Aetna unveils plan nudging members to CVS clinics, pharmacies

Responding to concerns over anticompetitive practices, Jim Boyman, local Aetna Market President, reiterated the purpose of the plan is to use CVS’ store footprint to help consumers manage their health more easily.

However, CVS does expect some additional front-store revenue at its retail locations as a result of the plan design, and plans to expand Aetna Connected to other metro markets beyond the pilot in the Kansas City region on a to-be-determined timeline, Boyman said.

David Balto, former policy director of the Federal Trade Commission, noted the novel plan design would likely result in less choice and higher costs for employers and consumers.

Employers should be “extraordinarily careful” before signing up if they want to ensure workers access to a full range of healthcare services, Balto said. “CVS is moving toward a restricted market approach that would only be attractive in the Soviet Union. You have many choices, as long as they’re CVS.”

• CVS Health-owned Aetna on Monday rolled out a plan design that would steer patients toward its parent company’s brick-and-mortar locations — a key concern of antitrust regulators in reviewing the almost $69 billion megamerger that closed in 2019.
• The Aetna Connected plan gives members access to appointments at CVS’ MinuteClinics and its newer wellness-focused HealthHUBs for no copay, along with other CVS services like free at-home prescription delivery and discounts on health-related items.
• The plan is launching for 2021 in the Kansas City insurance market, which includes Clay, Jackson and Platte Counties in Missouri and Johnson and Wynadotte Counties in Kansas. It’s targeted to employers with more than 101 employees.

https://www.healthcaredive.com/news/aetna-unveils-plan-nudging-members-to-cvs-clinics-pharmacies/584475/

Novavax Analyst: Covid Vaccine ‘Promising’; 6 Takeaways From Phase 1 September 3, 2020

Novavax, Inc. NVAX 2.7% shares were moving solidly higher Thursday following the publication of detailed results of the Phase 1 study of its coronavirus vaccine candidate in the New England Journal of Medicine. 

The Novavax Analyst: Cantor Fitzgerald analyst Charles Duncan has an Overweight rating on Novaxax with a $211 price target.

The Novavax Thesis: The NEJM publication is clear validation for Novavax’s coronavirus vaccine candidate NVX-CoV2373, as well as a read-through on the importance of a vaccine for the novel coronavirus, Duncan said in a Wednesday note. 

The data suggests Novavax’s adjuvanted recombinant spike protein nanoparticle vaccine is a “promising” candidate with a “top-tier: efficacy and safety profile, the analyst said.

He named the following takeaways from the detailed results: 

• All subjects receiving the smallest dose of 5mcg developed anti-spike IgG antibodies after a single dose, with most responses being neutralizing antibody responses. 
• 100% of subjects developed neutralizing antibody responses after a second dose. 
• Matrix-M boosted response, proving to be dose-sparing. 
• Neutralizing antibody titers have geometric mean titers of more than four times what was observed in convalescent serum. 
• Polyfunctional CD4+ T cell responses with a predominant Th1 phenotype. 
• Acceptable adverse event/safety profile, as well as potential advantages in stability that could enable broad distribution. 

Duncan said he is encouraged by the initial human data, which includes patients of ages up to 59.

A Phase 2 study in 1,500 healthy volunteers to evaluate immunogenicity, safety and preliminary efficacy is underway in the U.S. and Australia, with 50% of the study participants from the high-risk group of 60-84 years of age, the analyst said.

Preliminary results from the study are expected in the fourth quarter, he said. 

The results will likely closely mirror those observed in the Phase 1 portion of the study, Duncan said. 

Cantor Fitzgerald expects Phase 3 testing to begin this month. 

https://www.benzinga.com/analyst-ratings/analyst-color/20/09/17369955/novavax-analyst-says-coronavirus-vaccine-promising-6-takeaways-from-phase-1-results

High BP telemonitoring beats standard care for heart risks – study

A telemonitoring program to control high blood pressure helped cut cardiovascular events by half, a new study shows.

The study, published in the journal Hypertension, examined data from 450 people with uncontrolled high blood pressure across 16 clinics in Minnesota. Participants were divided into two groups — 288 patients were enrolled in a pharmacist-led telemonitoring program and 22 patients received standard care via in-person office visits.

The telemonitoring program included use of at-home monitors and phone conversations with pharmacists who guided their care.

