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.
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.
Identifying the target patient population accurately and quickly will be pivotal in ensuring patients have access to these new and innovative drugs at the right time, in the early stages of the disease.
Barriers to early diagnosis will likely include the scarcity of PET scan machines in the United Kingdom (machines require to identify amyloid plaques and diagnose dementia). Financial investment and a focus on enhanced efficiency will be required to reduce diagnosis bottlenecks and ensure patient access to available treatment.
The adverse events profile of both Donanemab and Leqembi® will need to be considered as part of Payer communications. The balance of treatment benefit vs. risk should be carefully analyzed and effectively communicated to demonstrate the value this drug will bring to eligible dimentia patients and the overall healthcare system in the longer term.
Delaying the decline of impairment associated with dementia could potentially reduce healthcare utlization overall and offer long term savings for the healthcare sytem. Differences in dosing between Donanemab and Leqembi® suggest potential cost savings can be achieved from treatment setting and frequency. Clearly understanding the health economic value will enable payers to make calculated decisions on the cost-effectiveness of dementia treatments.
Market shaping, payer and payer influencer awareness programmes and a market access strategy, focusing both on the product and the infrastructure, will be key to demonstrating meaningful value in this new dawn of dementia treatments. I look forward to seeing maximised access to these treatments in future, to start to address unmet needs in as many patients as possible.
Please reach out to Rina.Chotai@ipghealth.com with any questions.