Improving Health Outcomes for Hispanic Populations by Recognizing Their Diversity
Although often lumped together into one homogenous group, Hispanic people are incredibly diverse, coming from a wide range of backgrounds. Unfortunately, this impairs data collection efforts that could identify the unique health concerns faced by different groups within Hispanic populations. By improving data collection practices, public health officials could target known health disparities and discover new ones in need of addressing.
FDA Reagan-Udal Foundation Launches Real-World Accelerator to Address Health Equity
The US Food and Drug Administration’s (FDA’s) Reagan-Udal Foundation has announced the launch of its Real-World Accelerator initiative. The project is funded by the FDA’s Office of Minority Health and Health Equity (OMHHE) and will help improve the reporting of real-world data (RWD) related to health equity efforts by developing and providing best practices.
New Real-World Evidence Study on Cannabinoid-Based Transdermal Gel Begins
Avicanna and Santé Cannabis have announced the launch of a new real-world evidence study into the use of the RHO Phyto™ CBG Transdermal Gel Topical Product in treating musculoskeletal inflammation and pain. The study will enroll and follow 100 patients using the treatment over 3 months, with a 3 month follow-up. Participants will submit self-reported symptom data, which will be collected alongside demographic information and medical history.
Improving Medication Access by Addressing Price Instability
US citizens and residents pay more for prescription medication than those living in any other country, causing many to forgo life-saving medication. This problem is worsened by seemingly random fluctuations in price due to shifting rebates, discounts, and formulary inclusion on the part of drugmakers, payers, and pharmacy benefit managers (PBMs). Tackling price instability by considering national drug acquisition costs may be the first step to addressing high drug prices.
Integrating Evidence Strategies at Every Level to Improve Patient Outcomes
With the recent rise of real-world evidence (RWE) and non-traditional clinical trial formats in regulatory and market access decision-making, developing effective integrated evidence generation strategies has become a priority for all stakeholders in therapeutic development. The complexities of the modern evidence generation process are laid out in a recent Pharmaphorum article by experts from Fishawack Health.
Pharmaphorum Podcast: Innovations in Real-World Evidence
On the latest episode of the pharmaphorum podcast, listen to back-to-back interviews at last month’s PharmStars presentation. Host Jonah Comstock talks with speakers and guests about the current use of real-world data (RWD) and real-world evidence (RWE) in clinical trials and how different startups have managed these challenges.
US Senators Pillory Pfizer Over Coming Price Hikes
US Senators Elizabeth Warren (D-MA) and Peter Welch (D-VT) released a letter addressed to Pfizer’s CEO decrying the pharma giant’s plans to spike the price of its COVID-19 vaccines by $100. The jump would bring the price per vaccine up to $130, a far cry higher than the $20 price tag the federal government paid for the vaccine in 2020.
Orphan Drug Credits Make It onto Short-Term US Government Spending Bill
As a government shutdown looms large in US politics, certain pharma favorites have made it into a short-term continuing resolution. Key among these is the DeLauro bill, which includes nearly $7 million in funding for rare diseases and orphan drugs research. This program is a long-standing provision, funding work in rare diseases since 1983.
Making the Most of Oncology Patient Support Programs
A variety of real-world factors play into oncology outcomes that aren’t necessarily captured or accounted for in randomized controlled trials (RCTs). Drugmakers, care providers, and other stakeholders are attempting to collect data and address these gaps in care using patient support programs (PSPs), which allow for daily reporting of symptoms and treatment compliance.
Making Clinical Trials Populations Better Represent Patients
Clinical trial participants are often not representative of the patient populations. People from marginalized backgrounds are often overlooked, leaving lingering safety and efficacy questions remaining for those already facing barriers to access. In a new PM Live, article, Paul Chew of Phesi discusses diversity in clinical trials and why it is critical in improving health equity efforts.
Employers Reaping Benefits from Patient Assistance Programs
An increasing number of employers are leveraging patient assistance programs intended for patients to help cut spending on employee health plans. These programs, long objected to by many employers, are offered by drugmakers to help cover expensive treatments when a plan deems the treatment nonessential due to cheaper alternatives. This has led to employer plans changing essential status to capitalize on these programs.
States Ask Biden to Greenlight Plans to Import Drugs from Canada
Four US states so far have asked the federal government for permission to import medication from Canada to combat high drug prices. The decision to begin allowing the importation of medication was made in the Trump era, with Biden administration members signaling the current president is on board. While Xavier Becerra, Secretary of the Department of Health and Human Services, says that applications are open, he’s yet to make any promises on when they would be reviewed.
AstraZeneca’s Newest Push in Oncology RWE
The pharma giant AstraZeneca has expanded its presence in the chronic lymphocytic leukemia (CLL) space in recent years. Now, according to its VP and global medical franchise head of Hematology Carlos Doti, the company will help support these oncology therapeutic development efforts with a renewed focus using real-world evidence (RWE).
