NICE has recently published draft guidance on lecanemab for the treatment of mild cognitive impairment or mild dementia caused by Alzheimer’s disease in which they have advised that lecanemab is a non-cost-effective use of taxpayer money. Lecanemab provides a health economic case study of the challenges of demonstrating cost-effectiveness of health interventions for underserved patient populations. Specifically, when a patient population is underserved for so long, such as those in the early stages of Alzheimer’s, a clinically effective intervention, albeit with side effects requiring monitoring, will struggle to demonstrate it is a cost-effective use of NHS resources. A key reason for this is the need for significant service redesign due to novel and innovative treatments finally being available.
In the case of lecanemab, NICE note the need for significant changes to the existing clinical pathway including the establishment of specialist diagnostic clinics, confirmatory diagnostic tests, and genetic testing. Importantly, even though capital costs associated with the establishment of clinics were not included in the cost-effectiveness analysis (diagnostic/genetic tests/monitoring were), these are service changes the NHS would have had to implement in order for lecanemab to have been made available for eligible patients. This means that the NHS would have had to invest a considerable amount of resources in service redesign.
Additionally, the availability of a clinically effective intervention, would have led to increased demand in primary care and memory clinics from potentially eligible patients seeking to access lecanemab. This would have contributed to very high costs to the NHS and impacted treatment for patients living with other conditions thereby leading to potentially worse health outcomes for other patient populations.
Another issue at the forefront of this appraisal is the economics of pre-symptomatic treatment. As this appraisal showcases, treating patients for years with a disease-modifying treatment is unlikely to be cost-effective especially with a lack of long-term data on patient outcomes including uncertainty around survival. Prevention may be better than the cure, but it will likely always come with a hefty price tag.
Although the clinical trial results were promising, these high costs and impact on treatments for other patient populations would lead to a high opportunity cost for the NHS. The expected survival due to lecanemab was modelled as being small leading to small QALY gains; combined with the high costs as described above, this led to high ICERs. This meant that lecanemab was found to be non-cost effective. This decision may, of course, change following the next committee meeting dependent on whether a commercial arrangement can be agreed upon between the NHS and the company. However, despite the proportion of the total costs attributable to the costs discussed above being unknown, a confidential discount for lecanemab agreed with the NHS may not be enough to reduce the ICER to what is considered a cost-effective use of NHS resources.
However, a key question arising from this case study is how should any service redesign costs be funded? Should companies be expected to effectively pay for the lack of routine services through lower prices for drugs in these disease areas?
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