Aduhelm and Medicare
January 12, 2022 9:24 AM Subscribe
Derek Lowe on the Centers for Medicare and Medicaid Services' decision to not pay for the controversial Alzheimer's drug Aduhelm except for use during a clinical trial:
PhRMA should want drugs that work; instead, they're coming out in favor of drugs that are approved and are reimbursed by insurance, and Aduhelm is evidence that those categories are not the same. I wish they were. I wish a lot of things.
Aduhelm previously: 1, 2
Aduhelm previously: 1, 2
A relative of mine who had a terminal illness was given a faint glimmer of hope with a newly approved drug. This is how I remember it playing out:
Doctor: There's a new drug that's just been approved and I think you might benefit from it.
[Several months later]
Doctor: I'm a little concerned about this new drug. Several people have died, but they were taking much higher doses. I'm going to monitor the situation.
[A few more months]
Doctor: Unfortunately it doesn't look good for new drug, and I'm taking you off it.
[One year later]
The drug company sends a promotional pamphlet directly to my relative asking them to ask their doctor about the drug. The only way they could have gotten that address was from their shipping department since the drug was being purchased through their financial aid program because it was so new and expensive. The doctor was infuriated by this and said he'd "have a strong word" with the pharmaceutical rep.
Then my relative passed away. And a year after that, the pharmaceutical company AGAIN sent them another promotional pamphlet asking them to ask their doctor about this drug.
posted by RonButNotStupid at 10:23 AM on January 12, 2022 [14 favorites]
Doctor: There's a new drug that's just been approved and I think you might benefit from it.
[Several months later]
Doctor: I'm a little concerned about this new drug. Several people have died, but they were taking much higher doses. I'm going to monitor the situation.
[A few more months]
Doctor: Unfortunately it doesn't look good for new drug, and I'm taking you off it.
[One year later]
The drug company sends a promotional pamphlet directly to my relative asking them to ask their doctor about the drug. The only way they could have gotten that address was from their shipping department since the drug was being purchased through their financial aid program because it was so new and expensive. The doctor was infuriated by this and said he'd "have a strong word" with the pharmaceutical rep.
Then my relative passed away. And a year after that, the pharmaceutical company AGAIN sent them another promotional pamphlet asking them to ask their doctor about this drug.
posted by RonButNotStupid at 10:23 AM on January 12, 2022 [14 favorites]
Also, the "ask your doctor about" loophole to the otherwise-sensible ban on advertising prescription drugs needs to be closed, and pronto.
posted by Gelatin at 10:37 AM on January 12, 2022 [30 favorites]
posted by Gelatin at 10:37 AM on January 12, 2022 [30 favorites]
There's not so much a ban on advertising prescription drugs in the US. The rule is, if you advertise the on-label use, you have to present a fair and balanced explanation of the potential downsides of the drug, too. This is what leads to the very long side effects descriptions that alternate between humorous and terrifying, depending on your perspective.
By not discussing the benefits, then there is no need to discuss the side effects, either, as that is also considered fair and balanced. These are the 'ask your doctor' style ads
The US and New Zealand are the only two countries where DTC advertising of prescription medication is allowed. Other countries allow for non-branded consumer advertising campaigns focused on a specific disease or condition, rather than a specific treatment. Sort of an 'awareness' type of approach.
Further reading from FDA on 'fair and balanced.'
More FDA info on DTC advertising overall.
posted by jordantwodelta at 10:55 AM on January 12, 2022 [24 favorites]
By not discussing the benefits, then there is no need to discuss the side effects, either, as that is also considered fair and balanced. These are the 'ask your doctor' style ads
The US and New Zealand are the only two countries where DTC advertising of prescription medication is allowed. Other countries allow for non-branded consumer advertising campaigns focused on a specific disease or condition, rather than a specific treatment. Sort of an 'awareness' type of approach.
Further reading from FDA on 'fair and balanced.'
More FDA info on DTC advertising overall.
posted by jordantwodelta at 10:55 AM on January 12, 2022 [24 favorites]
I have to wonder how many people who think Medicare should pay for this drug are rejecting the vaccines because they aren't proven, were rushed through, they don't know what's in them, etc.
That said, people who are feeling desperate about illness really, really want something to work. I notice this a lot on the support board I'm on for multiple myeloma, a cancer currently considered incurable. Again and again, I see people who seem to think clinical trials mean access to "the secret drug they don't want you to know about" rather than, you know, a trial of something that may or may not work and that also might kill you. And I've also seen people cheer when a drug is approved with what seems to me a very limited benefit - like something that is shown to extend survival for less than six months. But it's hard to try to look at drugs dispassionately when you or someone you love is suffering.
