Skip to content

This Site is Intended for Healthcare Professionals Only

Search AI Powered

Latest Stories

Eisai, Biogen Alzheimer's disease drug could be available to some as early as next year

Japanese pharmaceutical firm Eisai Co plans to seek full approval of its experimental Alzheimer's drug lecanemab in the United States, Europe and Japan armed with data showing it can slow the brain-wasting disease for people with early symptoms, potentially getting the treatment to patients next year.

It remains unclear how widely the drug developed with U.S. biotech Biogen Inc will be used due to uncertainty over insurance coverage, including the U.S. government's Medicare plan for people age 65 and over, potential side effects and cost.


One Wall Street analyst told Reuters news agency that he is not counting on measurable sales until 2024. Several estimated lecanemab may be priced at around $20,000 per year.

"Most people who this (drug) would apply to are on Medicare, and most private payers look to Medicare as they make their own (coverage) decisions. So there's a massive roadblock in the way of all who could benefit from this treatment," said Robert Egge, Alzheimer's Association chief public policy officer.

Eisai confirmed on Tuesday (November 30) that lecanemab - an antibody designed to remove sticky deposits of a protein called amyloid beta from the brain - reduced the rate of cognitive decline on a clinical dementia scale by 27% compared to a placebo. It also gave new details on side effects including a dangerous type of brain swelling and brain bleeding.

The companies have already applied for accelerated approval with the U.S. Food and Drug Administration and expect a decision by Jan. 6. The new data will allow them to apply for full approval within days of that decision, Eisai's U.S. CEO Ivan Cheung said in an interview.

The medication is only for people in the very early stages of Alzheimer's," said Dr. Babak Tousi, a neuro-geriatrician at the Cleveland Clinic. These are people with some memory impairment but who can still engage in daily activities such as manage finances and medications, prepare meals and drive. "This is a very, very small, selective group," he said.

Guggenheim Partners analyst Yatin Suneja said he expects the drug to get full U.S. approval in the second half of 2023, adding that Medicare would likely wait for formal approval before deciding on coverage terms.

Most U.S. Alzheimer's patients are insured through Medicare, which will only cover patients in clinical trials for anti-amyloid drugs that have received a less stringent accelerated approval, severely limiting access to such medicines. There are no such trials ongoing, Egge said.

Michael Irizarry, Eisai's deputy chief clinical officer, told Reuters ahead of the data release that the company has been in discussions with the agency about reconsidering its policy on Alzheimer's drug coverage.

It is unclear how long the U.S Centers for Medicare & Medicaid Services (CMS) might take to make such a coverage determination. Irizarry said a formal process between Eisai and CMS could not begin until after the drug is approved.

CMS did not provide an immediate comment.

RBC Capital Markets analyst Brian Abrahams said he expects limited sales revenue from lecanemab in 2024.

"CMS might wait for full approval of the drug in the back half of next year before potentially broadening (its policy) and enabling coverage of lecanemab," Abrahams said.

He estimated about 23,000 U.S. patients for the drug in the first year, rising to over 300,000 by 2031.

In a June study on lecanemab's worth, Eisai said based on mid-stage trial data indicating the drug's effectiveness, a price between $9,249 to $35,605 per year represented a good value. The drug is given by infusion every two weeks based on a patient's weight.

More For You

Health minister assures House of Lords on measures to tackle UK-wide Creon drug shortage

Baroness Merron

Government taking steps to mitigate shortage of cancer drug Creon

Baroness Merron on Monday (9) assured the House of Lords that the government is taking measures to mitigate the shortage of pancreatic cancer drug Creon across the country.

Raising the issue, Baroness Margaret Ritchie wanted to know about the steps being taken by the government to ease the misery of patients suffering from pancreatic cancer.

Keep ReadingShow less
Janet Morrison: "Eventual outcome of spending review needs to tackle pharmacy underfunding"

Janet Morrison

Janet Morrison: "Eventual outcome of spending review needs to tackle pharmacy underfunding"

Community Pharmacy England (CPE) chief executive Janet Morrison has welcomed chancellor Rachel Reeves announcement today that day-to-day spending on the NHS will increase by £29bn a year but insisted that it must reflect in securing the future of pharmacy.

Reeves also revealed that the government will be increasing the NHS technology budget by almost 50 per cent, with £10bn of investment to "bring our analogue health system into the digital age, including through the NHS app".

Keep ReadingShow less
Lynsey Cleland named GPhC chief standards officer

Lynsey Cleland

Pic credit: X

Lynsey Cleland named GPhC chief standards officer

The General Pharmaceutical Council (GPhC) has brought back Lynsey Cleland to lead on a number of important departments in the role of chief standards officer.

Cleland had previously held a number of senior positions at GPhC, including director of Scotland.

Keep ReadingShow less
Pharma industry group unhappy with NHS drug pricing offer

The ABPI warned that £2 billion of potential investment could be under risk

Pic credit: istock

Pharma industry group unhappy with NHS drug pricing offer

The Association of the British Pharmaceutical Industry (ABPI) has rejected the UK government’s offer to cut the cost of NHS drugs pricing scheme as it felt it was inadequate.

The industry group warned that £2 billion of potential investment could be under risk and wanted prime minister Keir Starmer to intervene, The Times reports.

Keep ReadingShow less
Day Lewis celebrates 50 years of delivering care to communities

The Patel family at the unveiling of the commemorative plaque ceremony

Day Lewis celebrates 50 years of delivering care to communities

Day Lewis honoured "the people, purpose and partnerships" as it celebrated 50 years of service by unveiling a commemorative plaque at the company’s support office in Croydon.

As one of the UK’s largest independent pharmacy chains, Day Lewis has delivered trusted care to communities across the country since it was founded in 1975, by brothers Kirit and JC Patel, who was on hand to unveil the plaque.

Keep ReadingShow less