Although several vaccines for COVID-19 were rapidly created, tested, and received FDA emergency approval, vaccine hesitation remains a massive issue in the United States. Fears of the perceived rapid vaccine process along with concerns about side effects and a widespread lack of trust in the […]
FDA’s CDER Releases 2021 Guidance Calendar
The FDA (Food and Drug Administration)’s CDER (Center for Drug Evaluation and Research has released its guidance calendar for 2021. Many items on the agenda relate to clinical and medical topics, along with points related to generic drugs and clinical pharmacology. Four points relate to RWE (real […]
Perspectives on Usable RWD in COVID-19 Era at Aetion Summit
The massive amount of RWD (real world data) has been a growing issue in the past several years. The COVID-19 pandemic, as well as data collection related to vaccine development, prompted a closer look into how to manage data by health care providers and related industries. Aetion hosted a summit […]
RWD in a COVID-19 World
COVID-19 has been linked to the development of other, non-respiratory diseases including heart attacks. Understanding this correlation requires real world data (RWD). William Murk, Ph.D., M.P.H., at the Jacobs School of Medicine & Biomedical Sciences notes that one limitation of earlier studies […]
Can User Guide for Biden Inform Drug Cost Policy?
Drug costs will be a point of policy for Biden’s administration. Although there are many theories and proposed solutions, reducing prescription drug costs may not require any additional research. Christopher Morten of the New York University Technology Law and Policy Clinic has written a manual on […]
Tracking Costs of Common Drugs in the US Market
In a recent article, the authors discuss drug-pricing trends in medications. They restricted their study to brand-name medications used to treat chronic disease. One notable finding was the AWP (average wholesale price) across medications within each of the 5 classes. The authors note that such a […]
Registration is Open for Asembia’s Specialty Pharmacy Summit
Register today for Asembia’s Specialty Pharmacy Summit. Earlybird rates are available through April 16th, 2021 for both member pharmacies and industry partners. Standard rates are effective between April 17th and October 24th, 2021. The event will take place between October 26-29 and provides […]
Are Budget Caps a Solution to Skyrocketing Health Costs?
Healthcare costs and access to health services continue to be major points of discussion. One proposed solution is that of budget caps. In a recent article, the authors discuss the impacts of budget caps in the United States. Although some benefits were identified, the authors also note possible […]
NICE rejects MS drug Zeposia Citing Cost Concerns
Bristol Myers Squibb developed Zeoposia (ozanimod) for use in multiple sclerosis patients. NICE (National Institute for Health and Care Excellence) in Britain released a report detailing its findings on the drug, citing cost concerns. Drugs for use in MS are greatly needed and an ICER (Institute for […]
Positive Consequence of Senate Pharma Pricing Bill?
The Senate Finance Committee’s bill on drug pricing was co-authored and introduced by Chuck Grassley and Ron Wyden. The authors discuss limiting drug price increases under Medicare to the inflation rate. According to investor Ronny Gal and his team of analysts at Bernstein, the bill doesn’t block […]
Are Authorized Generics a Solution to High Drug Costs?
In response to concerns over drug prices, some pharmaceutical companies have released authorized generics as alternatives to brand-name products. These authorized generics could lower out-of-pocket costs for patients and also improve access to prescription drugs. The authors state “In recent […]
What Will Happen to Novartis Cholesterol Drug?
