The Remaining Leqembi Question: Will Sales Be Gargantuan or Merely Big

There is an unofficial rule at the Curve that when the Big Four -- WSJ, NYT, WaPo and AP -- all cover a biopharma story, I pretty much have to talk about it.

So even though the Leqembi full approval was not a surprise, and even though the implications of the decision have been clear for some time, it’s still worth a spotlight.

The fact of the case are well understood: the FDA granted full approval based on robust, outcomes-based efficacy data, CMS now has to reimburse (though patients data will have to be captured in a registry), the clinical impact is likely to be somewhat modest, there are some safety concerns, there are a lot of patients with Alzheimer’s.

The great unknown is how Leqembi will fare in the market. There seem to be two competing theories.

Theory One is that everyone is going to want this med for their partner/parent/etc., and that it doesn’t require a big share of the 6.7 million Alzheimer’s patients population to create serious budget impact.

KFF has done the math, and taking 10% of the Alzheimer’s population would translate into a hit of more than $17 billion for Medicare Part B. That would be an economic earthquake. For contrast, the highest-spend drug in Part B right now -- Keytruda -- accounts for $4 billion in Part B spending.

Theory Two -- the one pushed by the Eisai -- is that they’ll hit 100,000 patients by year three, which would be a budgetary hit of a little shy of $3 billion. That’s impressive, but it wouldn’t have a dramatic impact on Medicare.

Still, there are a lot of X factors.

The Wall Street Journal noted that there’s already a neurologist shortage that will constrain usage, and thought leaders in the area are sounding cautious notes. There will likely be a competitor from Lilly on the market by this time next year. And, at some point, data from the registry will impact growth, positively or negatively, based on a better understanding of safety and efficacy.

And I’m always thinking about IQVIA’s estimate that more than half of brands miss their first-year forecast, so a little cynicism about giant budget impact may be warranted.

If I had to bet, I’d bet on Theory Two.

• I really like this Consumer Reports service-journalism wrap of all of the ways that consumers can try to reduce their drug bill. It’s not perfectly comprehensive, but, pound-for-pound, it’s damn good advice.

• RxBenefits has a resource out called “Everything you need to know about 340B in 2023,” which seems like a pretty grandiose headline, but -- you know what -- it comes pretty close to paying off that hed. Nice overview.

• I mentioned that No Patients Left Behind and NPC had put some objections to ICER’s new value framework on the record. Via Endpoints, I learned that Amgen has its issues with ICER as well.

• The IRA’s out-of-pocket cap in Part D doesn’t get a ton of attention compared with the price-control parts of the law, but it’s likely to have a fairly dramatic impact, albeit for a small percentage of the population. The latest evidence of this comes from an assessment of prostate cancer treatments, with an article in Urology Practice concluding that, for three branded, oral therapies for prostate cancer, patients will save about $9,000 a year in out of pocket costs.

• While the legislative debate over PBM reform still piques my interest, I find the advertising battle less and less compelling. So you can skip the KFF coverage today (especially if you read the better story from STAT yesterday). And I’m even having a hard time getting into the latest twist, broken by Fox today, that Citizens Against Government Waste is wading into the battle on the side of the PBMs with a “multimillion-dollar” campaign that argues that any assault on PBMs paves the road to socialized medicine.

• Medscape is calling prior authorization “psychological warfare.”

• The Alliance for Regenerative Medicine said that a new, pan-European HTA slated to go into effect in 2025 would have rejected 90% of the cell and gene therapies now on the market in Europe. The ARM release hit three weeks ago, but I didn’t see it until an Endpoints story published this week.