What I want to know about Aduhelm
It’s been a week since Medicare announced it would only pay for Biogen’s controversial Alzheimer’s drug Aduhelm when patients enrolled in clinical trials, and everything is still crazy.
Here are two of my biggest questions about the impact of the decision:
How the heck does this impact patients, especially those who want to start the drug now?
Aduhelm is a drug patients, hypothetically, take each month for the rest of their life. It takes months for a patient to even begin getting the highest dose of the drug. So what happens if someone wants to start the drug now, before CMS hypothetically finalizes its coverage decision in April? Will doctors stop prescribing the drug now out of fear that patients won’t be able to afford it come April?
I posed that question to Dr. Jeff Gelblum, a private practice neurologist who says he’s treating roughly 80 people with the drug. He told me he isn’t turning people away, but he is warning them that the drug might not be covered come April and the patient may have to stop treatment, or start paying out of pocket.
“We are letting them know, we will do everything possible to make sure that this product is covered and to get you the medicine, but we cannot guarantee going forward after April that any of this is going to be covered,'' Gelblum said. “It’s a catastrophe, as far as I’m concerned.”
It’s also unclear if these patients would be able to enroll in Biogen’s patient access program, which provides the drug for free. A spokesperson told STAT “Biogen’s patient assistance programs are continuing for eligible patients” but did not specify how long a patient can stay on that program.
There’s also the question of how much Medicare patients would pay for the drug. No one has a good answer to that question, my colleague Rachel Cohrs reports.
How will opponents try to stop this?
There’s no doubt that pharmaceutical companies and patient advocates will flood CMS with comments urging them to rethink their approach – Biogen has already pledged to do exactly that. But I’m curious what else drug makers and patient groups will do to ratchet up the pressure on CMS, like pushing legislation to crack down on CMS authority.
The most obvious play is to use Congress to ratchet up the pressure.
Russ Paulsen, the CEO of UsAgainstAlzheimer's, told STAT his group "will be making sure that Congress understands just how unprecedented this proposed decision is." There’s also already one piece of legislation that could have a new life breathed into it thanks to CMS’ decision. That bill, the NOVEL Act, would mandate that any so-called coverage with evidence development decision, like the one that applies to Aduhelm, sunsets after four years.
Drug industry lobbyists who spoke with me were torn about the idea of pushing legislation. Some agreed that a legislative fix was necessary while others insisted asking Congress for anything could backfire, given the recent efforts to crack down on drug prices.
Here’s a few more Aduhelm stories worth your time:
Medicare’s Aduhelm decision has reignited a debate over racial inequity in Alzheimer’s care.
Biogen is trying to stem the controversy over Aduhelm by shopping for a company to acquire.
The biggest losers of Medicare’s decision might be Biogen’s competitors.
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