In August, the Medicines and Healthcare products Regulatory Agency (MRHA) approved a product license for lecanemab, for treating mild cognitive impairment and mild dementia due to AD in adults who are apolipoprotein (APO) E4 heterozygotes or non-carriers. At this time, the National Institute for Health and Care Excellence (NICE) issued draft guidance that does not recommend use of lecanemab for this indication, on the basis that it “is not a cost-effective use of NHS resources”.
In view of this, the Medicines and Pharmacy sub-committee (MPC), under the guidance of specialist clinicians, have developed a position statement that concurs with the NICE position. The position will be reviewed following publication of National Institute for Health and Care Excellence (NICE) technology appraisal guidance.
The position statement provides further details in relation to use of lecanemab including safety concerns and potential service implications, that have informed the licensing and NICE decision.
The license requires that lecanemab should be offered within a controlled access programme and with a post-authorisation safety study. Until the manufacturers are able to meet these license requirements, private access will not be feasible. Updates will be provided when further information is known.
A number of other disease modifying treatments for AD are in development. However, NHS commissioning would only start with a positive recommendation by NICE for routine use of any of these treatments.
Patients and their carers may be directed to the Alzheimer's Society for further information.
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