New Alzheimer's Drug -

[GailL1]

I thought after I reading this - No Way will the FDA approve this med.

KHN 06/04/2021 - FDA Weighs Approval of a Alzheimer’s Drug, but benefits are iffy 

Then Today I read this:

NPR 06/07/2021 - The FDA Has Approved A New Alzheimer's Drug — Here's Why That's Controversial 

and Biogen's stock went up 40% TODAY !

Be your own judge - Do you think this medication should have been approved by the FDA from the information in these (2) links?

[GailL1]

Here is an update:

(2) House Committees are now evaluating this new drug for Alzheimer's - name is Aduhelm - the cost, the cost sharing (Part B), and the associated test that may also be necessary to prove that it is working and is having no adverse effects.

STAT NEWS 06/25/2021 - House leaders to investigate FDA approval and price of Biogen’s Alzheimer’s d... 

. . .  two powerful committees on Friday announced an investigation into the approval and pricing of Biogen’s controversial Alzheimer’s drug, Aduhelm.

The House Committee over Oversite and Reform and the Energy and Commerce Committee.

Expensive drugs have been approved before - remember the hepatitis C (curative) drug Sovaldi began at $ 84,000 for a cycle - but that drug was proven and has saved a lot of money since then because the alternative was a liver transplant that cost even more.  Because of other new drugs coming onto the market for this disease (Hep C) - they have all dropped in price although still expensive but they are very much worth it.

from the link below:  

Aduhelm is different because Aduhelm hasn’t been proven to work, and will not have been proven to work before millions of people start taking it.

• Patients will likely take it for several years, and if it doesn’t provide any clinical benefit, it will simply add billions more to the financial and emotional costs that Alzheimer’s already extracts.

If the FDA is going to start greenlighting more drugs simply because they might work, that could unleash a flood of expensive and unproven products.

• One possible early sign: Eli Lilly announced Friday it will seek FDA approval for its own Alzheimer’s drug — which has not been proven to work.

Right now the price of Aduhelm is slated to be $56,000 per year (retail)  and that does not include the associate test many patient's will have to endure to monitor their condition.  

We have got to start doing better - this isn't gonna work IMO.

Axios 06/28/2021 - New Alzheimer's drug may be a catastrophe in the making 

Axios 06/28/2021 - New Alzheimer's drug may create a policy dilemma  

[john258]

It really does not matter what the average person thinks on this as the average person knows little if anything about how and what the drug does. We have experts to handle all the details on this so lets let them do their job and then be guided. The cost is high so lets make it free to all for 2 years to find out what it will really do. Who picks up the cost? Well if the drug really works then have the cost set at cost of production plus 10%. The cost of this drug was set on what the drug Mfg tells us it will save over the current drugs used. That is how you get really high drug prices.

[AARPRachelA]

Yikes. Thanks for sharing these articles @GailL1. I hadn't looked into the drug and had only heard about the FDA approval. Having had a grandma pass from Alzheimers and having other relatives with dementia, I was pretty excited by the news. However, it's clear that there are problems that need to be addressed. I'm pleased that the FDA is requiring another clinical study to determine the efficacy. I'm especially dismayed at the price being so high, but I can't say I'm surprised by that. I do still have hope, though. I know that there are other potential Alzheimers treatments that have shown promise.

[GailL1]

@AARPRachelA 

You wrote:

"I'm especially dismayed at the price being so high, but I can't say I'm surprised by that."

+++++++++++++++++++++++

It is also an injectable and thus will be covered under Medicare Part B with a bonus % to the doctor administering it as most all injectables.

Look out Medicare Part B premiums for next year but not just because of this drug.

Thank goodness for the SS Hold Harmless Provision !!!!

[somarco]

@GailL1 @AARPRachelA 

 A new $56,000-a-year Alzheimer's drug would raise Medicare premiums broadly, and some patients who are prescribed the medication could face copayments of about $11,500 annually

On Thursday, a third member of an FDA advisory panel that opposed the drug resigned over the agency's decision. Last November the 11-member group voted nearly unanimously against recommending approval for the medication, citing flaws and missing data in company studies. 

https://www.npr.org/2021/06/10/1005319693/medicare-copays-for-new-alzheimers-drug-could-reach-11-500...

Sounds politically motivated to me, but that is only my opinion.

[GailL1]

@somarco 

Yea, I heard about those (3) FDA Advisor Committee members resigning -

I don't think it is so much political as being some issuance of hope for those who could qualify for the drug (health and stage-wise) and their doctor prescribes it (which seems to be another discussion).  

However, the FDA has approved this drug under their "Accelerated Approval Method" and thus testing of it will continue.  To me, this is only one step above EUA (emergency use authorization) .  This seems to me to be just a way for the drug company to get some revenues during this continuing trial period.  This drug has been in actual clinical trials for quite sometimes.  At one time, the testing was stopped for adverse conditions to some patients, then started again.  It has got to be expensive for the drug company to run these particular trials and the associated testing of it for whatever results.

