How much does Aduhelm cost? Even if you can cover the expense, that doesn’t mean the drug is easy to get.
Aduhelm costs an average of $28,200 per year for patients who receive treatment without insurance coverage. But if you want to know how to get the first disease-modifying, FDA-approved Alzheimer’s drug — or whether it is even possible — it’s a little more complicated than just a dollar amount.
What is Aduhelm?
In June 2021, the U.S. Food and Drug Administration approved the first new drug treatment for Alzheimer’s disease in almost 20 years. Biogen and Eisai’s controversial anti-amyloid drug Aduhelm (generic name aducanumab) may be the first drug on the market that can modify the course of the disease rather than treat symptoms. To many, this innovation is invaluable. But in practical application, one of the best-known things about Aduhelm in its first year on the market was its sky-high price tag.
Where can you get Aduhelm?
When Aduhelm first hit the market, the price of the drug was set at $56,000. This raised concerns about insurance coverage for Aduhelm: Would private insurance be willing to cover such an expensive drug? Could Medicare afford to? Then, in November 2021, the drug was blamed as the primary cause of a projected hike in Medicare premiums. Biogen later slashed the tag by approximately half, making the new price just over $28,000 per year for a person of “average” body weight (163 pounds), according to Biogen.
But this move to make it (a little) more affordable didn’t make getting the drug as easy as patients might like for it to be. The Centers for Medicare and Medicaid Services (CMS) limited insurance coverage to patients in clinical trials, meaning that insurance wouldn’t cover that $28,000 for the general public. And even if you do have the funds to pay out of pocket and a doctor who will prescribe the drug, there are still caveats.
“Almost no one” is prescribing the controversial new Alzheimer’s treatment, STAT News reported in January. At that point, more than a dozen healthcare institutions and university-affiliated hospitals were not willing to prescribe nor administer Aduhelm, including the Cleveland Clinic, Johns Hopkins, UCLA and University of Michigan.
“Based on the current data regarding its safety and efficacy, we have decided not to carry aducanumab [Aduhelm] at this time,” Cleveland Clinic’s spokesperson wrote in a statement to Being Patient. “However, we support continued research in this area, and when additional data become available, we will re-evaluate this medication for use in our patients.”
As of September 2022, Penn Memory Center is no longer prescribing the drug, according to Penn Memory Center Co-director David Wolk. “We are not prescribing the drug, in part, because it is not available on formulary here,” Wolk wrote in an email to Being Patient. “So it is not really an option. At this point, we are just using in the context of research studies sponsored by Biogen.”
When asked how easy or difficult it is for patients with a prescription in hand to access the drug, Jason Karlawish at the Penn Memory Center — the author of The Problem With Alzheimer’s — said getting the drug is a problem.
“I’d say it is pretty hard to access it,” he told Being Patient over email. “A center has to be set up to deliver it. Because of the CMS and other insurer’s decisions, it is not on most formularies. The next few months promise results from three Phase 3 trials. [I think] this drug will fast become history.”
When asked how patients should go about getting access to this elusive drug, Biogen responded that patients can call a patient support Services hotline 1-833-425-9360 Operators are on hand to take calls between 8:30 a.m. and 8:00 p.m. ET.
Why does Aduhelm cost so much?
Anti-amyloid therapeutics are a class of treatments, termed “biologics,” which are expensive to manufacture. These drugs are designed to mimic the body’s own immune antibodies, which is very difficult. The original price tag, $56,000 per year, was set based on manufacturing costs and the belief from Biogen that cost will not impact who decides to receive treatment.
“We have not heard that price is the primary driver for any decision to treat patients,” Alisha Alaimo, Biogen’s president of U.S. organization said on an October conference call with investors.
“A center has to be set up to deliver it. Because of the CMS and other
insurer’s decisions, it is not on most formularies. The
next few months promise results from three Phase 3
trials. [I think] this drug will fast become history.”
However, an independent analysis from the Institute for Clinical and Economic Review previously estimated that Aduhelm should cost no more than $8,400 if it could successfully halt dementia progression.
In December of 2021, after months of dismal sales and failure to receive approval from European regulators, the price of Aduhelm was reduced to $28,200 — still unaffordable for most patients, especially considering the difficulty in getting insurance to cover the drug.
Will insurance pay for Aduhelm?
In January of 2022, the CMS drafted a plan which suggested that Medicare won’t cover Aduhelm for the general public. It also stipulated that Aduhelm and future anti-amyloid monoclonal antibody treatments might need to undergo additional clinical trials, even after FDA approval, before Medicare coverage would be green-lit.
The CMS opened up the draft proposal for public comments, receiving more than 10,000 submissions both in support of and against the proposal. In April, the Centers for Medicare and Medicaid Services announced that they will only cover payments for Aduhelm in patients in clinical trials. The drafted plan suggested that Medicare won’t cover the drug for the general public.
It also stipulated that Aduhelm and future anti-amyloid monoclonal antibody treatments might need to undergo additional clinical trials, even after FDA approval, before Medicare coverage would be green-lit. Unless you’re participating in ongoing clinical trials for Aduhelm or have a special arrangement with your own insurance provider, you will need to pay out of pocket.
Biogen and Eisai shift focus to new anti-amyloid Alzheimer’s drugs
In May 2022, Biogen announced that they were significantly scaling down infrastructure for the production of Aduhelm in response to the CMS decision to limit insurance coverage.
However, Biogen and Eisai aren’t stepping away from Alzheimer’s disease treatments entirely. Another anti-amyloid drug, lecanemab, is involved in rolling submissions under the U.S. accelerated approval pathway before submitting for full approval in 2023. It is unclear whether lecanemab will ultimately be approved and whether it will cost less than Aduhelm.
UPDATE, 13 September 2022, 3:51 P.M. ET: This article has been updated to note that the Penn Memory Center is no longer prescribing Aduhelm to patients.
UPDATE, 16 September 2022, 10:39 P.M. ET: This article has been updated to specify that the current price of Aduhelm is subject to body weight. According to Biogen, for a patient who weighs 163 pounds, the yearly cost at the maintenance dose (10 mg/kg) is $28,200.