Talking Remote Care and Reimbursement with Bronwyn Spira of Force Therapeutics
The US Centers for Medicare and Medicaid Services (CMS) introduced new CPT codes last year, reducing barriers via remote care. In a new video by Managed Healthcare Executive, Force Therapeutics’ Bronwyn Spira talks about how these new codes affected outcomes and why outcomes-based reimbursement models may help support these efforts going forward.
Real-World Data Study Identifies Negative Health Outcomes in Long COVID Patients One Year Out
A newly published study in JAMA Health Outcomes found several adverse health outcomes in people living with long COVID one year after their initial infection. The researchers analyzed data from 13,435 people with long COVID symptoms and nearly 27,000 without it, finding that those with long COVID had increased care utilization and higher rates of a litany of cardiovascular symptoms.
FDA to Hold Adcomm on Eisai’s Leqembi Alzheimer’s Treatment by July 6th
The US Food and Drug Administration (FDA) will hold an advisory committee (adcomm on Eisai and Biogen’s Alzheimer’s drug Leqembi by July 6th, according to an announcement from Biogen yesterday, March 5th. This comes a year after an adcomm turned down the application for Aduhelm, another amyloid-targeted Alzheimer’s disease therapy, followed by its controversial accelerated approval.
Sanders Calls on Insulin Manufacturers to Follow Eli Lilly and Drop Insulin Prices
One day after Eli Lilly pledged to cut prices on its insulin products and implement some price caps, US Senator Bernie Sanders (I-VT), the current Senate health committee chair, has sent letters calling on Novo Nordisk and Sanofi to follow in kind. The move comes amid growing public attention is directed toward manufacturers for insulin prices.
US FDA Issues Emergency Use Authorization for First At-Home COVID and Flu Combo Test Kit
After a winter hallmarked by coexiting waves of COVID-19, seasonal flu, and RSV, the US Food and Drug Administration has given the Lucira COVID and Flu Home Test emergency use authorization (EUA). The at-home test kit is the first of its kind approved by the agency, simultaneously testing for COVID-19 and the flu in patients experiencing respiratory symptoms characteristic of either disease.
Vertical Integration Has Negative Impacts on Patient Outcomes
Although many health systems are moving toward vertical integration by acquiring private practices, the strategy may be hurting the bottom line and patients. A newly published study examined how vertical integration impacts patients undergoing colonoscopies and their subsequent healthcare costs using data from over 2.6 million visits.
US Court Temporarily Shoots Down J&J’s Plan to Prevent Amgen from Releasing Stelara Biosimilar
A US District Court judge stopped J&J’s attempt to stop Amgen’s Stelara biosimilar from entering the market. The judge cited a “failure to comply,” noting that the Pfizer’s lawyers submitted documents exceeding the courts page limits. In addition, the lawyers only asked to go over the limit seven minutes ahead of submission. Pfizer may file again with documents that match the court’s specifications.
UK Increases Statutory Scheme and VPAS Revenue Clawback Rates
The UK’s voluntary scheme for branded medicines pricing and access (VPAS) controls National Health Service (NHS) spending by requiring drugmakers to recoup the government for a portion of sales if spending exceeds a certain rate of growth. The new clawback rate for VPAS increased to 26.5% while the Statutory Scheme increased to 27.5%. As a result several pharma companies are reconsidering their strategy in the nation.
iCAD to Present Real-World Evidence Supporting Profound AI as Diagnostic Tool for Breast Cancer
The medical technology company iCAD is set to present new real-world evidence (RWE) at the European Congress of Radiology (ECR) [...]
ICER Updates Leqembi Price Range Recommendations
The Institute for Clinical and Economic Review (ICER) released an update to its recently released value assessment of the Leqembi (lecanemab). ICER changed its price recommendation for Eisei’s new Alzheimer’s treatment to a range of $8,900 to $21,500 per year. This price is higher than its initial assessment but still lower than the drug’s list price.
Pfizer and BioNTech Apply for FDA Emergency Use Authorization of Omicron Booster in Children
Pfizer and BioNTech have applied for emergency use authorization from the US Food and Drug Administration for their Omicron-targeted bivalent COVID-19 vaccine in children 4 and under (to 6 months). The application specifically is for the vaccine as a second booster, or fourth dose, as it is already approved for young children as a third dose.
Medicare Advantage Insurer’s Margins on the Rise
An analysis from the Kaiser Family Foundation shows that insurers in Medicare Advantage saw strong margins in 2021, twice that of other markers. This is leading many insurers to enter into the market and many others to redouble their efforts, Humana which announced it is pivoting away from the commercial market.
