Thanks to widespread efforts to develop tools against COVID-19, several effective vaccines now exist. Still, data remain unclear regarding the frequency of possible booster shots and if current vaccines will require modifications in order to be effective against COVID-19 variants. The prices of […]
How Can Biden Lower Drug Costs Without Impacting Innovation?
A recent article explores why drug prices are so high in the United States and delves into solutions that would reduce prices without affecting the rapid pace of progress. Independent review boards could be the answer. Although ICER (Institute for Clinical and Economic Review) releases reviews with […]
Designing Clinical Trials During COVID-19 ERA
The ongoing pandemic has led to chaos in many industries, including in clinical trial design. The use of RWE (real world evidence) might be one solution for upended trials and incomplete data. A recent article details these challenges and how RWE can be used to make important decisions in the […]
How Should COVID-19 Vaccines Be Priced?
The US government has entered into contracts with several pharmaceutical companies to deliver COVID-19 vaccines. Although it is currently not clear how long immunity from these vaccines will last and if booster shots will be needed, vaccination efforts have provided much-needed hope. However, […]
[Whitepaper] Understanding and Using SDOH Data
SDOH (social determinants of health) data can be incredibly valuable. While these data can be immensely useful in reducing medical costs and in improving outcomes, it can be difficult to actually use these data. A new whitepaper provides insight on understanding and processing SDOH data. “Based […]
The Battle for FDA Commissioner
Advocacy groups are concerned that Acting Commissioner Janet Woodcock will become FDA Commissioner under the Biden administration, stating that she has contributed to the opioid epidemic. She also overruled a recommendation against dubious Duchenne Muscular Dystrophy drug eteplirsen, a decision that […]
Pros and Cons of Newsom’s Vaccine Distributer Pick
California Governor Newsom picked Blue Shield of California to distribute COVID-19 vaccines in an emergency authorization process. The role of Blue Shield is to serve as a centralized distributor for the state, rather than the alternative approach of each county being responsible for its own vaccine […]
Matthew McHugh Appointed Director for Health Outcomes and Policy Research
Matthew McHugh is taking on a new role as Director for Health Outcomes and Policy Research (CHOPR) at the University of Pennsylvania School of Nursing. This highly regarded evidence-based program makes decisions based on patient care and outcomes. McHugh’s previous roles were as Independence Chair […]
Remdesivir Effective and Profitable for Gilead – And Controversial
Antiviral remdesivir had been developed before the onset of the global COVID-19 pandemic, but was rather unsuccessful as a treatment for either Ebola or hepatitis C. Early on in the pandemic, remdesivir faced substantial controversy regarding its effectiveness. Now, it’s widely regarded as a tool to […]
Cytel Whitepaper Notes Changes in Clinical Trial Design
Advances in computation tools have forever changed clinical trial design and analysis. According to Nobel Prize winning behavioral economists Daniel Kahnemann and Amos Tversky, “statistical intuitions” can be affected by a variety of external factors. Understanding and making these statistical […]
Why Are US Drugs 344% More Expensive?
A recent study from the RAND Corporation comparing generic and brand-name drug prices in the US to those in other OECD countries found shocking results. While generic drug prices in the US are lower than in a number of other countries, brand name drugs were 344% more expensive. “As debate […]
New Scientist.com President Committed to Booming Future
Daniel Kagan is now President of Scientist.com. He was previously Vice President of Research and Chief Operating Officer, roles in which he succeeded in substantially growing the company—from $11M in sales in 2015 to $265M USD in 2020. Now, he plans to launch BaaS (Biotech-as-a-service), a service […]
Tenacious Sheila McLean Joins Patients for Affordable Drugs
Sheila Mclean began her position as Executive Director of Patients for Affordable Drugs in January 2021. In her new role, Sheila will draw on her vast experience as a journalist, Mid-Atlantic President of Markstein, and North America Social Purpose & Sustainability Practice Director of MSL […]
A Conversation with Perry Cohen on COVID-19 and PBMs
A recent episode of Tuning In to the C-Suite's Meet the Board features Perry Cohen. As CEO of The Pharmacy Group, Perry provides insight into the role of pharmacy benefit managers (PBMs) and the global COVID-19 response. “Perry has been on MHE's Editorial Advisory Board for over 25 years and has […]
PhRMA Details Concerns Over Recent HHS Ruling
The Department of Health and Human Services (HHS) released a mid-January ruling relating to insurance enrollment, changes to the Premium Adjustment Percentage calculation, and manufacturer cost-sharing assistance programs. In recent years, these programs have been immensely useful in effective […]
Science Invites Insight on 20th Anniversary of Human Genome Sequencing Project
