talks about the importance of hospitals in rural areas and how providers can work to improve rural health outcomes.
