With the full FDA stamp of approval on Eisai and Biogen’s Leqembi and regulatory decision on Eli Lilly’s donanemab expected by the end of this year, multiple arms of the healthcare industry stand poised for a cascade effect of increased demand—and considerable profit.
As many as 100,000 people are estimated to receive Leqembi by 2026, and that number is projected to grow as Alzheimer’s diagnoses more than double over the next 25 years. With an annual price tag of $26,500, the therapy will net a tidy income for its co-developers. But this number doesn’t come close to accounting for the profits that will funnel through to genetic test makers, medtech companies, infusion and imaging centers and healthcare providers involved in the complex treatment plan.
Here’s a breakdown of where the cash will flow.
Amyloid Burden of Proof
To qualify for treatment with an anti-amyloid antibody, a patient first must be diagnosed with mild cognitive impairment (MCI) or mild dementia with confirmed presence of amyloid-beta deposits, a hallmark of Alzheimer’s disease. While a cognitive assessment can be given by any primary care physician, amyloid confirmation requires specialized testing in the form of either an amyloid positron emission tomography (PET) scan or a cerebral spinal fluid (CSF) assay.
The cost of PET scans of the brain—the gold standard for amyloid confirmation—can range from $2,200 to $10,700. Howard Fillit, co-founder and CSO of the Alzheimer’s Drug Discovery Foundation (ADDF), told BioSpace he finds PET scans “very useful” for a definitive diagnosis.
Historically, use of the technology was restricted to those patients who were able to pay privately. But in July, the Centers for Medicare and Medicaid Services (CMS) proposed broader coverage for these diagnostics, looking to remove the once-per-lifetime limit on amyloid-beta PET scans that largely restricts their use to clinical trials.
With Medicare coverage, the use of these technologies will be greatly expanded and “improve the quality of diagnosis and quality of care for patients,” said Fillit, who counsels patients in a private practice. The ADDF provided early seed-funding for the Amyvid PET scan.
On its second quarter earnings call, GE Healthcare touted the commercial launch of Alzheimer’s treatments as a “profound growth opportunity” for all firms offering PET scans and molecular imaging, though CEO Peter Arduini said the opportunity would not be significant in 2023.
At around $1,000 a piece, CSF assays are more cost effective than PET scans, and neurologists who spoke with BioSpace said they have often relied on these tests for better insurance coverage. But many patients are hesitant to endure the discomfort of a lumbar puncture.
“My suspicion is that a lot of patients would prefer to have a PET scan as opposed to having a lumbar puncture,” John Dickson, attending neurologist at Massachusetts General, told BioSpace. It’s also unclear at this point if a CSF assay is sufficient to qualify patients for CMS coverage of Leqembi treatment.
Blood tests are also in the works to detect amyloid plaques, even in patients not yet experiencing cognitive decline. Quest Diagnostics recently launched the AD-Detect test, the first direct-to-consumer blood test for abnormal levels of amyloid-beta protein. The test has a $399 price tag, plus a $3 physician fee, but it is not endorsed by Quest as a diagnostic tool; rather, it is meant to reflect Alzheimer’s disease risk. C2N Diagnostics has a commercially available test in the U.S. that is similarly targeted at determining the risk of developing Alzheimer’s disease, specifically among individuals experiencing symptoms of dementia.
In the future, “blood-based biomarkers may make it even easier to get that definitive diagnostic determination,” Fillit said. They could also offer a more accessible option for patients, particularly in rural areas that may not have access to well-equipped radiology centers, he pointed out.
The Alzheimer’s disease diagnostic market is expected to grow close to 9% by 2030, reaching $7.1 billion.
Safety First: Genetic Testing and MRI
Once a person has been diagnosed with mild dementia or MCI with proof of amyloid, they’re still not ready for treatment just yet. Leqembi was approved with a boxed warning—treatment can cause amyloid related imaging abnormalities (ARIA), temporary brain swelling and/or bleeding that can be life-threatening. Any medicine in this class of anti-amyloid antibodies, which also includes donanemab, is likely to come with the same warning.
The risk of developing this side effect is particularly high for any patient carrying two copies of the APOE ε4 gene variant, according to the label. The variant is known to increase the risk of developing Alzheimer’s disease. Doctors are strongly advised to perform a genetic test on patients prior to the start of treatment.
Genetic tests for APOE ε4 are available for both doctors and patients to order. The popular genetic test maker 23andMe has an FDA-authorized health service kit for $229, which would include the APOE ε4 allele.
“It’s a broad screen for health information, so people purchase the test for a variety of reasons, one of which is to learn of their late-onset Alzheimer’s risk pertaining to the APOE variants we test for,” Andy Kill, 23andMe’s communications director, told BioSpace.
Another component of treatment risk assessment is a baseline MRI of the brain, required by Leqembi’s label, to check for pre-existing ARIA before treatment. Appropriate use guidelines also require serial MRIs before the 5th, 7th and 14th infusion, and anytime there is a symptom such as dizziness or confusion that could be related to drug effect.
An MRI of the brain can range from $1,600 to $8,400. It is unclear at this point how comprehensive CMS coverage will be for the repeated brain scans.
“The additional cost of these serial baseline and serial MRIs is also not insignificant when we think about the budget impact from the number of patients who will be treated,” Fillit said.
Ongoing Visits: Infusion Centers
The new amyloid-targeting antibodies will be administered as intravenous infusions over approximately one hour. Leqembi is administered every two weeks, and its use does not define a stopping point for treatment. Meanwhile, donanemab has a schedule of once every four weeks, with treatments lasting until a patient’s amyloid was cleared below a certain threshold—upwards of 18 months. Treatment with either drug will add up to a lot of visits to infusion centers.
Fillit said some neurologists are setting up their own small infusion centers in office in order to administer the treatment to their patients.
“I think we’re going to see several models of care evolve with this, depending on the setting,” he said.
The Fuller Cost Impact
After taking into account patient management, physician oversight, imaging and infusions, the cost of treatment with Leqembi—and, if approved, donanemab—increases substantially over the baseline pricetag.
The Institute for Clinical and Economic Review (ICER) estimates that treatment could cost U.S. taxpayers $82,500 per patient per year, on average.
While the approval of the first disease-modifying treatment for Alzheimer’s disease is landmark, analysts aren’t predicting a speedy uptake of the treatment. Both Biogen and Eisai are guiding investors toward a measured launch as the healthcare system adopts the necessary infrastructure.
“What we are finding are a diverse set of opinions [from physicians] on expected usage with both extremes captured in the range,” Salim Syed, a Mizuho analyst who covers Biogen, told BioSpace.
In his small practice, Fillit is already seeing a demand from patients wanting to know more about Leqembi and where they can get it. Most are interested in trying it, even once counseled on the risks, he said.
“From a Wall Street perspective, investors are not modeling in a significant amount of Leqembi sales in the near-term, but still expect peak sales for this product to be quite large,” Syed said—potentially “north of $10 billion.”
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