FDA On The Offensive Regarding New Alzheimer’s Drug

A woman sitting on the ground with another person.


The Food and Drug Administration’s Commissioner Robert Califf has defended the agency’s approval of the new Alzheimer’s drug called Aduhelm.  This follows an investigation by House Democrats which found close cooperation between the drug’s sponsors and regulators.  The findings were made by the Oversight and Reform Committee and the Energy and Commerce Committee which found an unusual number of meetings between Biogen Inc. and the FDA.  The FDA also co-authored with the company a briefing document presented to outside advisors, which is very unusual.  Unfortunately, the drug was pulled off the market because Medicare refused to cover the expensive drug.

Medicare Part B Patients Should Get A Premium Rebate

A building with the capitol in the background.


Advocates for participants in Medicare Part B such as AARP are arguing that they should be seeing a premium rebate this year, although it’s unlikely that this will happen.  The reason:  the fund has a large surplus after adding on $21.60/month, a record price increase.  It’s estimated that roughly $10/month to cover the cost of the new Alzheimer’s drug Aduhelm.  The annual cost of the drug was $28,200 but the Centers for Medicare and Medicaid Services (CMS) refused to cover it even though it received FDA approval and the drug was pulled from the market.  “It is unconscionable for a single outrageously priced drug to drive up premiums for all Medicare beneficiaries,†sadid Nancy LeaMond, AARP chief advocacy and engagement officer.  She ways savings from Aduhelm should be swiftly returned to Medicare Part B users.

Medicare Deals A Blow To Those Wanting To Take The New Alzheimer’s Drug Aduhelm

A woman looking out of the window at her home.


Medicare officials announced yesterday that coverage for the new Alzheimer’s drug Aduhelm should be restricted to patients that are participating in approved clinical trials.  After a thorough review of the scientific evidence and discussions with various stakeholders, their research team at the Centers for Medicare and Medicaid Services concluded that there remain significant doubts as to whether the potential benefits of Aduhelm for patients outweigh the safety risk. Scientists are worried about side effects such as headaches, dizziness, falls and brain bleed.   The maker of the drug, Biogen, said that the decision “denies the daily burden of people living with Alzheimer’s disease†and that the clinical trial requirement “will exclude almost all patients who may benefit.â€

https://www.nytimes.com/2022/01/11/health/aduhelm-medicare-alzheimers.html?campaign_id=4&emc=edit_dk_20220112&instance_id=50069&nl=dealbook&regi_id=52105769&segment_id=79435&te=1&user_id=7052b81671c57203c64c377c7522baa7

Future of New Alzheimer’s Drug, Aduhelm, Up To Medicare

A close up of some blue and yellow cells


Despite a recent price drop of roughly 50% for Aduhelm, the new drug for the treatment of Alzheimer’s disease, it is still extremely expensive at $28K per year, and its future now lies in the hands of Medicare.  They will meet this month to decide whether or not the government will cover this infusion drug for senior citizens.  Because the vast majority of prescriptions for this drug are likely to be for those on Medicare, this will be a very important decision for Biogen, the manufacturer of the drug.  Although the FDA has approved the drug, clinical trials showed the drug had significant safety risks and the benefit to patients is unclear.  Therefore, its approval for Medicare reimbursement is anything but a shoe-in.  Medicare almost always approves drugs which have received the stamp of approval of the FDA, but in this case it has not—researchers at Medicare have been studying the drug for over a month.  “It’s truly unprecedented,†James Chambers, a researcher at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, told the Wall Street Journal.

https://www.nytimes.com/2021/12/31/health/aduhelm-alzheimers-medicare.html?campaign_id=4&emc=edit_dk_20220103&instance_id=49255&nl=dealbook&regi_id=52105769&segment_id=78510&te=1&user_id=7052b81671c57203c64c377c7522baa7

Price Slashed For New Alzheimer’s Drug

A doctor and patient looking at a book


Biogen Inc. made a dramatic price cut on its new Alzheimer’s disease treatment called Aduhelm after the product launch got off to a slow start.  It’s still expensive, even after the company cut the price of the drug almost in half, from a $56K annual cost to $28K.  Aduhelm is the first new treatment for Alzheimer’s disease in almost too decades.  “Too many patients are not being offered the choice of Aduhelm due to financial considerations and are thus progressing beyond the point of benefitting from the first treatment to address an underlying pathology of Alzheimer’s disease,†said Biogen CEO Michel Vounatsos.

Patient Death In New Alzheimer’s Drug Aduhelm

A doctor and patient looking at a book


There was much excitement when the FDA approved a new drug called Aduhelm to treat patients with Alzheimer’s disease.  Although there was some debate over its efficacy, the fact that there have been no new drugs brought to market to treat this horrible disease in decades had some filled with hope.  However, Biogen Inc., the pharmaceutical company who makes the drug, admitted this week that there was one death linked to Aduhelm.  The company announced that a 75-year old who took the drug was hospitalized and diagnosed with swelling in the brain before dying.  It’s unclear that the brain swelling was linked to the drug, however, there is sure to be an investigation due to the fact that brain swelling, also known as ARIA-E, was cited as one of the most common side effects during testing of the drug.

