About Covid-19
As commercial COVID pivot looms, Moderna logs $2.8B in demand-related expenses “For all of 2022, the mRNA specialist logged a $1.3 billion charge for inventory write-downs, plus $725 million for contract cancelations. Moderna paid another $776 million for unused manufacturing capacity and CDMO charges, representing total expenses tied to slouching demand of around $2.8 billion.
All told, Moderna reported total 2022 sales costs of $5.4 billion, representing 29% of the company’s $18.4 billion that its roster of COVID shots and boosters brought home for the year. Aside from third-party royalty costs of $1.1 billion—plus other expenses related to activities like actually producing the shot—Moderna credited the charges to ‘overall lower demand’ for its vaccines ‘in particular from low-income countries.’ Moderna also cited a shift in demand to the company’s Omicron-busting bivalent boosters, alongside costs ‘associated with surplus production capacity.’”
About health insurance/insurers
Humana to Exit Employer Group Commercial Medical Products Business “Humana Inc. today announced that it will be exiting the Employer Group Commercial Medical Products business, which includes all fully insured, self-funded and Federal Employee Health Benefit medical plans, as well as associated wellness and rewards programs. No other Humana health plan offerings are materially affected. The company remains committed to the long-term growth of its core Insurance lines of business, including Medicare Advantage, Group Medicare, Medicare Supplement, Medicare Prescription Drug Plans, Medicaid, Military and Specialty (Dental, Vision, Life, etc.), as well as its CenterWell healthcare services business.
Following a strategic review, the company determined that the Employer Group Commercial Medical Products business was no longer positioned to sustainably meet the needs of commercial members over the long term or support the company’s long-term strategic plans. The exit from this line of business will be phased over the next 18 to 24 months. The company is committed to ensuring a smooth transition of services for members and commercial customers.”
U.S. Medicare says no change to Alzheimer's drug restrictions “The U.S. government health plan for people over the age of 65 on Wednesday said it would not reconsider strict coverage limits put in place last year for new Alzheimer’s treatments, rejecting a request from the Alzheimer’s Association.
The Centers for Medicare and Medicaid Services (CMS) reaffirmed its policy allowing coverage for drugs designed to clear amyloid plaques from the brains of Alzheimer’s patients only if a medication is approved under the Food and Drug Administration’s standard review process, not under its accelerated review program.
The agency said it would also continue to require a registry to collect evidence of patient outcomes to reflect ‘real-world’ care.”
About hospitals and healthcare systems
Costly discharge delays highlight need for more downstream care options, New York group's analysis shows “Rampant discharge delays last spring cost New York hospitals an average of $168,000 per inpatient case and $18,000 per day in the emergency department, much of which was not reimbursed by payers, according to hospital data from the Healthcare Association of New York State (HANYS).
The data collection pilot, published Tuesday, pulled information from 52 New York hospitals from April 1 to June 30, 2022.
Among these, HANYS found 1,115 patients who “for circumstances largely outside hospitals’ control” couldn’t be discharged from the ED for at least four days or from an inpatient unit for 14 days. These patients collectively represented about 60,000 days of ‘avoidable’ delays, according to the pilot.”
This problem has national scope.
About pharma
Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval[AA] “Among 5 oncology indications, 26.1% of eligible treatment initiations involved an AA indication subsequently withdrawn due to lack of benefit. An expected trade-off exists between expediting access to promising cancer drugs and withdrawal of some indications. Given the growth of withdrawals due to negative confirmatory trials and emerging evidence on the high spending associated with AA drugs, it is critical to balance early access against population-level exposure to cancer therapies with no benefit over standard of care.”
Moderna teams up with ElevateBio in mRNA gene editing pact “Moderna and ElevateBio's Life Edit Therapeutics on Wednesday announced a partnership to co-develop in vivo mRNA gene editing therapies using the latter's "large and diverse" library of base editors and RNA-guided nucleases (RGNs). Financial specifics about the multi-target collaboration were not disclosed, but the companies said the focus will be on creating potentially curative therapies for the ‘most challenging’ rare genetic and other diseases.”
HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules “The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year. It includes several rules that the Food and Drug Administration (FDA) will work on to address issues such as patient labeling, conduct of clinical trials and drug compounding.
On 22 February, HHS published its semiannual regulatory agenda, which included a number of rules either under development or set to be finalized by FDA, as well as a timetable for expected completion. Notably, several of the rules, including a rule on medication guides, have been listed in the regulatory agenda for multiple years.”
