Supporting Value-Based Health Care – Aligning Financial and Legal Accountability
Author: Pierre Etienne
Author: Pierre Etienne
Author: Pierre Etienne, Co-Founder and CMO
Author: Pierre Etienne, Co-Founder and CMO Our first podcast focuses on the growing discontent about pharma pricing practices in the US, particularly for new agents in cancer. Recent developments in this space seem to suggest that this status-quo can expect some much needed disruption.
Biogen’s Aducanumab has just received FDA approval for the treatment of Alzheimer’s Disease. During clinical trials of the drug the most common adverse events were headaches and amyloid-related imaging abnormalities of the ARIA-E type (ARIA-Edema, defined as vasogenic edema or sulcal effusion. Dubois, 2021). One-quarter of participants in the 6 mg/kg dose group and one-third […]
As we know, the evaluation of clinical benefits achieved with cancer drugs is a complex problem. It is well described in two recent reviews, a study that systematically synthesized and analyzed English, French, and Australian health technology assessments (HTAs) of all new cancer medicines licensed in the United States and Europe between 2003 and 2013 […]
I have received a number of comments to my previous (Blog 4), including one by Dr. Indersen Gandhi, a medical consultant in pharmaceutical medicine from Hyderabad that offers the following idea: Instead of making clinical trial participants pharma business partners at the outset i.e. when they are asked to sign the ICF, as it would […]
Currently, offers of payment to volunteers participating in clinical trials come in three categories, reimbursement for-out-of-pocket expenses, compensation for time and burdens, and recruitment incentive. Reimbursement and compensation are service-based reasons for offering payment; recruitment incentives, by contrast, aim simply to improve participation rates. (1) The payment guidance document from the Harvard Clinical and Translational […]
Value-based healthcare, so intuitively appealing yet so difficult to demonstrate. In the US, most healthcare spend is based on a fee-for-service reimbursement method; providers get paid based on the specific services that they perform. For most providers there are no financial incentives to reduce costs, improve quality, or enhance the patient’s experience. Under a value-based […]
The motivations of volunteers in clinical research are listed on the clinicaltrials.gov site; there is no treatment for their health problem or the treatments they have tried did not work or they may find out about new treatments before they are widely available, or they may contribute to the discovery of a treatment that could […]
In the second blog of this series focused on recruiting and retaining volunteers in cancer (and other difficult) trials, we shall review another aspect of pharmaceutical development, the cost of abandoning clinical trials that end up generating uninterpretable results because they miss the enrollment needed to demonstrate statistical significance at a predefined level of efficacy. […]
Introduction: Outcomes-based care and contracting or Value-based pricing or Performance-based risk s...
The concept of risk sharing is fundamental to all insurance products and contracts. At the simplest...
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