Commercial Plans Are Likely to Approach New Alzheimer’s Drug With Caution

Although the recent approval of Kisunla (donanemab) was celebrated by the Alzheimer’s Association as “real progress,” the challenge of getting commercial insurers to cover the drug will likely end up tempering that excitement.

Eli Lilly’s Kisunla, which received full FDA approval on July 2, is a once-monthly, IV-infused treatment for people with early symptoms of Alzheimer’s disease, including mild cognitive impairment and mild dementia. Like the drug Leqembi (lecanemab), which received full approval last July, Kisunla aims to slow the progression of Alzheimer’s by removing amyloid plaques from the brain. (The naturally occurring protein amyloid can create plaques when clumped together, and if those plaques build up excessively in the brain, it may lead to memory and cognitive issues associated with Alzheimer's disease.)

Kisunla stands apart, though, as the first therapy in its class that patients can stop after their amyloid plaques are removed, which Lilly noted “can result in lower treatment costs and fewer infusions.”

The cost for one vial of Kisunla is $695.65, and the total cost of the drug depends on the length of treatment. Lilly said it will cost $12,522 for six months of treatment, $32,000 for 12 months, or $48,696 for 18 months. In a Phase III clinical trial, 17% completed treatment at 6 months, 47% at 12 months, and 69% at 18 months, based on an assessment of amyloid levels via an amyloid PET scan. By comparison, Leqembi has a wholesale acquisition cost of $26,500, but that cost recurs as patients are meant to stay on the drug.

In that same clinical trial, according to Lilly, Kisunla slowed cognitive and functional decline by up to 35% compared to a placebo at 18 months, and it reduced participants' risk of progressing to the next clinical stage of disease by up to 39%.

‘Stringent’ Coverage Conditions Are Likely

While the vast majority of Alzheimer’s patients are Medicare-eligible, those who have early symptoms and are covered by commercial insurance plans could have a difficult time getting reimbursed for Kisunla treatment, suggests Mesfin Tegenu, chairman and CEO of RxParadigm.

“Commercial payers are likely to approach coverage of Kisunla with caution due to its high cost and safety risks,” Tegenu tells AIS Health, a division of MMIT. Like other amyloid-targeting therapies, a major risk associated with Kisunla is brain swelling and bleeding, a group of side effects called amyloid-related imaging abnormalities (ARIA). Although ARIA does not usually cause any symptoms, it can also be fatal.

To Tegenu, Kisunla is “notable” as the first amyloid plaque-targeting drug that allows patients to stop therapy. “However, with an annual cost of $32,000 and significant safety concerns such as brain swelling and bleeding, payers that adopt Kisunla into their medical policies are expected to implement stringent conditions to manage costs and ensure patient safety,” he adds. “Utilization management tools such as prior authorization are expected to be employed to ensure appropriate use.”

Looking ahead, though, “coverage policies will likely evolve as more real-world and ongoing clinical trial data on Kisunla’s long-term efficacy and safety become available,” Tegenu adds.

Last year, Pennsylvania insurers Highmark Inc. and Independence Blue Cross received public criticism from a Philadelphia-area neurology practice for labeling Leqembi “experimental” and thus not covering the drug for their commercial plan members.

NCD Paves Way for Medicare Coverage

As for patients with Medicare — both traditional and Medicare Advantage — the coverage picture is clearer.

Under a national coverage determination (NCD) issued in 2022, CMS said Medicare will cover FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease — a class of drugs that includes Leqembi and Kisunla — but with a few conditions. First, patients must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with documented evidence of beta-amyloid plaque on the brain. They also must be treated by a physician who participates in a qualifying registry to conduct real-world evidence on the drug’s efficacy, with an appropriate clinical team and follow-up care.

Those conditions only apply to amyloid-targeting drugs with a traditional FDA approval, however. Under the same NCD, CMS outlined far more restrictive coverage conditions for such drugs if they go to market under an accelerated approval. To qualify for Medicare coverage, patients taking those drugs must be enrolled in randomized, controlled clinical trials conducted either through the FDA or the National Institutes of Health.

The conditions applied to Biogen’s Aduhelm (aducanumab), a precursor to Leqembi that drew considerable controversy when it received accelerated approval in 2021, a move that conflicted with an advisory committee’s recommendation. Adding to the cloud that hung over Aduhelm, the House Committee on Oversight and Reform and the Committee on Energy and Commerce issued an investigative report in 2022 that found that the effort between Biogen and the FDA to get Aduhelm approved was “rife with irregularities.” Ultimately, Biogen said it would discontinue the development and commercialization of Aduhelm in 2024, and instead focus on Leqembi.

Regarding Kisunla, Lilly noted in a July 2 press release that as of October 2023, broad coverage and reimbursement for amyloid PET scans are available for eligible patients on Medicare. Additionally, more than 98% of eligible Medicare patients “have coverage that eliminates, limits, or caps their annual out-of-pocket exposure” to the costs, the manufacturer said.

The Alzheimer’s Association, meanwhile, heralded the approval of the drug as a promising step toward helping the nearly 7 million Americans struggling with the brain-wasting disease.

“This is real progress,” said Joanne Pike, president and CEO of the patient advocacy group. “Having multiple treatment options is the kind of advancement we’ve all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease.”

The Alzheimer’s Association also sternly warned that “access to these treatments should not be delayed at any stage or by any entity — not the Centers for Medicare & Medicaid Services (CMS) coverage with evidence development policy, private insurers, health systems or doctors.”

This story was reprinted from AIS Health’s biweekly publication Radar on Drug Benefits.