Inflection Point
If you’re into the IRA, it’s worth carving out a few minutes today to read this white paper from Avalere on the development path of cardiovascular medicines and how that will intersect with the incentives in the IRA.
The upshot is that winning approval for cardiovascular indications is difficult. The research shows the data the demonstrate that trials take a lot longer. They need to enroll more patients and more sites. And, even with all that, the success rates are lower than in other therapeutic areas.
In short, CV drug development is not only risky, it’s risky and expensive.
So what happens when a risky/expensive proposition runs into the IRA’s dictate that pills — and most hearts meds are pills — get slapped with price-controlled prices after only nine years? Avalere, in their typically sober fashion, gives this answer: “this dynamic will likely affect the range of products available on the market and the patient populations they treat.”
The translation: it’s going to be very, very hard for companies to rationalize going after CV indications, especially post-approval. And that’s very, very bad news for the fight against America’s biggest killer.
It’s worth noting that the Avalere work was sponsored by the Partnership to Advance Cardiovascular Health. Turns out, the people on the front lines don’t like the idea of future innovation being taken away, either.
The Arc
It’s impolite to say mean things about Joe Biden’s “Cancer Moonshot,” in part because Biden’s passion for the topic is so genuine and in part because improving survival rates in cancer ought to be a government priority.
But it seems like when I talk to people in the research community, they’re unimpressed. The dollars are too small, there’s not a clear focus on research gaps, it doesn’t seem to be particularly collaborative.
It’s not the best way to get to goal.
And there has been more and more chatter that the Moonshot itself is being undermined by other administration policies, notably the IRA. The future of cancer care will be guided far more by incentives around commercial R&D than it will by small cash infusions by well-meaning bureaucrats.
With that as prologue, a letter to the White House from pharmaceutical company R&D chiefs makes that chatter more concrete.
Industry is worried that the Biden administration is working at cross-purposes with its cancer-fighting goal by pursuing four policies likely to diminish innovation around cancer: the IRA’s small molecule penalty, the IRA’s disincentivizing of post-approval research, threats to roll back accelerated approval, and support for international efforts to roll back IP protections.
(In addition to the letter, PhRMA has a blog post from CEO Steve Ubl and a print ad. Bloomberg has coverage.)
If anything, the letter is a call for collaboration. As the R&D letter puts it, “We, too, are in the business of moonshots.” No one in industry questions that more attention and more money will help. But if policymakers really want to move the needle on cancer, they’re going to have to take counsel from industry, which knows a thing or two about creating breakthroughs.
Quick Turns
A couple of less-quick-than-usual takes this morning:
FIRST:
Joe Biden’s pick to lead the NIH, Monica Bertagnolli, had her day on Capitol Hill, and — as expected — she was peppered with questions about drug-pricing policy from both sides of the aisle during her Senate confirmation hearing
But this is Washington in 2023, so she was well-coached to avoid making any commitments. The Senators got their sound bites, and Bertagnolli checked the box.
Onward.
Sens. Bernie Sanders and Bill Cassidy asked Bertagnolli versions of the same question: will you require that fair-price provisions be included in license deals with the NIH? Sanders wanted a commitment to use fair-price language, Cassidy wanted a promise NOT to use such language.
Here’s Bertagnolli’s response, as captured by STAT: “I myself believe that the American people deserve a fair return on the investment that Congress has placed within the National Institutes of Health and the research that we do, and I will commit to working to make sure that the benefits of our research are affordable and available to all the American people. I cannot give further specifics at this time about the execution of that plan.”
She’s going to do just fine in DC.
SECOND:
Paxlovid, Pfizer’s COVID-19 treatment, will carry a commercial list price of $1,390 per five-day course. The government had been paying $529. No one will pay that $1,390: Pfizer and the government are building out an extensive safety net for the uninsured, and PBMs are already haggling with Pfizer to trade price concessions for access.
Pfizer didn’t show any math, but my suspicion is that Paxlovid looks pretty awesome from a cost-effectiveness standpoint, even at the higher price.
More broadly, though, it’s time to pour one out for the end of an era. For a brief period and for a narrow set of COVID-19-related products, the United States dabbled with a single-payer model. Moving the vaccines and now Paxlovid to the commercial market marks the end of that experiment.
