Aug 22 (Reuters) - Alzheimer's patients in Britain's
state-run health service are unlikely to get access to Eisai ( ESALF )
and Biogen's new Leqembi drug, after it was
approved on Thursday by the country's regulator but deemed too
expensive for wide use.
The Medicines and Healthcare products Regulatory Agency said
the drug, also known as Lecanemab, is the first treatment for
Alzheimer's licensed for use in the country "that shows some
evidence of efficacy in slowing progression of the disease."
But in its draft guidance published simultaneously, the
National Institute for Health and Care Excellence said the
medicine's high cost and need for intensive monitoring for side
effects "means it cannot be considered good value for the
taxpayer".
The UK cost effectiveness body's findings mark the latest
blow faced by the drugmakers amid slow take-up of the drug in
the U.S. It also highlights the complexities of a new class of
drugs that benefit early-stage Alzheimer patients but could
cause rare and serious side effects.
The therapy for early Alzheimer's disease has been approved
in the United States, China, Hong Kong, Israel, Japan, South
Korea and the UAE.
But last month the European Union's drugs regulator rejected
the drug, saying the risk of serious brain swelling did not
outweigh its small impact on slowing cognitive decline.
The companies said then that they will seek re-examination
of the recommendation, but did not disclose what information
they would provide the regulator.