1. A new era of Alzheimer’s care
Alzheimer’s Disease (AD) is entering a different phase of market access. In the UK, dementia already represents one of the defining health and care challenges of an ageing society. Alzheimer’s Society estimates that 982,000 people are living with dementia in the UK today, rising to 1.4 million by 2040, with total costs forecast to increase from £42 billion in 2024 to £90 billion by 20401. This pressure is not limited to specialist memory services - NHS England has reported that people with dementia occupy around a quarter of acute hospital beds and stay in hospital twice as long as other people over 653.
The therapeutic context has also changed. For many years, Alzheimer’s care was defined by symptomatic management, support services and a limited capacity to alter the underlying pathology of the disease. The pivotal lecanemab and donanemab trials changed this baseline assumption. In Clarity AD, lecanemab reduced amyloid markers and resulted in moderately less decline on measures of cognition and function over an 18-month period13. In TRAILBLAZER-ALZ 2, donanemab significantly slowed clinical progression over 76 weeks in people with early symptomatic AD and amyloid and tau pathology12.
Lecanemab and donanemab are now part of the established evidence base for AD modification. These are not cures, they do not halt progression but are regulated therapies that can alter measurable pathology and slow clinical decline in defined early-stage populations. The UK access story, however, remains unresolved. The MHRA licensed lecanemab and donanemab in 2024 for adults in the early stages of AD with one or no copies of ApoE45,6. NICE, however, concluded in June 2025 that the benefits remained too small to justify NHS costs, due to high acquisition and delivery costs, lack of long-term evidence and substantial implementation demands7. Following appeals, NICE agreed to reassess both drugs this year, with publication dates to be confirmed4,8,9.
This now means the question is no longer whether disease modification is scientifically possible, but rather if health systems can demonstrate real-world value convincingly enough to justify access, implementation and sustainable adoption.
2. Approval is only the beginning
Regulatory approval only confirms whether a drug has a positive benefit-risk profile in its indicated population. It does not, however, answer whether a health system is ready to identify eligible patients, deliver treatment safely, monitor risk, absorb resource requirements and generate evidence that supports continued use. In AD, that distinction is especially important.
The eligible population for anti-amyloid therapy is narrower than the headline prevalence of dementia suggests. Both UK licences exclude ApoE4 homozygotes due to the benefit-risk profile, and both treatments require confirmation of Alzheimer’s pathology and MRI-based risk assessment5, 6. NHS England’s preparatory pathway described the practical implications. Treatment access requires all of the following:
Real-world estimates suggest that the number of patients requiring triage will substantially exceed those eligible for treatment. A London service evaluation of 1,017 patients found that 32% of people attending community memory services might be eligible for triage, yet only 14% of those seen in a specialist cognitive clinic were potentially eligible for treatment once biomarker availability, cognitive severity, frailty, anticoagulant use and MRI-related exclusions were considered2. The same study highlighted that fewer than 1% of community memory clinic patients had amyloid biomarker testing, underlining the gap between patient eligibility and operational readiness2.
Safety monitoring adds another layer of complexity. Anti-amyloid therapies require ongoing MRI surveillance to detect and manage ARIA, placing additional demands on imaging services and specialist care pathways. Access therefore is also heavily dependent on the capacity of healthcare systems to safely monitor patients. Intensive monitoring requirements and controlled access programmes may mean that not all centres can offer treatment, even where a medicine is authorised 10. With NHS England estimating implementation costs of £500m to £1b per year across diagnosis, assessment, treatment and administration3, approval is better understood as the start of an implementation challenge than its resolution.
3. Real world evidence will answer the questions that determine value in practice
The pivotal trials established the therapeutic signal. Real world evidence (RWE) must now answer the questions that determine value in practice. In AD, that means moving beyond efficacy to understand durability, generalisability, safety, resource impact and the conditions under which benefits are meaningful enough to support access.
Durability is the most immediate evidence gap. NICE’s 2025 position explicitly referenced the lack of long-term evidence of effectiveness alongside implementation cost and modest trial benefits7. While RWE cannot replace randomised trials, it can test whether treatment effects persist in routine care, whether treatment discontinuation patterns alter expected benefit, and whether earlier treatment in less advanced disease translates into more time in lower dependency states.
