Uptake of Leqembi for Alzheimer’s may be slow

Full FDA approval of Eisai and Biogen’s Alzheimer’s disease therapy Leqembi may have unlocked the door to a broader rollout of the drug and potentially blockbuster sales, but commentators think uptake could initially be slow.

The regulatory milestone means that Medicare will cover most of the cost of the $26,500 per year anti-amyloid therapy, giving patients the option of accessing a disease-modifying drug for Alzheimer’s for the first time outside of a clinical trial.

The Centers for Medicare and Medicaid Services (CMS) indicated that it will foot the bill for 80% of the drug’s cost through Medicare Part B, which covers drugs administered to older patients in physicians’ offices or hospitals. That means patients will have to pay 20% of the approved amount for Leqembi once they meet their Part B deductible, either out of pocket or through secondary insurance.

The cost will have to be balanced against the modest slowdown in clinical decline that Leqembi (lecanemab) achieved in clinical trials, the risk of uncommon but potentially life-threatening side effects that are listed in a black box warning on its label, and additional healthcare costs stemming from clinic visits and diagnostic tests.

Analysts at Jefferies said the decision by the FDA to use its strongest warning was unexpected and could slow down Leqembi’s sales growth.

The antibody is administered by intravenous infusions in a doctor’s office or clinic every two weeks and will be available for people diagnosed as having early-stage Alzheimer’s, as well as for those with Alzheimer’s-related mild cognitive impairment and amyloid plaques in the brain.

Take-up of treatment could also be limited by access to infusion clinics, which can be patchy across the US, as well as to the PET scans needed to check amyloid levels in the central nervous system before treatment and every few months thereafter.

That could add logistical, as well as financial, barriers for some patients, as there is still some uncertainty around Medicare’s reimbursement policy for those tests, according to analysts at RBC Capital Markets cited by Barron's.

Other potential bottlenecks for treatment include the recommendation for genetic tests to look for the APOE4 gene mutation, as patients with two copies of that are at elevated risk of side effects from the drug, as well as the need to be enrolled in a patient registry that will be used to gauge the effects of Leqembi in a real-world setting over the coming years.

Patients organisations have said they are concerned that access to healthcare providers willing to participate in the registry programme may also be limited, particularly in rural areas and those without large, urban hospital systems.

Eisai – which is taking the lead on the commercialisation of Leqembi – said it has set up a patient assistance programme to provide the drug at no cost to “eligible uninsured and underinsured patients, including Medicare beneficiaries, who meet financial need and other programme criteria.”

It has previously said it expects sales of the drug to reach $7 billion by the end of the decade.

With full approval in hand for Leqembi, eyes are turning to Eli Lilly’s rival amyloid therapy donanemab, which is also gunning for full FDA approval and has the advantage of only needing to be infused once a month. The FDA is expected to decide on donanemab’s approval either later this year or early in 2024.

Another Biogen and Eisai drug – Aduhelm (aducanumab) – was given accelerated approval by the FDA in 2021, but questions about its efficacy led to CMS placing restrictions on its use and it never made any headway in the market.