Leading journal Science invited researchers to share insight into data integrity, polygenic disease risk, ethics related to genomics, the downfalls of insufficient diversity, and affordability in precision medicine, among other topics. Despite considerable progress into understanding disease and […]
ISPOR Short Course Begins February 10th – Network Meta-Analysis in Relative Effectiveness Research
Sarah Goring and Jeroen Jansen will present a short course on February 10th and 11th for two hours per day. Some experience with statistics and meta-analysis is necessary. “Based in part on the ISPOR Task Force Reports on Indirect Treatment Comparisons, the fundamentals and concepts of network […]
URAC Partners with Acentrus Specialty to Improve Patient Care
Healthcare accreditation organization URAC and pharmacy network Acentrus Specialty have partnered to improve patient outcomes and access to care. According to URAC, this move will allow the organization to accredit more healthcare systems and pharmacies. Specialty Vice President George Zula […]
Using RWD to Target Care Disparities in Cancer
Despite attempts to reduce or eliminate disparities in healthcare, these gaps continue to exist. When it comes to cancer, socioeconomic disparities increased even while the overall death rate decreased substantially. The ERACE (Engaging Research to Achieve Cancer Care Equality) initiative seeks to […]
Governor Baker Estimates $70 Million in Overcharging Penalties
A 2022 budget proposal released by Governor Charlie Baker estimates that $70 million will be collected from pharmaceutical companies for overcharging. The majority of the funds will go to a trust fund for community health centers and hospitals. Skeptics suggest that proposing penalties during the […]
Global HTA Comparison Finds 3 Top Organizations–Including ICER
Eight global HTA (health technology assessment) organizations were compared in a recent study. The leaders were NICE (UK), ICER (US), and TLV (Sweden). Only these three institutions “were closest to achieving the dual aim of improved sustainability and patient centricity.” In response to feedback […]
ICER Evidence Report for Inclisiran Released
Inclisiran by Novartis may be priced lower than other drugs targeting LDL cholesterol. Now that ICER has released its pricing report, the next question is: what will Novartis do? that keeping inclisiran cost-effective is a serious consideration. “In our recent Evidence Report, ICER concluded […]
Creating Master Protocols for Clinical Trials with Bayesian Methods
Clinical researchers have sought to streamline protocols and to thereby improve both reproducibility and efficiency. As a result, the use of master protocols in the drug development field has become more widespread. Analysis of the resulting data also requires a “master method.” In this webinar, […]
Local Officials Join in Fight Against High Drug Prices
High drug costs in the US result from a number of factors and face criticism from many different parties. Recently, local officials in one Pennsylvania county have put the blame on pharmacy benefit managers—a new source of criticism for the industry. A report details $1.4 million in excess costs for […]
Kathy High Reflects on Career and Future of Gene Therapy
Kathy High recently joined AskBio (Asklepios BioPharmaceutical, Inc.) as president after a long and successful career in gene therapy research. Jason Mast of Endpoints News discusses her impressive career and why taking a break made her more successful. Kathy High also reveals her thoughts on the […]
Survey Results Will Be Announced in February
There’s not always a “right answer” to a problem. A survey explored how participants might respond to a marketing colleague requesting to sit in at an important data-heavy meeting. The purpose is to give survey participants a moment to reflect on multiple avenues. Results to this poll are expected […]
Germany Announces RWE Data Collection for Novartis Zolgensma Gene Therapy
Germany’s Federal Joint Committee (GBA, Gemeinsamer Bundesausschuss) has announced a new registry study related to spinal muscular atrophy (SMA) drugs. Zolgensma (onasemnogene abeparvovec) gene therapy from Novartis will be compared to Spinraza (nusinersen) from Biogen. Nearly 500 children with SMA […]
Cytel’s Advanced Design Framework to Improve Clinical Trials
Cytel has released its Advanced Design Framework as a method to minimize failed clinical trials. Ideally, biostatisticians are involved in clinical trial planning from the very beginning. This isn’t always possible, nor is it possible to account for every single variable. Cytel’s new technology […]
2021 Medication Access Report Details Obstacles
The newly released 2021 Medication Access Report is now available. It details the challenges that people might face in accessing medication. In addition to patient testimony, the report includes data on medication access, as well as possible solutions. “The different paths to medication vary […]
Racial and Ethnic Disparities and Possible Solutions in Light of the COVID-19 Crisis
Many studies have been undertaken to better understand the effects of the COVID-19 pandemic. It has also been noted that there remain serious racial and ethnic disparities related to the disease, its complications, and access to vaccines and healthcare. A recent study using data from a national […]
