After initially saying no, the EU's pharmaceutical agency EMA gave the thumbs up to the Alzheimer's drug lekanemab in November. The Swedish-developed drug has been described as groundbreaking and the demand for a treatment for dementia is enormous.
However, several steps remain before the first patients in Sweden can begin treatment.
It will likely take about a year before we get a decision on whether the drug will be available to Swedish patients, says Linus Jönsson, doctor and professor of health economics at the Karolinska Institute.
Can Take a Stop
The first requirement is a formal approval from the EU Commission. They generally follow EMA's recommendation, but before they say yes, the drug cannot be marketed. Once that is done, the focus turns to the price. Lekanemab is administered as an infusion at hospitals and the decision on its use lies with the regions. There is a special system in place when new expensive drugs are introduced.
A special expert council, the NT Council, conducts an investigation and makes a recommendation. An important part of the analysis is the price, which has not yet been set in Sweden but has reached up to 300,000 kronor per patient and year in other countries.
It must be put in proportion to the benefit it can provide. For even though lekanemab has been described as revolutionary, it is far from a cure, and the council's recommendation may be that the regions should not start using it.
The treatment can delay cognitive decline by about four to six months, but the decline continues. It must also be given early in the disease process to be effective, says Linus Jönsson.
Mainly at Large Hospitals
Oskar Hansson, chief physician in neurology at Skåne University Hospital in Lund, who is soon to start a job at the pharmaceutical company Eli Lilly, estimates that it could involve 1,500-2,000 new patients per year who could be treated with lekanemab. Moreover, it is the large hospitals in the country that have the capabilities for diagnostics, treatment, and follow-up.
The patients must also be willing to come to the hospital twice a month to receive the infusion and undergo several examinations with MRI to detect any brain swelling, he says.
Despite the challenges, he is very pleased with the approval.
It is the first real treatment we have and an important first step in the development of new, more effective treatments.
The drug Leqembi contains the active substance lekanemab, which is an antibody. Its task is to attack harmful amyloid proteins in people with Alzheimer's disease. The medicine has shown signs of being able to slow down early signs in patients with Alzheimer's.
In clinical trials, the treatment has shown that it can delay cognitive decline by four to six months.
In addition to the costs of the drug itself, there are costs for imaging diagnostics, sampling, and personnel for patients to receive the drug. This poses new demands on healthcare.
When the EU Commission says yes to lekanemab, the question of price comes into focus.
A special expert council, the NT Council, which is part of the Swedish Association of Local Authorities and Regions, conducts an investigation and makes a recommendation on whether they think the treatment should be used in the regions or not.
An important part of their recommendation is a health economic analysis conducted by the Dental and Pharmaceutical Benefits Agency (TLV). For that analysis to begin, the company Bioarctic needs to submit a price application, which they had not done by mid-December.
If the price is too high in relation to the benefit of the treatment, the recommendation from the NT Council may be that the regions should not use lekanemab.
If the recommendation is to use it, the regions will need to set up systems for diagnostics, treatment, and follow-up of patients.
