Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
The evidence indicates that tenecteplase is at least as effective as alteplase for the thrombolytic treatment of acute ischaemic stroke, based on clinical trial evidence including preliminary results from a large ongoing UK trial and published results from completed trials.
Cost effectiveness
A cost comparison suggests that tenecteplase costs less than alteplase, with similar administration and adverse-event costs, indicating a strong economic value.
Quality of life
The document does not provide specific data on HRQoL improvements associated with tenecteplase compared to alteplase, indicating a lack of robust evidence in this area.
Supporting Domains
Safety and Adverse Effects
The document states that administration, adverse-event, and other resource-use costs are expected to be similar for tenecteplase and alteplase, suggesting an acceptable safety profile.
Comparator Selection
Tenecteplase is compared directly with alteplase, which is the standard of care for thrombolytic treatment of acute ischaemic stroke, providing a strong basis for comparison.
Patient Population and Subgroups
The indication for tenecteplase includes adults with acute ischaemic stroke, which is a relevant and representative patient population for the treatment being evaluated.
Care Pathway Integration
The guidance indicates that tenecteplase can be integrated into existing treatment pathways for acute ischaemic stroke without significant changes, as it is an alternative to alteplase.
Resource Use and Cost Implications
The document indicates that the costs associated with tenecteplase are expected to be lower than those for alteplase, suggesting a favorable budget impact.
Evidence Quality and Robustness
The evidence is supported by clinical trial data, including preliminary results from ongoing studies, indicating a good level of robustness.
Uncertainty, Sensitivity, and Broader Impacts
While there is some uncertainty regarding the long-term outcomes, the context of unmet need for effective stroke treatments supports the use of tenecteplase.
