Implications for radiology following the FDA’s approval of new Alzheimer’s treatment from Eli Lilly
The U.S. Food and Drug Administration approved a new treatment for Alzheimer’s disease on Tuesday with implications for the radiology industry.
Kisunla is indicated for adults with mild cognitive impairment or dementia classified at a mild stage of the disease. It’s administered via intravenous infusion every four weeks, according to an FDA announcement.
Providers are required to obtain a recent baseline brain MRI prior to initiating treatment and confirm the presence of amyloid beta pathology, according to prescribing details. And individuals also must undergo an MRI prior to the second, third, fourth and seventh infusions.
Brian Tanquilut, a research analyst with financial services firm Jefferies, believes the drug's approval will have a sizable impact on radiology.
"Alzheimer's presents a potentially significant opportunity for the diagnostic imaging space as new drug therapies require at least one PET scan and multiple MRIs," he told Radiology Business. "As we look at the new LLY drug, it requires 5 MRIs and those scans are more front-end loaded than the cadence required for [rival Alzheimer's drug] Leqembi. Even if patients choose to go down the spinal tap route to qualify for the therapy, we see access expansion and the resulting uptick in MRI demand as a notable positive for diagnostic imaging providers."
Along with the regimen of required MRIs, Manufacturer Eli Lilly also suggests that providers consider halting use of Kisunla based on the reduction of amyloid plaques to minimal levels on PET imaging.
“Kisunla can cause amyloid-related imaging abnormalities or ‘ARIA.’ This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal,” Lilly said in the “warnings” section of its announcement on the FDA approval. “Your healthcare provider will do magnetic resonance imaging brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms,” the company added later.
ARIA most commonly appears as temporary swelling in parts of the brain that usually go away after time. Some also may have spots of bleeding on the surface or inside of the brain and, infrequently, larger areas of bleeding can occur. Although most do not have symptoms, some may experience headaches, dizziness, nausea, difficulty walking, confusion, vision changes and seizures.
The total cost and out-of-pocket charges for Kisunla will vary based on whether the patient completes treatment and their insurance type. Coverage and reimbursement are available for eligible individuals on Medicare via a National Coverage Determination, Lilly noted. As of October, broad coverage and reimbursement for amyloid PET scans are available for those using the federal payment program. The manufacturer estimated that course of therapy costs could range from $12,522 for those treated in a six-month span to $48,696 on an 18-month basis. A single vial of the drug costs about $695.65.
“As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients," Howard Fillit, MD, co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation, said in the Lilly announcement.
Money implications for radiology
Kisunla could generate peak sales of up to $7.1 billion for the company, BMO estimates. Seeking Alpha Analyst Stephen Ayers, meanwhile, expects a high water mark between $2 billion and $5 billion. However, it’s unclear yet how much of a monetary impact its approval will have on radiology.
This marks the third addition to a new class of drugs geared toward slowing the brain’s decline. Leqembi from Eisai and Biogen operates in a similar fashion, while another dug from Biogen called Aduhelm was discontinued earlier this year. Ayers said he anticipates that Kisunla will have a leg up on its predecessor.
“While there is a lot of uncertainty about drugs like Kisunla and Leqembi in the AD market, I believe Eli Lilly’s Kisunla is a better choice,” he wrote. “Kisunla likely adds another blockbuster to Eli Lilly’s arsenal and investors should appreciate the diversity in therapeutic indications.”
An analysis published last year in JAMA Internal Medicine estimated that the approval of Leqembi could spur upward of $500 million in new Medicare spending on imaging. The drug requires a similar regimen of PET scans and follow-up MRIs after infusions. In 2021, radiology stakeholders anticipated a surge in imaging use after the approval of Aduhelm, though questions about the drug’s efficacy and the eventual discontinuation likely curbed the results.
“If [Aduhelm] reaches a significant number of patients who are considered eligible, it has the potential to increase the demand for brain MRIs pretty substantially. And of course, MRI scanners across the country generally are pretty busy already,” Eric Rohren, MD, PhD, associate chief medical officer for clinical research and education at Radiology Partners, said three years ago. “Radiology is going to be a major partner in the treatment of these patients. I’m excited to see where this all goes. It could truly be a gamechanger,” he added later.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.