New rules proposed by the US Drug Enforcement Agency (DEA) will require patients to have in-person visits when prescribing certain controlled drugs to patients who primarily receive care via telehealth. While many controlled drugs are targeted, the rules are an expansion to access for buprenorphine […]
EMA Committee Recommends Regeneron’s Libtayo + Chemotherapy Combo for Lung Cancer
Regeneron’s Libtayo (cemplimab-rwlc) has received a recommendation from the European Medicine’s Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for use in forms of non-small-cell lung cancer (NSCLC) as a combination therapy with a traditional chemotherapy agent. The […]
Talking Remote Care and Reimbursement with Bronwyn Spira of Force Therapeutics
The US Centers for Medicare and Medicaid Services (CMS) introduced new CPT codes last year, reducing barriers via remote care. In a new video by Managed Healthcare Executive, Force Therapeutics’ Bronwyn Spira talks about how these new codes affected outcomes and why outcomes-based reimbursement […]
Real-World Data Study Identifies Negative Health Outcomes in Long COVID Patients One Year Out
A newly published study in JAMA Health Outcomes found several adverse health outcomes in people living with long COVID one year after their initial infection. The researchers analyzed data from 13,435 people with long COVID symptoms and nearly 27,000 without it, finding that those with long COVID […]
FDA to Hold Adcomm on Eisai’s Leqembi Alzheimer’s Treatment by July 6th
The US Food and Drug Administration (FDA) will hold an advisory committee (adcomm on Eisai and Biogen’s Alzheimer’s drug Leqembi by July 6th, according to an announcement from Biogen yesterday, March 5th. This comes a year after an adcomm turned down the application for Aduhelm, another […]
Sanders Calls on Insulin Manufacturers to Follow Eli Lilly and Drop Insulin Prices
One day after Eli Lilly pledged to cut prices on its insulin products and implement some price caps, US Senator Bernie Sanders (I-VT), the current Senate health committee chair, has sent letters calling on Novo Nordisk and Sanofi to follow in kind. The move comes amid growing public attention is […]
US FDA Issues Emergency Use Authorization for First At-Home COVID and Flu Combo Test Kit
After a winter hallmarked by coexiting waves of COVID-19, seasonal flu, and RSV, the US Food and Drug Administration has given the Lucira COVID and Flu Home Test emergency use authorization (EUA). The at-home test kit is the first of its kind approved by the agency, simultaneously testing for […]
Vertical Integration Has Negative Impacts on Patient Outcomes
Although many health systems are moving toward vertical integration by acquiring private practices, the strategy may be hurting the bottom line and patients. A newly published study examined how vertical integration impacts patients undergoing colonoscopies and their subsequent healthcare costs […]
US Court Temporarily Shoots Down J&J’s Plan to Prevent Amgen from Releasing Stelara Biosimilar
A US District Court judge stopped J&J’s attempt to stop Amgen’s Stelara biosimilar from entering the market. The judge cited a “failure to comply,” noting that the Pfizer’s lawyers submitted documents exceeding the courts page limits. In addition, the lawyers only asked to go over the limit […]
UK Increases Statutory Scheme and VPAS Revenue Clawback Rates
The UK’s voluntary scheme for branded medicines pricing and access (VPAS) controls National Health Service (NHS) spending by requiring drugmakers to recoup the government for a portion of sales if spending exceeds a certain rate of growth. The new clawback rate for VPAS increased to 26.5% while the […]
iCAD to Present Real-World Evidence Supporting Profound AI as Diagnostic Tool for Breast Cancer
The medical technology company iCAD is set to present new real-world evidence (RWE) at the European Congress of Radiology (ECR) 2023 supporting its ProfoundAI software in assisting radiologists with breast cancer detection and assessment. The company will also display its Breast AI platform at its […]
ICER Updates Leqembi Price Range Recommendations
The Institute for Clinical and Economic Review (ICER) released an update to its recently released value assessment of the Leqembi (lecanemab). ICER changed its price recommendation for Eisei’s new Alzheimer’s treatment to a range of $8,900 to $21,500 per year. This price is higher than its initial […]
Pfizer and BioNTech Apply for FDA Emergency Use Authorization of Omicron Booster in Children
Pfizer and BioNTech have applied for emergency use authorization from the US Food and Drug Administration for their Omicron-targeted bivalent COVID-19 vaccine in children 4 and under (to 6 months). The application specifically is for the vaccine as a second booster, or fourth dose, as it is already […]
Medicare Advantage Insurer’s Margins on the Rise
An analysis from the Kaiser Family Foundation shows that insurers in Medicare Advantage saw strong margins in 2021, twice that of other markers. This is leading many insurers to enter into the market and many others to redouble their efforts, Humana which announced it is pivoting away from the […]
Eli Lilly Cuts US Insulin Price and Caps Out-of-Pocket Monthly Cost
Amid growing discontent with insulin prices in the US, Eli Lilly is lowering the price of its insulin products. Its brand name Humalog and Humulin will see a 70% price drop, while the company’s generic Lispro will be set at $25 a vial. In addition, the company will cap the price of insulin at $35 a […]
