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 […]
HealthVerity Conversation Provides Insight Into Pharma, RWE, Payers, and COVID-19
Jared Saul, Global Head of Healthcare and Life Sciences Startups at AWS, discusses the healthcare industry with Andrew Goldberg, Co-founder and COO of HealthVerity. Goldberg notes that the COVID-19 pandemic has sped up many industry-wide trends, such as the inclusion of RWE (real world evidence) and […]
First Transgender Nominee Confirmed by Senate As Assistant Health Secretary
Rachel Levine has been confirmed to the Senate as assistant health secretary amid bipartisan support. In her previous role, she served as Secretary of the Pennsylvania Department of Health. She previously held roles as Physician General of Pennsylvania and Health Secretary of Pennsylvania. As the […]
Comparing High US Drug Prices to Rest of World is Flawed, Reference Pricing Not a Solution
There are five key points driving high drug prices in the US, including better access in the US and robust competition. As speculation builds regarding the implementation of reference pricing as a possible ameliorative measure, not all are onboard. Would reference pricing really lead to reduced […]
New Review on Inclusion of RWE in Regulatory Decisions
A new paper discusses the state of RWE (real world evidence) and RWD (real world data) in the context of pharmacoepidemiology. Important conclusions can be drawn from EHRs (electronic health records) and healthcare claims, among other sources. These types of data are being increasingly used in the […]
Fishawack Health Acquires Major HEOR and Market Access Firm PRMA Consulting
Fishawack Health has announced its acquisition of PRMA Consulting, a leading HEOR (health economics and outcomes research) firm with insight into market access in the US, Europe, and the Asia-Pacific. This move is expected to broaden the reach of Fishawack following its acquisition of US-based […]
High Powered Computational Tools Are Bringing Changes to Clinical Trial Design
As High-Performance Computing (HPC) becomes more widespread and accessible, even for relatively small companies, clinical trial design is expected to shift and evolve. Processes that used to take months of in-depth analysis now take days. Notably, statisticians are expected to adapt to these new […]
How Can Payers Outperform the Market?
A new whitepaper details the challenging facing payers in an increasingly competitive market. LexisNexis Risk Solutions recently partnered with HealthcareDive’s studioID to survey over 100 professionals working in payer organizations. These professionals highlighted the importance of having access […]
Will the FDA Kill French Dressing? Are Other Salad Dressings Safe?
The FDA (Food and Drug Administration) has announced its intention to edit the accepted definition of French dressing and the ingredients required call it “French” following a discussion with the Association for Dressings & Sauces. This move would expand the condiment’s definition and allow for […]
Clora and Scientist.com Announce Partnership to Fill Considerable Talent Gaps in Life Science Industry and Expedite R&D
HealthEconomics.Com’s parent company, Scientist.com, has announced a new partnership with Boston-based company Clora. Clora has extensive experience in recruiting talent within budget and time constraints. Together, these companies aim to discover, build and manage life science teams, including […]
Scientist.com Reveals Expanded HEOR, Value, and RWE Category, Good News for Both Researchers and Suppliers
Scientist.com, parent company of HealthEconomics.Com, has recently announces a rebranding initiative for its “Value, Evidence and Access Marketplace.” This online solution arm of the company connects researchers and suppliers in an efficient, streamlined process. Access to RWD (real world data) and […]
NICE Issues Ruling on Bladder Cancer Drug Keytruda
MSD’s Keytruda (pembrolizumab) is a second-line bladder cancer drug. It has been shown to improve survival. However, it has not been demonstrated to be effective in progression-free survival. NICE has determined that Keytruda should not be eligible for NHS funding. An alternative drug (Tecentriq) […]
