Alzheimer’s patients and their loved ones cheered last year when the Food and Drug Administration approved Aduhelm, the first new treatment for the debilitating disease in 20 years.
The celebration, however, was premature. The approval set off a melee in Washington over whether Medicare would cover Aduhelm. Answer: for most patients, it won’t.
This is the first of the epic battles to come over coverage of breakthrough new medications. From now on, political meddling in Americans’ medicine cabinets will be intense as Medicare seeks ever-greater authority to set prices for drugs.
The Aduhelm decision was fraught for many reasons. First was that Medicare authorities deviated from all routine by restricting access to an FDA-approved use of a drug. Never before has CMS used this power.
Second, Medicare restricted access to an entire class of drugs based solely on Aduhelm’s clinical trial results. So much for following the science.
Third, in order to have a chance to get Aduhelm at all, patients must participate in a clinical trial. That means some will receive a placebo — an ethically dubious proposition for a drug the FDA has approved. Making matters worse, those receiving the placebo will pay coinsurance costs out-of-pocket despite having no potential for clinical benefit.
Fourth, CMS applied the clinical trial restriction to drugs using FDA’s “accelerated approval” process designed to speed treatments to patients. New treatments may forgo this process to reduce the risk of Medicare bureaucrats limiting access to their products. New treatments will therefore take longer to reach patients.
Finally, while Medicare officials couched their objections in terms of the need for more clinical study, their real concern was transparently the cost the government would incur paying for the treatment — notwithstanding the potential health benefits for millions of people.
Once the Centers for Medicare & Medicaid Service (CMS) said no to Aduhelm, the nation’s private insurers, as expected, followed suit. The drug has all but disappeared from the market.
In context, the government’s move on Aduhelm is the latest in a multi-dimensional chess game designed to transfer control of healthcare decisions to Washington by giving government officials the authority to control prices.
Under current law, federal officials are explicitly prohibited from negotiating with drugmakers over the price of Medicare medications. That task falls to health insurers contracted by Medicare. This aggressive negotiation has been effective, resulting in discounts averaging 25 to 35 percent — in some cases, discounts reach 90 percent. The Congressional Budget Office found that negotiations have been so effective that the average net price of prescriptions in Medicare’s drug benefit fell from $57 in 2009 to $50 in 2018.
Progressive lawmakers would love to take this negotiating authority away from health plans and empower political appointees and bureaucrats to set prices. Despite the evidence, they don’t trust the market and believe they can cut costs without risk by eliminating the profit motive throughout the system. But lawmakers have been unable to pass legislation to end the prohibition on government negotiating. The most recent attempt came in President Biden’s “Build Back Better” legislation, which floundered in December.
The Medicare determination for Aduhelm was an indirect step to the same end. Saying “no” to coverage was a way to test how to drive price negotiations. If Aduhelm’s developer came back with a price of pennies on the dollar, Medicare’s restrictions on coverage would likely have vanished overnight. The government would have made its point and pocketed its victory, confident that other drug developers got the message.
So they would, but the message would be to quit investing in potential blockbuster treatments that mainly benefit older Americans. Medicare officials know perfectly well that price controls, whether direct or indirect, will slow or cut off the flow of expensive new medications in the drug pipeline. That’s not an unintended consequence of gaining the control they want and have seized in the Aduhelm case. It’s the purpose. The question is whether seniors and lawmakers who want to preserve our world-class system of medical innovation will let them get away with it.
There are plenty of smart ways to reduce the cost of prescription drugs. Turning every new drug approval into a vitriolic public policy battle devoid of scientific reason and indifferent to patient welfare isn’t one of them.
Joel White is the president of the Council for Affordable Health Coverage, a nonprofit advocacy organization that seeks to lower the cost of healthcare for all Americans.
Reprinted with Permission from - Real Clear Health by - Joel White
I thought the anticipated cost of this medication is why the Medicare part B premium increased in January 2022. If Medicare isn’t incurring the cost, maybe premiums should be reduced in 2023
In case you haven’t been paying attention, this is all part of the depopulation efforts by the NWO. Horrific and incomprehensible. I sincerely hope that there is a VERY special place in Hell for this evil doers.
