This week, a product licence for the medicine lecanemab (Leqembi) was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adult patients in the early stages of Alzheimer’s disease.
The medication has shown some evidence of efficacy in slowing progression of the disease by between 4-6 months, and is recognised as the first medication licensed in the UK to potentially change the disease course of Alzheimer’s in patients who are not taking blood thinners or have a diagnosis of cerebral amyloid angiopathy (CAA).
Lecanemab is administered intravenously in a healthcare setting every two weeks, with each infusion lasting approximately one hour, under the supervision of a healthcare professional. If well tolerated, treatment continues until a patient progresses beyond mild Alzheimer’s disease to moderate disease.
In the main clinical trial of 1,795 people with early Alzheimer’s disease, the most common side effects of the medicine were found to be infusion-related reactions (which can cause fever and flu-like symptoms), headaches and Amyloid Related Imaging Abnormalities (ARIAs), which are most commonly seen as temporary swelling in one or more areas of the brain (ARIA-E) or small spots of bleeding in or on the surface of the brain (ARIA-H).
However, the National Institute for Health and Care Excellence (NICE), who provide evidence-based recommendations for the health and social care sector, have stated in their draft guidance “The benefits of the new Alzheimer’s drug lecanemab are too small to justify the cost to the NHS.”
Dr Samantha Roberts, chief executive of NICE said:
“This is a new and emerging field of medicine which will no doubt develop rapidly. However, the reality is that the benefits this first treatment provides are just too small to justify the significant cost to the NHS. It is an intensive treatment to give to patients involving a hospital visit every two weeks with skilled staff needed to monitor them for signs of serious side effects, plus the cost of purchasing the drug. Our independent committee has rigorously evaluated the available evidence, including the benefit for carers but NICE must only recommend treatments that offer good value to the taxpayer.”
The draft recommendation from NICE follows analysis of clinical trial evidence and review of the benefits of slowing disease progression, with the cost of treatment. A second independent committee will meet later in the year before producing its final recommendations.
Oxford Health’s R&D Director and University of Oxford Prof Vanessa Raymont said:
“This is the first drug that is approved in the UK that has the potential to change the course of the disease and have real impact on the progression of any memory impairment. However, it is clear the NHS still isn’t ready to roll out treatments like this. More ground-breaking treatments are coming and this is a great opportunity for us to offer improved care for all patients with Alzheimer’s disease.
“New treatments bring hope but they will mean nothing if we don’t urgently fix dementia diagnosis, which is why research projects like the Blood Biomarker Challenge and our READOUT programme – which aims to bring a blood test for dementia to the NHS within 5 years – are so important. A dementia diagnosis is important because it unlocks access to personalised care and support, allowing people and their families to plan for the future.”
Dementia Platform UK and Senior Clinical Researcher at University of Oxford’s Department of Psychiatry Dr Ivan Koychev, said:
“The approval of lecanamab by MHRA is a milestone in the treatment of Alzheimer’s disease in the UK as it is the first such therapy that has been shown to affect core Alzheimer’s disease pathology. Currently approved treatments in contrast only affect symptoms without changing the underlying disease.
“The MHRA’s decision concludes that the benefit for cognitive (memory and thinking) and functional abilities outweighs the risk of brain bleeds. This is the case for people with one or no versions of the Alzheimer’s disease risk gene APOE4; in those with two versions of this gene, the risk of brain bleeds is higher which led MHRA not to approve it in that group.
“In contrast, NICE looks at whether MHRA approved medications are good value for money in the NHS. To do this, it examines so-called quality-adjusted life years (QALYs) which look at how much a new intervention such as lecanamab benefits a patient in terms of quality of life gained relative to their expected years of life. This is done so that the NHS can have a shared benchmark for new interventions across disease areas and patient groups – this is critical in the resource constrained NHS. NICE found that lecanamab did not represent sufficiently good value for money as it stands.
“What follows is a period of further consultation with stakeholders and the company; a potential outcome may be that a revised, more acceptable, cost structure is put forward to NICE. Should NICE not eventually recommend lecanamab or similar therapies, access to these novel treatments will only be available through the private sector in the UK which would raise the issue of equality of access.”