Independent Market Access and Reimbursement Risk Assessment.

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Tenecteplase for treating acute ischaemic stroke

As of July 2024, MARA’s assessment finds Tenecteplase’s reimbursement risk concentrated in quality of life, with resource use and cost implications a strength; the current MARA Rating and full rationale are available in the report.

The assessment also weighs safety and adverse effects: what harms arrive alongside the benefit, which payers set against the gains before funding a treatment. The strength recorded in resource use and cost implications carries weight because that domain asks what the drug adds to, or removes from, the wider bill beyond its own price — administration, monitoring, hospital time.

Neurology

This rating sits within MARA’s Neurology coverage, alongside 61 other independently assessed treatments in the same area.

What payers will ask

Is the clinical benefit the kind payers reward? — 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.

Does the economic case hold at the expected price? — Cost effectiveness

A cost comparison suggests that tenecteplase costs less than alteplase, with similar administration and adverse-event costs, indicating a strong economic value.

Is there quality-of-life evidence payers weigh? — 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.

Does the safety profile hold up for payers? — 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.

Was the drug compared against what payers expect? — 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.

Is the population defined the way payers need it? — 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.

Does the drug fit how care is delivered and paid for? — 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.

Are the wider system costs understood? — 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.

Would the evidence survive payer scrutiny? — Evidence Quality and Robustness

The evidence is supported by clinical trial data, including preliminary results from ongoing studies, indicating a good level of robustness.

How exposed is the case to uncertainty? — 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.

Be alerted when this rating changes:

Sample two-page MARA Rating report for the fictional drug Samplinib: the rating with its decision record, and the ten graded payer questions with the reasoning behind each
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