Top of the Funnel, MACRO & EARNINGS
MRNA. Moderna beat the street but I have a few questions. First, they reported a 48% market share for the 2023-24 season. The CDC has reported about 25M cumulative doses for adults 18 and over from the first of October through December 31m, which suggests MRNA was responsible for about 12M shots. At list price, of ~130 that should translate into about 1.5B. Is the rest accounted for by rebates and other discounts?
The company is completed levered to the mRNA platform which is the subject of some concern by researchers, foreign governments, and state governors. (see below). Few products we can think of have received such negative attention. Yet, the street is not the least bit curious about the risk of regulatory action.
CONGRESS.
Another Way to Reduce the Deficit. Given Americans’ ambivalence about their federal elected officials that yields bare majorities in each house, the FY 2024 budget process is understandable stalled.
There is a possibility Congress approves something before the March 1 deadline for the Food and Drug Administration and March 8 for Health and Human Services but it isn’t likely.
Instead, there is an undertow of capitulation that seems to be recognizing that a FY 2024 budget is not going to happen. Departments, unless there are supplemental instructions, will be funded at FY 2023 levels. In effect, a budget cut.
I would not hold out too much hope for FY 2025 as the budget agreement would need to be reached this fall, in the heat of an election. In fact, the House Freedom Caucus has proposed, absent any policy riders, a year-long CR. That would trigger spending cuts for discretionary domestic programs like NIH.
Another AI Committee. House Speaker Mike Johnson has formed a bipartisan task force charged with producing policy proposals for governing artificial intelligence.
The crux of the problem and the one this task force hopes to work out is a disagreement on whether AI and AI-like technologies can be regulated under existing authorities or are additional permissions required.
Good Luck With That. House and Senate Democrats have sent a letter to UHG demanding that insurers demanding that insurers cover FDA-approved contraceptives without cost-sharing, using the therapeutic-equivalent standard.
Oversight Committees have claimed that insurers have refused to cover certain products or have applied certain Utilization Management practices.
WHITE HOUSE.
Prior Authorization for ASCs. I would not imagine that Ambulatory Surgery Centers would be the focus of anti-fraud efforts but CMS put a request for information on a demonstration directed at prior authorization of ASC services.
They are using what is called Section 402 authority which is a fraud-fighting part of the law. It will be interesting what they turn up.
OTHER STUFF.
Global Vaccine Data Network Study. Making the rounds is an observational study of 99 million people that received with one of the COVID vaccines. The study confirmed the previously established safety signals for myocarditis, pericarditis, Guillain-Barre syndrome and cerebral venous sinus thrombosis. Additionally, it picked up a safety signal for acute disseminated encephalomyelitis associated with the MRNA vaccine.
Comparative Efficacy and Safety Study. Another journal article reporting on a meta-analysis of PIII trials concluded that the 22 vaccines reviewed in 25 studies were all about the same in terms of efficacy. However, mRNA vaccines were inferior in their safety profile.
The ongoing worry here is that more and more studies are turning up problems while very little research is affirming the FDA's approval. The required post-market report on cardiac adverse events has yet to be released by the FDA.
Have a great weekend.
Emily Evans
Managing Director – Health Policy
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