Medicare To Limit Coverage Of Alzheimer’s Drug.
The Washington Post (1/11, A1, McGinley, Goldstein) reports that on Tuesday, the Centers for Medicare and Medicaid Services “proposed covering a pricey, controversial Alzheimer’s drug but, in a highly unusual step, restricted it to people enrolled in approved clinical trials, sharply limiting the number of eligible patients.” The draft decision “means the program would cover Aduhelm [aducanumab] and similar drugs in development...only in studies approved by CMS or supported by the National Institutes of Health.”
The New York Times (1/11, A1, Belluck) reports the agency’s final decision is “expected by April 11 after a public comment period that runs from now until mid-February.” HHS Secretary Xavier Becerra on Monday “said that he was instructing CMS to re-examine the premium hike ‘given the dramatic price change of the Alzheimer’s drug, Aduhelm.’”
The Wall Street Journal (1/11, Walker, Subscription Publication) reports that Medicare officials said they would cover Biogen’s drug Aduhelm for Alzheimer’s disease, but on the condition that patients are in clinical trials and have early-stage symptoms.
The AP (1/11, Alonso-Zaldivar) reports, “Medicare said Tuesday it will limit coverage of a $28,000-a-year Alzheimer’s drug whose benefits have been widely questioned, a major development in the nation’s tug-of-war over the fair value of new medicines that offer tantalizing possibilities but come with prohibitive prices.”
NBC News (1/11, Lovelace) reports that despite the move by HHS, “previous statements and confusing data by the company are likely to sway doctors who are still skeptical about recommending the drug.”
Advocacy Groups Vow To Fight CMS Decision To Restrict Coverage Of Alzheimer’s Drug Aducanumab To Patients In Agency-Cleared Trials.
The Washington Post (1/12, McGinley) reports, “Alzheimer’s advocacy groups on Wednesday vowed to fight a preliminary” decision by the Centers for Medicare and Medicaid Services (CMS) to restrict coverage of controversial Alzheimer’s drug Aduhelm (aducanumab) for Medicare patients enrolled in randomized controlled trials cleared by the agency. However, “winning broader coverage could be an uphill fight, experts said.” The Post says that the decision “would have major implications for patients, pharmaceutical companies, insurers, the Food and Drug Administration, Medicare and Medicaid.”
The AP (1/12) reports that CMS’ conditions are “an important caveat because Medicare is expected to cover most of the patients who opt for Aduhelm, and the drug can cost as much as $28,000 annually, not counting expenses for brain scans and other care patients will need while taking it.” The decision could “significantly limit access to Aduhelm, said Mizuho Securities USA analyst Salim Syed,” who “had previously estimated around $3.5 billion to $4 billion in peak annual sales for the drug.” Syed “said Wednesday he now assumes less than $100 million.”
Bloomberg Law (1/13, Subscription Publication) says “limiting Medicare coverage could be detrimental to Black people, Hispanics, and other groups that are typically underrepresented in drug studies, in part because they may not have easy access to them.” Some experts believe CMS “should use this new drug as an opportunity to promote diversity in enrollment and ensure that clinical trial populations are reflective of the communities most impacted by the memory-destroying disease.”
Reuters (1/12, Banerjee, Khandekar) reports, “Medicare’s draft decision essentially crushes any hopes of Aduhelm gaining traction any time soon, J.P. Morgan analyst Cory Kasimov said.” According to Reuters, “Analysts said the decision, if left in place, could result in negligible Aduhelm sales in 2022 and 2023.”
Biogen Vows To Reverse CMS’ Preliminary Decision To Limit Coverage Of Alzheimer’s Drug.
Bloomberg (1/13, Langreth, Peebles) reports Biogen “executives vowed to fight hard to reverse Medicare’s preliminary decision that would sharply limit coverage of the company’s Alzheimer’s drug, while saying more cost cuts and strategic measures are possible if the decision stands.” Just “a small number of patients, perhaps in the hundreds, with the resources and time to travel to major hospitals conducting the trials, would get access to the drug under the rule, Chief Executive Officer Michel Vounatsos said.”
Reuters (1/13, Maddipatla) reports the comments follow the Centers for Medicaid and Medicare Services’ draft decision, “saying it would cover Aduhelm [aducanumab] and similar treatments for” Alzheimer’s disease “only for patients enrolled in approved clinical trials.”
Bloomberg Law (1/13, Castronuovo, Subscription Publication) reports, “Minority groups could have a harder time accessing Biogen Inc.’s Alzheimer’s drug under Medicare’s preliminary decision to limit coverage to patients enrolled in clinical trials, policy analysts say.” The Centers for Medicare & Medicaid Services’ “draft coverage determination aims to allow for additional studies on the effectiveness of Biogen’s Aduhelm [aducanumab],” yet “limiting Medicare coverage could be detrimental to Black people, Hispanics, and other groups that are typically underrepresented in drug studies, in part because they may not have easy access to them.” The National Institutes of Health is mentioned.
CMS Proposal To Only Cover Biogen’s Alzheimer’s Drug For Some Patients Ignites Debate Over How To Improve Treatment Equity.
STAT (1/13, Florko) reports that the Centers for Medicare and Medicaid Services’ proposal to only cover Biogen’s Alzheimer’s drug Aduhelm (aducanumab) for patients enrolled in randomized clinical trials has “reignited a long-simmering debate over how best to address ongoing, systemic inequities in Alzheimer’s care experienced by Black and Hispanic patients.” Some experts “note that only a limited number of people can enter a clinical trial, and that those clinical trials are likely to occur at major medical institutions, which are more often located in wealthy, white areas of the country. Lower-income patients, too, might struggle to access the drug if they can’t drum up nearly $30,000 to pay for it out of pocket.” The National Institute on Aging is mentioned.
Becerra Directs CMS To Reassess Medicare Premiums Given Price Drop For Alzheimer’s Treatment.
The Washington Post (1/10, Goldstein) reports on Monday, HHS Secretary Xavier Becerra “directed Medicare to consider lowering the premium for the part of the program that covers visits to the doctor and other care outside hospitals.” This “marked the first time the vast federal health insurance system for older Americans and those with disabilities has rethought the monthly amount patients pay after a change has gone into effect.” Becerra instructed CMS to make the change, “saying a review of the Part B premium is needed because of a price drop in a controversial Alzheimer’s drug” Aduhelm (aducanumab-avwa) “that Medicare does not yet pay for but might begin covering soon.”
The AP (1/10, Alonso-Zaldivar) reports, “Becerra’s directive came days after drugmaker Biogen slashed the price of its $56,000-a-year medication, Aduhelm, to $28,200 a year – a cut of about half.” Becerra said, “With the 50% price drop of Aduhelm on Jan. 1, there is a compelling basis...to reexamine the previous recommendation.” The article says some “50 million Medicare recipients who pay the $170.10 monthly ‘Part B’ premium for outpatient care will see no immediate change to their costs, but Monday’s move could open the way for a reduction later in the year.”
Major Healthcare Systems Not Offering New Controversial Alzheimer’s Treatment.
STAT Plus (1/6, Florko, Subscription Publication) reports, “Almost no one is prescribing [aducanumab] Aduhelm, the controversial new Alzheimer’s treatment that roiled the health care landscape when regulators approved it this summer.” Major healthcare systems including “the Cleveland Clinic made it clear almost immediately that they wouldn’t offer the new therapy, citing a lack of convincing evidence that the drug actually helps treat Alzheimer’s disease.” STAT “has identified another 15 university-affiliated hospitals that aren’t offering the drug, including Johns Hopkins, University of California Los Angeles, and the University of Michigan.”