The ISPOR Awards Council is taking nominations for its annual awards. It has also announced a new award, the LMIC (Low- and Middle-Income Countries) Health Economics and Outcomes Research (HEOR) Excellence Award. This award recognizes high-achieving individuals in the HEOR field, especially academic […]
RWD Company Cerner Acquires Kantar Health for $375 Million
Cerner Corporation has announced its acquisition of life sciences company Kantar Health of Kantar Group for a cash sum of $375 million. Cerner’s focus on RWD (real world data) combined with Kantar Health’s expertise is expected to speed up drug development and to improve outcomes for patients […]
Certara Announces Symposium on RWE, Value Communication, and Strategic Evidence
Certara will hold a symposium on Wednesday, April 21st, from 12 PM to 2 PM EDT. The symposium is broken into two sessions. The first will feature insight on data visualization, engagement strategies, and value communication. The second session will focus on the use of RWE (real world evidence) in […]
US Department of Veterans Affairs Kicks Off ISPOR Series
HEOR professional society ISPOR will host a new series beginning with a live event on April 27th at 10 AM EST. Speakers will offer their insights into retaining market access, supporting the innovation cycle, and trends in healthcare systems. “During this inaugural Signal episode, Ryan J. Vega, […]
Patients for Affordable Drugs Seeks Story Submissions
Patients for Affordable Drugs is seeking stories from patients facing high drug costs. Stories will be shared with lawmakers to drive policy changes aimed at lowering drug costs. Exorbitant drug prices in the United States have a direct impact on medication adherence and quality of life. “Tell us […]
Phesi Partners with Accenture to Release Report on RWD in Drug Development
Analytics group Phesi partnered with Accenture to release the first of several reports on the use of RWD (real world data) and RWE (real world evidence) in the drug development pipeline. One of the key benefits discussed in the report is reduced costs. Oncology trials are especially expensive, with […]
CROs Consider a Post-COVID Clinical Trial Landscape
CROs (Contract Research Organizations) are hopeful that the COVID-19 pandemic will not last forever. Jim Reilly, Vice President of Vault R&D at Veeva discusses ongoing challenges. He notes that siloed systems are one major issue reported by CROs in a new Annual CRO Report and that companies […]
Biologics by McKesson Launches Oncology Pharmacy Solution to Improve Access to Care
A new pharmacy management solution, ScriptPAS, has been launched by McKesson. The fee-for-service solution is expected to help improve medication adherence in oncology patients and to reduce many of the barriers facing patients when seeking treatment. “ScriptPAS services also help practices […]
Remdesivir FDA Decision Alert Added to Aetion’s RWE Library
Aetion’s FDA Decision Alert Library includes examples of FDA submissions using RWE (real world evidence) and RWD (real world data). Gilead’s remdesivir was approved in 2020 for use in serious cases of COVID-19. During the submission process, Gilead included RWE findings. Data included adverse event […]
Webinar on RWE’s Role in Accelerating Drug Development
A webinar is now available featuring discussions with Drs. Nicolle Gatto, Senior Vice President of Scientific Research at Aetion; Julie Schiffman, Senior Vice President of Scientific Engagement and Delivery at Aetion; Bob LoCasale, Head of RWE at Sanofi; and Najat Khan, Chief Data Science Officer at […]
Webinar on RWE in Medical Device Trials Featuring FDA Statistician
Cytel’s new webinar is now available, featuring insight from former FDA statistician Dr. Ram Tiwari, now Head of Statistical Methodology at Bristol Myers Squibb. Industry-wide trends include utilizing RWD (real world data) and RWE (real world evidence) and the FDA has begun utilizing such data in […]
New Report by Patient Coalition on Substandard Healthcare Plans Resulting in Patient Cost Burden
A coalition of 30 patient organizations advocating for healthcare access for patients with preexisting health conditions has released a new report. The report details eight types of insurance plans that don’t follow ACA (Affordable Care Act) regulations, including Health Care Sharing Ministries […]
Cytel Expands Access to Powerful Computational Solara Software, Will Reduce Clinical Trial Costs
Cytel decision-making software Solara has been opened for general release. It comes in two setups: one for companies with an in-house biostatistician secondly as part of a consultancy program aimed at small biotechs or pharmaceutical companies lacking a biostatistician. The powerful software tool […]
Two Online Decision Modelling Courses for Health Economists and Health Professionals
The London School of Hygiene & Tropical Medicine and the University of York have partnered to offer two online courses on decision modelling. The courses are aimed at health professionals and health economists seeking to develop their cost-effectiveness analytical tools. The Foundations Course […]
Syneos Health and Science 37 Announce Partnership Aimed at RWE Integration Into Clinical Trial Design
In an effort to seamlessly incorporate RWE (real world evidence) into clinical trial design, Syneos Health and Science 37 announced a unique partnership aimed at the biotech and pharmaceutical industries. Each company will bring leading technology systems and solutions designed to reduce drug […]
