By Rina Chotai, Head of IPG Health Global Market Access
Dementia is a topic very close to my heart. Personally, experiencing a loved one suffer from the demons of dementia and wither away in front of my eyes has been a heart-breaking affair. The constant battle to hang on to each moment, wondering whether tomorrow they’ll remember the names of my children or how to eat their breakfast, is upsetting. While dementia slowly eats away at the patient, the impact on the family can be overwhelming, overlooked and, often, unseen.
Dementia incidence
The World Health Organisation (WHO) estimates approximately 50 million people have dementia, with approximately 885,000 patients living in the United Kingdom (aged 65 years and older).1 With the number expected to rise to nearly 1.6 million by 2040, dementia is a serious healthcare challenge in the UK.
New treatments on the horizon
I closely watch the development of dementia treatment, and I have been overwhelmed as I read through the news about Donanemab (Lilly) over the last couple of days. Donanemab was trialled for patients with early Alzheimer’s disease (the most common form of dementia). The TRAILBLAZER-ALZ 2 trial reported nearly half (47%) of patients receiving Donanemab had no clinical progression at the 1-year mark.2 Participants in this treatment arm also demonstrated 40% less decline in ability to perform activities of daily living.2 While the efficacy results look promising, there are always risks to consider. Amyloid-related imaging abnormalities (ARIA), commonly observed as brain swelling, occurred in 24% of treated participants.2 While in most cases this was mild to moderate and resolved with appropriate management, three patients died from ARIA.2
In addition to Donanemab, Leqembi® (Eisai / Biogen) was approved by the FDA in June 2023 after demonstrating a 27% reduction in clinical decline at 18 months compared with placebo.3 The most common side effects associated with Leqembi include headache, infusion-related reactions and ARIA. Studies have demonstrated that patients who are homozygous for the ApoE ε4 allele are at a higher risk of ARIA.3 It is recommended that patients be tested for ApoE ε4 status to inform any treatment decisions.3
As a new era for dementia patients appears on the horizon, the promise of novel treatments provides hope to patients, families and their caregivers. Reimbursement approval will be important, and the market access and uptake strategy will need to be carefully considered to ensure the drugs are accessible and not held back by guidelines or diagnostic restrictions.
Considerations and recommendations for access
For patients to benefit from Donanemab and Leqembi®, promoting awareness and demonstrating meaningful value and cost-effectiveness will be key.
