George Vradenburg, JD, the chair and cofounder of UsAgainstAlzheimer’s; and Ian N. Kremer, JD, executive director, Leaders Engaged on Alzheimer's Disease, offer their insight into the downstream effects of the new pricing of Biogen’s aducanumab (Aduhelm).
Earlier this week, Biogen announced that as of January 1, 2021, it was adjusting the wholesale acquisition cost of its new antiamyloid antibody for the treatment of Alzheimer disease (AD), aducanumab (Aduhelm), reducing it from the current cost of $56,000 yearly down to $28,200 yearly for the maintenance dose (10 mg/kg) for individuals of average weight (74 kg), a reduction of 50.3%.1
The company additionally announced that it plans to implement a series of “cost-reduction measures” in the next year “to better align its costs with its revenue base,” which it anticipates to be affected by the introduction of generics for the treatment of multiple sclerosis that compete with its agents, as well as the delayed uptake of aducanumab in the clinic.1 Financial reports from October 2021 suggested that the delayed uptake was significant, with the treatment only generating $300,000 in sales—drastically different from the $16M projections that were being levied by experts.2
This news came on the heels of months of debate in the field about the price and efficacy of aducanumab, and just a short time ahead of a pending decision from Centers for Medicare & Medicaid Services (CMS) on the potential coverage of the therapy, which could have implications that span across the breadth of Alzheimer care. An estimate from July published in JAMA suggested that if only 10% of those with AD were prescribed aducanumab at its original list price, spending for Medicare Part B would nearly double—from $37 billion to $69 billion per year.3
To find out more about the impact of this price reduction from an advocacy and a policy standpoint, NeurologyLive® reached out to experts in both of those respective areas: George Vradenburg, JD, chair and cofounder, UsAgainstAlzheimer’s; and Ian N. Kremer, JD, executive director, Leaders Engaged on Alzheimer's Disease (LEAD Coalition).
George Vradenburg, JD: We are excited and grateful. We have been pushing Biogen publicly and privately to reduce the cost of Aduhelm. Now that they have, more Alzheimer patients will have access to a treatment that has been proven to work, confirmed by the FDA as safe and effective. So, this is very good news, particularly for those in the early stages of dementia.
Ian N. Kremer, JD: Since the original price was announced, I have been pressing Biogen to make a substantial reduction of 50% (or more) and to be transparent about how the company determines prices. So I am gratified that Biogen has taken this first step, which is vitally important for people facing Alzheimer disease, their families, and the health care system. I also am pleased that Biogen has made public its estimate that approximately 50,000 people may initiate treatment in 2022. Many of the uptake estimates swirling in the media and among some policy-makers have been wildly irresponsible and have contributed to unconscionable decisions such as Medicare blaming people with Alzheimer disease for its planned premium increases. That patient-blaming struck me as fundamentally contradictory to Medicare’s mission; Medicare ought to have been celebrating the possibility of a first-ever disease-modifying therapy in an area of dire unmet need.
George Vradenburg, JD: There’s no question there’s been hesitancy because there’s been uncertainty regarding Medicare coverage. We’re hopeful Medicare will cover the drug and that hesitancy will dissipate.
Ian N. Kremer, JD: Uptake of Aduhelm would have been slowed by societal and health system barriers, even if there had been no controversy around its trial results or pricing. Those barriers remain. The vast majority of people who could be eligible for Aduhelm—those with mild cognitive impairment (MCI) due or mild (early stage) dementia due to Alzheimer disease—do not get diagnosed early enough in their disease progression even to consider this treatment.
That delayed diagnosis speaks to factors including widespread stigma about the disease, shocking shortages of specialists such as neurologists, geriatric psychiatrists, and geriatricians, and woefully lacking gaps in anti-discrimination laws. But even for people who have a standard clinical diagnosis, they face additional health system barriers to access. Aduhelm, and most likely the other amyloid targeting medications that may be available in the next few years, rightly requires confirmation of amyloid in the brain; typically, that amyloid confirmation will necessitate either PET imaging that most Americans cannot afford while CMS and most private insurers refuse coverage or CSF testing that most Americans are not willing to undergo. So, reducing the price of Aduhelm is an enormously positive step that will help some people and their doctors be able to consider whether this therapy is the right option, but for most people with MCI or mild dementia due to Alzheimer disease, the reduced price will not be enough to overcome all the other societal and health system infrastructure barriers.
George Vradenburg, JD: We expect a positive National Coverage Decision as a result of this announcement by Biogen. Aduhelm is the only treatment on the market to change the course of Alzheimer’s and the first one to be approved by the FDA in nearly 20 years. They’re the ones who determine whether a drug works and they see the promise in this first-in-class treatment. Aduhelm also announced last week it was going to speed up its confirmatory testing by five years. Clearly, they are working hard to make Aduhelm as safe, effective, and accessible as possible.
Now it’s time for CMS to do two things. First, reverse its planned Part B premium increase, which it blamed on Alzheimer patients. Second, CMS needs to issue a National Coverage Determination making Aduhelm available to any Alzheimer patient who needs it.
Ian N. Kremer, JD: While CMS is not supposed to take into account pricing as it makes coverage determinations, I remain deeply concerned that CMS’ previous public statements (such as blaming people with Alzheimer disease for its planned Medicare premium increase) demonstrate price could influence decisions. This would be inappropriate even if the National Coverage Determination (NCD) ruling applied only to one medication with an announced price. But CMS—by its own choosing—is making this NCD about the entire class of amyloid therapies and that then sweeps in numerous medications that have not yet finished their clinical trials, been reviewed by FDA, or had prices announced. We all should hope that pricing does not enter into the CMS decision-making process for this or any other NCD.
Ian N. Kremer, JD: In the abstract, lower pricing inherently reduces direct expenditures for states or other insurance payers. But states never should consider abandoning people with Alzheimer disease. Ageism and ableism are not acceptable policy.
Transcripts edited for clarity.