{"id":6024,"date":"2021-08-12T17:02:39","date_gmt":"2021-08-12T22:02:39","guid":{"rendered":"https:\/\/www.appliedpolicy.com\/staging\/7403\/?p=6024"},"modified":"2021-08-20T10:59:49","modified_gmt":"2021-08-20T15:59:49","slug":"presidents-blog-cms-is-not-prepared-for-aduhelm","status":"publish","type":"post","link":"https:\/\/www.appliedpolicy.com\/staging\/7403\/presidents-blog-cms-is-not-prepared-for-aduhelm\/","title":{"rendered":"President’s Blog: CMS Is Not Prepared for Aduhelm"},"content":{"rendered":"

[vc_row full_width=”stretch_row” gap=”35″][vc_column][vc_column_text]Two years ago, in my role as Chairman of the Board of the Alliance for Aging Research, I wrote<\/a> about the failure of CMS to adequately reimburse for the use of PET amyloid scans to help diagnose Alzheimer\u2019s disease. At that time, I noted that with the appropriate use of PET scans, which can detect the presence or absence of amyloid plaque, a marker of Alzheimer\u2019s, \u201cthousands of individuals would avoid the angst of an incorrect Alzheimer\u2019s diagnosis and receive precise and effective medication for a potentially more treatable condition.\u201d In other words, a PET scan can let a patient know if they might have Alzheimer\u2019s.\u00a0 Just as important, it can confirm that they don\u2019t.<\/p>\n

Two years down the road, for the first time in almost twenty years, we have FDA approval of a drug – Aduhelm – \u00a0that could offer hope to some Alzheimer\u2019s patients.\u00a0 Once again, we are stalled by CMS inaction along with FDA equivocation about the effectiveness of the drug, and sticker shock at the manufacturer\u2019s stated price for a year of treatment with the drug. With no CMS action related to reimbursement for the drug at the time of FDA approval, the discussion around it has been framed as, \u201cHow much should we pay as a society for a drug that is only slightly effective.\u201d\u00a0 More appropriately, we should be asking, \u201cHow will this medication be made available currently to Alzheimer\u2019s patients who have no other alternative, and how can we use this drug to spur innovation in the treatment and potential cure of Alzheimer\u2019s?<\/p>\n

The situation is now further exacerbated by the announcements from the Cleveland Clinic and Mount Sinai Hospital in Manhattan that they will not administer Aduhelm because of concerns about its safety. The drug is being made available under a program called accelerated approval, \u201cto provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit.\u201d<\/p>\n

Simply put, this approach allows drugs that have not yet met the usual rigorous standards set by the FDA but have shown some promise to nonetheless be taken to market to meet a critical need.\u00a0 In this case, the manufacturer of Aduhelm, Biogen, is being required to conduct a Phase 4 trial, usually referred to as post-marketing surveillance.\u00a0\u00a0 This allows researchers to follow the impact of a drug in the marketplace at large, to bring to the surface any problems with the drug, and to further assess its benefits.<\/p>\n

The cost of the drug has gotten almost more attention than its safety or efficacy, with an estimate from the manufacturer of $56,000 a year per patient. If, indeed, the Aduhelm were prescribed to just one in four Alzheimer\u2019s patients in the United States the bill would be $29 billion annually. The FDA has now taken action to limit prescribing to early onset patients, but the issue of cost related to Aduhelm remains unresolved.<\/p>\n

CMS has yet to offer any details about how it might handle coverage for this medication, announcing last month that they are \u201cbeginning a review\u201d to decide whether and how to standardize coverage of the drug.\u201d Aduhelm has been undergoing intensive clinical trials for the last seven years.\u00a0 Given that this drug came to market with extensive prior warning, CMS\u2019 lack of preparedness seems almost negligent<\/a>.<\/p>\n

There are, of course, multiple issues that need to be considered as this drug becomes available for health care providers and patients: the side effects, small brain bleeds, are not insignificant. The drug needs to be given monthly by infusion, necessitating a trip to the hospital or doctor\u2019s office. The medication has shown promise primarily among those with very early onset Alzheimer\u2019s. And even the most promising study shows only modest improvement in cognitive ability of patients.<\/p>\n

But the fact is that Alzheimer\u2019s is a devastating disease, with few treatments for symptoms, much less any drug that will stall or reverse the disease progression. And for Alzheimer\u2019s patients and their families, for the past two decades, hope has always been just over the horizon, just one more clinical trial away.\u00a0 The fact is that we have a medication now that shows promise, and failing to use it might deny patients a better life.\u00a0 Just as important, it also could point the way to new research. \u00a0This is the first drug to actually slow the progression of Alzheimer\u2019s disease and, according to the Alzheimer\u2019s Association website, \u201cis a milestone in the treatment of the disease and a beginning of a completely new future for Alzheimer\u2019s treatments.\u201d But until CMS creates some sort of certainty surrounding reimbursement issues, so that the focus can turn appropriately away from costs and more towards patients and ongoing research, hope for Alzheimer\u2019s patients will continue to be a future wish than a present reality.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_tweetmeme share_via=”AppliedPolicy”][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"

[vc_row full_width=”stretch_row” gap=”35″][vc_column][vc_column_text]Two years ago, in my role as Chairman of the Board of the Alliance for Aging Research, I wrote about the failure of CMS to adequately reimburse for the use of PET amyloid scans to help diagnose Alzheimer\u2019s disease. At that time, I noted that with the appropriate use of PET scans, which […]<\/p>\n","protected":false},"author":10,"featured_media":6026,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","ap4_related_services":"","footnotes":""},"categories":[436],"tags":[603,605,539,604,60,161],"class_list":["post-6024","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-healthcare-policy-development","tag-aduhelm","tag-aduhelm-coverage","tag-alzheimers-disease","tag-alzherimers","tag-cms","tag-health-policy"],"yoast_head":"\nPresident's Blog: CMS Is Not Prepared for Aduhelm - Applied Policy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/appliedpolicy.com\/presidents-blog-cms-is-not-prepared-for-aduhelm\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"President's Blog: CMS Is Not Prepared for Aduhelm - Applied Policy\" \/>\n<meta property=\"og:description\" content=\"[vc_row full_width=”stretch_row” gap=”35″][vc_column][vc_column_text]Two years ago, in my role as Chairman of the Board of the Alliance for Aging Research, I wrote about the failure of CMS to adequately reimburse for the use of PET amyloid scans to help diagnose Alzheimer\u2019s disease. 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