How cost-effective is donanemab as an Alzheimer’s treatment, and why did NICE reject its routine use on the NHS?
In June 2025, NICE concluded that the donanemab Alzheimer’s treatment cost-effectiveness does not justify routine NHS adoption for adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease. Despite offering some slowdown in cognitive decline, the modest clinical benefits of donanemab were outweighed by high costs and persistent uncertainties about long-term impact. This aligns with the NHS’s focus on evidence-based, sustainable care and highlights the rigorous cost-effectiveness standards facing new Alzheimer’s therapies.
Key Findings: Donanemab’s Clinical Benefits and Economic Challenges
- Insufficient Clinical Improvement:
Donanemab slowed cognitive and functional decline versus placebo in major trials (22–32% reduction in progression over 18 months), but the total benefit was less than what the wider research community regards as clinically meaningful.
- Cost-Effectiveness Concerns:
NICE’s health economic modelling revealed that the most plausible incremental cost-effectiveness ratio (ICER) for donanemab is about £69,000 per QALY gained, well above the £20,000 threshold typically used by the NHS.
- Substantial Uncertainty:
Key variables—such as the durability of donanemab’s effect, mortality risk changes, and impacts on patient and caregiver quality of life—introduced significant uncertainty into cost-effectiveness analyses.
- Implementation Barriers:
Adopting donanemab would require major changes to NHS infrastructure: expanded early diagnosis, specialist amyloid/genetic testing, frequent infusions, and close monitoring for side effects—all at considerable cost.
- No Managed Access:
NICE found that even with further data collection or restricted access, donanemab’s cost-effectiveness is unlikely to meet NHS criteria. Learn more about these considerations in NICE’s detailed analysis of Alzheimer’s treatments.
Background: Alzheimer’s Disease Treatments and Innovation
Alzheimer’s disease remains the most prevalent dementia in the UK, with current treatments largely limited to symptom management (e.g., acetylcholinesterase inhibitors like donepezil).
Donanemab represents a new category: monoclonal antibodies targeting amyloid beta, designed to slow disease progression rather than just alleviate symptoms. However, a parallel review also found lecanemab failed to meet NICE’s standards for cost-effectiveness.
Evidence and Expert Evaluation
- TRAILBLAZER-ALZ 2 Clinical Trial:
Data showed statistically significant—but modest—improvements in outcomes such as the integrated Alzheimer Disease Rating Scale (iADRS). The absolute gains were about half those considered truly meaningful to patients.
- Global Regulatory Perspective:
While the FDA and EMA have granted conditional approvals for similar drugs, they acknowledge unresolved questions about long-term benefits and real-world value.
Economic Modeling
NICE rigorously assessed donanemab Alzheimer’s treatment cost-effectiveness using comprehensive economic modeling. Key focal points included:
- Real-world costs associated with NHS implementation.
- Impacts on both patient and caregiver quality of life (QOL), despite QOL measurement challenges in dementia care.
- Transparency in assumptions about mortality, disease stage progression, and treatment durability.
These factors reinforce NICE’s prioritization of robust evidence and trusted methodologies in determining NHS coverage.
Health Economics and Policy Implications
The donanemab decision has broad consequences for future Alzheimer’s disease therapy assessments:
- Cost-Effectiveness Is Crucial:
Only treatments delivering substantial, clearly demonstrable value relative to their cost will be considered for NHS adoption.
- Standard-Setting for Future Drugs:
Other disease-modifying Alzheimer’s drugs must address clinical and economic uncertainties, and show improvement in both efficacy and long-term affordability.
- Service Delivery Equity:
Complex eligibility and diagnostic requirements may risk widening existing disparities in dementia care, making attention to health equity a necessary part of future decision-making.
- Stimulus for Innovation:
Drug developers must generate higher-quality real-world data and prioritize outcomes relevant to both patients and carers, as cost-effectiveness continues to drive NHS access policy.
Structured Summary Table: Donanemab at a Glance
| Factor |
Donanemab Outcome |
| Clinical Benefit |
22–32% slower decline in key markers, modest vs. meaningful threshold |
| ICER (Cost/QALY) |
~£69,000 per QALY (vs. NHS threshold up to £20,000) |
| Primary Evidence |
TRAILBLAZER-ALZ 2 trial, supported by phase 1/2 studies |
| Care Delivery Changes |
Requires early diagnosis, specialist testing, frequent infusions |
| NICE Final Guidance |
Not recommended for routine or managed access in the NHS |
Frequently Asked Questions (FAQ)
1. What is the main reason NICE rejected donanemab for NHS use?
The primary reason was that donanemab Alzheimer’s treatment cost-effectiveness remains far outside accepted thresholds, given only modest clinical benefits.
2. Did donanemab actually help patients with early Alzheimer’s?
Yes, there was a statistically significant slowing of cognitive decline, but the degree of improvement was not large enough to be considered meaningful for most patients.
3. How does this affect future Alzheimer’s drug approvals in the UK?
Future therapies will need to offer greater clinical benefit, address long-term uncertainties, and demonstrate clear, cost-effective value to meet NHS acceptance criteria.
Conclusion and Next Steps
The NICE assessment of the donanemab Alzheimer’s treatment cost-effectiveness sets a high bar for future innovations in dementia care. While the search for disease-modifying Alzheimer’s therapies continues, new drugs must demonstrate meaningful patient benefits, robust real-world impact, and sustainable cost profiles to meet NHS standards. Explore more about the evolving landscape of Alzheimer’s treatments and cost-effectiveness in NICE’s detailed guidance.
