It is a dumb bucket list thing but one day I will go experience the Groundhog Day festivities. Dream big, I know.
Cell and Gene Update. This week the Centers for Medicare and Medicaid Innovation (CMMI) released the Cell and Gene Therapy (CGT) Access model which will initially focus on sickle cell disease. It is a voluntary model that allows the Centers for Medicare & Medicaid Services to negotiate multi-state, outcomes-based agreements on behalf of Medicaid. CMS is looking for state letters of intent by April 1 and will send applicable manufacturers information in the spring. Criticism of the model has been that there aren’t a lot of details. My bigger concern? I wonder about the goal of reducing healthcare utilization and expenditures. These treatments are really expensive ($3m) and so a goal about saving money seems beyond the point, it should be value and efficiency. Are the people who are getting the drug benefiting from it? Then again, I feel that way about most CMMI work – a more efficient, effective system should be the goal of their efforts. If later it turns out to save money when rolled out in a bigger way, awesome.
On the Docket. The lawsuits by pharmaceutical manufacturers against the Inflation Reduction Act aren’t going well. My hope was in the AstraZeneca one because it used slightly different logic (not a first amendment argument) but definition of a single source drug and the bona fide marketing standard for generic drugs. It also used Fifth amendment – taking of property. Based on media reports by Bloomberg and Stat, it didn’t go well. “You’re free to do what you want. You just might not make as much money.” just doesn’t have a good ring to it. Can you imagine if manufacturers pulled out of all government markets? That wouldn’t be good for patients either. AstraZeneca asked for a judgement by March 1, right before their counteroffer on Farxiga is due.
Case Study. Novo Nordisk decided to discontinue their insulin Levemir in the United States after announcing last year that they were cutting its price. The company said that a variety of factors let to the discontinuation including limited formulary access, global manufacturing constraints and the fact that there are other forms of insulin. A polite way of saying ROI not there.
Speaking of ROI. The Congressional Budget Office (CBO) is responsible for modeling the impact of legislation for Congress. But what if they get it wrong?No Patient Left behind has a great letter how the Inflation Reduction Act (IRA) hurts small molecule development by offering 9 years before negotiation compared to 13 years for large molecules. And the thing about innovation is that it requires investment and investment requires the promise (or at least strong hope) of a return on that investment. Sure you could say this is whining by manufacturers but the letter was also signed by a LOT of investors. No Patient Left behind is calling for CBO to improve its modeling and for Congress to require equity at 13 years for small molecule drugs.
Slow like a Terrapin. The Maryland Prescription Drug Affordability board met this week and started gathering data about which drugs should undergo cost reduction efforts. They are working off a list of National Drug Codes and hope to whittle down the list to what is “unaffordable” by the Fall. The initial list of 2000 drugs is not available to the public.
Planning ahead. I liked this list of the top 10 most anticipated drug launches for 2024.
Ins and Outs. The Commonwealth Fund created their own list of issues to watch. A little light but it is an election year so maybe everyone else is just optimistic.
Woof. Those pandemic dogs don’t like return to work either? Dog bites led to almost 50,000 emergency room visits in 2022, the highest in 18 years.