Market Access Insights

Surveillance Update: Leqembi (lecanemab) Affirmed at B++ (Marginal) Following HTA Evidence Review (March 2026)

Link to the latest MARA Rating

Executive Summary
The MARA Rating for Leqembi (lecanemab) in early Alzheimer’s disease has been affirmed at B++ (Marginal) as of March 2026 following structured committee review. The rating band is unchanged from the prior assessment, but the underlying numerical Market Access Score is lower. This reassessment reflects newly available information from HTA agencies and its effect on reimbursement probability under the MARA framework. 

Trigger and Structural Context
The trigger for reassessment was the emergence of additional HTA-agency information relevant to reimbursement interpretation. Under HTA logic, agency conclusions do not need to change regulatory viability to alter reimbursement positioning. They can instead refine how comparative value, uncertainty, and system affordability are interpreted.

In therapies facing close scrutiny on incremental benefit, even when the broad reimbursement band is maintained, new agency analysis can narrow flexibility in pricing and positioning. That is why surveillance actions remain important even in the absence of a band shift: they preserve comparability over time and document how the structured signal evolves as evidence matures. MARA guidance is explicit that affirmations should be issued when new information is assessed but does not justify movement to a different band 

Domain-Level Drivers
This affirmation reflects reassessment across the MARA 10-domain framework.

Clinical Effectiveness
This adjustment reflects how HTA bodies interpret the magnitude and reliability of incremental benefit in practice-relevant terms. Where evidence remains open to differing judgments on patient-relevant benefit, reimbursement probability can remain only marginal even without a formal deterioration in the rating band.

Evidence Quality and Robustness / Residual Uncertainty
New HTA information can increase precision around uncertainty without necessarily producing a categorical shift in access expectations. In this case, the lower numerical score indicates weaker underlying support within the same band, consistent with a more constrained reimbursement profile.

Cost-Effectiveness and Comparator Positioning
This influences cost-utility anchoring by tightening the range within which price and positioning remain defensible. In closely watched classes, modest changes in agency interpretation can increase sensitivity in negotiation leverage and price corridor discussions.

No other domains are assumed to have shifted materially beyond what was necessary to support the affirmed band.

What the Rating Means
B++ (Marginal) indicates that reimbursement remains achievable but finely balanced, particularly in HTA systems where comparative benefit, uncertainty, and pricing pressure are closely examined. It does not signal failure of access. It signals a reimbursement case that remains viable, but with limited room for adverse interpretation.

This rating reflects reimbursement probability under HTA frameworks, not regulatory viability.

Structural Implications for Stakeholders
For market access teams, an affirmed B++ with a lower numerical score means the core access thesis remains intact, but with reduced margin for execution error.
For portfolio strategy and diligence, it reinforces a broader point: clinical success and reimbursement strength are not interchangeable.
For pricing negotiations and forecast modeling, it suggests continued sensitivity to evidence framing, comparative positioning, and payer interpretation.

A recurring governance question remains relevant: if this launch, pricing, or investment decision is later challenged, what independent benchmark was relied upon?

Methodological Integrity
This reassessment reflects application of the same structured framework used across all assets, ensuring comparability across time and portfolios. MARA rating actions are procedural updates to a standardized reimbursement risk signal designed to document governance, maintain comparability over time, and reduce interpretive variance 

MARA Ratings are determined through structured committee evaluation using publicly available evidence and are calibrated against historical HTA outcomes. The process is human-validated, evidence-linked, and subject to ongoing surveillance when material evidence events emerge. 

MARA will continue to monitor material evidence events and adjust the reimbursement risk signal accordingly.