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Somewhere, probably in a shoebox in my basement, is a photo of me shaking Jimmy Carter’s hand back in 1996. It was a big year for me and President Carter: I’d taken a class from him at Emory, and I’d had the opportunity to attend a small dinner with Carter ahead of his annual town-hall meeting with the university’s students.
At the time, Carter was excited about global public health, and he spoke to students often about one of the signature efforts of his nonprofit, the Carter Center, that was really hitting its stride: the river blindness elimination program.
In Carter’s telling, river blindness, or onchocerciasis, was clinically simple but logistically hard. We had a great treatment — ivermectin — but not great ways of getting it to where it was needed the most.
Thanks for pharma. access to the treatment has not been an issue: Merck has, over the course of decades, donated half a billion doses of the medicine. And the Carter Center made sure that the ivermectin made it to those who needed it most.
While the program has been touted by the Carter Center and Merck through the years, it never lodged in the public consciousness. And that’s too bad: it’s exactly the kind of thing that should be celebrated and held as a model for how pharmaceutical companies can (and often do!) have a broader impact.
So I’m taking a moment to not only mourn President Carter’s passing, but also reflect on what he has done in the service of — and what he has taught us about — global public health.
The problem with 340B is that everyone wants to get into the weeds, right away. And there are a lot of weeds: Duplicative discounts! Contract pharmacies! Hospital viability! The definition of “patient”!**
So at the end of the day, proponents of 304B reform probably need to back-burner a lot of important-but-complex arguments and go for a minimum viable explanation of the issue. I’d suggest there are three components:
This is a huge program.
It’s rife with abuse.
There is very, very little oversight.
If you can get a policymaker bought into those three statements, the battle is 90% won.***
The first statement ought to be self-evident. This is an objective fact.
Statements 2 and 3 are a little tougher, because it feels like those are squishier and more subjective.
That’s why the biggest news over the Christmas week was a lawsuit filed by Amgen, Lilly, and UCB against HRSA, the government agency that oversees 340B. (Endpoints was, I think, the only outlet to write a story.)
The suit centers around a provider called Sagebrush. It’s out in Nevada, and it’s a 340B covered entity because, among other services, it receives CDC funding as an STD clinic, which qualifies it for 340B pricing. That’s all well and good, as far as it goes.
But Sagebrush has allegedly abused its 340B status by roping in other providers, naming them “subgrantees” that are, therefore, also eligible for 340B pricing.
But these 340B grantees — for-profit physician practices — appear to have nothing to do with Sagebrush and, beyond passing out STD information or condoms, are not remotely STD-focused. Most of them treat cancer and rheumatoid arthritis.
At yet these subgrantees have made millions off of 340B meds (again: not STD drugs, but mostly cancer meds and antiinflammatories).
So Amgen, Lilly, and UCB have called out HRSA, asking them to step in and end the farce.
As always, I’m reticent to weigh in on the legal element here. But from a communications POV, this is gold for the forces of reform, because it really nails the “rife with abuse” and “very, very little oversight” points.
I cannot imagine that any group representing covered entities is ready to defend the idea that 340B pricing should be available to rando private practices. This feels like the classic definition of “abuse.”
And HRSA was made aware of Sagebrush back in March, per the lawsuit, and the agency refused to meet with Lilly on the topic in May. Lilly followed up again in August and received a polite “we’re looking into this,” followed by … nothing.
The Sagebrush saga might not get to the hot-button issues around 340B, but — in some ways — it’s a critical new front in the argument around the program that underscores the utter lack of oversight.
** Let’s be honest: if the average American learns that “the definition of a patient” is a legitimate dispute in 340B, their brains are going to shut off. It is a blinking signal that the whole thing is a silly, internecine dispute that most people would be well served by tuning out. It’s not “it depends what the meaning of ‘is’ is,” but it’s close.
*** j/k: The battle would be like 30% won. The details do matter a lot here, but we can’t get there until the foundation is laid.
The sharp eyes at No Patient Left Behind spotted a new policy from Independence Blue Cross — one of the Blues serving Pennsylvania — that refuses to cover medicines approved under Accelerated Approval for 18 months. That means at least one payer, when considering revolutionary products that have been fast-tracked for approval to ensure they made it to patients ASAP, will slow-walk reimbursement of some of the most novel treatments out there.
This is a fascinating NEJM piece that suggests that the solution to the government’s effort to stamp out hep C is not spending heavy on the existing HCV workhorses but rather finding a way to leverage the also-ran medicines to plug gaps in access.
David Wainer’s WSJ column on the future of PBM reform today is worth the read. His take is that legislative action is almost inevitable, but those expecting it to cripple the industry are overstating the impact of the proposed changes.
I like good news, and this Thorax paper showing a fairly compelling drop in cost-related nonadherence in adults with asthma is encouraging. There’s not much theorizing on the cause here: the authors float, but don’t test, the idea that it’s because of better coverage post-Affordable Care Act.
Over the next 10 days, we’re going to get a thousand pieces about the $2,000 out-of-pocket cap in Medicare kicking in. I won’t link to them all, but NBC News beat the rush and already has their take out there.
Header image via Flickr user Chupacabra Viranesque.
Cost Curve is produced by Reid Strategic, a consultancy that helps companies and organizations in life sciences communicate more clearly and more loudly about issues of value, access, and pricing. We offer a range of services, from strategic planning to tactical execution, designed to shatter the complexity that hampers constructive conversations.
To learn more about how Reid Strategic can help you, email Brian Reid at brian@reidstrategic.com.
