Just In
- 8 hrs ago Anant Ambani-Radhika Merchant's Wedding Function Details Are Out, Check out Ambani Bahu-To-Be's Chic Fashion!
- 9 hrs ago Nayanthara Poses With Husband Vignesh Shivan In Chic Saree, Check Her Sarees To Ace Summer Wedding Look
- 13 hrs ago Hanuman Jayanti 2024: These Are Lord Hanuman's Favourite Zodiac Signs, Check Out The List!
- 14 hrs ago Arushi Sharma-Vaibhav Vishant Wedding, Love Aaj Kal 2 Actor Looks Resplendent In A Pastel Ethnic Outfit, Pics!
Don't Miss
- Technology Apple Confirms Special Event for May 7: iPad Air, iPad Pro 2024 Models Expected
- Finance TCS Vs Infosys Vs Wipro Shares, ADRs, Upcoming Dividends: Which Mega IT Stocks To Buy After Q4 Results?
- Sports Who Won Yesterday's IPL Match 39? CSK vs LSG, IPL 2024 on April 23: Marcus Stoinis Fires 63-ball 124 To Quiet Chepauk
- News Senator Lambie Calls For Elon Musk's Imprisonment Over Wakeley Church Stabbing Posts
- Movies Mirzapur 3 OTT Release Date, Platform: When Will Mirzapur Season 3 Premiere On Amazon Prime Video?
- Education Telangana Inter Manabadi 1st and 2nd Year Results 2024 to be Declared Tomorrow
- Automobiles Chrysler Pacifica Marks Seven Years As Most Awarded Minivan With New Campaign
- Travel Kurnool's Hidden Gems: A Guide To Exploring India's Lesser-Known Treasures
The FDA Approved A New Drug Aduhelm To Treat Alzheimer’s, But Medicare Insurance Won’t Always Pay For It
Medicare finalised its decision to restrict its coverage of Aduhelm, Biogen's new Alzheimer's disease drug, on April 8, 2022.
The decision means only patients who have enrolled in clinical trials will receive Medicare coverage for Aduhelm, which goes by the generic drug name of Aducanumab.
Because of the restrictions, many Alzheimer's patients may be unable to use the drug.
Without Medicare coverage, Aduhelm's annual cost is USD 28,200, or USD 2,350 a month, a price that's prohibitively expensive for most Americans.
What's more, not everyone with mild Alzheimer's will be able to enrol in a clinical trial due to location or other logistical issues. And some of those in the trial may be randomized to only receive a placebo.
Medicare's ruling clashes dramatically with the Food and Drug Administration's decision in June 2021 to approve Aduhelm for all Alzheimer's patients without restrictions.
This is a departure for Medicare, which almost always pays for drugs the FDA approves, at least for authorised uses.
Biogen has criticised Medicare's decision, saying the added requirements "would significantly restrict and delay patient access to an FDA-approved therapy for a progressive disease."
But the core of this drug's issue is simple: Does it actually work?
As a physician and researcher who investigates the efficacy of medicines, I have been watching this story unfold over the past year. As of right now, I am certain of one thing: With 6 million people in the United States suffering from Alzheimer's, and current treatments only marginally effective, there is a desperate need for medications that can slow the disease.
But the evidence on Aduhelm so far is contradictory. Two-Phase III clinical trials were stopped early after an independent committee, appointed by Biogen, analysed the data and reported the studies were unlikely to show Aduhelm would demonstrate a benefit.
This is not unusual; clinical trials are often stopped when early data suggests a drug will not work.
After that analysis, Biogen announced it did find benefits that were statistically significant in one of the trials.
This came after evaluating results for 318 participants whose data was not available in time for the initial committee review.
That new data showed the cognitive function of participants in the high-dose group declined 23 per cent more slowly than those in the placebo group.
The low-dose group showed no benefit.
While the effects on cognitive decline may seem ambiguous, Aduhelm indisputably reduces patients' amyloid plaques.