Novartis drug inclisiran wasn’t reviewed on time by the FDA—largely because of COVID-19 travel restrictions. Now, the company seeks to price the drug when it hits the market. A recent review by the Institute for Clinical and Economic Review (ICER) provides insight on pricing. The ultimate fate of […]
Yes–Prescription Costs are Much Higher in the United States
According to a recent article, there are serious discrepancies in drug prices between the United States and many other countries. The timely report discusses both brand-name drugs and generic drugs and the authors used several methods to calculate pricing. Shockingly, drug prices in the United […]
Article Highlights Healthcare Challenges for Biden
A recent publication highlights ongoing issues in healthcare, along with strategies for addressing these issues for the newly elected administration. This article is part of the National Academy of Medicine’s Vital Directions for Health and Health Care: Priorities for 2021. The authors remark “We […]
Progress with Gene Therapies Requires Medicare Reform
Novel therapeutic approaches, although promising in the personalized medicine space, remain hampered by cost issues when it comes to Medicare paying for the treatment. Due to these financial considerations, the implementation of new therapies, such as CAR-T cell therapy, is falling behind. Jeet […]
Conversation with Aetion Chief Legal and Executive Officer Provides Insight
Lowell Schiller, J.D., now the Chief Legal and Executive Officer at Aetion, discussed his views on RWE, the FDA, and science policy. Having previously worked for the FDA as Principal Associate Commissioner for Policy, as Acting Chief Counsel and as Senior Counselor to the FDA Commissioner, he has a […]
COVID-19 Prompts RWE Discussion
During the 2020 Aetion Summit, invited speaker Amy Abernathy, MD, PHD, was invited to give her perspective on real world evidence in the context of the COVID-19 pandemic. This conversation was timely as greater thought has been given to how reporting data for COVID-19 vaccines will be collected and […]
Data Analytics Company Artemis Health Collects Employee Data
Artemis Health surveyed employees regarding their healthcare goals at hundreds of companies. Many employees rated focusing on their health as an important goal for 2020, a substantial increase over the previous year. These data inform human resource professionals on the values of employees at their […]
Understanding Machine Learning Tools that Will Impact Healthcare
Predictive machine learning tools are expected to help healthcare payers and providers make cost-effective choices. However, despite being powerful tools, several challenges can arise. Learn more here. (Source: DataRobot, 1/28/21) […]
New Robust Tool STaRT-RWE Brings Clarity
In a recent publication, Wang et al. discuss STaRT-RWE: a tool for reporting real world evidence data. This tool is expected to make study design more robust, reporting more efficient, and to also allow for studies of the effectiveness of medical safety products, among other uses. The authors hope […]
Will Pharma Prices Increase Under Biden Administration?
Pharma companies are preparing for changes under the Biden administration, including in-depth discussions about drug pricing—for both new drugs and older products like insulin. Increasing prices without good reason can lead to serious issues for consumers. According to CEO Ken Frazier of Merck […]
Pharma Companies Silently Raising Prices
Many pharmaceutical companies have been rapidly increasing prices of their drugs. In only one month of 2021, more drug prices have been increased than in the entire previous year. COVID-19 vaccine developer Pfizer has already increased the prices of nearly 200 drugs in January—a big increase from […]
$559 Million Saved in Medicare Costs by NAACOS
According to a recent NAACOS (the National Association of ACOs) report detailing Medicare savings, over $550 million was saved by Medicare in 2019. Although the program was scheduled to expire, the COVID-19 pandemic has pushed back the end of the cost-saving program beyond 2021. According to […]
ISMPP Takes Over MPIP Leadership
ISMPP revealed it would be taking over leadership responsibilities for MPIP (Medical Publishing Insights & Practices). MPIP has been an important player in medical research publications and in improving transparency. According to ISMPP president Robert J. Matheis, “MPIP has had […]
Can the Fauci Effect Lead to a Larger Pool of Health Care Workers?
In 2020, there were 18% more medical-school-ready applicants than in previous years. This higher number is due to several factors, including the prominent role of Dr. Anthony Fauci as director of the National Institute of Allergy and Infectious Diseases. He has been heavily featured in the news for […]
Bayesian Models are Underused yet Powerful Tools
In a recent study, Cytel researchers discussed the benefits of Bayesian models. They’re a good choice for both single arm and randomized clinical trials where control data must be integrated into the dataset. However, despite being developed before Frequentist models, they have not been widely used […]
2021 Brings Changes for Payers and Providers
COVID-19 has broadly impacted the healthcare system. Many fee for service providers were forced to switch to value-based payments over the past year, a change that was already on the horizon, but was greatly sped up by COVID-19. Payers are noting large numbers of Americans who have lost healthcare […]
Online Healthcare Pricing Information Unclear and Confusing
Healthcare systems and hospitals posted pricing information for their services beginning January 1st. However, consistency across hospital systems remains lacking. There is much variability in how much and what type of pricing information is posted by different healthcare systems, including the […]
Amazon Cloud Partnership Drives Cerner’s Shift to Digital Platform Company
Cerner announced a partnership with Amazon Web Services (AWS) one year ago. Cerner plans to leverage Amazon's artificial intelligence capabilities and customer experience expertise to drive future growth for its health IT business. The linkage with Amazon includes moving many of Cerner’s solutions […]
ICER Publishes Evidence Report on Therapies for High Cholesterol
This morning ICER issued the Evidence Report assessing the comparative clinical effectiveness and value of inclisiran (Novartis), bempedoic acid (Nexletol®, Esperion Therapeutics), and bempedoic acid/ezetimibe (Nexlizet™, Esperion Therapeutics) for treating heterozygous familial hypercholesterolemia […]
