Doctors have concerns and questions about Alzheimer’s drug, Aduhelm® (Aducanumab), on the market for patients September 23, 2021 by Tara Hernandez Aduhelm® (Aducanumab) was approved by the FDA on June 7, 2021, for the treatment of Alzheimer’s disease. To learn more about Aduhelm please click here. Aduhelm® (Aducanumab) was approved by the Food and Drug Administration (FDA) on June 7, 2021. It is the first medication approved by the FDA for slowing the progression of Alzheimer’s disease. However, there are some concerns with the study results upon which the decision to approve was made, said Herman Sullivan, MD, executive medical director, Hauenstein Neurosciences and medical director of the Multiple Sclerosis Clinic at Mercy Health Saint Mary’s. “Not every patient with Alzheimer’s will get this drug,” Dr. Sullivan said. “There are restrictions on who should get it. Patients with mild evidence of the disease could receive it but we have no evidence that it helps patients with moderate to severe Alzheimer’s since they were excluded from the study at enrollment.” “We anticipate prescribing Aduhelm for certain patients once we have further guidance on appropriate pre-requisite testing prior to using the drug and verification on insurance coverage,” Sullivan added. Aduhelm received accelerated approval for its ability to reduce the levels of amyloid protein deposited in the brain as plaques, but not for its ability to slow Alzheimer’s. This effect on the amyloid deposition was seen in a small number of selected patients who received a higher dose in one of the studies. “This drug failed the gold standard testing,” said Dr. Sullivan. “Aduhelm has a biological effect – it removes amyloid and prevents deposition. But the clinical effect has not been verified with a confirming second study. It’s like prescribing a drug that will bring your blood pressure down but has no evidence it will decrease the risk of a stroke, heart attack, or kidney disease. So, the question is – will you benefit from being on the drug? Right now, we have more evidence that you will not.” Additionally, there are safety concerns with the use of the drug. Approximately 40-percent of patients in testing developed ARIA (amyloid related imaging abnormalities), a type of brain swelling with and without small brain hemorrhages in an already injured brain due to the Alzheimer’s disease itself. Given this, it is appropriate for practitioners and patients to proceed with due caution when prescribing and receiving this drug. “There is a safety issue. There are concerns about other effects but based on the biological measure that it reduces amyloid deposition; the FDA overruled the Advisory Committee’s recommendation and said, ‘We’re going to approve your drug.’ To me, there is not substantial clinical evidence to approve it for use,” said Sullivan. Furthermore, the FDA has requested that Biogen conduct another study to show safety and efficacy – the kind of study that should be done prior to approval. Biogen is to complete the study within nine years. It is possible that this study will show that Aduhelm does not work. The cost of Aduhelm will be extremely expensive and prohibitive as well. “It’s not the most expensive drug but the added costs of monitoring scans, preliminary screening and duration of treatment, all add up,” said Sullivan. “The yearly cost for drug utilization will be quite hefty.” Mercy Health is reviewing more information to determine how to best implement this medication into practice. Clinics will not be able to widely dispense the medication until Medicare, Medicaid and third-party payer requirements for coverage are known. Only then will it be available on a limited basis. Share this: TwitterFacebook Like this: Loading... Top News Aducanumab, Aduhelm, alzheimers, Neuro, Neurology Baby Born at Mercy Health Saint Mary’s with Same Nurse Attending Who Helped Deliver Mother 26 Years Ago National Train Your Brain Day Challenge Share Your Thoughts Past Articles December 2021 November 2021 October 2021 September 2021 August 2021 July 2021 June 2021 May 2021 April 2021 March 2021 February 2021 January 2021 December 2020 November 2020 October 2020 September 2020 August 2020 July 2020 June 2020 May 2020 April 2020 March 2020 February 2020 January 2020 December 2019 November 2019 October 2019 September 2019 August 2019 July 2019 June 2019 May 2019 April 2019 March 2019 February 2019 January 2019 December 2018 November 2018 October 2018 September 2018 August 2018 July 2018 June 2018 May 2018 April 2018 March 2018 February 2018 January 2018 December 2017 November 2017 October 2017 September 2017 August 2017 July 2017 June 2017 May 2017 April 2017 March 2017 February 2017 January 2017 December 2016 November 2016 October 2016 September 2016 August 2016 July 2016 June 2016 May 2016 April 2016 March 2016 © 2021 Trinity Health