In a new announcement by the South Korean government, Canada and Australia will be added to the nation’s list of countries it uses as references for drug pricing purposes. Previously, the group of countries used for price-setting includes seven nations. The addition puts Canada and […]
The Latest Shifts in the FDA Accelerated Approval Pathway
The US Food and Drug Administration (FDA) is actively retooling its accelerated approval pathway, with or without actions by Congress. GSK announced yesterday, November 22nd, that the agency asked it to pull a multiple myeloma drug based on negative post-confirmatory trial data. Unlike previous […]
WHO Draft Pandemic Rules Could Make Pharma Disclose Prices
New draft rules by the World Health Organization (WHO) may force pharma companies to reveal the prices of any drugs under public procurement contracts. This comes after criticism of the industry over a lack of pricing transparency regarding therapeutics like vaccines during the COVID-19 […]
Real-World Evidence Studies Show Efficacy of COVID-19 Therapeutics
Two new real-world evidence studies exploring the efficacy of two treatments for COVID-19 have been published in the British Medical Journal (BMJ). The first study investigated real-world data (RWD) from fully vaccinated high-risk adult patients in England. Those taking sotrovimab had better […]
Study Highlights Barriers to Care for Disabled People in US Healthcare System
A newly published study in Health Affairs further characterizes significant physical and structural barriers to care. The survey found that many physicians felt uncomfortable taking on disabled patients, often denying care. Furthermore, many care delivery locations are not ADA compliant and […]
Study Finds Racial Health Disparities Negatively Impacted by Medicaid and Medicare DSH Payment Model
A recently published article in JAMA Network Open found that structural problems in Medicaid and Medicare DSH payment programs hurt the marginalized, low-income populations they are meant to benefit. Data was gathered from DSH programs in largely majority Black counties in all US states except […]
New Data Reveals Burden of Oral Disease on Managed Care Plans
New research in Managed Care shows the burden of oral disease on managed care plans. The researchers looked at data from the IBM Watson Medicaid Marketscan data base, the IBM Dental Database, and the Medical Expenditure Panel Survey to ascertain the burden on Medicaid and commercial plans […]
FDA Officials Point Out Interchangeability Essential to Biosimilar Competition
Despite a range of biosimilars entering the market, their ability to lower drug spending for patients is dependent on payer reimbursement, which is inconsistent and based on approved uses. According to FDA officials, one avenue to ease these issues is with interchangeables, drugs that can be […]
Drug Pricing Reform on the Back Burner in Ramp-Up to US Mid-Term Elections
Although healthcare is front and center on tomorrow’s ballot in terms of abortion and Medicare, drug pricing reform has not been a key talking point in the lead-up to the US mid-term elections. This is in spite of the Democrats’ recent legislative win with the Inflation Reduction Act, which included […]
Using Value-Based Payment to Support Health Equity Starts at Model Design
Although value-based payment (VBP) models offer the opportunity to advance health equity goals, doing so requires an intentional, carefully considered approach. Health equity must be centered in payment model design, according to newly published Health Affairs article in a recent series on VBPs. […]
FDA Panel Discusses Real-World Evidence Confirming Pulse Oximeters Inaccurate for People with Darker Skin Tones
The US Food and Drug Administration held a panel this week discussing “mounting real-world evidence” (RWE) that pulse oximeters do not work as well on people with darker skin tones. The topic, long discussed and highlighted by communities of color and patient advocacy groups, came to a head during […]
San Diego Non-Profit and Managed Care Company Brings Free Healthcare to Unhoused People
A non-profit team of clinicians is providing comprehensive care to San Diego’s unhoused population in a partnership with Medi-Cal, a medical provider for low-income people in California, and Molina Healthcare of California, a managed care company. The team, called Healthcare in Action, is comprised […]
ISPOR Releases Guidance on Reproducibility of Real-World Evidence Research
ISPOR has published a news guidance on using real-world evidence to determine efficacy and make healthcare decisions. The guidance puts forward a framework to address issues of data provenance, utilization, and analysis for researchers to follow in order to ensure reproducibility. This framework was […]
FDA Issues Final Guidance on Clinical Trials with Multiple Endpoints
Last week, the US Food and Drug Administration (FDA) released its final guidance on multiple endpoints in clinical trials. The goal of the guidance is to provide standardized strategies for clinical trials with multiple endpoints to avoid ambiguity in study findings that might have bearing on the […]
Meta-Analysis Confirms Racial Discrimination Worsens Pregnancy Outcomes
A recent meta-analysis in BMJ Global Health concluded that racial discrimination in the US negatively impacts health outcomes for pregnant people. The high maternal mortality rates experienced by Black Americans has been a pressing, but long-sidelined issue in the US. This work helps to pin down […]
FDA Opens Applications for PDUFA VII Real-World Evidence Programs
The US Food and Drug Administration (FDA) will start accepting applications for two programs that are part of the Prescription Drug User Fee Act (PDUFA VII). These programs are intended to help improve the use of real-world evidence (RWE) in approvals for new therapeutics. In addition, the program […]
US HHS Secretary Becerra Says March-In Rights Not “Off the Table”
While pharma and biotech companies are still reeling from the passage of drug pricing reform in the US, their worries are still not over. Secretary Xavier Becerra of the Department of Health and Human Services (HHS) has mentioned that march-in rights are not “off the table.” The federal government […]
Researchers Put Forward New Healthcare Data Use Framework
A group of researchers from around the world have proposed a new framework for the use of healthcare data in research. The framework, published in several journals, guides researchers in several aspects of healthcare usage, such as transparency, quality assessment, and more. The team constructing […]
The Impact of Alzheimer’s Care: A Managed Care Perspective
Alzheimer’s is the most common cause of dementia, affecting 6.5 million people in the US alone. Unfortunately, a crisis is brewing in many countries aging populations; the number of people facing the disease will double in the next 40 years. A newly published article in the AJMC breaks down the […]
EU Commission Approves Novavax COVID-19 Boosters
The EU Commission has approved the Novavax COVID-19 vaccine booster for adults 18 and above. The move comes only weeks after the European Medicine Agency (EMA) recommended the use of booster doses of the protein-based vaccine. The shot is currently authorized for the purpose in 3 APAC countries, […]
Cityblock Health Raises $400 Million in Megaround
Cityblock Health has raised $400 million in its latest funding round. This brings the value of the startup to a whopping $5.7 billion. The company focuses on delivering care to patients in marginalized groups, aiming to provide care for 10 million patients by the end of the decade. Two key parts of […]