Eli Lilly Cuts US Insulin Price and Caps Out-of-Pocket Monthly Cost
Amid growing discontent with insulin prices in the US, Eli Lilly is lowering the price of its insulin products. Its brand name Humalog and Humulin will see a 70% price drop, while the company’s generic Lispro will be set at $25 a vial. In addition, the company will cap the price of insulin at $35 a month for patients on commercial plans, mirroring the provision found in the Inflation Reduction Act for Medicare beneficiaries.
FDA Advisory Committee Recommends Approval of Pfizer’s RSV Vaccine
Pfizer received a recommendation from the US Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee (VRPAC) for its respiratory syncytial virus (RSV) vaccine, dubbed RSVpreF. The recommendation is for adults over 60 years old, the group most impacted by the recent wave of RSV infections.
Supporting Comprehensive Care at Safety-Net Providers Through Value-Based Pricing
Although safety-net care systems are essential for providing healthcare to under- and uninsured people, often from marginalized backgrounds, comprehensive care is often out of reach due to a dearth of funding. One way to help address this care disparity, according to a newly published article in Health Affairs, is to implement value-based care pricing models.
Drug Development Costs See Steep Increase, But Not Enough to Justify Exorbitant Launch Prices
The cost of developing a new drug has risen by 15% to $2.3 billion, according to a report from the consulting firm Deloitte. This steep figure was paired with data showing that return on investments faced an 82% decline in the past year. However, a study published in the British Medical Journal, shows that operating costs contribute more to the increased development cost than research. Moreover, the paper argues that rising drug prices far outstrip any cost increases for biopharma companies.
HealthCore Changes Name to Carelon Research
The healthcare data company HealthCore announced today, March 1st, that it has undergone a name change. The company, now dubbed Carelon Research, will continue its dedication to providing its healthcare data and evidence generation services to its clients across industry, academia, and other life science stakeholders. The change marks the company’s entrance into the broader Carelon family.
The FDA Omnibus Reform Act: 8 Points to Remember
The Food and Drug Omnibus Reform Act of 2022 (FDORA) was signed into law last year, granting more power to the US Food and Drug Administration (FDA) to perform inspections at home and abroad. Learn more about the bill and 8 points to note in a recent Pharmaceutical Online article by professionals at Greenleaf Health. The first takeaway is that the bill gives many new inspection tools to the agency.
Understanding the Impact of New EU Cybersecurity Directive on Medical Device Industry
As implementation of medical devices is on the rise, cybersecurity threats have become a pressing concern. In a Med Device Online guest column by John Giantsidis, President of CyberActa, discusses a recent EU directive that is set to change the cybersecurity landscape of the medical device industry, Directive (EU) 2022/2555 (NIS2).
ADA Calls for More Oversight and Transparency from Medicaid Managed Care Plans
In a new letter to the Centers for Medicare and Medicaid Services (CMS), representatives from the American Dental Association have asked for increased transparency regarding medical loss ratio (MLR) reporting from Medicaid managed care plans. The authors pointed out that many states were missing substantial chunks of MLR data in recent years.
Sanofi Launches “This is Rare” Campaign on Rare Disease Day
Sanofi is marking this year’s Rare Disease Day, February 28th, with its new “This is Rare” campaign, which will feature the voices of patients living with rare diseases. The campaign is part of a large push by the company and others to develop therapeutics for the rare disease community, which accounts for one in seventeen people in the UK.
Do Commercial Payers Rely on ICER Assessments During Specialty Drug Coverage Deliberations?
The Institute for Clinical and Economic Review (ICER) releases value assessment reports that determine cost-effectiveness ratios (CERs) for new and existing therapeutics. A newly published study in the Journal of Managed Care + Specialty Pharmacy, examines whether and how commercial insurance plans in the US incorporate these reports into their reimbursement decision-making process.
FDA Grants SpringWorks’ Desmoid Tumor Drug Priority Review
The SpringWorks Therapeutics, a spinoff of Pfizer, received priority review by the US Food and Drug Admnistration (FDA) for nirogacestat as a treatment for desmoid tumors. Patients taking the small molecule drug as a monotherapy had 71% lower risk of progression and had a better objective response rate compared to placebo.
Value in Health Review: Applying Machine Learning to Wearable Data to Generate HEOR Insights
An article in the latest issue of Value in Health breaks down how machine learning can be applied to data from wearable devices to advance health economics and outcomes research (HEOR). Wearables are a font of real-world data (RWD) that can be analyzed by machine learning (ML). By addressing existing issues of data quality and effective usage, such a trove of information could accelerate research and decision-making process for payers, regulatory bodies, and pharma companies.
Advancing Rare Disease Drugs Through Real-World Evidence
Patients with rare diseases often suffer with few effective treatment options. Therapeutic development for these drugs targeting rare diseases increasingly depends on real-world evidence (RWE). In a new IQVIA blog, learn more about efforts in the UK to advance the development of drugs for rare diseases through the careful use of RWE.