FDA Advisory Committee Recommends Approval of Pfizer’s RSV Vaccine
Pfizer received a recommendation from the US Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee (VRPAC) for its respiratory syncytial virus (RSV) vaccine, dubbed RSVpreF. The recommendation is for adults over 60 years old, the group most impacted by […]
Supporting Comprehensive Care at Safety-Net Providers Through Value-Based Pricing
Although safety-net care systems are essential for providing healthcare to under- and uninsured people, often from marginalized backgrounds, comprehensive care is often out of reach due to a dearth of funding. One way to help address this care disparity, according to a newly published article in […]
Potential Targets Emerge for Upcoming Medicare Price Negotiations
With Medicare negotiations beginning in 2026, some major sellers by Novo Nordisk, Eli Lilly, and Merck are likely early targets of the drug pricing reforms included in the US Inflation Reduction Act (IRA). This includes diabetes drugs like Januvia by Merck and cancer drugs like Pfizer’s Ibrance and […]
Drug Development Costs See Steep Increase, But Not Enough to Justify Exorbitant Launch Prices
The cost of developing a new drug has risen by 15% to $2.3 billion, according to a report from the consulting firm Deloitte. This steep figure was paired with data showing that return on investments faced an 82% decline in the past year. However, a study published in the British Medical Journal, […]
HealthCore Changes Name to Carelon Research
The healthcare data company HealthCore announced today, March 1st, that it has undergone a name change. The company, now dubbed Carelon Research, will continue its dedication to providing its healthcare data and evidence generation services to its clients across industry, academia, and other life […]
The FDA Omnibus Reform Act: 8 Points to Remember
The Food and Drug Omnibus Reform Act of 2022 (FDORA) was signed into law last year, granting more power to the US Food and Drug Administration (FDA) to perform inspections at home and abroad. Learn more about the bill and 8 points to note in a recent Pharmaceutical Online article by professionals at […]
Understanding the Impact of New EU Cybersecurity Directive on Medical Device Industry
As implementation of medical devices is on the rise, cybersecurity threats have become a pressing concern. In a Med Device Online guest column by John Giantsidis, President of CyberActa, discusses a recent EU directive that is set to change the cybersecurity landscape of the medical device industry, […]
ADA Calls for More Oversight and Transparency from Medicaid Managed Care Plans
In a new letter to the Centers for Medicare and Medicaid Services (CMS), representatives from the American Dental Association have asked for increased transparency regarding medical loss ratio (MLR) reporting from Medicaid managed care plans. The authors pointed out that many states were missing […]
Sanofi Launches “This is Rare” Campaign on Rare Disease Day
Sanofi is marking this year’s Rare Disease Day, February 28th, with its new “This is Rare” campaign, which will feature the voices of patients living with rare diseases. The campaign is part of a large push by the company and others to develop therapeutics for the rare disease community, which […]
Do Commercial Payers Rely on ICER Assessments During Specialty Drug Coverage Deliberations?
The Institute for Clinical and Economic Review (ICER) releases value assessment reports that determine cost-effectiveness ratios (CERs) for new and existing therapeutics. A newly published study in the Journal of Managed Care + Specialty Pharmacy, examines whether and how commercial insurance plans […]
FDA Grants SpringWorks’ Desmoid Tumor Drug Priority Review
The SpringWorks Therapeutics, a spinoff of Pfizer, received priority review by the US Food and Drug Admnistration (FDA) for nirogacestat as a treatment for desmoid tumors. Patients taking the small molecule drug as a monotherapy had 71% lower risk of progression and had a better objective response […]
Real-World Evidence Study Reveals Issues with BMI in Obesity Research
Body mass index (BMI) is widely used in research on the effects of obesity on health. A newly published paper in Population Studies found that BMI may not be as useful for population health as once thought, impacting health, based on data from over 18,000 patients. Analysis shows that relying on the […]
Value in Health Review: Applying Machine Learning to Wearable Data to Generate HEOR Insights
An article in the latest issue of Value in Health breaks down how machine learning can be applied to data from wearable devices to advance health economics and outcomes research (HEOR). Wearables are a font of real-world data (RWD) that can be analyzed by machine learning (ML). By addressing […]
Advancing Rare Disease Drugs Through Real-World Evidence
Patients with rare diseases often suffer with few effective treatment options. Therapeutic development for these drugs targeting rare diseases increasingly depends on real-world evidence (RWE). In a new IQVIA blog, learn more about efforts in the UK to advance the development of drugs for rare […]
CDC Launches Initiative to Accelerate Health Data Modernization Efforts
The US Centers for Disease Control and Prevention (CDC) has announced a new initiative to modernize its public health data infrastructure. The Initiative, announced today, February 27th, will be a cooperative public-private effort led by the agency, the National Coordinator for Health Information […]
