The ISPOR Nominations Committee is now inviting members to nominate themselves or a colleague or to serve as President-Elect or Director for the 2021–2022 Board of Directors. ISPOR is a member-driven organization that relies on the leadership, expertise, and vision of its members to fulfill the […]
Value-based Care at Risk
An April survey by the National Association of ACOs showed that more than half the organizations in at-risk models planned to drop out of the program because of pandemic-related losses. In response, CMS Administrator Seema Verma waived consideration of COVID-19 costs when calculating ACO savings […]
Payers: The New Catalysts of Better Health
As health care delivery is getting more complex, the traditional definition of healthcare is evolving. This shift is necessitating the move to more vertically-integrated patient care that is focused on holistic well-being, not just treatment episodes. Payers have the power to be agents of that […]
Trial Site Networks: Create Positive Change Through A Shift in Perspective
COVID-19 represents a stress test of sorts for our global healthcare system that will hopefully lead to positive changes over the long-term. In the short-term, there are pressing concerns about the feasibility of continuing clinical development in the context of widespread transmission of COVID-19. […]
Patient Intelligence and Insights Reports Available from Self Care Catalysts
Patients negotiate a shifting landscape of goals and aspirations. They have to navigate unmet needs, barriers to care, influencers and supporters, and various sources of information. Self Care Catalysts’ Health Storylines Patient Intelligence and Insight Reports identify the key domains of […]
Submit Your Abstracts for Virtual ISPOR 2021
Abstract Submissions Are Open for Virtual ISPOR 2021; May 17 – 20: "HEOR: Evolving for Tomorrow's Challenges" Submit under the following categories: Issue Panel Proposals One-hour oral presentations with scheduled time for Q&A. Workshop Proposals One-hour oral presentations with […]
Adaptive Trial Designs in Early Oncology
Our understanding of the genetic and molecular mechanisms that lead to cancer have improved greatly over the past decade thanks to significant advancements. Despite this, only 10 percent of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) demonstrate an overall survival […]
Bart Heeg on New Trends in HEOR
In this two-part blog series, Bart Heeg, Vice President HEOR and Founder at Ingress Health (A Cytel company) discusses trends in HEOR and explains why Bayesian methods are also important for Health Economics. Read part 1 here and part 2 here. (Source: Cytel Blog; 10/22/20) […]
Draft Scoping Document for the Assessment of Alzheimer’s Disease Posted by ICER
Yesterday the Institute for Clinical and Economic Review (ICER) posted a Draft Scoping Document detailing the planned review of the comparative clinical effectiveness and value of aducanumab (Biogen) for Alzheimer's disease. An FDA decision on aducanumab is expected in early 2021.Comments and […]
FDA Approved NDA for KOSELUGO™ (selumetinib)
Recently the FDA approved AstraZeneca’s KOSELUGO™ (selumetinib) for treatment of pediatric patients two years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). In support of the application, AstraZeneca’s submitted a natural […]
Pfizer Seeks Judgment Favoring Proposed Patient-assistance Programs
If Pfizer wins their lawsuit against the U.S. government, Medicare stands to spend much, much more on some drugs. Pfizer is seeking a judgment favoring proposed patient-assistance programs (PAPs) that allow it to help cover copays for many Medicare beneficiaries on Vyndaqual/Vyndamax (tafamidis). […]
Thomas Wilke Weighs In On Health Economics and Real-World Evidence Studies
In this interview, Thomas Wilke, Principal Scientist at Ingress-Health (a Cytel company), discusses his background and experience in HEOR to help guide the audience to a better understanding of important considerations when using real-world evidence studies. He also covers how the work of HEOR […]
Lessons Learned from COVID-19 Health Preference Research
The COVID-19 pandemic caused a major shift in the lives of many HEOR researchers, especially those conducting health preference research. A group of health preference researchers started conducting studies to better understand the value of health and health-related alternatives affected by COVID-19. […]
Building a More Consumer-Centric Future in the Era of COVID
The urgent need to scale healthcare innovation has been unmasked by the COVID-19 pandemic, making consumerism an essential tenet of business. To stay abreast of this evolving trend, healthcare CEOs will need to examine their strategic plan to determine how best to engage consumers. Optum’s recent […]
Beyond Real-World Data and COVID-19
Join Casey Ross and other industry leaders as they discuss applications of real-world data in the battle against Covid-19. In addition to discussing how real-world data are already being utilized, they will also discuss the potential limitations of RWD as the search for effective therapeutics […]
[Podcast] The MM+M Podcast: FDA’s Bakul Patel
Bakul Patel has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010. Tune in to this podcast as he speaks about the agency’s new Digital Health Center of Excellence, his goals for the center and how it sets the stage for advancing and realizing the […]
What Does the Rise of Real-World Evidence Mean For Pharma?