After five years, 5.3 percent of the telemonitoring program group had heart attacks, strokes, stent placements or heart failure hospitalizations, compared to 10.4 percent of the group that received standard care.

https://www.beckershospitalreview.com/cardiology/high-blood-pressure-telemonitoring-beats-standard-care-for-heart-risks-study-finds.html

Merck CEO sees human trials for COVID-19 vaccine candidate ‘fairly soon’

Merck aims to start human trials on one of its COVID-19 vaccine candidates “fairly soon,” with a second vaccine candidate likely to begin trials later this year, Chief Executive Kenneth Frazier said on Thursday.

Merck this year bought Austrian vaccine maker Themis Bioscience to gain its vaccine project that relies on a measles vector, and is also collaborating with research nonprofit IAVI on a second vaccine hopeful that uses the same technology as Merck’s Ebola vaccine ERVEBO.

“Both of those are going forward,” Frazier said during a virtual briefing sponsored by drug industry group International Federation of Pharmaceuticals Manufacturers & Association. “We expect to be able to start larger-scale human trials in the measles-virus vaccine fairly soon, and we expect to be able to start those clinical trials for the (IAVI vaccine) later this year.”

https://www.reuters.com/article/us-health-coronavirus-drugs-merck-co/merck-ceo-sees-human-trials-for-covid-19-vaccine-candidate-fairly-soon-idUSKBN25U2CL

Clinic plan by Tyson Foods could help in COVID-19 fight

Tyson Foods (TSN -1.9%) is planning to open medical clinics at several plants located in the U.S. in a development that could help protect workers from COVID-19, according to Associated Press.

The company plans to initially set up clinics near seven of its plants, including in Storm Lake, Iowa, and Holcomb, Kansas, as part of a pilot program.

The clinics would open early next year, providing primary care to thousands of Tyson workers and their families.

The clinics could also reduce health insurance costs by cutting out unnecessary emergency room visits and helping better manage chronic conditions such as diabetes and obesity.

“Some of our frontline team members aren’t using their health plan benefits, and others don’t seek care until there’s a crisis,” notes Tyson Chief Human Resources Officer Johanna Söderström. “We want to change that by providing access to care that can help detect health conditions early and promote healthy habits,” she adds.

https://seekingalpha.com/news/3611540-clinical-plan-tyson-foods-help-in-covidminus-19-fight

Pfizer announces investor event September 14 & 15

Pfizer (PFE -0.2%) will host its virtual Investor Day on Monday, September 14, from 1:00 pm – 4:00 pm ET and Tuesday, September 15, from 10:00 am – 1:00 pm ET.

Management will present updates on the R&D pipeline with particular emphasis on potential blockbusters expected to launch by 2025.

Speaking at a conference earlier today, CEO Albert Bourla said results from a 30K-subject, late-stage trial of its COVID-19 vaccine candidate BNT162b2 will be available in October. If results are positive, the company plans to immediately file for emergency use authorization with the FDA.

https://seekingalpha.com/news/3611504-pfizer-announces-investor-event-september-14-and-15

Amarin to contest appeals court panel decision on Vascepa patents

Amarin (AMRN -3.7%) is not yet admitting defeat in its patent infringement litigation against would-be generic Vascepa competitors Dr. Reddy’s Laboratories (RDY -0.2%) and Hikma Pharmaceuticals.

Within 30 days, it plans to file a petition for an en banc review of the U.S. Court of Appeals for the Federal Circuit panel decision upholding a Nevada court ruling in favor of the above two generic drug firms. An en banc review allows the full circuit court of 12 judges to potentially overturn a decision from the three-judge panel.

CEO John Thero says, “We are extremely disappointed with today’s ruling and plan to vigorously pursue available remedies. Importantly, we and our partners are continuing to pursue additional regulatory approvals for VASCEPA in China, Europe and the additional countries in the Middle East, and remain confident in the global market potential of VASCEPA. We are particularly excited about the anticipated commercialization opportunities for VASCEPA in Europe as we prepare for expected approval and launch in early 2021. At the same time, we will continue to meet the strong demand for VASCEPA here in the United States through our proven manufacturing capabilities.”

In a statement, Hikma says it received the FDA (conditional) nod in May and is now preparing for commercial launch.

https://seekingalpha.com/news/3611512-amarin-to-contest-appeals-court-panel-decision-on-vascapa-patents