It was on this basis that Biogen sought approval for Aduhelm through FDA's accelerated approval pathway, where drugs treating a serious illness may receive expedited approval if they are reasonably likely to provide a clinical benefit based on some other marker, such as amyloid plaque burden.
Aduhelm is a monoclonal antibody treatment delivered as an infusion. The drug targets amyloid, a protein that clumps in the brains of Alzheimer's patients.
While Aduhelm does reduce amyloid plaques in patients' brains, so do many other medications that haven't been shown to slow cognitive decline. It may be that reducing amyloid plaques does not necessarily improve cognitive function in Alzheimer's patients.
At the core of the question is the amyloid hypothesis, a central concept of Alzheimer's research for decades.
Simply put, the hypothesis assumes that accumulation of the peptide amyloid-B is the primary cause of Alzheimer's. Many researchers believe that it initiates a cascade of processes that include inflammation and the formation of neurofibrillary tangles, made up of the protein tau, within brain cells.
This is thought to lead to dysfunction of the communication points between brain cells known as synapses, which ultimately leads to cell death.
But amyloid plaques are often found in the brains of individuals who do not have Alzheimer's.
The reduced cognitive function seen in Alzheimer's is more closely correlated with the number and location of intracellular tau-tangles. It may be that those with plaques but no symptoms have an early stage of Alzheimer's.
While the benefits of Aduhelm remain murky, some risks are clear. The same Phase III trials showed that 41 per cent of patients who received the high dose of Aduhelm - the dose that may have led to cognitive benefits - experienced cerebral swelling or haemorrhage. Although the majority of these were minor and asymptomatic, a 75-year-old woman in the trial died after experiencing brain swelling and seizures.
The risk was considered high enough for the FDA to require the company to place a warning on Aduhelm's label, advising physicians to monitor patients and obtain two MRI brain scans during the first year of treatment.
Patients selected for the Phase III studies were excluded if they had any of the many medical complications common for older people.
This includes cardiac problems, the use of blood thinners or impaired liver or kidney function. These selected patients, who may be healthier than those in the general public who would receive the medication, underwent not two but seven MRIs for monitoring. MRIs are expensive procedures; they raise the real cost of Aduhelm by about 20 per cent.
Other anti-amyloid immunotherapy medications are in the pharmaceutical pipeline. More data may emerge to suggest these drugs delay progression of Alzheimer's, but so far, the relatively minor cognitive benefits seen do not seem to match the robust reduction in amyloid plaques.
While it's indisputable that Aduhelm can consistently and convincingly reduce the level of amyloid plaques in the brain, the cognitive benefit it provides to patients remains in doubt. This discrepancy speaks to the complexities of Alzheimer's - and the holes that remain to be filled in the understanding of this terrible disease.
Inputs From The Conversation
- healthCan Inhaling Menthol Help Improve Memory For Alzheimer's Disease?
- healthCan Daily Breathing Exercises Reduce Alzheimer's Disease Risk? 3 Exercises To Try
- wellness10 Herbs And Spices That May Help Reduce The Risk Of Dementia
- healthViral Infections May Promote Alzheimer's Like Diseases: Study
- nutritionExpert Article: Nutritional Care And Challenges In Feeding A Patient With Alzheimer’s
- disorders cureHow Are Common Eye Diseases Related To Increased Risk Of Dementia?
- diet fitnessWorld Alzheimer's Day 2022: Expert Speaks About Brain Exercises For Managing Alzheimer’s
- diabetesSome Diabetes Drugs May Help Reduce The Risk Of Alzheimer’s, Study
- wellness12 Amazing Health Benefits Of Turmeric Coffee And How To Prepare It
- nutritionAmazing Health Benefits Of Argan Oil And How To Use It
- healthFDA Approves Most Expensive Drug Ever, Priced At $3.5 Million-Per-Dose For Hemophilia
- disorders cureCOVID-19: FDA Authorizes Blood Purification Device For Treatment Of Coronavirus