Generalisability is equally important. Trial populations are necessarily selective, with routine NHS populations bringing multimorbidity, variable frailty, differences in referral timing, variable imaging access and differential capacity to attend repeated appointments. RWE can show whether observed benefits translate across broader populations, while also identifying where the pathway itself filters patients out. For payers and providers, this is especially important, because a treatment that is clinically promising but operationally accessible only to a small, highly selected subgroup requires a different value discussion from one that can be delivered equitably at scale.
Safety is another area where RWE will shape confidence. Lecanemab and donanemab both require careful management of ARIA risk, including ApoE4 testing, baseline imaging, regular MRI monitoring and contraindications such as anticoagulant use5, 6. Post-authorisation safety studies and controlled access programmes are therefore part of the therapeutic model. EMA notes that registry-based studies will further characterise ARIA in clinical practice and address uncertainties about long-term consequences10.
The resource question is broader. Alzheimer’s medicines enter pathways constrained by diagnostic capacity, specialist workforce, imaging access and memory service variation. RWE should quantify where capacity is consumed, where bottlenecks emerge, and which pathway designs offer the best balance of clinical benefit, patient burden and sustainability. That includes infusion capacity, MRI slots, PET-CT or CSF confirmation, genetic counselling, radiology expertise, follow-up scheduling and support for patients who are found ineligible for anti-amyloid drugs.
Finally, RWE is central to reimbursement. NICE’s reassessment following appeal places caregiver impact, unpaid care costs, long-term data and NHS infusion cost estimates back into the appraisal conversation4. The implication is that future access will depend not only on demonstrating cognitive or biomarker effects, but on robust evidence that links treatment, pathway delivery, patient outcomes, caregiver impact and costs. For AD, RWE can serve as the evidence architecture on which sustainable access will depend.
4. The next evidence challenge is not just how long treatment effects last, but what they mean
AD value assessment cannot rely solely on cognitive scales or amyloid reduction. Whilst these measures are essential, they do not fully capture what patients, carers, providers and payers need to know: whether treatment preserves function, independence, participation and lower levels of care for longer.
NICE acknowledged that any slowing of disease worsening could be meaningful to people with mild cognitive impairment or mild dementia and their carers because it could mean more time socialising, driving, being independent and the need for less day to day support from family members7. Alzheimer’s Society’s economic work shows why disease stage matters economically as well as clinically: estimating annual per-person costs rise from £28,700 in mild dementia to £80,500 in severe dementia, driven by increasing complex care needs1.
The outcomes that matter most therefore include activities of daily living, instrumental function, quality of life, caregiver burden, healthcare resource utilisation (HCRU), treatment persistence and transitions between disease stages. Real world datasets need to capture whether a patient remains at home, continues usual activities, sustains independence, or delays entry into higher-cost care settings. These endpoints determine whether a therapy is valuable in a health system.
The registry field is already moving in this direction. Initiatives such as the International Registry for AD and Other Dementias (InRAD) reflect the growing recognition that Alzheimer's value cannot be understood through cognitive outcomes alone. Future evidence frameworks will need to combine clinical outcomes, safety, functional status, quality of life, caregiver burden and healthcare utilisation if they are to provide a complete picture of treatment impact in routine care11.
For IQVIA and the wider evidence community, the challenge is no longer data collection, but evidence generation. The most valuable evidence will be that which connects clinical outcomes with real-world impact, linking disease progression, functional independence, caregiver burden and healthcare utilisation into a coherent picture of value.
5. The next decade of Alzheimer’s care
The next decade of Alzheimer’s care will be defined by innovation, but also whether evidence generation keeps pace with scientific progress. More medicines, biomarkers and delivery models are likely to enter evaluation. Each will raise familiar questions, including who should be treated, when, for how long, with what monitoring, at what cost, and with what measurable benefit to patients, carers and health systems.