About the public’s health
Flu vaccine was 68% effective at preventing hospitalization in children but less protective for seniors this season “The flu vaccine has been 68% effective at preventing hospitalizations in children and 35% effective at preventing hospitalization in seniors this season, according to preliminary CDC data.
Dr. Jose Romero, head of the National Center for Immunization and Respiratory Disease, said flu cases and hospitalizations are declining but that the U.S. could see a second wave later this year.”
For the full CDC report, click here.
Associations of timing of physical activity with all-cause and cause-specific mortality in a prospective cohort study “Moderate-to-vigorous intensity physical activity (MVPA) at any time of day is associated with lower risks for all-cause, cardiovascular disease, and cancer mortality. In addition, compared with morning group (>50% of daily MVPA during 05:00-11:00), midday-afternoon (11:00-17:00) and mixed MVPA timing groups, but not evening group (17:00-24:00), have lower risks of all-cause and cardiovascular disease mortality. These protective associations are more pronounced among the elderly, males, less physically active participants, or those with preexisting cardiovascular diseases. Here, we show that MVPA timing may have the potential to improve public health.”
CDC panel recommends Bavarian Nordic's mpox vaccine for all adults at risk “Advisers to the U.S. Centers for Disease Control and Prevention (CDC) on Wednesday voted in favor of use of Bavarian Nordic's Jynneos vaccine for all adults at risk of mpox during an outbreak.
The panel of outside experts voted unanimously in favor of use of two doses of the vaccine, and finalizing the interim guidelines provided by CDC during the mpox outbreak in the United States.
The recommendation of the committee is based on studies that showed vaccine effectiveness of 66%-83% for patients with full vaccination and 36%-86% for partial vaccination with no severe adverse affect.”
FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product Manufacturers The FDA “oday, the U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization. This is the first time the FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
It is illegal to manufacture, sell, or distribute e-liquids that the FDA has not authorized. The FDA previously warned each of the companies that, by making and selling their e-liquids without marketing authorization from the FDA, they were in violation of the FDA’s premarket requirements for tobacco products and that failure to correct these violations could lead to an enforcement action, such as a CMP. Despite the agency’s warning, these companies continue to make and sell their unauthorized e-liquids to consumers.”
Most parts of world saw maternal mortality rates spike in 2020 “Maternal mortality rates climbed or stagnated in nearly all regions across the world in 2020, according to a report released by U.N. agencies on Wednesday, marking a major setback in global efforts to combat complications during childbirth or pregnancy.
The report, which tracks maternal mortality nationally, regionally and globally from 2000 to 2020, showed there were an estimated 287,000 maternal deaths worldwide in 2020, and it marks only a slight decrease from 309,000 in 2016.
That translates to a woman dying every two minutes during childbirth or pregnancy, the report estimated.”
About healthcare IT
FDA Sees Spike in Drug Applications That Involve AI Tools “The number of drug applications that the FDA has received involving artificial intelligence (AI) and machine learning (ML) tools jumped from just a handful before the COVID-19 pandemic to more than 120 in 2021 and topped 150 in 2022.”
Teladoc Health Reports Fourth Quarter and Full Year 2022 Results Among the statistics: “Net loss totaled $3,810.1 million, or ($23.49) per share, for the fourth quarter of 2022, compared to $11.0 million, or ($0.07) per share, for the fourth quarter of 2021. Results for the fourth quarter of 2022 primarily included non-cash goodwill impairment charges of $3,772.8 million, or ($23.26) per share, stock-based compensation expense of $50.8 million, or ($0.31) per share, and amortization of acquired intangibles of $49.0 million, or ($0.30) per share.”
Does deidentification of data from wearable devices give us a false sense of security? A systematic review The quick answer is “No.”
“Correct identification rates were typically 86–100%, indicating a high risk of reidentification. Additionally, as little as 1–300 s of recording were required to enable reidentification from sensors that are generally not thought to generate identifiable information, such as electrocardiograms. These findings call for concerted efforts to rethink methods for data sharing to promote advances in research innovation while preventing the loss of individual privacy.”
About healthcare personnel
What’s your specialty? New data show the choices of America’s doctors by gender, race, and age Interesting breakdown and worth a read. The statistic on which the media is focusing is the 5.7% “Black or African American” category, which is significantly underrepresented given population proportion percentages (12%).