Zack Scott of Norwest Venture Partners Talks Digital Health and Real-World Evidence
In a new Digital Health Business and Technology interview, Dr. Zack Scott of Norwest Venture Partners discusses digital health technologies, [...]
CMS Lets States Cover Nonmedical Services for Medicaid Beneficiaries
Social determinants of health (SDoH) like housing instability and food insecurity dramatically impact patient health outcomes. To address these factors, the US Centers for Medicare and Medicaid Services (CMS) has issued a new guidance that allows states to offer benefits for nonmedical services, under the classification of “in lieu of services and settings.”
Real-World Data Startup Crescendo Health Launches with $3.4 Million Investments
Crescendo Health has announced its launch and its initial funding totalling $3.4 million. Crescendo offers real-world data (RWD) generation services to pharma, biotech, and other researchers, pulling data that is voluntarily shared by patients. This will allow clients to track the effects of therapeutics through real-world patient outcomes.
FDA Approves Alzheimer’s Treatment by Biogen and Eisai
The US Food and Drug Administration (FDA) has approved Biogen and Eisai’s new Alzheimer’s drug, lecanemab. The drug is the first of its kind because it slowed cognitive decline in patients, a sticking point with the ill-fated Aduhelm that was pulled from the market last year. However, it is unclear whether payers will cover the therapy, which looks to be expensive.
Connecting Payers to Patients with Rare Diseases
Patients with rare diseases often require complex, expensive medications that may or may not be on their payer’s formulary. In a recently published paper in Future Medicine, Siva Narayanan put forward a payer-patient engagement framework (PPEF) intended to connect rare disease patients with payers to make informed reimbursement decisions based on the individual's needs.
Pharma Braces for Challenges from Inflation, Drug Pricing Reform, and Reimbursement Changes
Although the pharma industry was bolstered by the successful rapid development and deployment of COVID-19 vaccines, it was still beset by challenges that are following it into the new year. High inflation rates and an employee-friendly labor market are driving up operational costs, all while supply chain issues are impeding production and distribution efforts.
Real-World Data Trends to Watch in 2023
2022 saw another year of growth in the generation and use real-world data (RWD) and real-world evidence, building on the momentum from the early stages of the COVID-19 pandemic. As the new year begins, Gene Online covers the trends in the RWD landscape to look out for, as well as those affecting related decentralized clinical trials (DCTs) and personalized medicine.
Racial Medicare Access Disparities Worsen Health Outcomes for Black Enrollees
Research early last year found that Black patients are routinely offered less high-quality Medicare Advantage plans compared to their white counterparts. A new study builds on this, finding that the decreased access to 5-star plans has measure effects on outcomes for Black enrollees. The researchers looked at hospitalizations that would be avoidable with disease management and outpatient care covered by better plans.
IQVIA Blog: Acquiring and Evaluating New Real-World Data Sources
Although real-world data (RWD) is being increasingly used by a wide range of healthcare-related organizations, many struggle with finding the right RWD sources, evaluating them for quality, and gleaning actionable insights from them. In a new IQVIA blog, learn about how organizations can find quality RWD resources and implement them to advance their research goals. The first concept covered is data landscaping and sourcing.
ISPOR 2023 – Last Chance to Submit Abstracts – January 12th
The deadline to submit abstracts for ISPOR 2023 is fast approaching! ISPOR 2023 takes place in Boston, MA, USA, from May 7th-10th, and is a leading conference for the field of health economics and outcomes research (HEOR), bringing together professionals from pharma, healthcare, payer organizations, academia, and more. Abstract submissions are due no later than January 12th.
Interview with Director of FDA’s CBER, Peter Marks
Ben Comer, Chief Editor of Life Science Leader, spoke with Peter Marks, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) last year to discuss the Center’s goals for the coming year. The first priority is working through a backlog of vaccine-related submissions and reviewing evidence from vaccines approved via Emergency Use Authorizations (EUAs).
Pfizer Wins US Patent Case with Astellas and Gilead Over Generic Lexiscan
Pfizer was granted a win by the US Court of Appeals for the Federal Circuit in its legal battle with Astellas and Gilead. The case centered around the active ingredient in Hospira, which is also the active ingredient in Astellas and Gilead’s myocardial perfusion imaging drug Lexiscan. The court decided that Hospira didn’t pose any direct infringement on Gilead and Astellas’ patents.