A friend of mine is suffering from dementia at a comparatively young age, and it's heartbreaking to watch his deterioration, so I get the desperation. And I will once again recommend the documentary "How to Survive a Plague" about the early days of the AIDS epidemic. You can see how the activists' understandable desperation and the FDA's wanting to wait for proof of efficacy played out.
posted by FencingGal at 11:07 AM on January 12, 2022 [14 favorites]
That said, people who are feeling desperate about illness really, really want something to work. I notice this a lot on the support board I'm on for multiple myeloma, a cancer currently considered incurable. Again and again, I see people who seem to think clinical trials mean access to "the secret drug they don't want you to know about" rather than, you know, a trial of something that may or may not work and that also might kill you. And I've also seen people cheer when a drug is approved with what seems to me a very limited benefit - like something that is shown to extend survival for less than six months. But it's hard to try to look at drugs dispassionately when you or someone you love is suffering.
A friend of mine is suffering from dementia at a comparatively young age, and it's heartbreaking to watch his deterioration, so I get the desperation. And I will once again recommend the documentary "How to Survive a Plague" about the early days of the AIDS epidemic. You can see how the activists' understandable desperation and the FDA's wanting to wait for proof of efficacy played out.
posted by FencingGal at 11:07 AM on January 12, 2022 [14 favorites]
Good.
posted by lalochezia at 11:32 AM on January 12, 2022 [1 favorite]
posted by lalochezia at 11:32 AM on January 12, 2022 [1 favorite]
They do things that are so wildly cruel & inhumane and things that make sense and are correct in seemingly equal measure, and when we yell really hard sometimes they listen, so it's really hard to figure out what they're doing and what we should be doing from one minute to the next.
posted by bleep at 11:42 AM on January 12, 2022 [5 favorites]
posted by bleep at 11:42 AM on January 12, 2022 [5 favorites]
Just to add a little more background to my earlier comment. The fact that the new drug didn't work was disappointing and disheartening, but that kind of took a back seat to the anger over the pharmaceutical directly contacting my relative to "suggest" they take it again.
It was an expensive drug. Not as expensive as some ludicrously expensive drugs, but yearly retail costs were almost six figures. I can only imagine a big part of the pharmaceutical company's "we'll help you pay for it" program was to get the drug out there in as many people as possible so soon after it had been approved in the hopes of attracting attention. We also knew from the doctor who had initially prescribed it that the safety/efficacy of the drug was being reviewed and that's exactly why he took my relative off it. It was pretty clear from our perspective that someone at the company went down the list of people they had been shipping the drug to and ran that list over to the marketing department.....TWICE!
posted by RonButNotStupid at 1:05 PM on January 12, 2022
It was an expensive drug. Not as expensive as some ludicrously expensive drugs, but yearly retail costs were almost six figures. I can only imagine a big part of the pharmaceutical company's "we'll help you pay for it" program was to get the drug out there in as many people as possible so soon after it had been approved in the hopes of attracting attention. We also knew from the doctor who had initially prescribed it that the safety/efficacy of the drug was being reviewed and that's exactly why he took my relative off it. It was pretty clear from our perspective that someone at the company went down the list of people they had been shipping the drug to and ran that list over to the marketing department.....TWICE!
posted by RonButNotStupid at 1:05 PM on January 12, 2022
Would love to see pharma goons have to address why, if the drug actually worked and was worth what they're charging, essentially nobody would pay out of pocket. Certainly many couldn't afford it if they wanted to (which is part of the point), but there are plenty of people who could afford it and I guarantee are not going to seek it.
posted by a robot made out of meat at 1:59 PM on January 12, 2022
posted by a robot made out of meat at 1:59 PM on January 12, 2022
I can only imagine a big part of the pharmaceutical company's "we'll help you pay for it" program was to get the drug out there in as many people as possible so soon after it had been approved in the hopes of attracting attention.
Wrong grift; it's not really a product awareness marketing push where the coupon tracks advertising effectiveness. It's to unwind the effects of copays. When a drug is expensive, insurance asks the patient to cover some of the bill. And if the drug isn't effective, or isn't any better than a cheaper alternative, the copay is often sufficient to convince the patient stop filling / making claims.