RWD in Action: Determining COVID-19 Reinfection Odds
RWD (real world data) is critical in understanding the likelihood of COVID-19 reinfection. One recent study sought to identify the level of protection resulting from humoral antibody response. Carly Kabelac discusses the study’s methodology, including the utilization of health insurance data from […]
Understanding ICER’s New Life Years Metric
ICER (the Institute for Clinical and Economic Review) revealed a new metric in 2018: evLYG (equal value of life years gained). The metric is intended as an alternative to the controversial QALY (quality-adjusted life year). Disability advocacy groups and payers in the US raised concerns over the […]
Comparing ICER and IVI in Shifting Value-Based Reimbursement Landscape
The US healthcare system is transitioning from a volume- to a value-based reimbursement payment structure. Assigning value continues to be a difficult and complex process. In a new article, the authors discuss IVI (Innovation and Value Initiative), founded in 2016, and ICER (the Institute for […]
Pharma Price Negotiations and Reimbursement Hurdles in Germany
Negotiating the prices of Advanced Therapy Medicinal Products (ATMPs) is a challenging and convoluted process in Germany. The majority of these approved products are orphan drugs, meaning only a relatively small amount of long-term data are available. As a result, determining drug benefits is a […]
The Role of RWE in FDA Regulatory Decisions
RWE (real world evidence) and RWD (real world data) have risen in prominence when it comes to clinical trial design and utilizing existing patient records to draw conclusions. The 2016 21st Century Cures Act has led to the FDA placer greater importance and value on RWE in the context of its […]
Preparing for the COVID-19 Economic Impact
The total burden of COVID-19 remains unknown. A toolkit from HMS (Health Management Systems) provides strategies for mitigating underlying issues in healthcare. Important information regarding the optimization of patient engagement, the use of RWD (real world data), the identification of waste in […]
Aetion Co-Founder and President Discusses Bias in RWE Studies
One major challenge for researchers utilizing RWE (real world evidence) in their studies is avoiding biases. In contrast, RCTs (randomized controlled trials) do not face this issue. Aetion Co-Founder, President, and Chief Science Officer Jeremy Rassen, Sc.D. discusses his thoughts in light of his […]
New Survey Results on Impact of COVID-19 on Provider Supply Chains
Advisory Board surveyed 70 professionals in supply chain, financial, and operations roles in US-based healthcare systems. The main goal of the study was to understand how healthcare systems adapted to supply chain challenges resulting from COVID-19. “During the first Covid-19 surges last spring, […]
Aurinia Announces ICER’s Favorable Review for Lupus Nephritis Drug
Aurinia Pharmaceuticals announced that ICER (the Institute for Clinical and Economic Review) has released a positive Evidence Report for its LUPKYNIS (voclosporin) drug. This drug is a significant improvement over the current standard of care for lupus nephritis. In addition, ICER noted that […]
Assigning Value to Cell and Gene Therapies With Analytics
A whitepaper from MMIT provides information on value assessments and insight into market access for gene and cell-based therapies. MMIT utilizes advanced analytical tools to provide market access insights. “How do payers value a treatment that slows down a disease vs. silencing it or even curing […]
Upcoming Webinar on Managed Care Pharmacy Practices and RWE
A webinar hosted by the AMCP (Academy of Managed Care Pharmacy) will take place on Thursday, April 1st from 2 to 3 PM ET. It will include speakers from diverse backgrounds including research and industry. Points raised will include the application of RWE (real world evidence) and the use of […]
Abbvie HEOR Expert Shares Thoughts on RWE and Improving Health Equity
Christopher Boone, Vice President and global head of HEOR (health economics and research outcomes) at Abbvie, recently gave an informative keynote presentation at HIMSS’ Accelerate Health event. He’s hopeful that incorporating RWE (real world evidence) into clinical trials will speed up drug […]
Why Does Pharma Make Record Profits From Taxpayer-Funded Research? Does Pricing Regulation Really Impact Innovation?
Vaccines have been developed quickly and efficiently since the start of the COVID-19 pandemic, in part due to taxpayer-supported funding. The federal government negotiated special prices of $10 and $19.50 per dose, although a Pfizer executive expects a substantial price hike. Now, tension is […]
FDA Reveals Data Modernization Action Plan Including RWD Details
The FDA released DMAP (a Data Modernization Action Plan) in response to changes and trends in the pharma industry. Some of these trends, such as the use of RWD (real world data) have been hastened by the COVID-19 pandemic. DMAP contains three major goals and is meant to help experts in the industry […]
Can RWE Improve Odds in FDA Applications for Medical Devices?
Christian Howell, Vice President and General Manager of Medical Devices and Diagnostics at Aetion, provides insight into when and how RWE (real world evidence) can be used in regulatory approval applications for medical devices. Over 90 FDA approvals included RWE and this number is expected to […]
