Midweek update

David Ermer–CMS, COVID-19, Rx coverage, U.S. Healthcare–

From the Delta variant front —

The Boston Globe informs us that

U.S. regulators on Wednesday signed off on extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine and said anyone eligible for an extra dose can get a brand different from the one they received initially. * * *

Specifically, the FDA authorized a third Moderna shot for seniors and others at high risk from COVID-19 because of their health problems, jobs or living conditions — six months after their last shot. One big change: Moderna’s booster will be half the dose that’s used for the first two shots, based on company data showing that was plenty to rev up immunity again.

For J&J’s single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months following their initial vaccination.

The FDA rulings differ because the vaccines are made differently, with different dosing schedules — and the J&J vaccine has consistently shown a lower level of effectiveness than either of the two-shot Moderna and Pfizer vaccines.

As for mixing and matching, the FDA said it’s OK to use any brand for the booster regardless of which vaccination people got first. The interchangeability of the shots is expected to speed the booster campaign, particularly in nursing homes and other institutional settings where residents have received different shots over time. * * *

The Food and Drug Administration’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month. But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel Thursday before finalizing official recommendations for who should get boosters and when.

The Wall Street Journal adds that

A panel of outside experts at the FDA is scheduled to review the data [on Pfizer’s modified COVID mRNA vaccine for children ages 5 to 11] Tuesday. Although the agency doesn’t have to follow the group’s recommendation, it typically does. The CDC’s independent advisory committee will meet on Nov. 2-3 to consider the vaccine. 

The White House said the administration has been coordinating with state and local leaders on plans to distribute the vaccines. If authorized, young children would receive two injections of the vaccine, three weeks apart, just like adolescents and adults do but at a lower dosage.

Mr. Zients said the doses will be shipped with all the supplies necessary to administer the shots, including smaller needles. The vaccines will also be shipped in smaller packages containing about 100 doses each, the White House said, and can be stored for up to 10 weeks at standard refrigeration temperatures and for 6 months at ultracold temperatures. * * *

[Furthermore,] the Biden administration is preparing to distribute shots to children at doctors’ offices, pharmacies and schools should federal regulators clear the inoculations for kids ages 5-11.

Also, Govexec reminds us that the Veterans Administration is acting as the guinea pig agency for the President’s vaccine mandate for federal employees. The VA initiated a mandate program while the President was still in the vaccination screening program stage so its discipline deadlines are occurring earlier.

The Veterans Affairs Department has begun disciplining employees who have not proven that they are vaccinated against COVID-19, sending an untold number into counseling following a deadline to turn over their documentation. 

Just 70% of the 380,000 employees at the Veterans Health Administration met the Oct. 18 deadline to show proof of vaccination, VA Secretary Denis McDonough said on Wednesday, leaving 114,000 workers who have yet to do so. VA previously reported that 88% of their health care workforce had said they were vaccinated, but that was based on data from self-reported “attestation forms.” Under stricter guidance the Biden administration has rolled out, VA employees must now submit paperwork to actually demonstrate that they have been inoculated.

From the third quarter financial results department —

Healthcare Dive reports that

  • Anthem’s medical costs during the third quarter beat Wall Street expectations despite the wave of COVID-19 hospitalizations and cases that were fueled by the delta variant during the quarter. The medical cost results are likely to ease investor fears, SVB Leerink analysts said in a Wednesday note.
  • On top of that, Anthem increased medical membership by nearly 6% over the prior-year quarter, ending the period with 45.1 million members. The largest membership gains were recorded in its government book of business, a continuing trend throughout the pandemic.
  • Anthem generated a $1.5 billion profit for the third quarter, a dramatic leap from the prior-year period when net income was $222 million. The payer again hiked its outlook for the remainder of the year on the results released Wednesday.

STAT News tells us that

Biogen made just $300,000 from the Alzheimer’s disease treatment Aduhelm in the first full quarter since its approval, a number far below Wall Street’s expectations and the company’s internal goals.

Aduhelm’s third-quarter sales, disclosed Wednesday, are nowhere near the roughly $14 million analyst consensus estimate, calculated by the investment bank Cowen. Last month, STAT reported that only about 100 patients had received a dose of Aduhelm between its June approval and Sept. 11. The final revenue number suggests Biogen failed to accelerate the drug’s commercial launch.

Also from the Rx coverage front, Fierce Healthcare informs us that

Express Scripts will prefer the first Food and Drug Administration-approved interchangeable biosimilar product, a move it says will lead to millions in savings.

Semglee, which was developed by Viatris, was approved by the FDA in late July. Express Scripts will move the product to its National Preferred Formulary, which reaches 28 million members. By making the change, the pharmacy benefit manager estimates it could achieve $20 million in savings in 2022.

In addition, Express Scripts said Sanofi’s biologic insulin injection Lantus will be excluded from its National Preferred Formulary.

From the reports and studies front

  • The CMS Center for Medicare and Medicaid Innovation issued a strategic plan for its second decade.
  • NCQA and Grantmakers in Health released a valuable report on how federal action is needed to improve race and ethnicity data in federal public health programs such as Medicare and Medicaid.