Hence the 'coupon' programs to help customers buy expensive drugs that don't even work. Giving a huge consumer discount doesn't matter if you can raise reimbursement prices.
posted by pwnguin at 2:47 PM on January 12, 2022 [4 favorites]
Wrong grift; it's not really a product awareness marketing push where the coupon tracks advertising effectiveness. It's to unwind the effects of copays. When a drug is expensive, insurance asks the patient to cover some of the bill. And if the drug isn't effective, or isn't any better than a cheaper alternative, the copay is often sufficient to convince the patient stop filling / making claims.
Hence the 'coupon' programs to help customers buy expensive drugs that don't even work. Giving a huge consumer discount doesn't matter if you can raise reimbursement prices.
posted by pwnguin at 2:47 PM on January 12, 2022 [4 favorites]
And I've also seen people cheer when a drug is approved with what seems to me a very limited benefit - like something that is shown to extend survival for less than six months.
I suspect being on a multiple myeloma support board you don’t need or want me to explain a whole lot but I lost a family member with multiple myeloma fairly recently and he had lived for eight years after diagnosis riding the pipeline of new treatments so I’d suggest that “six months (on average) is a very limited benefit” might not be the way to think about treatments for a disease like that, where incremental advances have added up to legitimately quite improved medium-term prospects for many patients compared to what the diagnosis used to represent, even though it’s still ultimately incurable. It’s a little different from Alzheimer’s, in which there’s really been nothing shown to slow the actual mechanisms of disease progression.
The one treatment he received that was actually a clinical trial didn’t work or perhaps was too late, though. It was the last one.
posted by atoxyl at 4:59 PM on January 12, 2022
I suspect being on a multiple myeloma support board you don’t need or want me to explain a whole lot but I lost a family member with multiple myeloma fairly recently and he had lived for eight years after diagnosis riding the pipeline of new treatments so I’d suggest that “six months (on average) is a very limited benefit” might not be the way to think about treatments for a disease like that, where incremental advances have added up to legitimately quite improved medium-term prospects for many patients compared to what the diagnosis used to represent, even though it’s still ultimately incurable. It’s a little different from Alzheimer’s, in which there’s really been nothing shown to slow the actual mechanisms of disease progression.
The one treatment he received that was actually a clinical trial didn’t work or perhaps was too late, though. It was the last one.
posted by atoxyl at 4:59 PM on January 12, 2022
A robust ‘coupon’ program isn’t indicative of malfeasance - there’s plenty of them for drugs that patients will take for the rest of their lives, for chronic diseases - or when there’s equivalent drugs and the copay might be the deciding factor.
For example, a drug I used to give was $1400/month out of pocket; on average patients were on it for 18 months. But it was available as a pill for about $20/month so the pharmaceutical company had a good coupon program to make them comparable.
Or biologics, which are hugely expensive but have robust coupons because 1) there’s a fair number of options these days and, 2) interrupting treatment can decrease effectiveness, 3) patients may be on them for life.
posted by shesdeadimalive at 5:20 PM on January 12, 2022
For example, a drug I used to give was $1400/month out of pocket; on average patients were on it for 18 months. But it was available as a pill for about $20/month so the pharmaceutical company had a good coupon program to make them comparable.
Or biologics, which are hugely expensive but have robust coupons because 1) there’s a fair number of options these days and, 2) interrupting treatment can decrease effectiveness, 3) patients may be on them for life.
posted by shesdeadimalive at 5:20 PM on January 12, 2022
Full disclosure that I am a co-author on a position statement on how awful this drug is. Basically, even if it were free, it would be unethical to prescribe because it (1) doesn't help and (2) kills people. Happy to provide a copy of that statement to anyone who is interested. I also have access to an essay written by a neurologist who has Alzheimer's, was in one of the aducanamab trials, and suffered ARIA (the brain swelling/hemorrhage that hits 40% of aducanamab patients). The essay is a wild read -- he survived but not everyone is so lucky.
I wish CMS would just come out and say Nope instead of this wishy-washy hedge. They seem to have no problem denying MRIs, which are a heck of a lot cheaper and more useful.
I'm also pretty sure that the Biogen conference where they decided to cherry pick their data for FDA is the conference that unleashed covid in the US in 2020. There were isolated clusters before then, but that particular conference was a superspreader event.
Fuckin Biogen.
posted by basalganglia at 8:01 PM on January 12, 2022 [23 favorites]
I wish CMS would just come out and say Nope instead of this wishy-washy hedge. They seem to have no problem denying MRIs, which are a heck of a lot cheaper and more useful.
I'm also pretty sure that the Biogen conference where they decided to cherry pick their data for FDA is the conference that unleashed covid in the US in 2020. There were isolated clusters before then, but that particular conference was a superspreader event.
