Boxing Day Update

David Ermer–Congress, FDA, OPM, Rx coverage–

Congress is on a State / District work break until January 3, 2023, when the 118th Congress convenes.

Govexec informs us

President Biden on Friday issued an executive order implementing his plan to provide federal civilian employees with an average 4.6% pay raise in January.

As proposed in his fiscal 2023 budget plan last March, the raise provides federal workers with a 4.1% across-the-board raise to basic pay, as well as an average 0.5% increase in locality pay. * * *

The Office of Personnel Management now must publish pay tables outlining the pay raise across all General Schedule pay grades and locality pay areas. Once updated, they will be available on the OPM website. The pay raise will go into effect for the first full pay period of 2023.

From the public health front —

  • The Wall Street Journal spoke with ear, nose, and throat specialists about they treat their own flu and colds.
  • McKinsey Consulting suggests the secret to great health is escaping the healthcare matrix. “The blueprint for achieving a lifetime of great health is increasingly clear and within our control. But unlocking it requires challenging the orthodoxies currently guiding individuals and institutions.”

From the Rx coverage front —

  • The Wall Street Journal delves into health plan strategies for covering million-dollar-plus gene therapies.

A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription. 

Harm Reduction Therapeutics Inc. said its 3 milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. The company said Monday that the FDA gave it a target approval date of April 28. The FDA declined to comment.

HRT said it would give away one-tenth of its product and sell the rest to pharmacies, public-sector employees and groups that work with drug users at-cost, about $18 a dose. HRT said it plans to produce 2 million doses a year.  * * *

Emergent BioSolutions Inc., maker of the Narcan brand of naloxone nasal spray, said earlier this month that its application for over-the-counter status had received an expected approval date of March 29. The company’s two-dose prescription-only nasal spray was selling at pharmacies recently at a cash price of more than $100 without insurance.

Pocket Naloxone Corp. is applying for a nasal-swab version of the drug it said would be cheaper than nasal-spray versions. The startup said earlier this month that it submitted results to the FDA showing that its drug works more quickly than prescription versions. * * *

Other nonprofits are also working to lower drug prices. Civica Rx, a nonprofit founded in 2018, introduced a cancer drug this year with a recommended price of $171 a month versus more than $3,000 a month without discounts for an older version charged to patients on Medicare Part D. Medicines360, a women’s health group, developed a hormonal intrauterine birth-control device it said it sells to safety-net clinics for $100, about a 90% discount.