About the public’s health
Moderna's COVID-19 Vaccine Shines In Clinical Trial: Today’s top story. Like Pfizer-BioNTech’s vaccine, this one is also based on messenger RNA. The vaccine is reported to be about 95% effective after 2 doses. It does not require as stringent freezing as does the one from Pfizer-BioNTech.
Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration: How fast are “usual” vaccines developed? “Since 2010, most novel vaccines approved by the FDA required about 8 years [emphases added] of clinical development and were based on evidence from a median of 7 clinical trials, including at least 2 pivotal efficacy trials that were randomized, masked, and used a comparator group. These pivotal efficacy trials enrolled a median of 5000 patients, who were followed up for serious adverse events for at least 6 months.”
Unexpected detection of SARS-CoV-2 antibodies in the prepandemic period in Italy: “This study shows an unexpected very early circulation of SARS-CoV-2 among asymptomatic individuals in Italy several months before the first patient was identified, and clarifies the onset and spread of the coronavirus disease 2019 (COVID-19) pandemic. Finding SARS-CoV-2 antibodies in asymptomatic people before the COVID-19 outbreak in Italy may reshape the history of pandemic.”
Premature Years of Life Lost [PYLL] Due to Cancer in the United States in 2017: Just so we don’t lose track of other major illnesses during the pandemic, this article puts cancer deaths in perspective:
”PYLL was defined as the sum of the total years of life lost prior to age 75 years…The largest number of PYLL in 2017 was due to deaths from cancers of the lung/bronchus (891,313; 20.8%), colon/rectum (409,538; 9.6%), and breast (400,643; 9.4%). Cancers with the highest PYLLs generally also caused the largest number of deaths and had the highest mortality rates, with the exception of prostate cancer (5.1% of deaths, 2.0% of PYLL). In contrast, PYLLs per death were greatest for deaths due to cancers of testis (mean = 34.0 years), bones/joints (26.4), and other endocrine sites including thymus (25.2).” In sum, in 2017 there were more than 4 million PYLL.
J&J tops list of healthcare supply chains amid COVID vaccine effort—and Pfizer wins kudos, too: “J&J topped Gartner's top 25 list of healthcare supply chains for the second year in a row, just as the drugmaker gears up to distribute up to 1 billion doses of its investigational COVID-19 vaccine, Ad26.COV2.S, in 2021…Further down Gartner's list were fellow drugmakers Novo Nordisk (No. 11), Pfizer (No. 15), Roche (No. 21) and Biogen (No. 25). The list also highly ranked distributor McKesson (No.4), the U.S. government's partner in rolling out a range of COVID-19 vaccines to American patients.”
The Hot New Covid Tech Is Wearable and Constantly Tracks You: The article provides examples of all the entities using, or planning to use, wearable tracking devices that could pick up early signs of COVID-19.
About health insurance
Evaluation Of Medicare Alternative Payment Models: What The Data Show : This article is an excellent update evaluating the success of these different models. For example:
”The evidence indicates that ACOs continue to realize value-based care’s goal of providing better care at lower costs. Data from MedPAC, researchers at Harvard University, and the analytic firm Dobson DaVanzo and Associates show that ACOs are lowering Medicare spending annually by 1 percent to 2 percent. Knowing Medicare Parts A and B cost $636 billion in 2018, a 2 percent reduction in spending would save nearly $200 billion when compounded over a decade, assuming Medicare spending would grow at 4.5 percent per year without ACOs.
Importantly, based on the authors’ analysis of Centers for Medicare and Medicaid Services Public Use Files, ACOs also hit an average quality score of more than 94 percent in 2019, the latest year for which Medicare data are available.”
Insurers' strong financial performance continues in Q3 as they brace for a potentially rocky Q4: “Major national health insurers continued to largely turn a significant profit in the third quarter, though numbers didn't quite reach the sky-high figures reported in the first half of the year.
And some warned that the fourth quarter could be ugly, with pent-up utilization and costs related to COVID-19 coming to a head.”
See the article for a good summary of the performances of the major companies.
About pharma
Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial: “We assessed the efficacy and safety of inhaled nebulised interferon beta-1a (SNG001) for the treatment of patients admitted to hospital with COVID-19…Patients who received SNG001 had greater odds of improvement and recovered more rapidly from SARS-CoV-2 infection than patients who received placebo, providing a strong rationale for further trials.”
As with many other drugs in this situation, more research needs to confirm its effectiveness.
Recommendations for five new drugs lead decisions from CHMP's November meeting: This article provides a good summary of what is happening in the pharma industry viewed through drug actions in the EU: “At its November meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended five drugs for approval, including one following a re-examination, as well as six line extensions. Meanwhile, the committee issued one negative opinion following a re-examination, with three companies also withdrawing marketing applications.”
11 drugs PBMs are adding back to their formularies after dropping last year: The headline speaks for itself; the article lists these medicines and the PBMs that re-added them.
About healthcare professionals
Authority of VA Professionals To Practice Health Care: This statement from the Federal Register is a really important departure from state-specific licensure laws. The immediate impact will be on telemedicine.
“The Department of Veterans Affairs (VA) is issuing this interim final rule to confirm that its health care professionals may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice. Specifically, this rulemaking confirms VA's current practice of allowing VA health care professionals to deliver health care services in a State other than the health care professional's State of licensure, registration, certification, or other State requirement, thereby enhancing beneficiaries' access to critical VA health care services. This rulemaking also confirms VA's authority to establish national standards of practice for health care professionals which will standardize a health care professional's practice in all VA medical facilities.”
About healthcare quality
A Call for Action: Insights From a Decade of Malpractice Claim: A really good summary of trends by specialty and cause. For example, the top two allegations are surgery/procedure-related (29.2%) and diagnosis-related (27.3%). Together they account for 59% of payments.