Today in Apex:
Leading: The White House promotes a cause and a treatment for autism, and the shoddy science immediately gets attacked
Looking: Injected versions of cancer drugs deliver value, but that’s not enough to silence critics
Surfacing: The chatter around efforts to move away from the “Big 3” PBMs gets a little louder
Resourcing: The IRA litigation tracker gets an update as we move toward the resolution of the final remaining cases
INFLECTION POINT/ The Reviews on the Autism Announcement Are In: ‘Junk Science,’ ‘Not Backed by Science,’ ‘Unfounded’
Yesterday’s White House announcement on autism marked a terrible day for science. But it was a pretty good day for journalism, as reporters leaned into the facts to fight back. Here’s a selection of the headlines, all of which nail the takeaway of the event:
Bloomberg (🎁): Trump’s Tylenol Briefing Peddled Junk Science
As a rule of thumb, you should read everything written by STAT’s Matt Herper. He has a great wrap-up on the science here. Also solid was the NYT fact check of the event.
The other piece worth reading is STAT’s story on the effort to push changes to the FDA status of leucovorin, which is a bit more subtle (and lengthy) a process than was presented in a lot of the coverage.
THE ARC/ Injectable Versions of Infused Drugs Deliver Value, But Payer Pushback Remains
On Friday, Merck won approval for a subcutaneous version of Keytruda. It’s the latest in a string of medicines that have been reformulated to be more convenient.
But “more convenient” really doesn’t do the idea justice. Yes, injections are quicker than infusions, but they can also change where the treatment is given, freeing patients (and providers!) from having to deal with infusion centers, where scheduling and chair availability add another layer of complexity.
The data is pretty solid that moving to an injected option drives higher value, both in terms of health system savings and in terms of patient preference, productivity, and quality of life. Here’s what the most exhaustive look at the topic concluded:
SC administration was associated with savings in HCP time and patient chair time. Direct and indirect cost-savings were also observed. Increased treatment satisfaction and patient/HCP preference was reported with SC administration, as was improved caregiver productivity.
And given that the two versions are generally priced the same, it’s clear, from a value POV, where the market should be headed.
And yet there’s a push to limit the use of the injected version, which is spelled out in this New York Times piece (🎁). The logic goes like this: The infused version of these medicines will go biosimilar before the injected versions face competition, so the best way to keep costs down is to never transition patients to injected versions.
Just pretend like the innovation doesn’t exist and wait for the loss of exclusivity.
To be clear, there are now no biosimilar versions of any of these medicines. And there won’t be for years. But out of a sense of pre-emptive cost control, there are efforts to limit access to injected medicines baked into formulary design.
Certainly, the value conversation will be different in the presence of lower-cost options. When that day comes, economists will be able to look at the cost differential and decide if it’s large enough to swamp the value of the more-convenient treatment.
But that day isn’t here yet. And, in the meantime, there is an option that will save everyone -- especially patients -- time and money … if the PBMs allow it.
QUICK TURNS/ Projecting the Impact of Tariffs on India, PCMA Readies a Low-Wattage Ad Campaign
Bloomberg ran the numbers (🎁) on the kinds of generic meds most likely to be impacted by tariffs out of India. Nearly two-thirds of the birth control market could be affected, along with more than 50% of hypertension and depression meds.
The PBM lobby is launching an ad campaign to take some shots at the pharmaceutical industry, per Politico. Two reasons that I don’t find this compelling. First, it’s being billed as a “six-figure” campaign, which is peanuts. Second, here’s a snippet of the canned quote from PCMA’s head, JC Scott: “[manufacturers] alone set and raise the sticker prices …”
No one who is seriously engaged in this conversation thinks that sticker prices are the core issue with drug prices, and trying to shift the debate in that direction might be good politics, but it’s not good for solving the problem.
I generally think the narrative that employers are fleeing the “Big 3” PBMs is overblown (or, perhaps, premature), despite articles like this one from Healthcare Brew suggesting that employers have had it with the old model. On the flip side, there is some evidence that the general frustration with big PBMs is driving some change, with this move in Louisiana as the most recent example.
Antonio Ciaccia and the team over at 46Brooklyn published a semi-regular update on drug pricing trends. Brand-name list-pricing moves seem pretty much in line with last year, but generics -- bucking historical norms -- seem to be increasing in price in ways that sparked Antonio to do a much more in-depth take.
Congrats to A.J. Loiacono and the crew at CapitalRx (to be known, going forward, as Judi Health) for another big capital raise. A.J. has done a ton to enable the transition to a transparent PBM model, and he has his sights set even higher. Forbes.com has the details.
I’ve updated the Apex | IRA Lawsuits Tracker. The government filing is now in on the PhRMA appeal, though I don’t think it received any coverage. PhRMA will get one more brief, and then it’s an oral argument in two weeks before the Fifth Circuit. I’m assuming we’ll get a decision in the Novo Nordisk case (Third Circuit) in the next little bit, too.
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