2022 FDA New Drug Approvals Lowest in Six Years
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) gave the nod to 37 new drugs for clinical use last year, a low after the past five years. However, this number was buffered by a slate of approvals by the Center for Biologics Evaluation and Research (CBER), reflecting a growing push for biologics.
Driving Clinical Trial Recruitment Through Real-World Data
Poor recruitment is the most cited reason that clinical trials fail. However, many healthcare giants are gathering sources of real-world data (RWD) like electronic health records (EHR) that can yield deep insights into patient recruitment strategies if used correctly. In particular, RWD from patients can help narrow down the recruitment focus to patients who are most likely to qualify.
US Drug Price Hikes Extensive but Don’t Match Inflation Rate
Hundreds of drugs have just had their wholesale prices raised at the beginning of the year, a well-treaded practice for the pharma industry. However, these hikes did not outstrip inflation, sitting around 5% on average. Companies raising prices include Pfizer, which drove up the prices of over 90 drugs, many of which are for cancer.
OIG Calls for CMS to Improve Medicare Part B Payment Accuracy
The US Office of the Inspector General (OIG) released a recommendation for the Centers for Medicare & Medicaid Services (CMS) to work on better internal processes to improve the accuracy of Medicare Part B drug payment data. The OIG found notable gaps in the agency’s processes for drug payment tracking data and concluded that CMS was unable to calculate prices for 8 percent of drugs at least once over the observed period, 2016-2020.
Improving Health Outcomes Through Digital Health: An Interview with Senu Sam of Mykare Health
The rise of digital health technology in recent years has helped expand access to care for numerous patients. In a [...]
Fluctuating Income as a Social Determinant of Health
A freshly-published study has identified fluctuating income as a social determinant of health (SDoH) that negatively impacts health outcomes. The paper, published in the Journal of Applied Psychology, surveyed gig workers, servers, delivery drivers, and other workers whose daily income is not steady. These workers faced health disparities in several key areas of health.
NIH Looking to Fund ‘All of Us’ Data Precision Medicine Research Projects
The US National Institutes of Health (NIH) has announced new funding for precision medicine research projects that use data from the All of Us Project, a collaboration between 27 groups within the NIH. The details of these funding opportunities are presented in two Funding Opportunity Announcements (FOAs). The first FOA is an RO3 entitled, “Small Grants to Enhance the Use of the All of Us Research Program’s Data (R03)”.
Achieving EU Medical Device Regulation Compliance
Medical device companies must apply a coordinated approach to achieve compliance with the EU Medical Device Regulation (MDR). In a recent Life Science Leader article, learn key strategies for planning for MDR compliance. The first such strategy is the establishment of an effective leadership team that can synchronize activities company-wide.
Employer Plan Beneficiaries Still Struggling to Pay for Healthcare
Despite employer health insurance coverage, a newly published study in JAMA finds that many employers are still having difficulties affording healthcare. The results come from the National Health Interview Survey, which was conducted between 2000 and 2020 and contains responses from 238,000 adults with employer sponsored health insurance.
Improving Recruiting of Black and Rural Patients
In the US, Black and rural residents are often significantly underrepresented in clinical trials. This negatively impacts these populations and decreases the clinical potential of new therapeutics. In a recent Clinical Leader article, Chief Editor Ed Miseta discusses the underlying causes of clinical trial under-representation and insights from two studies on how to address it.
Modern Segregation in US Worsens Cancer Outcomes
In a newly published JAMA Oncology paper, researchers find that people living in US counties with higher levels of racial and socioeconomic segregation face a 20% increase in mortality rates. This effect was more pronounced in lung cancer, with mortality rates spiking by 50% in the most segregated counties.
Pharma Looks to Raise US Prices on Over 350 Drugs for 2023
In the coming weeks, pharma companies from across the industry will raise the price of 350 drugs in the US. The industry contends that the cost increases will come from higher manufacturing costs caused by supply chain disruptions and high inflation rates. Many speculate that the price hikes are in preparation for the coming drug pricing reform under the Inflation Reduction Act.
Top 5 Managed Care Executive Tuning in to the C-Suite Podcast Episodes of 2022
Managed Healthcare Executive (MHE) has published its top 5 most-listened episodes of its Tuning in to the C-Suite podcast. The episodes feature host Jim Graham’s interviewed with executives in pharma and healthcare, as well as a member of the MHE advisory board, Ateev Mehrotra. At number 5 is an interview with Tim Ashe of Wellsky
