Disease-modifying therapies for Alzheimer’s disease are advancing the science. But translating this clinical progress in to patient experience is proving a challenge.
The question
Disease-modifying treatments for Alzheimer’s disease have been developed and approved, but few payers have agreed to fund them, despite high disease burden and few alternatives. Why?
To understand what has shaped these decisions, our HEOR & Market Access team undertook an AI-supported review of publicly available HTA and reimbursement documents from agencies across Europe and North America, covering both the new anti-amyloid antibodies and established symptomatic treatments.
The findings
There was no single deciding factor.
HTA and reimbursement decisions reflected a combination of clinical meaningfulness, uncertainty in the evidence, cost-effectiveness, safety, monitoring requirements, and whether health systems were considered ready to deliver the treatment.
Caregiver utility emerged as a central point of contention: the NICE appraisal committee’s decision to estimate it using the EQ-5D, rather than the vignette-based evidence submitted, was among the points upheld at appeal for both lecanemab and donanemab
And a favorable cost-effectiveness estimate alone was not always sufficient where uncertainty in the underlying evidence or concerns about health system readiness remained.
Why it matters
Evidence is not assessed in isolation.
For developers of emerging therapies in Alzheimer’s disease, as well as other therapy areas facing similar scrutiny, anticipating access means understanding the full decision environment, from the strength of the clinical evidence to whether health systems can realistically deliver the treatment.
The takeaway
Demonstrating a treatment effect is the first step. The next is showing that health systems can translate that effect into value for patients.
HTA submission strategies need to connect clinical and economic evidence with patient and caregiver impact, infrastructure, and real-world feasibility to build a more complete case for value and access.