Registries, linked datasets and long-term safety monitoring will be central to answering those questions. Internationally, initiatives such as InRAD and other emerging dementia registries reflect a broader move towards structured, longitudinal real-world data collection after approval11. In the UK, the opportunity is to connect this logic with NHS pathway data, imaging, biomarker results, medicines use, hospital activity, social care proxies where available, and patient- and carer-reported outcomes.
This evidence infrastructure can influence reimbursement, adoption and pathway design. It can support managed access models where uncertainty remains. It can identify which patients benefit most, which monitoring schedules are proportionate, where pathway redesign improves access, and which outcomes should carry greater weight in HTA. It can also make visible the consequences of inaction: missed diagnosis, delayed referral, avoidable hospital use, caregiver strain and unequal access to specialist diagnostics.
AD modification has moved the field beyond a purely symptomatic paradigm. The commercial challenge now is to demonstrate real-world value with enough rigour to justify access and support implementation. The winners in the next phase will not be defined only by the strength of their clinical trial data. They will be defined by their ability to generate credible, decision-grade evidence across the patient journey. For AD, the next frontier is not simply proving that treatment can slow decline. It is proving, in the real world, that slowing decline changes what matters.
References
1. Alzheimer’s Society (2024) The economic impact of dementia. Available at: https://www.alzheimers.org.uk/what-we-do/policy-and-influencing/economic-impact-of-dementia
2. Dobson, R. et al. (2024) ‘Eligibility for antiamyloid treatment: preparing for disease-modifying therapies for AD’, Journal of Neurology, Neurosurgery & Psychiatry, 95(9), pp. 796–803. doi:10.1136/jnnp-2024-333468.
3. NHS England (2024) Dementia programme and preparation for new AD modifying treatments. Available at: https://www.england.nhs.uk/long-read/dementia-programme-and-preparation-for-new-alzheimers-disease-modifying-treatments/
4. Iacobucci, G. (2026) ‘Alzheimer’s drugs: Lecanemab and donanemab to be reconsidered for NHS after appeal’, BMJ, 392, s551. doi:10.1136/bmj.s551.
5. Medicines and Healthcare products Regulatory Agency (MHRA) (2024a) Lecanemab licensed for adult patients in the early stages of AD. Available at: https://www.gov.uk/government/news/lecanemab-licensed-for-adult-patients-in-the-early-stages-of-alzheimers-disease
6. Medicines and Healthcare products Regulatory Agency (MHRA) (2024b) Donanemab licensed for early stages of AD in adult patients who have one or no copies of apolipoprotein E4 gene. Available at: https://www.gov.uk/government/news/donanemab-licensed-for-early-stages-of-alzheimers-disease-in-adult-patients-who-have-one-or-no-copies-of-apolipoprotein-e4-gene
7. National Institute for Health and Care Excellence (NICE) (2025) Final draft guidance finds benefits of 2 Alzheimer’s treatments remain too small to justify the additional costs to the NHS. Available at: https://www.nice.org.uk/news/articles/the-benefits-of-alzheimers-treatments-donanemab-and-lecanemab-remain-too-small-to-justify-the-additional-costs-says-nice-in-final-draft-guidance
8. National Institute for Health and Care Excellence (NICE) (2026a) Lecanemab for treating mild cognitive impairment or mild dementia caused by AD [ID4043]. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta11220
9. National Institute for Health and Care Excellence (NICE) (2026b) Donanemab for treating mild cognitive impairment or mild dementia caused by AD [ID6222]. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta11221
10. Guizzaro, L. et al. (2026) ‘Balancing benefit and risk in early AD: the European Medicines Agency assessment of lecanemab and donanemab’, The Lancet Regional Health – Europe, 63, 101644.
11. Perneczky, R. et al. (2025) ‘Real-world datasets for the International Registry for AD and Other Dementias (InRAD) and other registries: An international consensus’, The Journal of Prevention of AD, 12(4), 100096. doi:10.1016/j.tjpad.2025.100096.
12. Sims, J.R. et al. (2023) ‘Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial’, JAMA, 330(6), pp. 512–527. doi:10.1001/jama.2023.13239.
13. van Dyck, C.H. et al. (2023) ‘Lecanemab in early AD’, New England Journal of Medicine, 388(1), pp. 9–21. doi:10.1056/NEJMoa2212948.
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