The FDA, the American drug watchdog, has recently approved a promising Alzheimer’s treatment for reimbursement. This is a game changer for patients: Lecanemab is the first drug that can slow the evolution of the condition. However, its current price in the US is up to €24,700 a year. In the EU too, the cost could be high. “We run the risk of a two-track policy: the patients that can afford it will be able to pay for treatment, and the others won’t,” says Prof Sebastiaan Engelborghs, head of Neurology at UZ Brussel and board member of the European Alzheimer’s Disease Consortium (EADC).
According to Engelborghs and his colleagues in the EADC, Lecanemab can make a difference for millions of Alzheimer’s patients in the EU. “We estimate the population that could potentially be eligible for treatment with Lecanemab at 5.4 million people,” he says. This comes with a big price tag. “The treatment costs would be more than €133 billion per year if the price of the drug is comparable to the situation in the US. That’s more than half of the total spending on medicines in the EU. It threatens to be unaffordable for the healthcare authorities in some countries, which could lead to a two-track policy: the patients that can afford it will be able to pay for treatment, and the others won’t.”
The FDA very recently approved the drug from the Japanese-American pharma company Eisai-Biogen. “The dossier was also submitted to the European Medicines Agency, which may give its approval for the drug by the end of this year,” says Engelborghs. “Then price negotiations will begin in the EU. Unfortunately, the negotiations will take place country by country, which increases the risk of inequality within the EU. As the board of the EADC, my colleagues and I are calling for a price policy that gives access to new, innovative medicines for all affected patients in the EU. That requires continued investment in research, development and infrastructure. To address affordability and inequality in access for patients, we need more infrastructure for new therapies in routine care and new payment models.”
According to Engelborghs, it’s not only about the cost of the drug itself. “We shouldn’t forget that, if the drug is approved, it will have an impact on healthcare in general. Alzheimer’s diagnosis is done through biomarker research that is currently not reimbursed. There are also regular MRI scans required for patients in treatment to detect side effects and the treatment itself takes place as an inpatient, based on fortnightly infusions. That means extra costs and pressure on healthcare, on top of the cost of the drug itself.”
Engelborghs states there are also ethical and societal considerations. “We’re never going to have the capacity and resources to treat every person with Alzheimer’s with this new medication,” he says. “Nor is that desirable. Not every person with Alzheimer’s is expected to benefit. This is a treatment that creates an extra burden and will have side effects, albeit in a minority of those treated. We need to think carefully within the relevant bodies about which patients’ treatment we can reimburse. Unfortunately, these too are conversations that will happen country by country. We hope to still be able to formulate recommendations at European level so that good and safe care is guaranteed in Europe for all those affected.”
Prof Dr Sebastiaan Engelborghs: +32 479 68 62 17