Medicare independent on Aduhelm

Any decision by Medicare has Macro implications because the dollar amounts can be astronomical.

https://www.cms.gov/Research-Statistics-Data-and-Systems/Sta…

National Health Expenditures (NHE) grew 9.7% to $4.1 trillion in 2020, or $12,530 per person, and accounted for 19.7% of Gross Domestic Product (GDP). Medicare spending grew 3.5% to $829.5 billion in 2020, or 20 percent of total NHE. Prescription drug spending increased 3.0% to $348.4 billion in 2020

https://www.gao.gov/prescription-drug-spending

**The U.S. spends more than other countries for prescription drugs. For example, in 2020, for 20 selected brand-name prescription drugs, estimated U.S. prices paid at the retail level by consumers and other payers, such as insurers, were more than two to four times higher than prices in Australia, Canada, and France. ...**

**Medicare Part D is a voluntary outpatient prescription drug program for self-administered drugs. Gross Part D expenditures, which reflect what was paid to the pharmacy by Part D plans and beneficiaries, increased 20% from 2014 through 2016 (from $120.7 billion to $145.1 billion). Once rebates and other price concessions from manufacturers and others were taken into account, net Part D expenditures increased 13% (from $103.2 billion to $116.1 billion). ...**

Medicare is prohibited by law from negotiating drug prices. Medicare Part D (which covers prescription drugs) is controlled by private insurance companies. The “open enrollment period” is agonizing because each company insures different drugs by different amounts in a “formulary” which can change every year.

I got my Shingrix vaccination today. I got a better price using GoodRx.com than my Medicare Part D price.

Alzheimer’s disease is an especially important area since there are no effective drugs yet and the cost to families and the public of caring for AD patients is extremely high. Any drug that shows the slightest chance of positive results draws a deluge of lobbying by families and the manufacturer.

Aduhelm, a monoclonal antibody by Biogen costing $56,000 per year, showed no significant improvements and significant harms. The clinical trial evidence reviewed by the F.D.A. showed that patients in one trial appeared to experience slight slowing of cognitive decline, while patients in a nearly identical trial didn’t appear to benefit at all. About 40 percent of patients on the dosage later approved experienced brain swelling or brain bleeding, often mild, but sometimes serious. Both a council of senior F.D.A. officials and the agency’s independent advisory committee had said there wasn’t enough evidence for approval.

Aduhelm is so expensive that Medicare imposed one of the biggest-ever increases in Medicare Part B premiums for 2022, partly driven by the possibility of coverage for Aduhelm. This is a serious hardship for millions of retirees whose Medicare is taken out of their meager Social Security.

Due to the outrage and refusal of major hospitals to buy Aduhelm, Biogen cut the price in half. The Wholesale Acquisition Cost (WAC) of Aduhelm, which is an infusion once every four weeks, will be $2,171.40 per monthly infusion for a patient of 74 kg – the average weight of a US patient with mild cognitive impairment (MCI) or mild dementia.

Medicare, which

https://www.nytimes.com/2022/04/07/health/aduhelm-medicare-a…

**Medicare Officially Limits Coverage of Aduhelm to Patients in Clinical Trials**

**Officials cited data showing the new Alzheimer’s drug has serious safety risks and may not help patients.**

**By Pam Belluck, The New York Times, April 7, 2022**

**...**
**...On Thursday (4/7/2022), Medicare officials announced their final decision. Though the Food and Drug Administration has approved Aduhelm for some 1.5 million people, Medicare will cover it only for people who receive it as participants in a clinical trial....**

**A major issue for Medicare had been how to deal with other similar drugs for Alzheimer’s, several of which are likely to be considered for F.D.A. approval soon. ...If, unlike with Aduhelm, the F.D.A. finds that there is clear evidence that a drug can help patients, Medicare would cover it for all eligible patients and would only impose a requirement that the patients’ experience be tracked....**

**The decision is extremely unusual for Medicare, which almost always automatically pays for drugs that the F.D.A. has approved, at least for the medical conditions designated on labels....** [end quote]

Medicare Part A is projected to become insolvent in 2026. The budget won’t be helped by super-expensive drugs used by millions of people.

I’m glad that Medicare made an independent, data-based decision to restrict Aduhelm. I hope that they can resist pressure to approve future drugs with minimal benefits.

Wendy

6 Likes

Medicare is prohibited by law from negotiating drug prices.

There are ways to get around that restriction. It just requires Medicare to do it.

I got my Shingrix vaccination today. I got a better price using GoodRx.com than my Medicare Part D price.

I found the same thing.

Thing is, if anyone thinks they are saving money by not enrolling in Part D, they aren’t. At some time, most people will end up taking some expensive drugs. If they don’t sign up for Part D until they need to use it, a penalty will be assessed against them that would cost about as much as having paid for the cheapest possible Part D plan all along.

Of course, once you are on a lot of meds, you can shift from the cheapest plan, to a plan that is more beneficial for someone that actually takes a lot of drugs, without paying a penalty.

Steve

2 Likes

There are ways to get around that restriction. It just requires Medicare to do it.

Medicare can’t do it. It is against the law. For Medicare to negotiate prices, the law would need to be changed. There is plenty of “protected free speech” ready to fill a majority of 535 pairs of hands to prevent the law being changed.

Steve

1 Like

“Medicare can’t do it. It is against the law.”

What’s the penalty if they break the law?

Medicare can’t do it. It is against the law. For Medicare to negotiate prices, the law would need to be changed.

The law does not need to change–which is the point.

Lower prices NOW. But only if you know how to do it. How many $$$ is that worth?

What’s the penalty if they break the law?

Nullified contracts and the requirement to pay the previous (last agreed?) price for whatever was received.

But, of course, that can all be avoided AND lawfully lower prices obtained.