EMA and ECDC Collaborate on Vaccine Real-World Evidence Generation Efforts
Officials from the European Centre for Disease Prevention and Control (ECDC) and European Medicines Agency met earlier this month to begin a new collaboration intended to boost real-world evidence (RWE) generation for vaccine safety and efficacy trials. The collaboration, the Vaccine Monitoring Platform (VMP), will work to develop an RWE infrastructure for vaccines in the EU without outside industry funding.
Moody’s Report Finds Risk Rising in the Healthcare Industry
A new report from Moody’s Investors Service finds that healthcare companies are facing increasing financial and social risk. The report, which looked at 193 healthcare companies in North America, shows that the number of companies rated B3 negative or lower has jumped from 9 in 2015 to 34 today.
Americans Still Not Fond of Sharing Health Data
A new poll finds that the majority of US Americans would not share their anonymized health data to prevent another public health emergency. While only 47% would share vital signs, health stats, and personal info to a national database, even fewer would share genetic data and information from wearables, like fitness trackers or continuous glucose monitors. The poll echoes results from previous years and other nations.
Real-World Evidence Supports Young Adults and Adolescents Taking Pediatric Regimens for Acute Lymphoblastic Leukemia
Newly-reported real-world evidence (RWE) from Servier shows that adults and adolescents taking asparaginase-based pediatric inspired regimens (PIR) have better outcomes with acute lymphoblastic leukemia than those on non-pediatric treatment plans. The retrospective data, presented at this years American Society of Hematology meeting, comes from claims data of 11,650 patients.
China’s Boao Lecheng International Medical Tourism Pilot Zone is a Booming Destination for Real-World Data Studies
Since 2019, the Boao Lecheng International Medical Tourism Pilot Zone has served as prime testing grounds for medical devices, representing the only zone in the nation where real-world data (RWD) studies can be performed easily by outside groups. In a recent international conference, industry leaders discussed the insights gleaned and products approved based on RWD studies in the region.
Patient Perceptions of Treatment Quality and Price Vary by Insurance Coverage
Data from a recently published study by researchers at the Harvard Business School finds that the value patients ascribe to high- and low-cost treatments varies depending on the level of insurance coverage they have. Those with a higher degree of insurance coverage tended to view more expensive therapies as more effective, with the opposite being found in those with low insurance. These perceptions were unrelated to the actual efficacy of a given therapeutic.
Addressing Structural Stigma to Improve Health Equity
Structural stigma refers to forms of stigma reinforced by systems that exert some degree of control or influence over one’s lives, often through legal institutions. In a new Health Affairs brief, authors discuss the ramifications of structural stigma on health disparities through the lens of people living with substance use disorder (SUD). The laws surrounding substance use and the ramifications of their enforcement play an important role in negative health outcomes for people with SUD.
Real-World Data Study Explores Duration and Efficacy of Checkpoint Inhibitors in Skin Cancer
In a recently published paper in Cancers, researchers used real-world data (RWD) to investigate the efficacy of first-line checkpoint inhibitor treatment for cutaneous squamous cell carcinoma (cSCC) and the durability of the response. The data, taken from 39 patients receiving treatment at one of eight cancer centers in Germany, shows all most half of patients had a tumor response, with a median progression-free survival rate of 29 months.
ED Coding Leaves Payers and Providers at Odds
Recent increases in high-intensity emergency department (ED) billing in the US have put payers and providers at odds. A recently published study in Health Affairs investigates the underlying causes of this growth, looking at data from the Nationwide Emergency Department Sample. Almost half the increases come down to administrative changes and higher utilization by older adults. Another reason for the recent increase in high-intensity billing, the authors argue, comes down to coding changes.
Connecticut Shelter Targets Health Disparities by Addressing Housing Insecurity
Housing insecurity is just one of many social determinants of health (SDoH) that negatively impact health outcomes. A shelter in Milford, CT, US, is attempting to improve health outcomes for people facing housing insecurity by promoting co-living arrangements with older adults. Participants pay a reduced rent, while the older adults have an individual nearby in case of emergency.
Drug Price May Not Be Magic Bullet for Patient Access in LMICs
There has been a recent push from private, public, and legal fronts for drugmakers to reveal the prices they charge for medications worldwide to help improve access to patients, especially in lower- and middle-income countries (LMIC). However, Christine Truelove argues in a recent Value & Outcomes Spotlight article that this approach may be counterintuitive.
Aligning Cancer Therapeutic Evidence Between EMA and EU HTAs
Many of the health technology assessment agencies (HTAs) of EU member nations have evidence requirements for cancer drugs that are different than those of the European Medicines Agency (EMA). This disparity often delays patient access. In a new article in Value in Health, authors break down these different requirements to highlight the need for alignment between EMA and EU HTA requirements.
