About health insurance
Supreme Court declines to hear insurers' appeal seeking full reimbursement of CSR [cost-sharing reduction] payments: “The court declined Monday an appeal from Maine Community Health Options and Community Health Choice over an appellate court decision that plans that engaged in “silver loading” are not eligible to be repaid for lost CSR payments.
The court did not give a reason for not taking up the case, but the decision deals a blow to insurers looking to recoup CSR payments they believe they are owed by the federal government.
The Supreme Court had previously ruled in April 2020 that the federal government had to fully repay insurers for risk-corridor payments under the Affordable Care Act (ACA). The court ruled insurers were entitled to more than $12 billion in unpaid payments.”
About pharma
Blood-Brain Barrier Crossing Renin-Angiotensin Drugs and Cognition in the Elderly: A Meta-Analysis: Perhaps one more factor in considering tailored anti-hypertensive treatments:
”Older adults taking blood-brain barrier-crossing renin-angiotensin drugs exhibited better memory recall over up to 3 years of follow-up, relative to those taking nonpenetrant medications, despite their relatively higher vascular risk burden. Conversely, those taking nonblood-brain barrier-penetrant medications showed better attention over the same follow-up period, although their lower vascular risk burden may partially explain this result. Findings suggest links between blood-brain barrier crossing renin-angiotensin drugs and less memory decline.”
Roche's Alzheimer's antibody lowers biomarkers in inherited form of disease, though impact on symptoms is unclear: This study highlights the problem of using surrogate endpoints as the measure of success.
”In trial participants with dominantly inherited Alzheimer's disease (DIAD), which causes early onset of memory loss and other symptoms, Roche’s drug lowered biomarkers of the disorder and neurodegeneration in the brain, Washington University said in a study published in Nature Medicine.
The study did not show evidence of a cognitive benefit to people with DIAD [emphasis added], though it was not designed to measure the cognitive impact of gantenerumab on people who started taking the drug before they developed symptoms.”
BMS, Eisai Strike $3.1 Billion Deal for Cancer Drug: “Bristol Myers Squibb (BMS) and Eisai have inked a collaboration deal worth up to $3.1 billion focused on Eisai’s experimental cancer drug, MORAb-202, which is aimed at patients with advanced solid tumors.”
GSK to slash dividend in order to fuel growth at pharma unit: ”CEO Emma Walmsley is expected to unveil plans later this week to boost growth at GlaxoSmithKline's pharmaceutical division in an effort to appease investors who have become disillusioned with the company's recent performance. Reports suggested that the executive will unveil a large cut to the drugmaker's dividend at its capital markets day on June 23, with funds to be diverted into drug development, including through alliances and takeovers.”
AbbVie loses bid to have US high court intervene in AndroGel antitrust case: “US Supreme Court justices on Monday declined to hear AbbVie's challenge to a lower court ruling that it violated federal antitrust law by lodging a ‘sham’ patent complaint in order to stifle competition for AndroGel. Last year, a US appeals court said the "objective baselessness" of AbbVie's claims in its 2011 infringement lawsuit against Perrigo, showed that the drugmaker had no hope of winning the case, but rather intended to use the litigation process only to delay Perrigo's proposed generic version of the testosterone replacement treatment.”
Availability of Cost-effectiveness Studies for Drugs With High Medicare Part D Expenditures: “In this cross-sectional study of 250 drugs with the greatest Medicare Part D spending in 2016, cost-effectiveness analyses were unavailable for 46.0%, with these drugs representing 33.0% of Medicare Part D spending. For the 54.0% of drugs with available cost-effectiveness studies, many of the studies did not meet minimum quality standards.” This finding is only the first part of a problem. The other part is that, even if available, data cannot be used to approve/disapprove a therapy. This problem is one of the fundamental reasons prescription drugs cost more in this country than in others.
Merck's Keytruda extends life for cervical cancer patients in first-in-class win: “Adding Keytruda to chemotherapy with or without Roche’s Avastin for the first-line treatment of cervical cancer significantly extended patients’ lives in a phase 3 trial, Merck said Tuesday. The Keytruda regimen also performed better at staving off cancer progression in the study…”
Amgen dealt another blow in closely watched PCSK9 patent case against Sanofi, Regeneron: “In a Monday order (PDF), the U.S. Court of Appeals for the Federal Circuit declined Amgen's request for a rehearing of a prior patent loss on PCSK9 cholesterol drug Repatha. With the decision, Amgen can either try to appeal further or drop the issue.”
About Covid-19
U.S. administers more than 318 mln doses of COVID-19 vaccines - CDC: “The United States has administered 318,576,441 doses of COVID-19 vaccines in the country as of Monday, the U.S. Centers for Disease Control and Prevention said.
Those figures are up from the 317,966,408 vaccine doses the CDC said had gone into arms by June 20.
The agency said 177,342,954 people had received at least one dose while 150,046,006 people are fully vaccinated as of Monday.”
The distribution continues to be uneven with respect to geographic, demographic and political characteristics.
