Value-based drug pricing: When does it work best?

“while the U.S. lags behind in adopting value-based agreements, many policymakers are realizing that value-based pricing can be an important, viable solution to the high and rising expenditures that payers lay out for prescription drugs. Developing value-based agreements has never been easier. A large number of value-based agreements are now available and can be used to help payers, manufacturers, and providers develop new ones appropriate to their specific situations. [..] Here are four scenarios for which I believe value-based pricing is appropriate. When expected outcomes for a new treatment are clear and objectively measurable. [..] Treatments with clearly defined, meaningful, … Read More

Measuring Performance of the Diagnostic Process

“During the diagnostic process, it is not unusual, or incorrect, for working diagnostic labels to change as new information is acquired and as the patient’s condition evolves both naturally and in response to interventions. The language used to communicate risk of disease and uncertainty about diagnosis is not uniform and may be overly ambiguous (eg, “cannot rule out,” “consider the possibility”). Thus, attempts to standardize and measure diagnostic processes should avoid unrealistic expectations or overzealous judgments to be both accurate and fair in judgment (eg, driving performance not feasible under the conditions at the time, or expecting actions predicated on … Read More

FDA rule would facilitate prescription-to-OTC switches but nix a third class of drugs

“The proposed rule would establish an Additional Condition for Nonprescription Use [ACNU] category for prescription products the FDA says consumers currently can’t appropriately self-select and use without a prescription. This is somewhat analogous to the Risk Evaluation and Mitigation Strategies, which allow certain prescription drugs with potential safety issues to be approved for patients with additional requirements for use, such as verifying a negative pregnancy test for a drug that can cause birth defects or requiring a monthly lab test before the drug can be dispensed. With an ACNU, a drug company must meet several FDA-approved conditions to ensure that … Read More

Athletic Greens as More Wellness Nonsense

Excerpt – For a company that’s been around for more than a decade, it seems to have appeared out of nowhere. Athletic Greens aggressively advertises (and sells) only one product: AG1, a moss-toned powder that costs $99 for a 30-serving bag and claims to be “all you really need, really.” But it isn’t a meal replacement nor is it a pre- or post-workout drink, as the brand’s name implies. AG1 promises “75 vitamins, minerals, whole-food sourced superfoods, probiotics and adaptogens” in one scoop. The ingredient list is biblically long and rife with parentheses, its components categorized by wellness buzzwords: “Alkaline, … Read More

Health Care Spending Effectiveness: Estimates Suggest That Spending Improved US Health From 1996 To 2016

“US data from the period 1996–2016 are now available on health care spending by cause from the Disease Expenditure Project (DEX) and on DALYs [disability-adjusted life-years] by cause from the Global Burden of Disease (GBD) Study 2017. DALYs are the sum of years of life lost due to premature mortality, as well as years lived with disability among people living with a given cause. Intuitively, DALYs are a measure of burden, and therefore the goal of health systems is to avert DALYs. A decrease in DALYs is a measure of health gain referred to as DALYs averted. [..] We estimated … Read More

More work on diabetes

David H Jiang et al. published an article in Health Affairs last month arguing for a set of diabetes quality measures that are actually linked to optimal diabetes health. Composite measures that include “all-or-nothing” components will incentivize providers to focus on patients who are most likely to achieve the measure rather than those who would benefit the most clinically. This would also adversely affect patients with socioeconomic barriers to optimal health, as those patients are more likely to have multiple unmet measures or not meet a measure that is more difficult to achieve (e.g., smoking cessation). A more equitable approach … Read More

The Quest by Circadian Medicine to Make the Most of Our Body Clocks

Excerpt – In the early 2000s, advances in the ability to detect the activity of genes in various tissues revealed that the cell clocks are organized into separate organ-level clocks representing every physiological system: There’s a skin clock and a liver clock and an immune-system clock; there’s a clock for the kidney, heart, lungs, muscles and reproductive system. Each of those clocks syncs itself to the central clock in the brain like an orchestra section following its conductor. But those sections also adjust how and when they perform based on guidance they receive both from the environment and from one … Read More

Why Privacy Matters

“as Vox reporter Sara Morrison wisely observed, “[D]eleting a period tracker app is like taking a teaspoon of water out of the ocean.” So much data is collected about people these days that removing a small amount of data from an app or a phone is not going to erase all traces of a newly criminalized activity. The Electronic Frontier Foundation notes that pregnant people are far more likely to be turned over to law enforcement by hospital staff, a partner or a family member than by data in an app —and that the types of digital evidence used to … Read More

Society of Family Planning interim clinical recommendations: Self-managed abortion

“While the medical risks of SMA [self-managed] may be few, the legal risks for people attempting SMA may be significant. Although only three states currently have laws explicitly criminalizing SMA, almost half of U.S. states have at least one law in place that could be used to prosecute people attempting or assisting with SMA. These policies include legislation explicitly banning SMA, criminalizing harm to the fetus, and criminalizing abortion. For those who have been targeted with criminalization for SMA, many came into contact with law enforcement following interactions with healthcare professionals. However, to date, legal experts are unaware of any … Read More

Smartphone apps promised to help combat the pandemic. How well did they work?

“A new review paper, published Monday in Nature Biotechnology, explores the wide range of apps rolled out to combat the pandemic [..]. Here are four questions that still need to be answered about how apps can combat Covid. [1] How do you get broad swaths of the public to adopt an app? “Contact tracing had a lot of problems,” said [physician and Director of Digital Medicine at Scripps Research Translational Institute and a co-author of the new paper Jay] Pandit. [..] The initial goal for the U.K. National Health Service’s Covid-19 app was to reach a 60% adoption rate. [..] … Read More