 

https://www.wsj.com/articles/biogen-investigates-death-of-aduhelm-patient-11636479862

Biogen’s Aduhelm Not Accessible To Most Alzheimer’s Victims

A doctor and patient looking at a book


There was much excitement when Biogen’s Aduhelm was approved by the FDA for use on Alzheimer’s patients in June.  Although there was controversy in the medical community regarding whether or not it was effective, it gave hope for many suffering from a disease which hasn’t seen a promising new drug in nearly 20 years.  The problem is, the cost of the drug is so high at $56K/year few people have access to it.  Medicare recipients won’t find out until next year if they are going to cover the drug and, if so, for whom.  Stephen Salloway, director of Butler Hospital’s Memory and Aging Program, one of the few places serving up the drug, says that by next week it will have treated ten patients with the drug, with more than 100 others on a waiting list.  Those few are paying cash.  “That’s not the way I want to go about this, that only people with means can access the drug,†said Dr. Salloway.  “That’s not what the FDA intended.  It isn’t equitable.â€Â  I agree, however, with the Medicare fund quickly running out of money without even covering drugs like this, a solution needs to come from Congress at the behest of President Biden.

https://www.wsj.com/articles/biogens-new-alzheimers-drug-beyond-reach-for-many-patients-11630077741

New Prescription Drugs Are Coming With A Hefty Price : By Derek Baine


More and more prescription drugs are coming to market with outrageous wholesale prices and many have wondered whether Medicare and private insurance companies will cover them.  They got their answer on Friday for the new Alzheimer’s drug from Biogen when The Department of Veterans Affairs said they won’t cover Aduhelm.  Medicare has yet to weigh in.  The VA cited the risks of causing series side effects and a lack of evidence that it improves cognitive function in denying coverage.  By law, the VA has greater leeway than other government health programs like Medicare and Medicaid to deny coverage of medicines it deems to be of poor value.  A group of VA doctors concluded last month that more than 150K veteran beneficiaries diagnosed with Alzheimer’s could receive the drug.  However, it would come at a cost of $4 billion annually.

FDA Approves First New Alzheimer’s Drug In 18 Years

A close up of some blue and yellow cells


In a very controversial decision, the Food & Drug Administration, FDA, has approved a new drug to treat Alzheimer’s disease—the first new medication approved in almost two decades.  The move was hotly debated as some questioned the results of a clinical trial.  The agency’s independent advisory committee and some experts on dementia believe that there is not enough evidence that the drug is effective.  Aducanumab, which will be marketed under the brand name Aduhelm, is a monthly IV infusion meant to slow the onset of Alzheimer’s disease.  The FDA granted approval only on the condition that Biogen, the manufacturer, conduct a new clinical trial.  This will take seven years.  However, in the meantime those showing early signs of Alzheimer’s can opt in to the treatment.  “The data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit,†the FDA’s director of the Center for Drug Evaluation and Research, Dr. Patrizia Cavazzoni, wrote on the agency’s website.  However, she stated that the agency decided to approve the drug through a program called “accelerated approval.â€Â  Although it’s uncertain that the drug will work, many of those suffering from early-onset Alzheimer’s disease will likely be willing to take the risk.

https://www.forbes.com/sites/leahrosenbaum/2021/06/04/fdas-decision-on-biogen-alzheimers-drug-will-be-a-watershed-moment-for-the-agency—and-the-biotech-industry/?sh=26b742d2439a&utm_source=newsletter&utm_medium=email&utm_campaign=dailydozen&cdlcid=607e1442fe2c195e916f3bb4

https://www.nytimes.com/2021/06/07/health/fda-approves-alzheimers-drug.html

New Hope For Those With Alzheimer’s Disease

A purple square with the words " the end of alzheimer 's starts with me ".


The U.S. Food and Drug Administration (FDA) is set to rule soon on whether a promising drug by Biogen called aducanumab can be prescribed from those suffering from Alzheimer’s disease.  Although it has already been recommended by an FDA advisory panel of medical experts that the drug not be approved as two clinical trials had completely different results, Bloomberg Businessweek interviewed a man, Jeffrey Borghoff age 57, who was diagnosed with early-stage Alzheimer’s disease at 51.  He gave cudos to the drug, which he has been taking for years as part of an experimental drug trial.  :We’re fighting like hell to get this drug approved,†Borghoff told a reporter.  “Every day they are making progress in cancer and diabetes and other diseases.  We need something for Alzheimer’s disease,†he said.  Fingers crossed that the FDA approves the drug—they have until June 7 to make a decision.