Fuckin Biogen.
posted by basalganglia at 8:01 PM on January 12, 2022 [23 favorites]
I'd be curious to see the position statement basalganglia.
But yeah, I mean the real outrage is the FDA approval. It doesn't show efficacy. Their advisory panel voted to reject. (I hadn't heard of strong evidence of increased mortality but it's sort of beside the point: If it doesn't help, any side effect is too much.)
Once the FDA approves, all CMS can do is fund or not. They can assess cost effectiveness. PhRMA is correct in the very narrow sense that Medicare is not supposed to second guess the FDA on efficacy--but then, the FDA should make decisions that demand second guessing.
There is going to be a real challenge if we ever find an Alzheimer's drug that does work. Payers have an incentive not to buy expensive drugs that treat a lot of people even if the drug works. (More worried about private payers than Medicare, and we can assume all the usual observations about what this says about American health care and capitalism have been read into the record.)
I'm also pretty sure that the Biogen conference where they decided to cherry pick their data for FDA is the conference that unleashed covid in the US in 2020.
I appreciate the search for a grand unified source of evil, but even if the infamous Biogen meeting were the sort of place were people made decisions like this (it's not), the reanalysis and decision to pitch to the FDA had been made months earlier.
posted by mark k at 10:24 AM on January 13, 2022
But yeah, I mean the real outrage is the FDA approval. It doesn't show efficacy. Their advisory panel voted to reject. (I hadn't heard of strong evidence of increased mortality but it's sort of beside the point: If it doesn't help, any side effect is too much.)
Once the FDA approves, all CMS can do is fund or not. They can assess cost effectiveness. PhRMA is correct in the very narrow sense that Medicare is not supposed to second guess the FDA on efficacy--but then, the FDA should make decisions that demand second guessing.
There is going to be a real challenge if we ever find an Alzheimer's drug that does work. Payers have an incentive not to buy expensive drugs that treat a lot of people even if the drug works. (More worried about private payers than Medicare, and we can assume all the usual observations about what this says about American health care and capitalism have been read into the record.)
I'm also pretty sure that the Biogen conference where they decided to cherry pick their data for FDA is the conference that unleashed covid in the US in 2020.
I appreciate the search for a grand unified source of evil, but even if the infamous Biogen meeting were the sort of place were people made decisions like this (it's not), the reanalysis and decision to pitch to the FDA had been made months earlier.
posted by mark k at 10:24 AM on January 13, 2022
This is interesting, especially in light of the CMS justification for higher Medicare premiums this year, which was…the cost of Aduhelm. I wonder if we’ll see lower premiums as a result of this recent decision? Ha! Who am I kidding?
posted by dbmcd at 10:55 AM on January 13, 2022
posted by dbmcd at 10:55 AM on January 13, 2022
This is interesting, especially in light of the CMS justification for higher Medicare premiums this year, which was…the cost of Aduhelm. I wonder if we’ll see lower premiums as a result of this recent decision? Ha! Who am I kidding?
Earlier this week, the secretary of Health and Human Services ordered CMS to reassess the 2022 Medicare Part B premium increase in light of Biogen slashing Aduhelm's price in half on Jan 1, so it seems at least plausible that CMS would factor the NCD result as well.
posted by bassooner at 12:57 PM on January 13, 2022 [1 favorite]
Earlier this week, the secretary of Health and Human Services ordered CMS to reassess the 2022 Medicare Part B premium increase in light of Biogen slashing Aduhelm's price in half on Jan 1, so it seems at least plausible that CMS would factor the NCD result as well.
posted by bassooner at 12:57 PM on January 13, 2022 [1 favorite]
Does anyone know if the Alzheimer's Association is in Biogen's pocket? Because I got an email the day of the announcement from Harry Johns, the CEO, saying:
posted by wnissen at 1:15 PM on January 13, 2022 [1 favorite]
Today’s announcement from CMS is shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics.What? Medicare saved a bunch of likely medically fragile people from brain swelling! And saved Medicare recipients as a whole billions of dollars. With three parentals who have some kind of dementia, I wish as much as anyone who's not doing direct care work in this area that there were a cure, or at least a halfway decent treatment. But putting people on an extremely expensive, dangerous drug is only giving them false hope.
posted by wnissen at 1:15 PM on January 13, 2022 [1 favorite]
Does anyone know if the Alzheimer's Association is in Biogen's pocket?
Probably not. Advocacy groups want drugs for their disease approved. The interests are aligned on that issue. Partly of course it's that people who run these groups are representing sick people and prone to want something no matter what; beyond that, it's arguably rational.
