A Virus Knocked Me for a Loop, So I'm Playing Catch Up

I woke up this morning not feeling myself. Per Binax, I’m technically fine, COVID-wise, but I was still thrown for a loop. I’d intended to take tomorrow off -- there’s a 3:30 a.m. wake-up call involved -- but I fear that if I don’t gather bullet points on what has been quite the day, I’ll be hopelessly behind. 

I’m going to reserve the right to go back at some of the more deserving topics, but wanted to touch as many bases as I could before I return to my sickbed: 

• Joe Biden is going to up the ante on Medicare price controls in the State of the Union speech, according to this White House fact sheet. That means 50 medicines a year, rather than 20, as part of the “negotiation” process. There is also a vague reference to “bringing more drugs into the negotiation process sooner,” which is really the pain point. He wants inflation penalties and the $2,000 out-of-pocket cap to touch the commercial market, too. So if you think the IRA is bad now, know that great forces are working to make it worse. 

• The big mega-oral-argument in four of the IRA lawsuits is tomorrow. Bloomberg has a preview. I’m not expecting fireworks, but I can’t not note the milestone. In other lawsuit news, PhRMA has appealed the ruling in the Texas case, too, but I haven’t read the filing yet. 

• Sanofi dropped its annual “Pricing Principles Report” and it is -- as always -- chock full of good stuff … not only the numbers but some thinking on the company’s policy viewpoints. The topline numbers: list prices rose 4.3% and net prices fell a whopping 15.7%. Discounts and rebates accounted for 46% of net sales. The big net price number is fascinating. Sanofi pegged it to “including dynamics within our insulin portfolio and heightened demand for rebates and fees from health plans and PBMs,” and I have to wonder if the rebate environment around its mega-blockbuster Dupixent played a part. More on this to come. 

• We’ve already discussed the UCB numbers, but the company has distilled all of the value and access figures in a “U.S. Sustainable Access and Pricing Transparency Report.” I’m really glad companies are continuing to push these kinds of efforts.  

• Sen. Elizabeth Warren is worked up about the Flovent authorized generic. While her letter to GSK CEO Emma Walmsley seems to point the finger at the drugmaker, I’m really curious to see what happens when all of the pricing data is in. I don’t think that the prices she’s citing in her letter -- which are, in turn, sourced to media accounts -- really tell the whole story. 

• Enhertu is a kick-ass breast cancer drug that delivers pretty incredible value. So it’s noteworthy that the medicine isn’t being covered in the UK. When industry talks about access challenges in other countries, this is exactly the kind of thing they’re thinking of. Bernie Sanders should have some UK-based patient advocates testify before his committee about what it’s like trying to get access to innovation outside of the United States. 

• There seems to be an effort to turn questions about the impact of the IRA into a binary: either the law is going to wreck innovation or else the effects will be pretty chill. (The latest example is this Endpoints piece about Pfizer.) But reading the actual quotes in Endpoints makes clear that this is a much more fluid situation. The IRA is going to have broad, subtle effects, and trying to paint it in blacks and whites — especially before a single medicine is price-controlled — is a disservice to the conversation. 

• Similar thinking infects this new Health Affairs Forefront piece that looks at venture-funding numbers in hopes of reaching a judgment about the IRA’s impact on innovation. But these are noisy, limited-duration datasets impacted by dozens (hundreds?) of variables. I’m not sure it's fair to draw conclusions, but that doesn’t stop folks from trying. 

• Sen. Bill Cassidy is going to try to stop the Biden administration’s march-in rights effort on a technicality. 

• At some point, I’m going to stop linking to pieces about issues with obesity-med coverage, like this recent effort from WSJ. We’re not getting any closer to having the right kind of dialogue, which is to say: these medicines are great deals, but the budget impact is real. The solution isn’t (or isn’t only) to futz with price. We need to talk priorities and tradeoffs. 

• I feel the same way about Humira biosimilars. This could be a reporter’s whole beat. Instead, we get one-off summaries of the problem without getting close to the bone. That said, that Boston Globe story has one of the great shameless quotes of the year (from PCMA):  “The biggest obstacle to biosimilars reaching their cost savings potential is Big Pharma gaming the patent system to block biosimilar competition, unfairly extending monopolies to keep prices high on brand-name biologics.” I’m not saying that patent games aren’t a legitimate topic. I’m just saying that topic has close to zero to do with the Humira landscape. 

• And, finally, if you only read one deep dive on how broken the 340B program is today, please make it this one, from 46Brooklyn’s Antonio Ciaccia. Antonio’s point is that the 340B program -- like lots of the drug supply chain -- takes money intended for sick people and uses it to feather the nest of the healthy. Dude doesn’t miss. 

I’m sure I’ve missed something -- it’s a drinking-from-a-firehose week -- so shout with omissions or gentle correctives. I’ll be back Friday or Monday, depending on the deluge.