This article does not tell the whole story. Aduhelm was rushed through the FDA approval process without adequate evidence that it is effective. I personally know one of the clinical researchers who was involved in the trials. The drug should never have been released in the first place. It is not surprising that Medicare and private insurers were unwilling to pay the astronomically high cost for Aduhelm. The fact that it was rushed to market is a good indication that Aduhelm was more about making money for the manufacturer than it was for helping individuals with Alzheimer’s disease.
Precisely. cancer anyone?
Too bad they used the population at large for clinical trials for their jabs that are garbage.
Every American needs to learn to ask questions, do research, challenge the trust of the medical community. Since Covid began they have shown who they really are and it is nothing good. Every American needs to realize their health and what drugs/vaccines they choose are 100% their responsibility. We are on our own on this one.
Need more Organic RX for all issues
CUT Medicare DC bureaucracy alone
Advocates for socialized medicine never mention how government bureaucracies and price controls stifle the discovery of new medical solutions. All those advocates ever talk about are the great benefits of robbing Peter to pay Paul–all the while ignoring the tremendous cost to everyone of funding the ever expanding government bureaucracy.
This whole crowd is going to be gone soon enough, I hope.
Once more, it’s all about MONEY, and the greedy drug producers are always there with their hands held out, palms up! They drool over any so-called “new” drug, and recently, the FDA has failed to show any statistical proof that certain drugs are effective, and blow aside the side effects.
Oh my, and we thought the government, medicare, & the insurance companies were here to help us out of the kindness of their hearts, if they had any. Nothing changes. Just follow the money.
I wonder if Medicare patients could be better served by being under the blanket of a insurance company (not the federal government) and included with all the rest of the pool of people covered under their policies. Wouldn’t that reduce the cost to a Medicare patient and get the federal government out of the healthcare business for senior citizens?
You’re speaking of a double edged sword. Personally I don’t trust insurance companies any more than any government agency. The insurers are bottom line oriented and willing to screw over the public at the drop of a hat.
Those that have paid into the federal government all their lives are the first ones to be denied on Medicare coverage for new drugs.
The government needs to get OUT of everybody’s lives and STAY OUT.
I can live MY LIFE just fine and CAN THINK for myself unlike the government can.
I know what’s BEST FOR ME.
The government sure as Hell doesn’t.
AMEN David!! NO ONE WANTS THE FEDERAL GOVERNMENT INTERFERING IN THEIR LIVES IN ANY WAY, SHAPE OR FORM! WHENEVER a person needs something, who’s on MEDICAID OR MEDICARE, THEY take THEIR SWEET RESPONDING. Yet WHENEVER THEY’VE MADE A MISTAKE AND SAY THEY SAY “SOMEONE HAS BEEN RECEIVING TOO MUCH MONEY IN HIS/HER SS CHECK because of the LENGTH OF TIME IT TOOK TO INVESTIGATE AND FIND WHEN/HOW THE MISTAKE HAPPENED. THEY’LL DEDUCT MONEY FROM THE PERSON’S CHECK (SOMETIMES. LARGE AMOUNTS) WITHOUT GIVING ANY EXPLANATIONS OR THE LETTER CONTAINING THE REASON COMES LATE OR NO EXPLANATION, AND THE VICTIM OF THE MISTAKE HAS ALREADY FOUND OUT THE REASON ON THEIR OWN. THIS IS JUST ONE EXAMPLE. I believe THE UNITED States WOULD BE BETTER OFF WITHOUT GOVERNMENT INTERFERENCE AND LESS GOVERNMENT-NOT MORE GOVERNMENT, THAT’S WHAT THE DEMOCRATS AND PROGRESSIVE DEMOCRATS WANT .
researching this further, the original study had a lot of bad indicators or poor results and required more testing. Also all delivery of the drug is done by doctor at hospital IV for many months and the research results were not very conclusive. Also the cost of the drug if approved would be 56K per year, So even with medicare it would be at least $5600 per year out of pocket.
horrific! so frustrated with current “administration” if you can even call them that!
The only thing they have administered with effectiveness is the printing of money and corruption. Who sells their vital oil reserves to a world scale enemy?
Said right. (Least of all) “PATIENT WELFARE” (very end of article).