It’s the Friday of Memorial Day weekend, let’s blow this pop (pup?) stand.
I’m playing with the format of these posts so let me know what you think. The aim is to be more of a newsletter than a blog, but still give you everything you need to know in just a few minutes a week.
Caught my Eye
Actions, not Words. Despite repeatedly saying that there would not be cuts to Medicaid, the House bill has cuts to Medicaid. It is estimated that 8.7 million beneficiaries would lose coverage. Next up — the Senate.
Mother May I? Last year some pharmaceutical manufacturers attempted to move to a rebate model for 340B where hospitals would provide data before the manufacturer provided the discount. Hospitals did not like that. To be fair, I bet manufacturers would prefer a clean process where there were no double-discounts and they could check the claims data easily, but we are where we are. Late last week, the U.S. District Court for DC ruled that pharmaceutical manufacturers may not unilaterally implement rebate models in the 340B program without approval from the Health Resources and Services Administration (HRSA.) Open question as to whether HRSA will grant that approval.
Some Good News. A good friend was taking care of her mom with Alzheimer’s and her mom remembered me and was so excited that my friend knew me, all while having no idea that she was talking to her daughter. Alzheimer’s is awful that way. But I’m hoping things will be better in the future. The Food and Drug Administration (FDA) gave approval (gift link) to a blood test that can help diagnose Alzheimer’s disease. The test is for people 55 and over who are already experiencing cognitive decline. I think we’re moving toward a place where Alzheimer’s, while scary, will be an earlier diagnosis with more hope. There are survey results show patients want to know if they have Alzheimer’s and a move toward talking about brain health and even earlier screening screening. I feel optimistic about the future here.
Rx for All. Governor Wes Moore signed into law legislation that would expand the reach of the state’s prescription drug affordability board (PDAB) to all Maryland residents, not just those employed by the state.
No Moosin’ Around. The FDA said it is making enhancements to help states import drugs from Canada. While the waiver pathway was established during Trump’s first term, no state has successfully implemented large scale importation. It is unclear how this would work given Canadian’s historic opposition to importation much less with the current political climate where they aren’t even willing to buy our bourbon.
Reviewing the Fundamentals – MFN Next Steps
This week the Department of Health and Human Services provided a statement with a little more information on implementation of the Most Favored Nation Executive Order. If you’re just catching up with MFN, I liked this Wash Post piece.
So, we know two more things –
- It is envisioned as applying for all branded products across all markets (Medicare, Medicaid, etc.) that do not currently have generic or biosimilar competition with the lowest price of a set of economic peer countries
and
2. The MFN target price is the lowest price in an OECD country with a GDP per capita of at least 60 percent of the U.S. GDP per capita.
This barely scratches the surface in terms of things we’d need to know to implement something, even if we wanted to. Which, no one should want to because the whole thing is unenforceable. At least for now.
That being said, I think it makes sense for pharmaceutical manufacturers to look under the hood and see what OECD countries they might be selling in and what their prices are in those countries.
Let’s pause and review. The OECD is the Organisation for Economic Co-operation and Development (OECD), an international organization comprising 38 member countries. The core mission of the OECD is to promote policies that improve the economic and social well-being of people worldwide.
And if you’re trying to figure out which OECD countries to include, you’d have to figure out which ones qualify as having 60% of the U.S. GDP. There are lots of sources for the data but one of the questions is whether you consider Purchasing Power Parity (PPP). PPP is an economic theory that compares the relative value of currencies by examining the cost of a “basket of goods and services” in different countries.
I used the CIA World Factbook Data (which uses PPP) and I created a table of the countries I think will be included (see below.) Time to start digging! And don’t forget that even if your company licenses out the global sales, it still likely counts.
For the Files
The Kaiser Family Foundation (KFF) has a nice tracker of the reconciliation bill against current law. And, in usual KFF style, easy to read.
