
Feeling unsure how to model and predict one of the hottest growing drug segments, Neurology? You are not alone. The main condition of focus, Alzheimer’s, has been steeped in controversy leading to a roller coaster of expected costs. One day analysts are stating they expect wide-scale use of a new Alzheimer’s drug with significant budgetary impacts and the next day the projections are greatly diminished. Think back to the significant headlines for the potentially explosive use of Aduhelm. Within days a new headline emerged stating several of the FDA Advisory Physicians resigned in protest over the approval to make a public statement and warn against such wide-scale use. The impact change was dramatically shifted, and Biogen eventually announced its market removal in February 2024.
From soaring profits to market removal, it’s easy to see how a lack of confidence emerges in this class. Today, the most recent shock is being felt within the financial predictions sharply increasing Medicare spend for a similar, yet different drug, Leqembi. Due to many similarities to Aduhelm, utilization predictions initially started very low for this new drug Leqembi. This time the roller coaster is going in reverse. The low utilization expectation is now taking off due to an updated accelerated approval to full approval status. Despite continued clinical and safety concerns, Leqembi is skyrocketing in expected use. This isn’t just a Medicare issue, as many people know. Alzheimer’s is one of the main drivers for neurological spend, according to the IQVIA 2024 Global Use of Medicines report . IQVIA anticipates as many as 50 novel therapies in the next 5 years will emerge in the market. Many of the new Alzheimer’s therapies will continue to be for “early in disease” or “mild” disease which can occur much younger in age.
Yesterday’s discussions for Aduhelm and today’s for Leqembi are the beginning of many more headlines to come. No known curative options are expected in the immediate future. Therefore, let’s dive deep into what we should expect ranging from symptomatic treatments to stem cells. The chart below shows the multitude of development for this disease:
Here are a few meaningful take-aways from the data:
There were 187 Phase 1, 2 or 3 clinical trials registered with ClinicalTrials.org.
Approximately 10-15 treatment categories include a variety of unique targets, providing hope that patients will benefit from the potential variety of treatment options.
Trials include 141 unique therapies highlighting:
8 Stem cell opportunities exist, early in the development.
28% are repurposed drugs, most of which are generic formulations.
A few suggestions for how we can leverage this information:
Talk with your provider (or provide a plan design) about clinical trial options. Of those open trials identified in the graphic, 57,465 patients were needed to enroll. Greater than 70% of the required patients are specifically needed in Phase 3 trials. With numerous agents seeking accelerated approval, it is a worthy conversation to start these therapies within the clinical oversight of a trial, full of experts ready to assist and track long-term outcomes. Encouraging clinical trial enrollment also increases the enrollment period efficiency.
With almost one-third of drugs in clinical trials being studied are repurposed agents (drugs already proven to be safe and on the market for a different indication) this is a great opportunity to bring lower cost agents (typically generic or biosimilar) to the market. Funding for repurposed drugs is 80% driven from NIH, academic, advocacy and philanthropy. Plan sponsors can assist by encouraging members to learn and enroll in these trials, if appropriate. Plan sponsors may even consider helping to fund some of these trials, allowing more market access to reasonably priced agents.
If drug spend trend in neurology wasn’t on your radar, ask your advisors and vendors what they predict. Ask for their coverage rules specific to Leqembi. Do not be intimidated to mention reports from groups like ICER, Alzheimer's Disease - ICER, who compile the outcomes and compare the price to health outcomes the drug is expected to provide. Use today’s coverage discussions to stand firm on fair pricing and access to Leqembi. Leqembi continues to chase a surrogate end-marker that has many open questions for long-term effects compared to the safety risk of brain bleeds (1 in 15 will have microhemorrhages compared to placebo, while 1 in 25 will stop due to an infusion reaction). If your vendor does not have appropriate clinical management rules and reasonable prices, go another route. Provide members with a safer, more affordable option. Educate them to the potential power of enrolling in a clinical trial.
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