The COVID-19 pandemic has highlighted the urgent need for real-world evidence to inform decision making. This month’s issue of ISPOR Value and Outcomes Spotlight features a Q&A with Dr. Jennifer Graff, Vice President, Comparative-Effectiveness Research at the National Pharmaceutical Council. Dr. […]
Unlocking the Promise of Real-World Evidence
At present, researchers have an abundance of real-world data. Although these data have been primarily used for safety surveillance, they are increasingly used in regulatory and reimbursement decisions. Now, the COVID-19 pandemic is accelerating the use of real-world evidence analyses despite a […]
Updates From the Real-World Evidence Transparency Initiative
The ISPOR Real-World Evidence (RWE) Transparency Initiative moves forward towards the Society’s goals while underscoring the need for transparency in studies utilizing secondary data—especially for evaluating treatment effect or comparative-effectiveness research. This month, ISPOR and […]
[ebook] Version 4.1 of the AMCP Format: Product Dossiers
On December 23, 2019, the Academy of Managed Care Pharmacy (AMCP) released Version 4.1 of the AMCP Format for Formulary Submissions. This new version of the AMCP Format describes three types of dossiers that manufacturers may choose to develop: Unapproved Product Dossiers provide […]
[Webinar] Patient-Focused Medicines Development During COVID-19
The COVID-19 pandemic has turned the lives of many patients upside down by adding additional layers of complexity. How exactly has the pandemic affected patients’ ability to access care in both the short and long term? How will these needs be translated into research priorities with respect to […]
Dascena’s COViage Receives Emergency Use Authorization from FDA
The FDA issued an Emergency Use Authorization to a clinical decision support (CDS) tool that predicts when hospitalized COVID patients are at risk of further complications. Developed by Dascena, an Oakland, California-based diagnostic algorithm developer, the COViage Hemodynamic Instability and […]
High Standards Needed to Inspire Trust in Digital Health Companies
Digital health companies are making big promises about affordability, access, prevention, early detection and intervention. Proponents claim that these companies have the potential to modify the social determinants that have been barriers to good health. Fulfilling those promises and transforming […]
[Webinar] Driving Value and Sustainable Health Care Economics Through Consumer Engagement
Tune in to this on-demand webinar to hear industry leaders David Wichmann, CEO, UnitedHeath Group, Laura Kaiser, President & CEO, SSM Health discuss key components of a consumer-focused sustainable economic model for health care. Hosted by Mitch Morris, MD, President, Optum Advisory Services, […]
ICER Publishes Evidence Report on Therapies for Hemophilia A
Today the Institute for Clinical and Economic Review (ICER) released a report concluding that compared to common current dosing levels of prophylactic factor VIII, Emicizumab provided comparable or better clinical benefits. The report also found Emicizumab to be cost-saving due to the extremely high […]
How is it Possible For an X-ray Price to Be Unknowable? Convenience!
On Thursday a panel of three judges heard oral arguments in a case that could usher in a great many changes within the larger hospital industry. However, some health economists argue that it will harm consumers in the form of higher prices. During proceedings, the hospital lobby argued that […]
Has Value-based Care Truly Moved the Needle?
Humana recently published a report stating that Medicare Advantage members covered by value-based care (VBC) arrangements have better outcomes and lower costs than members in non-VBC Medicare Advantage or regular Medicare FFS. However, Humana spends more than double on primary care for VBC […]
[Webinar] COVID-19: The Biggest Challenge to Cold Chain Supply Disruption Ever
Distributing and deploying a COVID-19 vaccine remains a great challenge filled with uncertainty as to the initial results, stability data and recommendations. Key to the success of any vaccination campaign will be distribution and storage. How can healthcare and public health officials best prepare […]
Will more journals start charging submission fees?
COVID-19 has negatively impacted research and library budgets and reduced available funds for subscriptions and article processing charges (APCs). The downstream impacts arising from COVID-19 on publishers is the topic of a guest post by Roy Kaufman for The Scholarly Kitchen. Kaufman predicts that […]
IQVIA Joins Forces with FDA to Improve Understanding of COVID-19’s Community Impact
IQVIA announced a scientific partnership with the U.S. Food and Drug Administration that will serve to provide timely analytics from IQVIA’s CARE Project COVID-19 registry. The project aims to improve understanding of how people in the community are affected by exposure to COVID-19. IQVIA’s research […]
