There have been a lot of news stories about pharmaceutical treatments for memory care disorders over the past few years. Understandably, healthcare leaders and patients are hoping for an effective treatment for Alzheimer's and other dementias.
We wanted to understand how likely this is. In this piece we examine the state of the memory care drug pipeline, to determine the likelihood of a paradigm-shifting pharmaceutical product hitting the market in the next five years.
We also explore what the effects of the pipeline analysis are for drug manufacturers in this space, and how they can leverage cross-stakeholder relationships to better position themselves for success in this difficult market.
Drug manufacturers have spent billions of dollars over the past three decades searching for a treatment that could effectively treat the progression of memory care diseases, but have yet to successfully identify one.
Manufacturers continue to pour large sums of money into this product line, so we examined what the likelihood is of a successful memory care treatment hitting the market in the next five years according to EvaluatePharma:
While there have been some promising reports emerging from the clinical trials of the two treatments hitting the market in 2023 that target the progression of Alzheimer's—Eisai/Biogen's Lecanemab and Eli Lilly's Donanemab—how well these therapies will work in the broader population remain to be seen. If neither of those therapies prove to be broadly effective—and history tells us that the odds are against them—the outlook for a transformative pharmacological intervention in memory care looks unlikely.
Only Anavex's Anavex 2-73 drug is given a better than 50% chance of making it to market in that timespan, so while it is certainly possible that a product could emerge from the life sciences that would reshape the memory care landscape, it appears unlikely that this will be the case in the near to mid-term.
Although manufacturers have spent billions of dollars in search of "breakthrough" drugs for memory care patients, this decades long search has largely been a history of failures. Recent revelations that call into question the validity of the research which claimed to uncover the biomechanical source of Alzheimer's (the build-up of the protein amyloid beta in the brain)—on which most pharmaceutical development for Alzheimer's drugs is based—has only reenforced this narrative around the futility of memory care drug development.
In 2021 Biogen brought their Alzheimer's drug Aduhelm to market but found few payers that were willing to cover it even after a 50% price reduction. The treatment successfully reduces amyloid beta protein build up in the brain for most patients, but stakeholders have remained unconvinced that it can produce consistently demonstrable outcomes across its indicated population.
This is in part due to new FDA oversight regulations, which have lowered the threshold for market approval so long as clinical trial evidentiary guidelines are followed. Moving forward, payers and providers are increasingly demanding evidence that drugs (especially high costs ones) will be effective from a clinical and cost perspective over time. This will require drug manufacturers to move beyond randomized clinical trials and invest in real-world evidence.
So, while the Aduhelm experience is the latest chapter in the longer narrative of challenges for the life sciences in this domain, it also marks a new direction in this story for the relationship between manufacturers and their purchasers.
In the face of the changes made by FDA, and the challenges Biogen faced convincing payers to cover Aduhelm, Eli Lilly is taking a mixed approach with their upcoming Alzheimer's drug, Donanemab. Eli Lilly has asked the FDA for accelerated approval in order to get their product enough market exposure to gather sufficient post-market, real world evidence to apply for full FDA approval down the road.
Eli Lilly's recognition that clinical trial data alone will likely not be enough to convince payers (particularly CMS), which have become skeptical of the efficacy of Alzheimer's drugs, to cover Donanemab illustrates how important it will be for manufacturers of memory care treatments to demonstrate real world outcomes for their products.
This increasing emphasis on real world evidence will require manufacturers to explore new, cross-stakeholder relationships with providers and Health IT organizations in order to quickly and efficiently gather data from the market.
Anne White, the head of Eli Lilly's neuroscience division, noted in a recent earnings call that Lilly plans to "build out the diagnostic ecosystem, to help physicians with the referral process and infusion systems" in the period between accelerated and full FDA approval, with the hope that "CMS would not continue to limit coverage for on-label treatments" after full approval.
We expect other manufacturers in the memory care space to follow this example and treat FDA approval process as another step toward gathering the kinds of real-world evidence necessary to convince skeptical payers to cover their treatments.
Organizations in the senior care marketplace are being challenged to address the needs of a growing number of older Americans with a workforce that is limited in size and exhausted from the pandemic. Innovators in this space are experimenting with new technologies and non-traditional collaborations to better meet the needs of this population.
Download this market scan to learn about the current innovators in the senior care landscape and their future outlook.
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