In a change from previous policy, the Centers for Medicare and Medicaid Services (CMS) will cover new Alzheimer’s drugs with one catch – the manufacturer must participate in a new real-world data (RWD) registry. Patients eligible for coverage must have mild cognitive impairment, be a Medicare Part B […]
FDA Brief Supports Full Approval for Alzheimer’s Drug Leqembi
In a newly released brief, the US Food and Drug Administration (FDA) vocalized support for the full approval of Eisai and Biogen’s Alzheimer's drug Leqembi. The brief, which comes before an FDA adcomm this Friday, June 9th, shows that the agency considers the drug’s efficacy well-supported by […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
Pfizer’s RSV Vaccine Gets FDA Approval
The US Food and Drug Administration (FDA) has given approval for the use of Pfizer’s respiratory syncytial virus (RSV) vaccine in older adults. The move comes shortly after the agency approved another RSV vaccine from GSK. This sets up a marketplace standoff between the two, competing over a market […]
Over 500,000 Disenrolled from Medicaid After COVID-19 PHE Ends
Shortly following the end of the COVID-19 public health emergency, pandemic-era restrictions on Medicaid redetermination ended. In that time, over 500,000 people have been disenrolled, interrupting their coverage and impacting their access to healthcare. Some states have kicked off more […]
CMS Opens Up Coverage of Alzheimer’s Drugs
Once Lequembi, Easai’s amyloid-targeting Alzheimer's drug, is potentially approved by the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) have announced they will expand coverage for the class of drugs. Previously, CMS only covered amyloid therapies in […]
