About pharma
AstraZeneca probes 'mistake' behind 90% COVID-19 vaccine efficacy: As previously reported, the vaccine dose that was 90% efficacious was a half dose followed by a full dose. That regimen was mistakenly given to some volunteers but proved better than two full doses.
Moderna to charge $25-$37 for COVID-19 vaccine, says CEO: ”Moderna will charge governments between $25 and $37 per dose of its COVID-19 vaccine candidate, depending on the amount ordered, Chief Executive Stephane Bancel told German weekly Welt am Sonntag (WamS).
‘Our vaccine therefore costs about the same as a flu shot, which is between $10 and $50,’ he was quoted as saying.
On Monday, an EU official involved in the talks said the European Commission wanted to reach a deal with Moderna for the supply of millions of doses of its vaccine candidate for a price below $25 per dose.”
Purdue Pharma Pleads Guilty to Felonies Over OxyContin Sales:”Purdue Pharma LP pleaded guilty Tuesday to three federal felonies related to the marketing and distribution of its powerful opioid painkiller OxyContin, ending the bankrupt company’s exposure to U.S. government action but leaving other liabilities to state and local governments looming.”
3 pharmacy industry groups sue to stop new US drug import rule: “Three pharma industry groups are suing HHS and the FDA to block a rule that would allow the importation of certain prescription drugs from Canada.
The groups filing the suit are Pharmaceutical Research and Manufacturers of America, Partnership for Safe Medicines and the Council for Affordable Health Coverage.”
Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person: “ Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person (post-exposure prophylaxis).” It is only approved for those age 12 and older. Many sites list the cost at $150, but say couponing will bring the out of pocket expense down.
About health insurance
Employers start sending workers shopping for health coverage: This article is a reminder about a subject previously reported:
”Instead of offering one or more options, some companies are turning health insurance shopping over to employees.
A federal rule change last year stoked this new approach. It allows employers to reimburse workers for coverage they bought without paying a tax penalty.
The concept sends employees to individual insurance markets where they can find more choices for coverage. It also protects employers from huge annual cost spikes. But it’s a big change for workers who are used to having their employer give them benefit choices every year.
This new approach — known as an Individual Coverage Health Reimbursement Arrangement or ICHRA — started with coverage plans for this year. More workers will likely see them offered this fall during their company’s annual sign-up window for 2021 coverage.”
Texas and Louisiana can cut Medicaid funding for Planned Parenthood, federal appeals court rules: “The ruling was handed down by the 5th U.S. Circuit Court of Appeals in New Orleans. While it expressly reversed decisions in Texas and Louisiana, it also affects Mississippi, which is under 5th Circuit jurisdiction. The issue is likely to go next to the U.S. Supreme Court.
Opponents of legal abortion have long sought to deny federal Medicaid funding for Planned Parenthood clinics.”
Insurer Participation on the ACA Marketplaces, 2014-2021: “For the third straight year, several insurers are entering the market or expanding their service area in 2021. This year, we find that 30 insurers are entering the individual market across 20 states (Table 1) and an additional 61 insurers are expanding their service area within states they already operated. There will be an average of 5.0 insurers per state in 2021, up from a low of 3.5 in 2018 but still below the peak of 6.0 in 2015. The number of insurers per state ranges from one company operating in Delaware to thirteen operating in Wisconsin.” The article has some helpful graphics that explain the trends.
Cigna CEO, Board Sued for ‘Black Ops’ Effort to Kill Anthem Deal: “A Massachusetts-based pension fund alleges that Cigna CEO David Cordani sought to “poison” the deal after failing to secure the top post in the merged company. He hired lawyers and public relations specialists to help in a ‘Trojan Horse’ campaign, the fund claims. The deal, which would have created the largest U.S. health insurer, collapsed in 2017.”
About the public’s health
There was a 28% increase in child Covid-19 cases over the last two weeks, American Academy of Pediatrics says: “There were more than 144,000 new cases of Covid-19 reported among children last week, the American Academy of Pediatrics (AAP) said Monday.
Over the last two weeks, there has been a 28% increase in child Covid-19 cases and children now account for more than 11% of all confirmed coronavirus cases in the US, according to the AAP.
About 144,145 new cases among children 17 and under were reported from November 12 to 19, AAP said.”
Assessment of 135 794 Pediatric Patients Tested for Severe Acute Respiratory Syndrome Coronavirus 2 Across the United States: “Among the 5374 patients with positive test results, 359 (7%) were hospitalized for respiratory, hypotensive, or COVID-19–specific illness. Of these, 99 (28%) required intensive care unit services, and 33 (9%) required mechanical ventilation. The case fatality rate was 0.2% (8 of 5374).”
”This study suggests that for most pediatric patients, the risk of SARS-CoV-2 infection appears low, but higher concern may be warranted for patients with medically complex conditions or those of minority race/ethnicity.”
A $10 Covid-19 Test? Walmart Heirs Back Startup Developing At-Home Tests: “The billionaire Walton family that controls Walmart Inc. is among a group of investors backing a startup aiming to design at-home Covid-19 tests to sell for as little as $10 at the retail giant’s stores and elsewhere.
NowDiagnostics Inc., based 20 miles south of Walmart’s corporate headquarters, has filed requests for emergency authorization from the U.S. Food and Drug Administration for a Covid-19 antibody blood test, according to the Springdale, Ark., company.
It is also developing two at-home Covid-19 tests that would use a patient’s saliva and deliver results in minutes, said Chief Executive Kevin Clark.”
About healthcare quality
Variations in processes for guideline adaptation: a qualitative study of World Health Organization staff experiences in implementing guidelines: “The contrasting models of guideline adaptation encountered in the interviews show the differing processes employed by WHO staff in different regions in the world. One is a Copy or Customise model of adaptation through consultation with local health authorities and stakeholders. This model takes parts of WHO guidelines and applies them as is or in modified form in-county, while taking into account the local epidemiology, system capacity and existing policies. The other model is based on capacity building where WHO regional offices help build and support national guideline development and adaptation programs so national guidelines can be developed based on WHO or other evidence-based guidelines using thorough framework for evidence evaluation to inform the strength of recommendations in the local setting. The actual processes of guideline adaptation revealed by our interviews existed along a spectrum between these 2 models.”
About health policy
Association of State Certificate of Need Regulation With Procedural Volume, Market Share, and Outcomes Among Medicare Beneficiaries: “Among Medicare beneficiaries who underwent a range of surgical procedures from 2016 through 2018, there were no significant differences in markers of hospital volume or quality between states without vs with certificate of need laws. Policy makers should consider reevaluating whether the current approach to certificate of need regulation is achieving the intended objectives and whether those objectives should be updated.” See also the accompanying editorial: Revisiting States’ Experience With Certificate of Need.
This research is in a long line of other studies that show how ineffective CON regulations are.