Desperate for Covid Care, Undocumented Immigrants Resort to Unproven Drugs: The headline is the story, but the intro paragraphs to the article exemplify the problem:
”FRESNO, Calif. — On a Tuesday afternoon in April, among tables of vegetables, clothes and telephone chargers at Fresno’s biggest outdoor flea market were prescription drugs being sold as treatments for Covid.
Vendors sold $25 injections of the steroid dexamethasone, several kinds of antibiotics and the anti-parasitic drug ivermectin. Chloroquine and hydroxychloroquine — the malaria drugs pushed by President Donald J. Trump last year — make regular appearances at the market as well, as do sham herbal supplements.”
If reporters can find these abuses, why can’t law enforcement officers remove these public health threats?
New COVID-19 approach exploits protein response in human cells to combat virus: “The mechanism, called the ‘unfolded protein response’ (UPR), is present in human cells infected with SARS-CoV-2... Combining two drugs targeting different prongs of the pathway significantly inhibited viral replication in human lung cell cultures to near undetectable levels, according to results published in the journal PLOS Pathogens.”
About healthcare IT
Algorithmic Bias Playbook: This report, from the University of Chicago, is a very well-done, clear explanation of the problem and steps to correct it:
”This playbook will teach you how to define, measure, and mitigate racial bias in live algorithms. By working through concrete examples—cautionary tales—you’ll learn what bias looks like. You’ll also see reasons for optimism—success stories—that demonstrate how bias can be mitigated, transforming flawed algorithms into tools that fight injustice.”
External Validation of a Widely Implemented Proprietary Sepsis Prediction Model in Hospitalized Patients: “In this cohort study of 27 697 patients undergoing 38 455 hospitalizations, sepsis occurred in 7% of the hosptalizations. The Epic Sepsis Model predicted the onset of sepsis with an area under the curve of 0.63, which is substantially worse than the performance reported by its developer.”
Softbank-Backed Pear Therapeutics Plans To Go Public In $1.6 Billion SPAC Deal: “Pear Therapeutics, which has three FDA-authorized apps to treat psychiatric disorders, plans to go public in a $1.6 billion special purpose acquisition corporation, or SPAC deal, the company announced on Tuesday. Pear has raised more than $250 million to date with Softbank leading the startup’s Series D funding round…
The company, which launched in 2017, zeroed in on mental health quickly due to the high unmet need, says McCann, who has an MD and PhD in neurobiology. Pear’s flagship product reSET, developed out of Dartmouth, is a 90-day prescription app that provides cognitive behavioral therapy for the treatment of substance use disorder and is meant to be used alongside outpatient treatment. The list price for a 90-day prescription is $1,665.”
AWS [Amazon Web Services] announces AWS Healthcare Accelerator for startups in the public sector: “The AWS Healthcare Accelerator is a four-week technical, business, and mentorship accelerator opportunity open to U.S.-based healthcare startups or international healthcare startups that have existing U.S. operations. A cohort of 10 healthcare startup companies with an established product-market fit with existing customers and revenue, who seek to use AWS to help solve the biggest challenges in the healthcare industry, will be selected to participate in this new program. The program is tailored to accelerate growth in the cloud, with a focus on solutions like remote patient monitoring, voice technology, analytics, patient engagement, and virtual care. Applications are open today and proposals are due by July 23, 2021.”
The size and discovery delay of the following breaches are noteworthy.
Class action targets Scripps over data breach that exposed 147,000+ patients' info:”Scripps Health is being accused of failing to properly secure and protect patients' health information stored within the San Diego-based system's network, which a malware attack compromised April 29, according to court documents.”
Hacker removes files from New Mexico hospital's computers, exposes 69,000 patients' info: “San Juan Regional Medical Center in Farmington, N.M., recently began notifying nearly 69,000 patients that their protected health information was compromised by hackers.
SJRMC reported the breach to HHS on June 4, saying it affected 68,792 individuals. The hospital said it discovered that an unauthorized individual accessed its network from Sept. 7-8, 2020, during which the unauthorized individual removed some information, according to a June 4 online notice.
Some of the files the hacker removed contained patient information including names, Social Security numbers, birthdates, driver's license numbers, financial account numbers and medical record details.”
About healthcare systems
LifePoint Health Announces Agreement to Acquire Kindred Healthcare: “The transaction brings together LifePoint’s national network of community-based hospitals, providers and access points with Kindred’s expertise in delivering long-term acute care, rehabilitation services and behavioral health services…
LifePoint will invest $1.5 billion over the next three years to improve care for the communities that the combined organization will serve…the transaction is expected to be completed in the fourth quarter of 2021.”
About the public’s health
Trends and projections of caesarean section rates: global and regional estimates: “The use of CS has steadily increased worldwide and will continue increasing over the current decade where both unmet need and overuse are expected to coexist [emphasis added]. In the absence of global effective interventions to revert the trend, Southern Asia and sub-Saharan Africa will face a complex scenario with morbidity and mortality associated with the unmet need, the unsafe provision of CS and with the concomitant overuse of the surgical procedure which drains resources and adds avoidable morbidity and mortality. If the Sustainable Development Goals are to be achieved, comprehensively addressing the CS issue is a global priority.”