About Covid-19
House votes to declassify info about origins of COVID-19 The House voted unanimously Friday to declassify U.S. intelligence information about the origins of COVID-19, a sweeping show of bipartisan support near the third anniversary of the start of the deadly pandemic.
The 419-0 vote was final congressional approval of the bill, sending it to President Joe Biden’s desk. It’s unclear whether the president will sign the measure into law, and the White House said the matter was under review.”
QuidelOrtho Gains De Novo Authorization for COVID-19 Test “QuidelOrtho has received FDA’s de novo authorization for its Sofia 2 SARS Antigen+ FIA rapid test for COVID-19 — making it the first antigen test for COVID-19 to gain a full authorization rather than an emergency use authorization from the agency.”
Emphasis added.
Hard to believe this is the first non-EUA 3 years after the pandemic was declared.
About quality and safety
Pediatric mental health, workplace violence are top 2023 safety concerns: ECRI It is well worth following this report annually, not only to focus on the current list, but to compare it with previous years’ lists. The article goes back to 2020. It is not only a reflection of current science as well as prevalent social factors.
About hospitals and healthcare systems
Hospitals Barred From Suing HHS Over Uncompensated Care Pay “Forty-five hospitals that the HHS allegedly underpaid for providing uncompensated care to low-income people can’t challenge the agency’s methodology for calculating those payments.
The Medicare Act bars agency and judicial review of the US Health and Human Services Department’s estimates for determining hospitals’ disproportionate share payments, the US Court of Appeals for the D.C. Circuit said Friday.
It also renders unreviewable HHS’ instructions for auditing a form that hospitals use to report their uncompensated care for the ultimate purpose of calculating DHS payments, the court said.”
Ascension operating margin falls to -2.9% “St. Louis-based Ascension saw its operating margin fall to -2.9 percent in the six months ending Dec. 31, 2022, down from 0.2 percent for the same period in 2021 and 5.7 percent in 2020, according to its most recent financial report.
The 139-hospital system recorded a $410 million operating loss in the second half of 2022, compared with an operating income of $31 million during the same period last year.”
About pharma
More than one-third of Americans haven’t filled a prescription due to cost: survey “That’s according to a poll completed by 1,500 U.S. adults in March 2023. Of these, 37 percent said they’ve not filled a prescription due to cost. Another 10 percent preferred not to answer the query.
Both women and individuals with an annual family income less than $50,000 were more likely to say they’ve skipped filling prescriptions due to cost, at 43 percent and 44 percent, respectively.
However, similar shares of Democrats and Republicans said they’ve had this experience, poll results show.”
Highlights the need for pharma payment reform. Generics have saved billion of dollars but some people need expensive medications to live. Charging high rates for non-discretionary services is cruel and counterproductive, as noncompliance often results in the need for more expensive care.
Medicare Part D Coverage of Antiobesity Medications — Challenges and Uncertainty Ahead “The Institute for Clinical and Economic Review (ICER), a nonprofit health technology assessment organization based in the United States, recently evaluated the cost-effectiveness of lifetime use of semaglutide and three other antiobesity-medication regimens (brand-name liraglutide, phentermine–topiramate, and bupropion–naltrexone; including generic versions of phentermine and topiramate, and bupropion and naltrexone) for a 45-year-old patient as compared with lifestyle modification alone. ICER’s evaluation concluded that semaglutide wasn’t cost-effective, with an estimated cost of $237,000 per quality-adjusted life-year gained…
Under current U.S. thresholds, the annual $13,618 price of semaglutide would need to decrease to $7,500 to $9,700 for the drug to be cost-effective as compared with lifestyle modification alone.In that price range, however, it still wouldn’t be cost-effective as compared with generic phentermine and topiramate. Even with such discounted prices, the budgetary effects for Medicare could be substantial.”
Bottom line is a $26.8B annual price tag for one drug.
Gambian child deaths fuel alarm over rules in ‘world’s biggest pharmacy’ India Although this article uses examples from Gambia, the “deaths have sparked concerns about quality control in India, the self-styled pharmacy of the world, as well as under-resourced regulatory agencies in low-income nations…
India, which has 20 per cent of the global market for generic drugs, supplies more than 50 per cent of generic drugs sold in Africa, according to Invest India, the government’s national investment promotion and facilitation agency.”
The FDA does not have enough personnel or money to comprehensively cover foreign sources of food and drugs.
The top 10 drugs losing US exclusivity in 2023 To get an idea of the impact of generic equivalents, subtract about 15% from biologics (frequently ending in “ab” or “ib”) and 80% from non-biologic products. The caveat is that, like any other goods, there has to be sufficient competition to bring those numbers down.
Veterans Health Administration will cover the newest Alzheimer’s drug “In an unexpected move, the Veterans Health Administration announced Monday that it will widely cover a new Alzheimer’s treatment, even as Medicare has decided to wait for additional data about the medicine before taking the same step.
The VA will provide coverage to veterans who meet agency criteria for using the medicine — called Leqembi — as well as stipulations on the product labeling, according to a statement from Eisai, which is partnering with Biogen to market the treatment. About 80% to 90% of veterans who clear these hurdles may be eligible for the treatment, but the exact number is uncertain…”
About the public’s health
Long-term intensive endurance exercise training is associated to reduced markers of cellular senescence in the colon mucosa of older adults “Our data suggest that chronic high-volume high-intensity endurance exercise can play a role in preventing the accumulation of senescent cells in cancer-prone tissues like colon mucosa with age. Future studies are warranted to elucidate if other tissues are also affected, and what are the molecular and cellular mechanisms that mediate the senopreventative effects of different forms of exercise training.”
Massachusetts could become the next state to allow aid in dying A really good review of the topic, including legal status among the states.
E-Cigarette Screening in Primary Care “Overall rates of e-cigarette screening were significantly lower than that of other substances. Use of combustible tobacco or illicit substances was associated with an increased likelihood of being screened. This finding may be due to the relatively recent proliferation of e-cigarettes, the recent addition of e-cigarette documentation to the electronic health record, or a lack of training on screening for e-cigarette use.”
About healthcare IT
Commercially available AI tool could reduce radiologist workloads by 10% or more “The AI tool was able to correctly classify 28% of the images labeled as normal. This equates to approximately 7.8% of the entire cohort that could be safely classified using AI alone.
The tool’s sensitivity was recorded as 99.1% for abnormal radiographs and 99.8% for critical radiographs—better than two board-certified radiologists who also interpreted the exams.”
A reminder about how good AI is getting at reading images.
Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need Really good discussion of the topic. In short: “Behind the scenes, insurers are using unregulated predictive algorithms, under the guise of scientific rigor, to pinpoint the precise moment when they can plausibly cut off payment for an older patient’s treatment. The denials that follow are setting off heated disputes between doctors and insurers, often delaying treatment of seriously ill patients who are neither aware of the algorithms, nor able to question their calculations.”
About healthcare finance
With $43B buyout, Pfizer sees cancer specialist Seagen as a 'goose' laying 'golden eggs' “It is the largest acquisition in biopharma since June of 2019, when AbbVie acquired Allergan for $63 billion. Five months before that, Bristol Myers Squibb pulled off the biggest transaction in industry history with its $74 billion purchase of Celgene.
Seagen, long considered one of the world’s most attractive biotech targets, brings four commercial medicines and a deep pipeline full of antibody-drug conjugate (ADC) candidates.”
Sanofi throws down $2.9B to acquire diabetes partner Provention Bio “The deal gives Sanofi access to Provention’s approved immunotherapy Tzield, greenlighted in November, which is designed to stall progression of type 1 diabetes.”