FDA.gov 06/07/2020 - FDA Grants Accelerated Approval for Alzheimer’s Drug 

It sounds to me like not only will Medicare Part B be picking up their part of the cost and then the beneficiary picking up the remainder 20% for this injectable drug + the doc fee for administering it + their bonus for doing so but there will also be other expensive testing that the beneficiary must also do while taking the drug - PET Scan + cerebral fluid test to see if it is working, some, or not at all.  It seems these too will be paid under the Medicare program.

Then we have the Alzheimer's Association's support - I understand completely that they  (and we) want to find an early stage treatment - there are millions of people diagnosed with early stages that are looking for some help.  But then I have to ask myself, if there is some conflict of interest here since the Alzheimer's Association gets so much money from the pharma industry to support their cause.

A 22% supposed positive rate compared to the cost of the drug (even once discounted) and all the follow up testing cost and monitoring - that's not a very good efficacy rate.  But since it is the only drug out there at present for this - the sky is the limit - there is not what you would call any competition.  

It will be interesting to follow what happens to this drug - FDA approval, doctor's prescribing it and how much it affect Part B premiums and beneficiary out of pocket cost.  Wonder what will be the Medicare cost for the drug itself?  

It will also be very interesting to see WHEN, IF and at what cost other countries may decide to get onboard and approve its use (and coverage based on their specific health care plan).

[somarco]

@GailL1 the decision to approve may or may not be politically motivated. Much of the information and misinformation about COVID was political. Why should this be any different?

But that is another discussion . . .

The things that jumped out at me include:

patients who are prescribed the medication could face copayments of about $11,500 annually

That essentially puts the cost of the medication out of reach for many Medicare beneficiaries. Absent a grant or some sort of financial assistance the number of people who might try the drug is a smaller pool than the total.

11-member group voted nearly unanimously against recommending approval for the medication, citing flaws and missing data in company studies.

Begs the question . . . what kind of flaws and missing data? Why did the FDA choose to ignore this and move forward anyway?

Medicare has not made a formal determination on covering Aduhelm

Even with FDA approval CMS is not required to authorize use of the drug. This could become an orphan drug in short order, if for no other reason, the cost to the patient.

"We have priced Aduhelm at roughly a third the level of the cancer immunotherapies,

This fails to account for long term use vs relatively short term use for expensive cancer drugs. Alzheimer's patients can, and often do, live for years before succumbing to the illness.

Conversely, cancer patients receiving higher cost drugs (some costing $200,000 per year or more), typically have shorter lifespans when they arrive at the stage of using "last resort" medications. The 20 most expensive cancer drugs are priced at $28,000 to $86,000 per month.

These drugs do not cure and rarely (if ever) extend lifespan more than a few months.

The vaccine was approved for EUA but has yet to receive full FDA approval. Final approval may or may not ever happen.

Perhaps my perspective is off, but I don't equate a new Alzheimer's drug as a possible "emergency use" drug akin to the COVID "vaccine".

[GailL1]

@somarco 

Question for you:  How are those select outpatient drugs under Part B, administered in a docs office or sometimes in an outpatient hospital facility, covered with a Medigap (supplemental) plan   Does the Medigap Insurance company pick up part of the cost of the drug ????

Medicare.gov - Medicare Part B (Outpatient) Coverage of Certain Drugs Administered by a Physician 

Seems this drug would be about the same - doesn't it fit this type of scenario (from the link - 

• Injectable and infused drugs: Medicare covers most of these when given by a licensed medical provider because they aren't usually self administered.

Medicare.gov says Medicare Part A  AND  Medicare Part B help pay for an injectable drug for osteoporosis . . . . 

Further Medicare.gov say

 https://www.medicare.gov/coverage/prescription-drugs-outpatient 

Your Costs in Original Medicare

In most cases, you pay 20% of the Medicare-approved amount for covered Part B prescription drugs that you get in a doctor’s office or pharmacy, and the Part B deductible applies. Flu, pneumococcal, and Hepatitis B shots have no cost sharing, and the deductible doesn’t apply. In a hospital outpatient setting, you pay a copayment of 20%. If your hospital is participating in a certain outpatient drug discount program (called “340B”), your copayment will be 20% of the lower price, with some exceptions. Doctors and pharmacies must accept assignment for Part B-covered drugs, so you should never be asked to pay more than the coinsurance or copayment for the Part B drug itself.

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As far as how the FDA approved it -  under the "Accelerated Approval" process - clinical trial & various supportive testing will continue until final conclusion is reached.  That's why I said, it looks like just a clinical trial  method to get more people into the trial & pharma co gets some monetary benefit.

From the link:  FDA.gov 06/07/2020 - FDA Grants Accelerated Approval for Alzheimer’s Drug 

News Release from the FDA - It describes the Accelerated Approval Pathway - another manner of approval by the FDA like the EUA.  Yes, very similar, as the process used in Orphan Drug approval - 

from the above FDA link above:

. . . . Under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.

Aduhelm was granted Fast Track designation, which seeks to expedite the development and review of drugs that are intended to treat serious conditions where initial evidence showed the potential to address an unmet medical need. 

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Maybe no person is gonna pay - and the government is just gonna pick up the cost all the way around 😮  since at this point, it is still just a glorified clinical trial with perhaps more test subjects -