There have been a string of extremely high profile failures, many by Lily, and one very promising drug by Merck. That's convinced a lot of researchers the prevailing beta-amyloid hypothesis is wrong (or at least not clinically useful), but there's not a good backup position. It's not like there are more good drug candidates taking other approaches that will get more attention.
And while I certainly don't believe this is going to work, it hasn't been 100% disproven.
So from the point of just "curing Alzheimer's," if FDA approves and Medicare funds then you have more money flowing into this disease they care about, more companies spending private money on the amyloid hypothesis, and are pretty much guaranteed the data keeps coming in until it's absolutely certain this doesn't work.
Sure, it costs the government a lot of money but patient advocacy groups don't exist to solve general budgeting issues on the backs of the patients they care about!
giving them false hope.
That's the point. They don't think it's false hope; they think it's a hope.
posted by mark k at 1:50 PM on January 13, 2022 [1 favorite]
Probably not. Advocacy groups want drugs for their disease approved. The interests are aligned on that issue. Partly of course it's that people who run these groups are representing sick people and prone to want something no matter what; beyond that, it's arguably rational.
There have been a string of extremely high profile failures, many by Lily, and one very promising drug by Merck. That's convinced a lot of researchers the prevailing beta-amyloid hypothesis is wrong (or at least not clinically useful), but there's not a good backup position. It's not like there are more good drug candidates taking other approaches that will get more attention.
And while I certainly don't believe this is going to work, it hasn't been 100% disproven.
So from the point of just "curing Alzheimer's," if FDA approves and Medicare funds then you have more money flowing into this disease they care about, more companies spending private money on the amyloid hypothesis, and are pretty much guaranteed the data keeps coming in until it's absolutely certain this doesn't work.
Sure, it costs the government a lot of money but patient advocacy groups don't exist to solve general budgeting issues on the backs of the patients they care about!
giving them false hope.
That's the point. They don't think it's false hope; they think it's a hope.
posted by mark k at 1:50 PM on January 13, 2022 [1 favorite]
Does anyone know if the Alzheimer's Association is in Biogen's pocket?
In fiscal year 2021, Biogen "donated" almost $500,000 to the Alzheimer's Association. Up from $275,000 the year before. A bargain for all the help the association got them in their FDA approval. A good way towards Harry Johns's million dollars in compensation.
shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics
A twitter thread by research equity expert Jonathan Jackson responds well to this cynical and gross performative allyship.
posted by grouse at 8:59 AM on January 14, 2022 [3 favorites]
In fiscal year 2021, Biogen "donated" almost $500,000 to the Alzheimer's Association. Up from $275,000 the year before. A bargain for all the help the association got them in their FDA approval. A good way towards Harry Johns's million dollars in compensation.
shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics
A twitter thread by research equity expert Jonathan Jackson responds well to this cynical and gross performative allyship.
posted by grouse at 8:59 AM on January 14, 2022 [3 favorites]
those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics
Yeaaah, no. The whiteness of the EMERGE and ENGAGE trials was appallingly bad, even in a field where most trials recruit mostly college-educated white men. Like, <1%. That was one of many issues raised by the independent advisory board when they unanimously voted against approval. The other two issues were that it (1) doesn't help and (2) kills people. Do you know how hard it is to get neurologists to agree on anything?? I can't even get my division of 6 to use the same note template!
If Alz Assoc legitimately cared about the disproportionate impact of AD on "women, Blacks, and Hispanics," they'd be lobbying for Medicare to cover in-home care in full, and also for home health aides (also disproportionately women, Blacks, and Hispanics) to be paid a real wage.
posted by basalganglia at 9:21 PM on January 14, 2022 [3 favorites]
Yeaaah, no. The whiteness of the EMERGE and ENGAGE trials was appallingly bad, even in a field where most trials recruit mostly college-educated white men. Like, <1%. That was one of many issues raised by the independent advisory board when they unanimously voted against approval. The other two issues were that it (1) doesn't help and (2) kills people. Do you know how hard it is to get neurologists to agree on anything?? I can't even get my division of 6 to use the same note template!
If Alz Assoc legitimately cared about the disproportionate impact of AD on "women, Blacks, and Hispanics," they'd be lobbying for Medicare to cover in-home care in full, and also for home health aides (also disproportionately women, Blacks, and Hispanics) to be paid a real wage.
posted by basalganglia at 9:21 PM on January 14, 2022 [3 favorites]
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Delightful! It's so exhausting, the BS that gets vomited out by trade organizations.
posted by ropeladder at 9:52 AM on January 12, 2022 [16 favorites]